Implantable cochlear system with integrated components and lead characterization

文档序号：310091 发布日期：2021-11-26 浏览：16次中文

阅读说明：本技术 具有集成组件和引线表征的可植入耳蜗系统 (Implantable cochlear system with integrated components and lead characterization ) 是由保罗·R·马赞内克特拉维斯·迈克尔·贝克尔蒂莫西·J·欧内斯特本杰明·R·惠廷顿约书于 2020-02-21 设计创作，主要内容包括：耳蜗植入物系统可以包含信号处理器,所述信号处理器编程有传递函数并且被配置成接收输入信号并且基于接收到的输入信号和所述传递函数输出刺激信号。系统可以包含与所述信号处理器通信的可植入电池和/或通信模块。所述可植入电池和/或通信模块可以被配置成与所述信号处理器介接并且更新所述信号处理器的所述传递函数。所述可植入电池和/或通信模块可以与一个或多个外部装置通信并且可以促进所述系统的校准和归一化。可以使用数字和/或模拟滤波来补偿系统行为跨频率范围的不均匀性。单个可植入电池和/或通信模块可以向作为单独的子系统的部件植入的多个信号处理器提供电力和数据。(A cochlear implant system may include a signal processor programmed with a transfer function and configured to receive an input signal and output a stimulation signal based on the received input signal and the transfer function. The system may include an implantable battery and/or a communication module in communication with the signal processor. The implantable battery and/or communication module may be configured to interface with the signal processor and update the transfer function of the signal processor. The implantable battery and/or communication module may communicate with one or more external devices and may facilitate calibration and normalization of the system. Digital and/or analog filtering may be used to compensate for non-uniformities in system behavior across a frequency range. A single implantable battery and/or communication module may provide power and data to multiple signal processors implanted as components of separate subsystems.)

1. A cochlear implant system, comprising:

a cochlear electrode;

a stimulator in electrical communication with the cochlear electrode;

a signal processor in communication with the stimulator;

an input source in communication with the signal processor;

an implantable battery and/or communication module configured to provide power to the signal processor; and

a plurality of conductors electrically coupling the signal processor with the implantable battery and/or communication module, wherein

The signal processor and/or the implantable battery and/or the communication module are configured to:

grounding a first conductor of the plurality of conductors;

applying a test signal to a second conductor of the plurality of conductors; and is

Measuring one or more electrical parameters of the first conductor, of the second conductor and/or between the first conductor and the second conductor.

2. The cochlear implant system of claim 1, wherein applying the test signal to the second conductor comprises continuously applying a plurality of signals, each of the plurality of signals having a different frequency.

3. The cochlear implant system of claim 2, wherein measuring the one or more electrical parameters comprises measuring impedance between the first conductor and the second conductor as a function of frequency.

4. The cochlear implant system of claim 3, further comprising comparing the measured impedance as a function of frequency to a baseline measurement of impedance as a function of frequency.

5. The cochlear implant system of claim 1, wherein the measuring the one or more electrical parameters comprises determining whether the second conductor is intact.

6. A cochlear implant system, comprising:

a signal processor;

an implantable battery and/or communication module; and

a first lead comprising a first conductor, a second conductor, a third conductor, and a fourth conductor and coupling the signal processor with the implantable battery and/or communication module, wherein

The implantable battery and/or communication module is configured to generate and transmit a power signal, an inverse power signal, a data signal, and an inverse data signal to the signal processor over the first conductor, the second conductor, the third conductor, and the fourth conductor of the first lead, respectively; and is

The implantable battery and/or communication module and/or the signal processor are configured to perform one or more characterization processes to determine one or more characteristics of the first conductor, the second conductor, the third conductor, and/or the fourth conductor.

7. The cochlear implant system of claim 6, wherein the power signal and the inverted power signal are transmitted at a first clock rate, and the data signal and the inverted data signal are transmitted at a second clock rate, the second clock rate being higher than the first clock rate.

8. The cochlear implant system of claim 7, wherein performing the one or more characterization processes comprises determining an integrity of the third conductor and/or the fourth conductor.

9. The cochlear implant system of claim 8, wherein if the third conductor and/or the fourth conductor is found to be faulty, the implantable battery and/or communication module is configured to transmit the data signal to the signal processor over one of the first conductor or the second conductor at the first clock rate and to transmit the inverse data signal to the signal processor over the other of the first conductor and the second conductor at the first clock rate.

10. The cochlear implant system of claim 6, wherein performing the one or more characterization processes comprises grounding one of the first, second, third, or fourth conductors and applying a test signal to another of the first, second, third, or fourth conductors at a plurality of frequencies.

11. The cochlear implant system of claim 10, wherein performing the one or more characterization processes comprises determining an impedance versus frequency relationship between two conductors.

12. The cochlear implant system of claim 6, wherein performing the one or more characterization processes comprises:

driving a test signal through a test conductor, the test conductor being one of the first conductor, the second conductor, the third conductor, or the fourth conductor;

measuring a current sent through the test conductor; and

measuring a voltage at which the current is sent through the test conductor.

13. The cochlear implant system of claim 12, wherein performing the one or more characterization processes further comprises determining an impedance of a test conductor.

14. The cochlear implant system of claim 6, wherein performing the one or more characterization procedures comprises measuring one or more electrical parameters of one or more of the first, second, third, and fourth conductors and comparing the one or more measured electrical parameters to corresponding one or more baseline parameters.

15. The cochlear implant system of claim 14, wherein the implantable battery and/or communication module is configured to: outputting a measurement and/or warning if one or more of the one or more measured electrical parameters deviate more than a predetermined threshold from the corresponding one or more baseline parameters.

16. A method of determining one or more characteristics of at least one conductor in a cochlear implant system, the method comprising:

grounding a first conductor connected between an implantable battery and/or communication module of the cochlear implant system and a signal processor of the cochlear implant system;

applying a test signal to a second conductor connected between the implantable battery and/or communication module and the signal processor; and

determining one or more characteristics of at least one of the first conductor and the second conductor.

17. The method of claim 16, wherein applying the test signal to the second conductor comprises applying a plurality of test signals, each of the plurality of test signals having a different frequency content.

18. The method of claim 17, wherein the determining one or more characteristics of at least one of the first conductor and the second conductor comprises determining an impedance versus frequency relationship between the first conductor and the second conductor.

19. The method of claim 18, further comprising comparing the determined impedance versus frequency relationship between the first conductor and the second conductor to a baseline impedance versus frequency relationship.

20. The method of claim 19, further comprising outputting a measurement and/or warning if the determined impedance versus frequency relationship deviates from a baseline measurement of impedance versus frequency by more than a predetermined threshold.

21. The method of claim 16, wherein the determining one or more characteristics of at least one of the first conductor and the second conductor comprises determining whether the second conductor is intact.

22. A cochlear implant system, comprising:

a cochlear electrode;

a stimulator in electrical communication with the cochlear electrode;

a sensor configured to receive a stimulation signal and to generate an input signal based on the received stimulation signal; and

a signal processor in communication with the stimulator and the sensor, the signal processor programmed with a transfer function and configured to:

receiving the input signal from the sensor; and is

Outputting a stimulation signal to the stimulator based on the received input signal and the transfer function, wherein

The stimulator and the signal processor are integrated into a single hermetically sealed housing, and wherein the cochlear electrode extends from the single hermetically sealed housing.

23. The cochlear implant system of claim 22, wherein the single hermetically sealed housing includes an outer surface having a first side, a second side generally opposite the first side, and a return electrode coupled to the outer surface on both the first side and the second side.

24. The cochlear implant system of claim 23, wherein the single hermetically sealed housing is configured to be implanted on a right side or a left side of a wearer.

25. The cochlear implant system of claim 23, further comprising a plurality of return electrodes.

26. The cochlear implant system of claim 23, wherein the signal processor is configured to output the stimulation signal to one or more contact electrodes on the cochlear electrode, wherein the one or more contact electrodes are in contact with cochlear tissue of the wearer to provide electrical stimulation to the cochlear tissue.

27. The cochlear implant system of claim 26, wherein the return electrode is electrically connected to internal circuitry of the single hermetically sealed housing.

28. The cochlear implant system of claim 27, wherein the return electrode comprises platinum or a platinum alloy.

29. The cochlear implant system of claim 27, wherein the single hermetically-sealed housing comprises an electrically conductive material.

30. The cochlear implant system of claim 29, wherein the single hermetically-sealed housing comprises titanium.

31. The cochlear implant system of claim 29, wherein the single hermetically sealed housing comprises a first hub comprising a non-conductive material, wherein the first hub provides electrical isolation between the return electrode and the single hermetically sealed housing.

32. The cochlear implant system of claim 31, wherein the first needle hub comprises a biocompatible polymer.

33. The cochlear implant system of claim 31, further comprising an implantable battery and/or communication module in communication with the signal processor through a first connector that interfaces with the single hermetically sealed housing through the first hub.

34. The cochlear implant system of claim 31, further comprising a second hub comprising a non-conductive material, and wherein:

The sensor is in communication with the signal processor through a second connector; and is

The second connector interfaces with the single hermetically sealed housing through the second hub.

35. The cochlear implant system of claim 22, wherein the sensor comprises a middle ear sensor or a microphone.

36. A signal processing unit for a cochlear implant system, the signal processing unit comprising:

a housing defining an interior and an exterior, the interior enclosed by the housing, the exterior of the housing having a first side and a second side, the second side opposite the first side;

a cochlear electrode extending from the interior of the housing, through the housing, and away from the housing;

a signal processor housed within the housing and programmed with a transfer function and configured to receive an input signal from a source representative of a received audio signal and process the received input signal in accordance with the transfer function to generate a stimulation signal;

a stimulator located within the housing and configured to receive the stimulation signal from the signal processor and output an electrical signal corresponding to the received stimulation signal to the cochlear electrode; and

A return electrode connected to the first side of the exterior of the housing.

37. The signal processing unit of claim 36, wherein the return electrode is connected to both the first side and the second side of the exterior of the housing.

38. The signal processing unit of claim 37, wherein the return electrode comprises platinum or a platinum alloy.

39. A signal processing unit according to claim 38, wherein the housing comprises titanium.

40. The signal processing unit of claim 39, wherein:

the housing includes a needle hub;

the cochlear electrode extends from the interior defined by the housing to the exterior of the signal processing unit via the hub; and is

The hub includes a non-conductive material.

41. The signal processing unit of claim 40, wherein the needle hub comprises a polymer.

42. The signal processing unit of claim 36, wherein the cochlear electrode comprises a plurality of stimulation electrodes, and wherein the electrical signal comprises a plurality of electrical signals, each of the plurality of electrical signals applied to a unique one of the plurality of stimulation electrodes.

43. A cochlear implant system, comprising:

a cochlear electrode;

a stimulator in electrical communication with the cochlear electrode;

a middle ear sensor configured to receive a stimulation signal and to generate an input signal based on the received stimulation signal; and

a signal processor in communication with the stimulator and the middle ear sensor, the signal processor having an analog processing stage and a digital processing stage and programmed with a transfer function and configured to:

receiving the input signal from the middle ear sensor;

inputting a received input signal to the analog processing stage and processing the received input signal by the analog processing stage to generate an analog processed signal;

inputting the analog processed signal to the digital processing stage and processing the received analog processed signal by the digital processing stage to generate a digitally processed signal corresponding to a normalized stimulation signal with gain variability reduced across a frequency range and compensating for variability in the frequency response of the middle ear sensor; and is

Outputting a stimulation signal to the stimulator based on the digitally processed signal and the transfer function.

44. The cochlear implant system of claim 43, wherein processing the received input signal by the analog processing stage includes flattening a frequency response curve of the received input signal.

45. The cochlear implant system of claim 44, wherein the analog processing stage includes one or more filters and/or amplifiers.

46. The cochlear implant system of claim 43, wherein the stimulator and the signal processor are integrated into a single hermetically sealed housing, and wherein the cochlear electrode extends from the single hermetically sealed housing.

47. The cochlear implant system of claim 46, wherein the single hermetically sealed housing includes an outer surface having a first side, a second side generally opposite the first side, and a return electrode coupled to the outer surface on both the first and second sides.

48. The cochlear implant system of claim 43, wherein the signal processor is configured to apply the transfer function to the generated digitally processed signal to generate the stimulation signal.

49. A cochlear implant system according to claim 43, wherein the digital processing stage is adjustable to calibrate the signal processor with respect to the middle ear sensor.

50. The cochlear implant system of claim 49, further comprising an external device in communication with the signal processor, and wherein the external device is configured to receive the digitally processed signal generated by the signal processor and adjust the digital processing stage to change a frequency response of the digital processing stage.

51. The cochlear implant system of claim 50, further comprising an implantable battery and/or communication module in communication with the signal processor and configured to wirelessly communicate with the external device to facilitate communication between the external device and the signal processor.

52. The cochlear implant system of claim 43, wherein the signal processor is configured to:

receiving a broad spectrum input signal corresponding to a broad spectrum stimulation signal comprising a plurality of frequencies received at the middle ear sensor; and is

Determining a frequency response of the analog processing stage and the digital processing stage.

53. The cochlear implant system of claim 52, wherein the signal processor is configured to adjust the digital processing stage to normalize the frequency response of the combined analog and digital processing stages based on the fast Fourier transform of the broad spectrum stimulation signal and/or broad spectrum input signal.

54. The cochlear implant system of claim 43, wherein the signal processor is configured to receive a plurality of input signals and to determine a frequency response of the analog processing stage and the digital processing stage, each input signal representing a stimulation signal having a unique frequency content.

55. The cochlear implant system of claim 54, wherein the signal processor is further configured to adjust the digital processing stage to normalize the frequency response of the combined analog and digital processing stages.

56. The cochlear implant system of claim 55, wherein normalizing the frequency responses of the combined analog and digital processing stages makes the ratio of digitally processed signal to received corresponding stimulation signal substantially constant across a plurality of frequencies or frequency ranges.

57. A method of compensating for variability of a middle ear sensor, the method comprising:

receiving a stimulation signal by a middle ear sensor;

generating, with the middle ear sensor, an input signal based on the stimulation signal;

applying an analog filter to the generated input signal to generate an analog filtered signal;

applying a digital filter to the generated analog filtered signal to generate a digitally filtered signal;

measuring a frequency response of the digitally filtered signal and/or the analog filtered signal relative to the input signal; and

adjusting the digital filter to normalize a frequency response of the digitally filtered signal relative to the stimulus signal.

58. The method of claim 57, wherein:

the stimulation signals comprise broad spectrum stimulation signals; and is

Measuring the frequency response of the digitally filtered signal and/or the analog filtered signal relative to the input signal includes performing a transform on the broad spectrum signal to determine frequency content of the broad spectrum signal and determining the frequency response based on the determined frequency content.

59. The method according to claim 57, further comprising applying a plurality of stimulation signals having known frequency content to the middle ear sensor, and wherein said measuring a frequency response of the digitally filtered signal relative to the stimulation signal is performed for each stimulation signal of the plurality of stimulation signals.

60. The method of claim 59, wherein said applying the plurality of stimulation signals comprises applying stimulation signals having a frequency range between 100Hz and 10 kHz.

61. The method of claim 59, wherein measuring a frequency response of the digitally filtered signal relative to a received stimulation signal comprises determining a ratio of a magnitude of the digitally filtered signal to a magnitude of the stimulation signal for a plurality of frequencies or frequency ranges.

62. The method of claim 61, wherein adjusting the digital filter to normalize the frequency response relative to the received stimulation signal comprises adjusting the digital filter such that the determined ratio is approximately equal for each of the plurality of frequencies or frequency ranges.

63. The method of claim 57, wherein applying an analog filter to the generated input signal comprises applying a plurality of analog filters and/or analog amplifiers.

64. The method of claim 63, further comprising adjusting the analog filter to normalize the frequency response of the digitally filtered signal relative to the stimulation signal.

65. A system, comprising:

a cochlear electrode;

a stimulator in electrical communication with the cochlear electrode;

a middle ear sensor configured to receive a stimulation signal and to generate an input signal based on the received stimulation signal; and

receiving the input signal from the middle ear sensor;

inputting a received input signal to the analog processing stage to generate an analog processed signal;

inputting the analog processed signal to the digital processing stage to generate a digitally processed signal corresponding to a normalized stimulation signal for reducing variability of a frequency response of the middle ear sensor; and is

Outputting a stimulation signal to the stimulator based on the digitally processed signal and the transfer function.

66. A cochlear implant system, comprising:

a cochlear electrode;

a stimulator in electrical communication with the cochlear electrode;

A signal processor in communication with the stimulator, the signal processor programmed with a transfer function and configured to receive one or more input signals and to output a stimulation signal to the stimulator based on the received one or more input signals and the transfer function;

an implantable battery and/or communication module in communication with the signal processor, the implantable battery and/or communication module including an implantable near-field communication device for communicating via a first wireless communication protocol and an implantable wireless communication device for communicating via a second wireless communication protocol, the second wireless communication protocol having a longer wireless communication distance than the first wireless communication protocol; and

an external device having an external near field communication device configured to wirelessly communicate with the implanted near field communication device via the first wireless communication protocol and an external wireless communication device configured to wirelessly communicate with the implanted wireless communication device via the second wireless communication protocol; and wherein

Communication between the external wireless communication device and the implanted wireless communication device via the second wireless communication protocol is achieved by: communication is first established between the implanted near-field communication device and the external near-field communication device via the first wireless communication protocol.

67. The cochlear implant system of claim 66, wherein the external device comprises a charger.

68. The cochlear implant system of claim 67, wherein the implanted near field communication device comprises an implanted coil and the external near field communication device comprises an external coil.

69. The cochlear implant system of claim 68, wherein the external device is configured to charge a power source within the implantable battery and/or communication module through the implanted coil and the external coil.

70. The cochlear implant system of claim 66, wherein the second wireless communication protocol comprises Bluetooth communication.

71. The cochlear implant system of claim 66, further comprising a second external wireless communication device configured to wirelessly communicate with the implantable wireless communication device.

72. The cochlear implant system of claim 71, wherein the external wireless communication device is configured to enable wireless communication between the second external wireless communication device and the implantable battery and/or communication module.

73. The cochlear implant system of claim 66, wherein the external wireless communication device is configured to transmit control signals and/or streaming audio to the implantable battery and/or communication module.

74. The cochlear implant system of claim 66, wherein once communication between the external wireless communication device and the implanted wireless communication device via the second wireless communication protocol is first achieved, each subsequent connection between the external wireless communication device and the implanted wireless communication device can be achieved without establishing communication between the implanted near-field communication device and the external near-field communication device via the first wireless communication protocol.

75. The cochlear implant system of claim 66, wherein the external wireless communication device is a laptop, a PC, a smartphone, a tablet, or a watch.

76. The cochlear implant system of claim 75, wherein the external wireless communication device is configured to control one or more attributes of the cochlear implant system via the second wireless communication protocol after communication between the external wireless communication device and the implanted wireless communication device has been achieved.

77. The cochlear implant system of claim 76, wherein the external wireless communication device is configured to adjust the transfer function of the signal processor via the second wireless communication protocol.

78. The cochlear implant system of claim 77, wherein the external wireless communication device comprises a microphone configured to collect environmental auditory data representative of the surrounding environment, and wherein the external wireless communication device is configured to adjust the transfer function of the signal processor based on the collected environmental auditory data.

79. The cochlear implant system of claim 78, wherein the external wireless communication device is configured to identify background noise in the collected ambient auditory data and update the transfer function to reduce a contribution of the identified background noise in the stimulation signal.

80. The cochlear implant system of claim 79, wherein updating the transfer function to reduce the contribution of the identified background noise comprises attenuating frequencies outside of a typical human speech range.

81. The cochlear implant system of claim 80, wherein attenuating frequencies outside of the range of typical human speech comprises attenuating signals having frequencies below about 200 Hz.

82. The cochlear implant system of claim 79, wherein updating the transfer function to reduce the contribution of the identified background noise comprises emphasizing signals having a frequency content between about 200Hz and 20 kHz.

83. The cochlear implant system of claim 82, wherein updating the transfer function to reduce the contribution of the identified background noise comprises emphasizing signals having a frequency content between approximately 300Hz and 8 kHz.

84. The cochlear implant system of claim 76, wherein the external wireless communication device is configured to receive location data and implement one or more predetermined settings based on the received location data.

85. The cochlear implant system of claim 84, wherein the external wireless communication device comprises a smartphone, and wherein the location data comprises GPS data.

86. The cochlear implant system of claim 84, wherein the external wireless communication device comprises an internet-ready device (internet-ready device), and wherein receiving location data comprises identifying one or more available wireless internet networks.

87. The cochlear implant system of claim 76, wherein

The external wireless communication device is configured to provide an input signal to the implanted wireless communication device via the second wireless communication protocol; and is

The signal processor is configured to output a stimulation signal to the stimulator based on the input signal provided from the external wireless communication device.

88. The cochlear implant system of claim 87, wherein the input signal provided by the external wireless communication device is based on audio generated by the external wireless communication device.

89. The cochlear implant system of claim 88, wherein the audio generated by the external wireless communication device comprises at least one of: audio from telephone calls, automatically read text messages, alerts, and media audio.

90. A method of pairing an external device with an implanted cochlear implant system, the method comprising:

Establishing communication between the implanted cochlear implant system and the external device via a near field communication protocol;

pairing the external device with the implanted cochlear implant system;

establishing wireless communication between the implanted cochlear implant system and the external device through a wireless communication protocol having a longer communication distance than the near field communication protocol.

91. The method of claim 90, wherein the wireless communication protocol comprises bluetooth.

92. The method of claim 90, further comprising receiving, at the external device, instructions for pairing the external device with the implanted cochlear implant system.

93. The method of claim 92, further comprising: after receiving the instructions to pair the external device with the implanted cochlear implant system, outputting, by the external device, instructions to position the external device to enable near field communication between the implanted cochlear implant system and the external device over the near field communication protocol.

94. The method of claim 90, wherein the external device comprises a charger.

95. The method of claim 94, wherein the charger comprises an external coil and the implanted cochlear implant system comprises an implanted coil, and wherein the near field communication protocol comprises communication between the external coil and the implanted coil.

96. The method of claim 95, wherein the charger is configured to provide power to the implanted cochlear implant system by transferring electrical energy from the external coil to an internal coil.

97. The method of claim 90, further comprising:

detecting, by the external device, a presence of a second external device capable of communicating with the implanted cochlear implant system via the wireless communication protocol;

receiving, by the external device, a selection of the second external device; and

pairing the second external device with the implanted cochlear implant system in response to the received selection such that the second external device communicates with the implanted cochlear implant system over the wireless communication protocol.

98. The method of claim 97, further comprising receiving control signals and/or streaming audio from the external device and/or the second external device over the wireless communication protocol at the implanted cochlear implant system.

99. The method of claim 98, further comprising determining, by the second external device, ambient auditory data representative of an ambient environment and receiving, at the implanted cochlear implant system, a control signal from the second external device based on the determined ambient auditory data.

100. The method of claim 98, wherein the method comprises receiving streaming audio, and wherein the streaming audio comprises at least one of: audio from telephone calls, automatically read text messages, alerts, and media audio.

101. A method of pairing an external device with an implanted cochlear implant system, the method comprising:

pairing the implanted cochlear implant system with a first external device by: establishing communication between the implanted cochlear implant system and the first external device through a near field communication protocol; and

after the first external device is paired with the implanted cochlear implant system, pairing a second external device with the implanted cochlear implant system using the established communication between the implanted cochlear implant system and the first external device by: establishing wireless communication between the implanted cochlear implant system and the second external device through a wireless communication protocol having a longer communication distance than the near field communication protocol.

102. A system, comprising:

a fully implantable cochlear implant, the fully implantable cochlear implant comprising:

a cochlear electrode;

a stimulator in electrical communication with the cochlear electrode;

an input source configured to receive a stimulus and to generate an input signal representative of the received stimulus;

a signal processor in communication with the stimulator and the input source, the signal processor programmed with a transfer function and configured to receive one or more input signals from the input source and output a stimulation signal to the stimulator based on the received one or more input signals and the transfer function; and

an implantable battery and/or communication module in communication with the signal processor and configured to provide power to the signal processor; and

an external hub including a speaker and a wireless communication interface, the external hub configured to wirelessly communicate with the implantable battery and/or communication module, the external hub configured to output a predetermined acoustic signal through the speaker and to communicate information about the predetermined acoustic signal to the implantable battery and/or communication module through the wireless communication interface.

103. The system of claim 102, wherein in response to the external hub outputting a predetermined acoustic signal through the speaker:

the input source receiving a stimulus produced by the predetermined acoustic signal and generating the input signal in response thereto;

the signal processor receiving the input signal from the input source and transmitting information representative of the received input signal to the implantable battery and/or communication module; and wherein

The implantable battery and/or communication module is configured to:

receiving, from the external hub, information about an acoustic signal output from the speaker of the external hub;

analyzing the information received from the external hub regarding the outputted predetermined acoustic signal and the information received from the signal processor representing the received input signal to determine a relationship between the predetermined acoustic signal outputted from the speaker of the external hub and a resulting input signal generated by the input source.

104. The system of claim 103, wherein the implantable battery and/or communication module is configured to update the transfer function of the signal processor in response to the determined relationship.

105. The system of claim 103, wherein

The external hub is configured to output a plurality of predetermined acoustic signals; and is

For each predetermined acoustic quote in the output predetermined acoustic signal, the implantable battery and/or communication module is configured to:

receiving, from the external hub, information about the acoustic signal output from the speaker of the external hub;

analyzing information received from the external hub regarding the outputted predetermined acoustic signal and information received from the signal processor representing the received input signal to determine a relationship between the predetermined acoustic signal outputted from the speaker of the external hub and the resulting input signal generated by the input source.

106. The system of claim 105, wherein said each acoustic signal of said plurality of predetermined acoustic signals comprises a plurality of frequencies and/or intensities.

107. The system of claim 106, wherein each acoustic signal of the plurality of predetermined acoustic signals comprises substantially the same intensity.

108. The system of claim 102, wherein the speaker of the external hub comprises an in-ear speaker.

109. The system of claim 108, wherein the input source comprises a middle ear sensor, and wherein the implantable battery and/or communication module is configured to:

receiving, from the signal processor, information representative of an input signal output from the middle ear sensor in response to the received stimulus; and is

Detecting a stapedial reflex of the wearer based on the information received from the signal processor.

110. The system of claim 109, wherein the external hub is configured to provide an acoustic signal at a first intensity through the in-ear speaker and increase in intensity over time.

111. The system of claim 110, wherein the implantable battery and/or communication module is configured to:

detecting the stapedial reflex of the wearer in response to an increase in the strength of the acoustic signal;

determining an intensity of the acoustic signal from the external hub that causes the stapedial reflex; and is

Updating the signal processor transfer function based on the determined intensity.

112. The system of claim 111, wherein

The external hub is configured to output a predetermined acoustic signal of the first intensity for each of a plurality of frequencies and increase in intensity over time; and is

For each predetermined acoustic quote in the output predetermined acoustic signal, the implantable battery and/or communication module is configured to:

detecting the stapedial reflex of the wearer in response to an increase in the strength of the acoustic signal;

determining an intensity of the acoustic signal from the external hub that causes the stapedial reflex; and is

Updating the signal processor transfer function based on the determined intensity.

113. The system of claim 112, further comprising an external device in communication with the external hub; and is

Wherein the external device comprises a user interface and provides the user interface for communicating with the external hub.

114. A method of calibrating an implanted cochlear implant system, the method comprising:

receiving, by a first implanted signal processor, a first input signal, the first input signal representing a predetermined acoustic signal;

providing a stimulus signal from a signal processor to a stimulator based on the first input signal and a transfer function;

outputting, by the stimulator, an electrical signal to cochlear tissue of a wearer, the electrical signal based on the stimulation signal;

Receiving a measurement signal by an implanted middle ear sensor;

detecting a stapedial reflex of the wearer based on the received measurement signal.

115. The method of claim 114, further comprising:

outputting a predetermined acoustic signal of a first intensity, wherein the first input signal represents the predetermined acoustic signal of the first intensity; and

increasing the intensity of the predetermined acoustic signal over time.

116. The method of claim 115, wherein the method further comprises the steps of:

detecting the stapedial reflex of the wearer in response to an increase in intensity of the predetermined acoustic signal; and

determining an intensity of the predetermined acoustic signal that causes the stapedial reflex.

117. The method according to claim 116, further comprising updating the transfer function based on the intensity of the predetermined acoustic signal that causes the stapedial reflex.

118. The method of claim 115, further comprising:

receiving, by the first implantable signal processor, a plurality of first input signals, each first input signal of the plurality of first input signals representing a corresponding plurality of predetermined acoustic signals, and wherein each predetermined acoustic signal of the plurality of predetermined acoustic signals comprises a corresponding frequency of a plurality of frequencies;

Increasing the intensity of each of the plurality of predetermined acoustic signals over time;

detecting the stapedial reflex of the wearer in response to an increase in intensity of each predetermined acoustic signal of the plurality of predetermined acoustic signals; and

determining an intensity of each predetermined acoustic signal of the plurality of predetermined acoustic signals that causes the stapedial reflex.

119. The method according to claim 118, further comprising updating the transfer function based on the intensity of each of the predetermined acoustic signals that causes the stapedial reflex.

120. The method of claim 118, wherein each input signal of the plurality of input signals representative of the plurality of predetermined acoustic signals is provided at a different time.

121. The method of claim 114, wherein the first input signal is received by the first implantable signal processor positioned on a first side of the wearer and the measurement signal is received by a second implantable signal processor positioned on a second side of the wearer.

122. The method of claim 114, wherein the first input signal and the measurement signal are received by the first implantable signal processor.

123. The method of claim 114, wherein the first input signal is provided through an external speaker.

124. The method of claim 123, wherein the external speaker comprises an in-ear speaker.

125. The method of claim 114, wherein the first input signal is provided from an external device over a wireless communication link.

126. The method of claim 125, wherein the external device comprises at least one of: laptop computers, PCs, smart phones, tablet computers, and smart watches.

127. A calibration system for a cochlear implant, the calibration system comprising:

a fully implantable cochlear implant, the fully implantable cochlear implant comprising:

a cochlear electrode;

a stimulator in electrical communication with the cochlear electrode;

an input source comprising a middle ear sensor, the input source configured to receive a stimulus and generate an input signal representative of the received stimulus;

An implantable battery and/or communication module in communication with the signal processor and configured to provide power to the signal processor;

an external device including a wireless communication interface, the external device configured to:

wirelessly communicating with the implantable battery and/or communication module;

outputting a predetermined acoustic signal, the predetermined acoustic signal having a first intensity;

increasing the intensity of the predetermined acoustic signal over time; and is

Communicating information about the predetermined acoustic signal to the implantable battery and/or communication module through the wireless communication interface; and wherein

The implantable battery and/or communication module is configured to:

receiving, from the signal processor, information representing an input signal output from the middle ear sensor;

detecting a stapedial reflex of the wearer based on the received information from the signal processor; and is

Determining an intensity of the predetermined acoustic signal from the external device corresponding to the detected stapedial reflex.

128. The calibration system according to claim 127, wherein the implantable battery and/or communication module is further configured to update the signal processor transfer function based on the determined intensity of the predetermined acoustic signal corresponding to the detected stapedial reflex.

129. The calibration system of claim 128, wherein:

the external device is configured to:

outputting a plurality of predetermined acoustic signals, each of the plurality of predetermined acoustic signals comprising a corresponding frequency of a plurality of frequencies; and is

Increasing the intensity of each of the plurality of predetermined acoustic signals; and is

The implantable battery and/or communication module is configured to:

receiving, from the signal processor, information representative of a plurality of input signals output from the middle ear sensor in response to a plurality of received stimuli, the plurality of received stimuli corresponding to the plurality of predetermined acoustic signals;

detecting the stapedial reflex of the wearer in response to an increase in intensity of the plurality of predetermined acoustic signals;

determining, for each frequency of the plurality of frequencies, an intensity of the predetermined acoustic signal that triggers the stapedial reflex; and is

Updating the signal processor transfer function based on the determined intensities of the plurality of predetermined acoustic signals that trigger the stapedial reflex.

130. The calibration system of claim 129, wherein each predetermined acoustic signal of the plurality of predetermined acoustic signals is provided at a different time.

131. The calibration system of claim 127, further comprising a speaker, the speaker in communication with the external device; and wherein the predetermined acoustic signal is provided by the speaker in communication with the external device.

132. The calibration system of claim 127, wherein:

the predetermined acoustic signal is provided to the implantable battery and/or communication module through the wireless communication interface; and is

The signal processor receives the input signal from the implantable battery and/or communication module, the input signal being based on the predetermined acoustic signal provided to the implantable battery and/or communication module from the external device.

133. The calibration system of claim 127, wherein the external device is configured to connect to the internet and provide communication between a clinician and the implantable battery and/or communication module through the internet and the external device.

134. The calibration system of claim 127, wherein the external device comprises a user interface.

135. The calibration system of claim 134, wherein the implantable battery and/or communication module is configured to receive an input through the user interface of the external device indicating whether the wearer can detect the predetermined acoustic signal.

136. The calibration system of claim 127, wherein:

the external device is configured to output a predetermined acoustic signal to a middle ear sensor of a first side of the wearer; and is

The implantable battery and/or communication module is configured to detect the stapedial reflex of the wearer at a second side of the wearer, wherein

The first side is the left or right side of the wearer and the second side is the other of the left or right side of the wearer.

137. A cochlear implant system, comprising:

a first subsystem, the first subsystem comprising:

a first cochlear electrode;

a first stimulator in communication with the first cochlear electrode;

a first input source configured to receive a first stimulation signal and to generate a first input signal based on the received first stimulation signal; and

a first signal processor in communication with the first stimulator and the first input source, the first signal processor programmed with a first transfer function and configured to:

receiving the first input signal from the first input source; and is

Outputting a first stimulation signal to the first stimulator based on the first input signal and the first transfer function;

a second subsystem, the second subsystem comprising:

a second cochlear electrode;

a second stimulator in communication with the second cochlear electrode;

a second input source configured to receive a second stimulation signal and to generate a second input signal based on the received second stimulation signal; and

a second signal processor in communication with the second stimulator and the second input source, the second signal processor programmed with a second transfer function and configured to:

receiving the second input signal from the second input source; and is

Outputting a second stimulation signal to the second stimulator based on the second input signal and the second transfer function; and

an implantable battery and/or communication module in communication with and configured to provide power to the first and second signal processors.

138. The cochlear implant system of claim 137, wherein the first subsystem is implanted near a left ear of a patient and the second subsystem is implanted near a right ear of the patient.

139. The cochlear implant system of claim 138, wherein

The first stimulator and the first signal processor are housed in a first housing;

the first cochlear electrode extends from the first housing;

the second stimulator and the second signal processor are housed in a second housing; and is

The second cochlear electrode extends from the second housing.

140. The cochlear implant system of claim 139, wherein the first and second housings each have an outer surface with:

a first side;

a second side opposite the first side; and

a return electrode extending from the first side to the second side.

141. The cochlear implant system of claim 137, wherein the implantable battery and/or communication module is configured to adjust the first transfer function associated with the first signal processor and to adjust the second transfer function associated with the second signal processor.

142. The cochlear implant system of claim 141, wherein

The implantable battery and/or communication module communicates with the first signal processor through a first lead;

The implantable battery and/or communication module communicates with the second signal processor through a second lead, the second lead being different from the first lead;

the implantable battery and/or communication module is configured to adjust the first transfer function by communicating with the first signal processor through the first lead; and is

The implantable battery and/or communication module is configured to adjust the second transfer function by communicating with the second signal processor through the second lead.

143. The cochlear implant system of claim 141, wherein the implantable battery and/or communication module communicates with both the first signal processor and the second signal processor through a bifurcated lead.

144. The cochlear implant system of claim 143, wherein the implantable battery and/or communication module sends the same signal to each of the first and second signal processors through the bifurcated lead.

145. The cochlear implant system of claim 144, wherein

The implantable battery and/or communication module is configured to transmit an addressed output signal to the first signal processor and the second signal processor through the bifurcated lead, the addressed output signal including address information specifying at least one of the first signal processor and the second signal processor.

146. The cochlear implant system of claim 145, wherein the first signal processor is unaffected by the output signal including addressing that specifies address information for the second signal processor instead of the first signal processor.

147. The cochlear implant system of claim 141, wherein the implantable battery and/or communication module is configured to receive commands for adjusting the first and second transfer functions from an external device over a wireless communication interface.

148. The cochlear implant system of claim 147, wherein the external device comprises a smartphone, tablet, charger, or programmer.

149. The cochlear implant system of claim 147, wherein the wireless communication interface comprises a bluetooth communication or near field communication network.

150. The cochlear implant system of claim 147, wherein the implantable battery and/or communication module is configured to:

adjusting the first transfer function based on the received command and the first transfer function, and

adjusting the second transfer function based on the received command and the second transfer function such that

Adjusting the first transfer function is independent of adjusting the second transfer function.

151. The cochlear implant system of claim 150, wherein

The received command comprises a command to change a volume associated with the cochlear implant system; and is

In response to the received command, the implantable battery and/or communication module is configured to:

determining an existing first transfer function associated with the first signal processor;

determining an updated first transfer function based on the determined existing first transfer function and the received command, the updated first transfer function reflecting a change in perceived volume relative to the existing first transfer function as specified in the received command;

determining an existing second transfer function associated with the second signal processor;

determining an updated second transfer function based on the determined existing second transfer function and the received command, the updated second transfer function reflecting a change in perceived volume relative to the existing second transfer function as specified in the received command.

152. The cochlear implant system of claim 137, wherein

The first input source comprises a microphone or a middle ear sensor; and is

The second input source includes a microphone or a middle ear sensor.

153. A method for adjusting operation of a cochlear implant system, the method comprising:

receiving a command to adjust operation of the cochlear implant system;

determining a first existing transfer function associated with a first cochlear subsystem, the existing first transfer function defining a relationship between a received stimulation signal and a first output stimulation signal;

determining a first updated transfer function that reflects an adjusted operation associated with a received command, the first updated transfer function based on the first existing transfer function and the received command;

updating operation of a first cochlear implant subsystem to replace the first existing transfer function with the first updated transfer function;

determining a second existing transfer function associated with a second cochlear subsystem, the existing second transfer function defining a relationship between the received stimulation signal and the second output stimulation signal;

determining a second updated transfer function that reflects an adjusted operation associated with the received command, the second updated transfer function based on the second existing transfer function and the received command; and

Updating operation of a second cochlear implant subsystem to replace the second existing transfer function with the second updated transfer function.

154. The method of claim 153, wherein the updating operation of the first cochlear implant subsystem to replace the first existing transfer function with the first updated transfer function includes:

outputting a signal specifying the first cochlear implant subsystem and the first updated transfer function to both the first cochlear implant subsystem and the second cochlear implant subsystem; and

updating a transfer function associated with only the first cochlear implant subsystem and not the second cochlear implant subsystem.

155. The method of claim 154, wherein outputting the signal to both the first cochlear implant subsystem and the second cochlear implant subsystem includes outputting the signal through a bifurcated lead in communication with both the first cochlear implant subsystem and the second cochlear implant subsystem.

156. The method of claim 153, wherein the received commands for adjusting operation of the cochlear implant system include commands for adjusting volume of the cochlear implant system.

Background

Cochlear implants are electronic devices that may be surgically implanted at least partially into the cochlea, the hearing organ of the inner ear, to improve the hearing of a patient. Cochlear implants may contain components that are worn externally by the patient and components that are implanted internally within the patient.

The external components may include a microphone, a processor, and a transmitter. The cochlear implant may detect sounds through an ear level microphone that transmits these sounds to the wearable processor. Some processors may be worn behind the patient's ear. Electronic signals from the processor may be sent to a transmission coil located on the implant, worn externally behind the ear. The transmission coil may send a signal to an implant receiver located below the patient's scalp.

The internal components may contain a receptor and one or more electrodes. Some cochlear implants may contain additional processing circuitry between the internal components. The receiver may direct signals to one or more electrodes that have been implanted within the cochlea. The response to these signals can then be transmitted along the auditory nerve to the cortex where the response is interpreted as sound.

Some cochlear implants may be fully implanted and may contain a microphone-like mechanism for measuring sound, signal processing electronics, and means for directing signals to one or more electrodes implanted within the cochlea. A fully implanted cochlear implant typically does not contain a transmission coil or a receiver coil.

The internal components of such cochlear implant systems typically require power to operate. Thus, the power supply is typically included with other internal components. However, the performance of such power supplies typically degrades over time, and the power supplies may need to be replaced. In addition, processing circuitry technology continues to advance rapidly. Improvements in processing techniques over time may render the processing techniques in the implanted processing circuitry obsolete. Therefore, it is sometimes advantageous to replace/upgrade processing circuitry.

However, this replacement procedure can be difficult. The location of the implantable internal components is not optimal for surgical procedures and often does not heal completely after multiple incisions. Additionally, replacing some components, such as the signal processor, may require removing components, such as electrical leads, and reintroducing the components into the patient's cochlear tissue, which may damage the tissue and may negatively impact the efficacy of cochlear stimulation.

In addition, transmitting electrical signals through the body of a patient presents different challenges. For example, safety standards may limit the amount of current (particularly DC current) that can safely flow through a patient's body. In addition, the patient's body may act as an undesirable signal path between different components within the body (e.g., through contact with the housing or "can" of each component). This may result in reduced signal strength and/or undesirable communication or interference between components. In some cases, the electrical signals may even stimulate undesired regions of the patient's cochlear tissue, thereby interfering with the efficacy of the cochlear implant.

Disclosure of Invention

Some aspects of the present disclosure generally relate to cochlear implant systems. Such a system may include a cochlear electrode, a stimulator in electrical communication with the cochlear electrode, an input source, and a signal processor. The signal processor may be configured to receive an input signal from the input source and output a stimulation signal to the stimulator based on the received input signal and a transfer function of the signal processor.

In some instances, the signal processor and implantable battery and/or communication module may be electrically coupled by a plurality of conductors, for example, to communicate data and/or deliver power between components. In some such embodiments, the signal processor and/or the implantable battery and/or communication module may be configured to ground a first conductor of the plurality of conductors and apply a test signal to a second conductor of the plurality of conductors. The signal processor and/or the implantable battery and/or the communication module may be configured to measure one or more electrical parameters of the first conductor, of the second conductor, and/or of the first conductor and the second conductor. In some embodiments, this applying the test signal may comprise: continuously applying a plurality of signals, wherein each of the signals has a different frequency; and determining an impedance between the first conductor and the second conductor as a function of frequency. Additionally or alternatively, in some examples, measuring the one or more electrical parameters includes determining whether the second conductor is intact.

In some embodiments, the signal processor and the implantable battery and/or communication module may be coupled by a first lead having a first conductor, a second conductor, a third conductor, and a fourth conductor. In some such examples, the implantable battery and/or communication module may be configured to generate a power signal, an inverted power signal, a data signal, and an inverted data signal. The implantable battery and/or communication module may communicate the power signal, the inverse power signal, the data signal, and the inverse data signal to the signal processor through the first conductor, the second conductor, the third conductor, and the fourth conductor of the first lead, respectively. The power signal and the data signal may be provided at similar or different clock rates.

The implantable battery and/or communication module may be configured to perform one or more characterization processes to determine one or more characteristics of the first conductor, the second conductor, the third conductor, and/or the fourth conductor. In some examples, performing one or more characterization processes includes determining an impedance versus frequency relationship between two conductors. Additionally or alternatively, in some examples, performing one or more characterization processes includes measuring a current sent through a test conductor, measuring a voltage at which the current is sent through the test conductor, and determining an impedance of the test conductor.

In some examples, the signal processor and the stimulator may be integrated into a single hermetically sealed housing, with the cochlear electrode extending from the single hermetically sealed housing. In some examples, the single hermetically sealed hose includes a return electrode coupled to an outer surface thereof. In some such examples, the return electrode extends between a first side of the housing and a second side of the housing opposite the first side.

In some embodiments, the housing comprises an electrically conductive material and contains a hub comprising an electrically non-conductive material, such as a biocompatible polymer. In some such embodiments, the non-conductive material of the hub provides electrical isolation between the return electrode and the conductive housing.

In some examples, the signal processor includes an analog processing stage and a digital processing stage. In some such examples, the signal processor is configured to receive an input signal from an input source and input the received input signal to the analog processing stage to generate an analog processed signal. The signal processor may input the analog processed signal to the digital processing stage to generate a digitally processed signal. In some examples, the signal processor is configured such that the digitally processed signal corresponds to a normalized stimulation signal with gain variability reduced across a frequency range and compensation for variability in the frequency response of the middle ear sensor.

In some embodiments, the analog processing stage and/or the digital processing stage are adjustable to normalize the frequency response of the combined analog and digital processing stages. In some examples, the frequency response is normalized such that the ratio of the digitally processed signal to the received corresponding stimulation signal is approximately constant across a plurality of frequencies or frequency ranges.

Some aspects of the present disclosure relate to a method for compensating for variability in a middle ear sensor. In some examples, a method includes receiving, by a middle ear sensor, a stimulation signal and generating, by the middle ear sensor, an input signal based on the stimulation signal. The method may include applying an analog filter to the generated input signal to generate an analog filtered signal, and applying a digital filter to the generated analog filtered signal to generate a digital filtered signal.

In some examples, methods include measuring a frequency response of the digitally filtered signal and/or the analog filtered signal relative to the input signal and adjusting the digital filter to normalize the frequency response of the digitally filtered signal relative to the stimulus signal. In some examples, such methods further include applying a plurality of stimulation signals to the middle ear sensor having a known frequency content. In some such examples, measuring the frequency response of the digitally filtered signal relative to the stimulation signal is performed for each stimulation signal of the plurality of stimulation signals.

In some embodiments, the implant system includes a near field communication device for communicating over a first wireless communication protocol and a wireless communication device for communicating over a second wireless communication protocol. In some such examples, the near field communication device and the wireless communication device are included in the implantable battery and/or communication module.

In some embodiments, the system includes an external device having an external near field communication device configured to wirelessly communicate with the implanted near field communication device via the first wireless communication protocol. The external device may include an external wireless communication device configured to wirelessly communicate with an implanted wireless communication device via the second wireless communication protocol.

Communication between the external wireless communication device and the implanted wireless communication device via the second wireless communication protocol may be achieved by: communication between the implanted near field communication device and the external near field communication device via the first wireless communication protocol is first established. In one example embodiment, bluetooth wireless communication between the implanted system and the external device may be established by enabling bluetooth communication via near field communication.

In some embodiments, an external device in wireless communication with the implantable system via the second wireless communication protocol may enable wireless communication between the implantable system and a second external device via the second wireless communication protocol. For example, in one example, bluetooth communication with another external device may be achieved using a bluetooth paired external device.

In some examples, an external device may provide audio and/or data to the implanted system via the second wireless communication protocol. In some embodiments, one or more external devices may interface with the implantable system by providing input signals such as streaming audio data, wake-up alarms, etc. for causing stimulation of the cochlear tissue of the wearer. Additionally or alternatively, in some examples, the external device may be used to interface with the implantable system, such as by adjusting one or more settings of the system.

In some embodiments, the external device includes one or more sensors, such as a position sensor, an ambient sound sensor, and the like. In some such instances, the external device may be in communication with the implantable battery and/or communication module, and may be configured to cause the implantable battery and/or communication module to update the signal processor transfer function in response to information determined from the one or more sensors. Causing the implantable battery and/or communication module to update the transfer function may include providing sensor data to the implantable battery and/or communication module, wherein the implantable battery and/or communication module updates the transfer function based on the received data, or the external device determines that the transfer function should be updated based on the data received from the sensor. Updating the transfer function may include adjusting one or more settings (e.g., gain settings, filter settings, etc.) or may include implementing a predetermined transfer function. In one example, the external device comprises a GPS sensor, and the external device and/or the implantable battery and/or communication module is configured to update the transfer function to a predetermined transfer function associated with a particular location based on detecting a predetermined location.

Additionally or alternatively, in some instances, the external device includes an ambient sound sensor, and updating the transfer function may include attenuating frequencies outside of a typical human voice range to reduce background noise and emphasize voice. In some examples, updating the transfer function includes attenuating frequencies based on a frequency content of the detected ambient sound.

In some examples, a system may include an external hub having a speaker and a wireless communication interface. The external hub may be configured to wirelessly communicate with an implantable battery and/or a communication module. The external hub may be further configured to output a predetermined acoustic signal and communicate information regarding the predetermined acoustic signal to the implantable battery and/or communication module via wireless communication.

In some embodiments, the implantable battery and/or communication module is configured to receive information from the external hub regarding acoustic signals output from the speaker of the external hub. The implantable battery and/or communication module may analyze information about the acoustic signal and information received from the signal processor representing a received input signal generated by sound output from the external hub. The implantable battery and/or communication module may determine a relationship between the acoustic signal output from the speaker of the external hub and a resulting input signal generated by an input source. In some such instances, the implantable battery and/or communication module may be configured to update a transfer function of the signal processor in response to the determined relationship.

In some examples, the input source includes a middle ear sensor and the speaker of the external hub includes an in-ear speaker. In some such instances, the implantable battery and/or communication module may be configured to receive information from the signal processor representative of input signals output from the middle ear sensor in response to received stimuli and detect a stapedial reflex of the wearer based on the information received from the signal processor. The external hub may be configured to provide an acoustic signal of a first intensity through an in-ear speaker and increase in intensity over time, and the implantable battery and/or communication module may be configured to determine the intensity causing a stapedial reflex. The implantable battery and/or communication module may update the signal processor transfer function based on the determined intensity.

Some aspects of the present disclosure generally relate to cochlear implant systems. In some examples, a cochlear implant system may include a first subsystem having a first cochlear electrode, a first stimulator, a first input source, and a first signal processor. The first input source may be configured to receive a first stimulation signal to generate a first input signal. The first signal processor may be configured to receive a first signal from the first input source and output a first stimulation signal to the first stimulator based on the first input signal and a first transfer function associated with the first signal processor.

Some such systems include a second subsystem, similar to the first subsystem, including a second cochlear electrode, a second stimulator, a second input source, and a second signal processor. The second input source may be configured to receive a second stimulation signal to generate a second input signal. The second signal processor may be configured to receive a second signal from the second input source and output a second stimulation signal to the second stimulator based on the second input signal and a second delivery function associated with the second signal processor. In some embodiments, the wearer may have a second subsystem implanted near a first subsystem implanted in the first ear and near the second ear.

The system may include an implantable battery and/or a communication module in communication with both the first signal processor and the second signal processor. The implantable battery and/or communication module may be configured to provide power to both the first signal processor and the second signal processor. Additionally or alternatively, the implantable battery and/or communication module may be configured to transmit data to and/or receive data from each of the first and second signal processors. In various embodiments, the implantable battery and/or communication module may communicate with each of the first and second signal processors through a separate lead or through a bifurcated lead.

In some examples, the implantable battery and/or communication module may be configured to update a transfer function associated with each of the first and second signal processors. In instances where there is a separate lead connecting the implantable battery and/or communication module with the respective signal processor, the implantable battery and/or communication module may transmit a signal to each respective signal processor, updating the transfer function associated with each respective signal processor. In some examples, as in the example where both the first signal processor and the second signal processor communicate with the implantable battery and/or communication module through a bifurcated lead, the implantable battery and/or communication module may transmit an addressing signal to both signal processors. The addressed signal may contain addressing information designating one of the signal processors as the intended recipient of the signal. Each signal processor may be configured to respond to signals addressed only thereto.

In some examples, the implantable battery and/or communication module may receive a command, such as a command to adjust the volume of the system. In some such instances, the implantable battery and/or communication module may be configured to update each signal processor transfer function based on the existing transfer function of each respective signal processor, as each subsystem may operate differently and independently of one another.

Drawings

Fig. 1 shows a schematic illustration of a fully implantable cochlear implant system.

Fig. 2 shows an embodiment of a fully implantable cochlear implant.

Fig. 3A and 3B are exemplary diagrams illustrating communication with a signal processor.

Fig. 4 and 5 illustrate an embodiment of an exemplary middle ear sensor for use in conjunction with an anatomical feature of a patient.

Fig. 6 shows a diagram of an exemplary detachable connector.

Fig. 7 shows an exemplary cochlear implant system for a patient with an incompletely developed body, such as a child.

Fig. 8 is a process flow diagram illustrating an exemplary process for installing and/or updating an implantable cochlear implant system into a patient.

Fig. 9 is a schematic diagram illustrating an exemplary implantable system including an acoustic stimulator.

Fig. 10A is a high-level electrical schematic diagram illustrating communication between an implantable battery and/or communication module and a signal processor.

Fig. 10B illustrates an exemplary schematic diagram showing a cochlear electrode having a plurality of contact electrodes and fixedly or detachably connected to an electrical stimulator.

Fig. 12B is an alternative schematic diagram illustrating exemplary electrical communication between an implantable battery and/or communication module and a signal processor in a cochlear implant system, similar to that shown in fig. 12A.

Fig. 12C is another alternative schematic diagram illustrating exemplary electrical communication between an implantable battery and/or communication module and a signal processor in a cochlear implant system, similar to that shown in fig. 12A.

Fig. 12D is a high-level schematic diagram illustrating exemplary electrical communication between an implantable battery and/or communication module and a signal processor in a cochlear implant system, similar to that shown in fig. 12A.

Fig. 13A shows an exemplary schematic representation of the processor and stimulator combined into a single housing.

Fig. 13B shows a simplified cross-sectional view of the processor/stimulator shown in fig. 13A taken along line B-B.

Fig. 14A is a schematic diagram illustrating an exemplary signal processing configuration for adapting to variability of the sensor frequency response.

Fig. 14B shows exemplary gain versus frequency response curves for signals at various stages in a processing configuration.

FIG. 15 is a process flow diagram illustrating an exemplary process for establishing a preferred transfer function for a patient.

FIG. 16 is a process flow diagram illustrating an exemplary process for establishing a preferred transfer function for a patient.

FIG. 17 is a process flow diagram illustrating an exemplary method of testing the efficacy of one or more sounds by means of a preprocessed signal using one or more transfer functions.

Fig. 18 is a schematic representation of an exemplary database of pre-processed sound signals.

Fig. 19 is a schematic diagram illustrating possible communication between various system components according to some embodiments of a fully implantable system.

Fig. 20 is a schematic diagram illustrating establishing secure wireless connections between various components in an implantable system.

Fig. 21 illustrates a process flow diagram showing an exemplary method for pairing a charger with an implanted system.

Fig. 22 illustrates a process flow diagram showing an exemplary method for pairing another device with an implanted system using a paired charger.

Fig. 23 is a graph showing various parameters that can be adjusted by each of various external devices.

FIG. 24 shows an example configuration of interfacing devices configured to facilitate system calibration.

Fig. 25 is a process flow diagram illustrating an example process for calibrating an implantable system.

Fig. 26 illustrates an example embodiment in which a cochlear implant system includes components implanted to both sides of a wearer (e.g., to both the right ear and the left ear).

Detailed Description

Fig. 1 shows a schematic illustration of a fully implantable cochlear implant system. The system of fig. 1 includes a middle ear sensor 110 in communication with a signal processor 120. Middle ear sensor 110 may be configured to detect incoming sound waves, for example, using a patient's ear structure. The signal processor 120 may be configured to receive the signal from the middle ear sensor 110 and generate an output signal based on the signal. For example, the signal processor 120 may be programmed with instructions for outputting certain signals based on the received signals. In some embodiments, the output of the signal processor 120 may be calculated using an equation based on the received input signal. Alternatively, in some embodiments, the output of the signal processor 120 may be based on a look-up table or other programmed (e.g., in memory) correspondence between the input and output signals from the middle ear sensor 110. Although not necessarily explicitly based on a function, the relationship between the input of the signal processor 120 (e.g., from the middle ear sensor 110) and the output of the signal processor 120 is referred to as the transfer function of the signal processor 120.

The system of fig. 1 further includes a cochlear electrode 116 implanted into cochlear tissue of a patient. The cochlear electrode 116 is in electrical communication with an electrical stimulator 130, which may be configured to provide electrical signals to the cochlear electrode 116 in response to input signals received by the electrical stimulator 130. In some examples, the cochlear electrode 116 is fixedly attached to the electrical stimulator 130. In other examples, the cochlear electrode 116 is removably attached to the electrical stimulator 130. As shown, the electrical stimulator 130 is in communication with the signal processor 120. In some embodiments, the electrical stimulator 130 provides electrical signals to the cochlear electrode 116 based on the output signals from the signal processor 120.

In various embodiments, cochlear electrode 116 may include any number of contact electrodes in electrical contact with different components of the cochlear tissue. In such embodiments, the electrical stimulator 130 may be configured to provide electrical signals to any number of such contact electrodes to stimulate cochlear tissue. For example, in some embodiments, the electrical stimulator 130 is configured to activate different contact electrodes or combinations of contact electrodes of the cochlear electrode 116 in response to different input signals received from the signal processor 120. This may help the patient to distinguish between different input signals.

During exemplary operation, the middle ear sensor 110 detects audio signals, for example, using features of the patient's ear anatomy as described elsewhere herein and in U.S. patent publication No. 2013/0018216, which is hereby incorporated by reference in its entirety. The signal processor 120 may receive such signals from the middle ear sensor 110 and generate an output to the electrical stimulator 130 based on the transfer function of the signal processor 120. The electrical stimulator 130 may then stimulate one or more contact electrodes of the cochlear electrode 116 based on the received signals from the signal processor 120.

Referring to fig. 2, an embodiment of a fully implantable cochlear implant is shown. The device in this embodiment includes a processor 220 (e.g., a signal processor), a sensor 210, a first lead 270 connecting the sensor 210 to the processor 220, and a combined lead 280 attached to the processor 220, where the combined lead 280 contains both a ground electrode 217 and a cochlear electrode 216. The processor 220 shown includes a housing 202, a coil 208, a first female receptacle 271 and a second female receptacle 281 for insertion of leads 270 and 280, respectively.

In some embodiments, the coil 208 may receive power and/or data from an external device, for example, including a transmission coil (not shown). Some such examples are described in U.S. patent publication No. 2013/0018216, which is incorporated by reference. In other examples, processor 220 is configured to receive power and/or data from other sources, such as the implantable battery and/or communication module shown in fig. 1. Such a battery and/or communication module may be implanted, for example, in the pectoral region of a patient to provide sufficient space for larger devices (e.g., relatively large batteries) to extend operation (e.g., longer battery life). In addition, in the event that the battery needs to be eventually replaced, several replacement procedures may be performed in the pectoral region of the patient without some of the vascularization problems that may occur near the cochlear implant location. For example, in some cases, repeated procedures (e.g., battery replacement) near a cochlear implant may reduce the ability of the skin in the region to heal after the procedure. Placing replaceable components, such as batteries, in the pectoral region may facilitate replacement procedures with reduced risk of such problems.

Fig. 3A and 3B are exemplary diagrams illustrating communication with a signal processor. For example, referring to fig. 3A and 3B, a processor 320 containing the housing 302, the coil 308, and a universal lead 380 are shown. The lead 380 is removable and may be attached to the processor 320 by inserting the male connector 382 of the universal lead 380 into any available female receptacle, shown here as 371 or 381. FIG. 3A shows the processor 320 with the universal lead 380 removed. Fig. 3B shows the processor 320 with a universal lead 380 attached. The male connector 382 may be modified and functions as a seal to prevent or minimize the transfer of fluid into the disposer 320.

Fig. 4 and 5 illustrate an embodiment of an exemplary middle ear sensor for use in conjunction with an anatomical feature of a patient. Referring to fig. 4, an embodiment of a fully implantable cochlear implant sensor 410 is shown. Here, the sensor 410 touches the malleus 422. The sensor may include a cantilever 432 within a sensor housing 434. Sensor 410 may communicate with processor 420 via at least two wires 436 and 438, which may form a first lead (e.g., 270). The two wires may be made of biocompatible material, but need not be the same biocompatible material. Examples of such biocompatible materials may include tungsten, platinum, palladium, and the like. In various embodiments, one, both, or either of the conductive wires 436 and 438 are coated and/or disposed within a housing, as described in U.S. patent publication No. 2013/0018216, which is incorporated by reference.

The illustrated cantilever 432 includes at least two ends, at least one of which is in operative contact with one or more bones of the tympanic membrane or ossicular chain. The cantilever 432 may be a laminate of at least two layers of material. The material used may be piezoelectric. One example of such a cantilever 432 is a piezoelectric bimorph (see, e.g., U.S. patent No. 5,762,583), which is well known in the art. In one embodiment, the cantilever is made of two layers of piezoelectric material. In another embodiment, the cantilever is made of more than two layers of piezoelectric material. In yet another embodiment, the cantilever is made of more than two layers of piezoelectric and non-piezoelectric materials.

Sensor housing 434 of sensor 410 may be made of a biocompatible material. In one embodiment, the biocompatible material may be titanium or gold. In another embodiment, for example, sensor 410 may be similar to that described in U.S. Pat. No. 7,524,278 to Madsen et al or as ESTEEM^TMSensors such as those used in implants (Envoy Medical, corp., st. paul, Minn., st.) are available. In alternative embodiments, the sensor 410 may be an electromagnetic sensor, an optical sensor, or an accelerometer. Accelerometers are known in the art, for example, as described in U.S. patent No. 5,540,095.

Referring to fig. 5, an embodiment of a fully implantable cochlear implant sensor 510 is shown. Also shown are portions of the subject's anatomy that, if the subject is anatomically normal, contains at least the malleus 522, incus 524, and stapes 526 of the middle ear 528, and the cochlea 548, oval window 546, and circular window 544 of the inner ear 542. Here, the sensor 510 touches the incus 524. The sensor 510 in this embodiment may be as described for the embodiment of the sensor 410 shown in fig. 4. Further, although not shown in the figures, the sensor 510 may be in operative contact with the tympanic membrane or stapes or any combination of the tympanic membrane, malleus 522, incus 524, or stapes 526.

Fig. 4 and 5 illustrate an exemplary middle ear sensor for use with the systems described herein. However, other middle ear sensors may be used, such as sensors using a microphone or other sensors capable of receiving an input corresponding to a detected sound and outputting a corresponding signal to a signal processor. Additionally or alternatively, the system may include other sensors configured to output signals representative of sound received at or near the user's ear, such as a microphone or other acoustic microphone located in the user's outer ear or implanted under the user's skin. Such a device may act as an input source, e.g., a signal processor, such that the signal processor receives an input signal from the input source and generates and outputs one or more stimulation signals according to the received input signal and a signal processor transfer function.

Referring back to fig. 1, signal processor 120 is shown in communication with middle ear sensor 110, electrical stimulator 130, and implantable battery and/or communication module 140. As discussed elsewhere herein, the signal processor 120 may receive input signals from the middle ear sensor 110 and/or other input sources and output signals to the electrical stimulator 130 for stimulating the cochlear electrode 116. The signal processor 120 may receive data (e.g., process data to establish or update a transfer function of the signal processor 120) and/or power from the implantable battery and/or the communication module 140. In some embodiments, signal processor 120 may communicate with such components through inputs, such as those shown in FIG. 3.

In some embodiments, the implantable battery and/or communication module 140 may communicate with external components such as the programmer 100 and/or the battery charger 102. When the battery charger 102 is brought into proximity with the implantable battery and/or communication module 140 in the pectoral region of the patient, the battery charger may wirelessly charge the battery in the implantable battery and/or communication module 140. This charging may be accomplished using, for example, inductive charging. Programmer 100 may be configured to wirelessly communicate with implantable battery and/or communication module 140 via any suitable wireless communication technology, such as bluetooth, Wi-Fi, and/or the like. In some instances, programmer 100 may be used to update system firmware and/or software. In an exemplary operation, programmer 100 may be used to communicate updated transfer functions of signal processor 120 to implantable battery and/or communication module 140. In various embodiments, programmer 100 and charger 102 may be separate devices or may be integrated into a single device.

In the shown example of fig. 1, the signal processor 120 is connected to the middle ear sensor 110 by a lead 170. In some embodiments, leads 170 may provide communication between signal processor 120 and middle ear sensor 110. In some embodiments, lead 170 may comprise a plurality of isolated conductors that provide a plurality of communication channels between middle ear sensor 110 and signal processor 120. The lead 170 may include a coating such as an electrically insulating sheath for minimizing any conduction of electrical signals to the patient's body.

In various embodiments, one or more communication leads may be detachable such that communication between two components may be disconnected in order to electrically and/or mechanically separate such components. For example, in some embodiments, the lead 170 includes a detachable connector 171. The detachable connector 171 may facilitate decoupling the signal processor 120 and the middle ear sensor 110. Fig. 6 shows a diagram of an exemplary detachable connector. In the example shown, the detachable connector 671 includes a male connector 672 and a female connector 673. In the example shown, the male connector 672 includes a plurality of isolated electrical contact regions 682 and the female connector 673 includes a corresponding plurality of electrical contact regions 683. When the male connector 672 is inserted into the female connector 673, the contact regions 682 make electrical contact with the contact regions 683. Each pair of corresponding contact regions 682, 683 may provide a separate communication channel between components connected by the detachable connector 671. In the illustrated example, there may be four communication channels, but it should be understood that any number of communication channels is possible. Additionally, while shown as a single circumferentially extending contact region 683, other configurations are possible.

In some embodiments, male 672 and female 673 connectors are attached to the ends of leads 692, 693, respectively. Such leads may extend from components of the implantable cochlear system. For example, referring to fig. 1, in some embodiments, lead 170 may include a first lead extending from middle ear sensor 110 having one of a male (e.g., 672) or female (e.g., 673) connector and a second lead extending from signal processor 120 having the other of the male or female connector. The first lead and the second lead may be connected at a detachable connector 171 to facilitate communication between the middle ear sensor 110 and the signal processor 120.

In other examples, components of the detachable connector 171 may be integrated into one of the middle ear sensor 110 and the signal processor 120 (e.g., as shown in fig. 3). For example, in an exemplary embodiment, the signal processor 120 may include a female connector (e.g., 673) integrated into the housing of the signal processor 120. The lead 170 may extend completely from the middle ear sensor 110 and terminate at a corresponding male connector (e.g., 672) for insertion into a female connector of the signal processor 120. In still further embodiments, the leads (e.g., 170) may include a connector on each end configured to removably connect with a connector integrated into each of the communicating components. For example, lead 170 may include two male connectors, two female connectors, or one male connector and one female connector for removably connecting with corresponding connectors integrated into middle ear sensor 110 and signal processor 120. Thus, the lead 170 may include two or more detachable connectors.

A similar communication configuration may be established for the detachable connector 181 of the lead 180 that facilitates communication between the signal processor 120 and the stimulator 130 and the detachable connector 191 of the lead 190 that facilitates communication between the signal processor 120 and the implantable battery and/or communication module 140. The leads (170, 180, 190) may comprise pairs of leads with corresponding connectors extending from each piece of communication equipment, or the connectors may be built into any one or more of the communication components.

In such a configuration, each of the electrical stimulator 130, the signal processor 120, the middle ear sensor 110, and the battery and/or communication module may each be enclosed in a housing, such as a hermetically sealed housing comprising a biocompatible material. Such components may include feedthroughs that provide communication with internal components enclosed in the housing. The feedthrough may provide electrical communication with the assembly through a lead extending from the housing and/or a connector integrated into the assembly.

In a module configuration such as the module configuration shown in fig. 1, individual components may be individually accessed from other components (e.g., for upgrade, repair, replacement, etc.). For example, as signal processor 120 technology improves (e.g., in terms of size, processing speed, power consumption, etc.), signal processor 120 implanted as a component of the system may be removed and replaced independently of other components. In an exemplary procedure, implantable signal processor 120 may be disconnected from electrical stimulator 130 by cutting removable connector 181, from middle ear sensor 110 by cutting removable connector 171, and from implantable battery and/or communication module 140 by cutting removable connector 191. Accordingly, the signal processor 120 may be removed from the patient, while other components, such as the electrical stimulator 130, the cochlear electrode 116, the middle ear sensor 110, and the battery and/or communication module, may remain in place within the patient.

After removal of the old signal processor, a new signal processor may be connected to the electrical stimulator 130, the middle ear sensor 110 and the implantable battery and/or communication module 140 by detachable connectors 181, 171 and 191, respectively. Thus, the signal processor (e.g., 120) may be replaced, repaired, upgraded, or any combination thereof without affecting other system components. This may reduce the risk, complexity, duration, recovery time, etc. of this procedure. In particular, the cochlear electrode 116 may remain in place in the patient's cochlea while other system components may be adjusted to reduce trauma to the patient's cochlear tissue.

This modularity of system components may be particularly advantageous when replacing a signal processor 120 as described above. The continued improvement in processor technology and the likely continued significant improvement in the future have made the signal processor 120 a possible candidate for significant upgrade and/or replacement during the life of the patient. Additionally, in embodiments such as the one shown in FIG. 1, the signal processor 120 is in communication with a number of system components. For example, as shown, signal processor 120 is in communication with each of electrical stimulator 130, middle ear sensor 110, and implantable battery and/or communication module 140. Removably connecting such components with the signal processor 120 (e.g., via the removable connectors 181, 171, and 191) enables the signal processor 120 to be replaced without disturbing any other components. Accordingly, in the event of an available signal processor 120 upgrade and/or a signal processor 120 failure, the signal processor 120 may be disconnected from other system components and removed.

While there are many advantages to interchangeable signal processor 120, the modularity of other system components may also be advantageous, for example, for upgrading any system component. Similarly, if a system component (e.g., middle ear sensor 110) should fail, the component can be disconnected from the rest of the system (e.g., by detachable connector 171) and replaced without disturbing the remaining system components. In another example, even rechargeable batteries contained in the implantable battery and/or communication module 140 may eventually wear out and need to be replaced. The implantable battery and/or communication module 140 may be replaced or accessed (e.g., for battery replacement) without disturbing other system components. Further, as discussed elsewhere herein, this procedure may leave the patient's needle hub untouched, as in the illustrated example, when the implantable battery and/or communication module 140 is implanted in the patient's pectoral region, thereby eliminating unnecessarily frequent entry beneath the skin.

Although the various components are described herein as being removable, in various embodiments, one or more components configured to communicate with each other may be integrated into a single housing. For example, in some embodiments, the signal processor 120 may be integrally formed with the stimulator 130 and the cochlear electrode 116. For example, in an exemplary embodiment, the processing and stimulation circuitry of the signal processor 120 and stimulator 130 may be integrally formed as a single unit in a housing coupled to the cochlear electrode. The cochlear electrode and signal processor/stimulator may be implanted during an initial procedure and operated as a single unit.

In some embodiments, system upgrades are possible while the integrated signal processor/stimulator/cochlear electrode assembly is not removed from the patient due to potential damage to the cochlear tissue in which the cochlear electrode is implanted. For example, in some embodiments, a modular signal processor may be implanted along and in communication with the integrated signal processor/stimulator assembly. In some such examples, the integrated signal processor may include an internal bypass for allowing a later implanted signal processor to interface directly with the stimulator. Additionally or alternatively, the modular signal processor may be in communication with an integral signal processor, which may be programmed with a unit transfer function. Thus, in some such embodiments, signals from the modular signal processor may pass through the integrated signal processor substantially unchanged, such that the modular signal processor effectively controls the action of the integrated stimulator. Thus, in various embodiments, there are hardware and/or software solutions for integrally attached signal processors that may be difficult or dangerous to remove.

Another advantage of the modular cochlear implant system as shown in fig. 1 is the ability to implant different system components into a patient at different times. For example, infants and children are often not suitable for a fully implantable system as shown in fig. 1. Instead, such patients are often candidates for wearing conventional cochlear implant systems. For example, fig. 7 shows an exemplary cochlear implant system for a patient with an incompletely developed body, such as a child. The system includes a cochlear electrode 716 implanted into cochlear tissue of a patient. Cochlear electrode 716 of fig. 7 may incorporate many of the properties of the cochlear electrodes described herein. The cochlear electrode 716 may be in electrical communication with an electrical stimulator 730, which may be configured to stimulate a portion of the cochlear electrode 716 in response to an input signal as described elsewhere herein. The electrical stimulator 730 may receive an input signal from the signal processor 720.

In some cases, components such as middle ear sensors are not compatible with patients whose bodies are not fully developed. For example, the ever-increasing variety of dimensions within the anatomy of patients, such as the spacing between anatomical structures or between locations on anatomical structures (e.g., device attachment points), may change as the patient grows, thereby potentially rendering the middle ear sensor that is extremely sensitive to motion ineffective. Similarly, an immature patient may not be able to support the implantable battery and/or communication module. Thus, the signal processor 720 may communicate with a communication device for communicating with components external to the patient. Such communication components may include, for example, a coil 708 shown connected to the signal processor 720 by a lead 770. The coil 708 may be used to receive data and/or power from a device external to the user. For example, a microphone or other audio sensing device (not shown) may be in communication with the external coil 709, which is configured to transmit data to the coil 708 implanted in the patient. Similarly, a power source (e.g., a battery) may be coupled to the external coil 709 and may be configured to provide power to the implantable component through the implantable coil 708. Additionally, data to be processed (e.g., updates to the transfer function of the signal processor 720) may also be transmitted from the external coil 709 to the implanted coil 708. While generally discussed using coil 708, it should be understood that communication between the external component and the implanted component (e.g., signal processor 720) may be performed using other communication techniques, such as various forms of wireless communication. As shown, in the embodiment of fig. 7, the signal processor 720 is coupled to the coil 708 by leads 770 and a detachable connector 771. Thus, the coil 708 may be detached from the signal processor 720 and removed without destroying the signal processor 720.

When the patient is fully developed to the point where, for example, the patient can safely house the middle ear sensor and implantable battery and/or communication module, the coil 708 can be removed and the remaining components of the fully implantable system can be implanted. That is, once the patient develops, the cochlear implant system (e.g., the cochlear implant system of fig. 7) may be updated to a fully implantable cochlear implant system (e.g., the fully implantable cochlear implant system of fig. 1). In some examples, a patient is considered to have developed sufficiently once the patient reaches the age of 18 years or another predetermined age. Additional or alternative criteria may be used, such as when various anatomical sizes or determined developmental states are reached.

Fig. 8 is a process flow diagram illustrating an exemplary process for installing and/or updating an implantable cochlear implant system into a patient. A cochlear electrode may be implanted in communication with cochlear tissue of a patient, and an electrical stimulator may be implanted in communication with the cochlear electrode (step 850). A signal processor may be implanted in the patient (step 852). The signal processor may be connected to the electrical stimulator via a detachable connector (step 854), as described elsewhere herein. In instances where the signal processor is integrally formed with one or more components, such as the stimulator and the cochlear electrode, steps 850, 852 and 854 may be combined into a single step including implanting the cochlear electrode, stimulator and signal processor components.

If, when the process of FIG. 8 is performed, it can be determined whether the patient is deemed to be sufficiently developed (step 856). If not, a coil (or other communication device) as described with respect to FIG. 7 may be implanted (step 858). The coil may be connected to the signal processor through a detachable connector (step 860), and the cochlear implant may operate in conjunction with external components such as a microphone and an external power source and coil (step 862).

However, if the patient has developed sufficiently or has become sufficiently developed (step 856), additional components may be implanted into the patient. For example, the method can include implanting a middle ear sensor (step 864) and connecting the middle ear sensor to a signal processor via a detachable connector (step 866). Additionally, the method may include implanting the battery and/or communication module (step 868) and connecting the battery and/or communication module to the signal processor via the detachable connector (step 870). If the patient becomes fully developed after wearing a portion of the external device as described with respect to fig. 7 and steps 858-862, the method may include removing the various components that have been previously implanted. For example, the coil implanted in step 858 may be disconnected and removed during the procedure of implanting the middle ear sensor (step 864).

The process of fig. 8 may be embodied in a method of fitting an implantable hearing system to a patient. The method may comprise implanting a first system (e.g., the system of fig. 7) into the patient at a first age. This may include, for example, performing step 850-562 in FIG. 8. The method can further include, when the patient reaches a second age, the second age being greater than the first age, e.g., via step 864 of fig. 8 and 870, removing some components (e.g., coils) of the first system and implanting non-implanted components of a second system (e.g., the system of fig. 1).

There may be several advantages to transitioning from the system of fig. 7 to the system of fig. 1, such as through the process of fig. 8. From a patient preference perspective, some patients may prefer a system that is fully implanted and does not require wearable external components. Additionally, an implanted battery and/or communication module in communication with the signal processor via leads 190 (and removable connector 191) may relay power and/or data to the signal processor more efficiently than an external device such as a coil.

Such a modular system provides significant advantages over previously implantable or partially implantable cochlear implant systems. Typically, prior systems contain several components that are contained in a single housing that is implanted within the patient. For example, the functions of the signal processor, electrostimulator and sensor may be enclosed in a single complex assembly. If any such aspect of the component fails, which becomes more likely to occur as complexity increases, the entire module must be replaced. In contrast, in a modular system as shown in FIG. 1, individual components may be replaced while other components are held in place. In addition, communication, such as through the lead 190, of such systems that include, for example, coil-to-coil power and/or data communication through the patient's skin is also typically less efficient than internal connections. The modular system as shown in fig. 1 and 7 also allows for a smooth transition from a partially implantable system for a patient that has not yet fully developed and a fully implantable system when the patient has fully developed.

Although generally described herein as using an electrical stimulator to stimulate cochlear tissue of a patient via a cochlear electrode, in some examples, the system may additionally or alternatively include an acoustic stimulator. The acoustic stimulator may include, for example, a transducer (e.g., a piezoelectric transducer) configured to provide mechanical stimulation to the ear structure of the patient. In an exemplary embodiment, the acoustic stimulator may be configured to stimulate one or more portions of the ossicular chain of the patient through the amplified vibrations. The acoustic stimulator may comprise any suitable acoustic stimulator, such as those found in ESTEM^TMIn implants (Envoy medical company, st paul, mn) or as described in U.S. patent nos. 4,729,366, 4,850,962, and 7,524,278, and U.S. patent publication No. 20100042183, each of which is incorporated herein by reference in its entirety.

Fig. 9 is a schematic diagram illustrating an exemplary implantable system including an acoustic stimulator. The acoustic stimulator may be implanted near the ossicular chain of the patient and may communicate with the signal processor through a lead 194 and a detachable connector 195. The signal processor may behave as described elsewhere herein and may be configured to cause acoustic stimulation of the ossicular chain by the acoustic stimulator in response to an input signal from the middle ear sensor according to a transfer function of the signal processor.

The acoustic stimulator of fig. 9 may be used similarly to the electrical stimulators as described elsewhere herein. For example, the acoustic stimulator may be mechanically coupled to the patient's ossicular chain when the system is implanted and coupled to the signal processor by lead 194 and detachable connector 195. Similar to the systems described elsewhere herein with respect to the electrical stimulator, if the signal processor needs to be replaced or repaired, the signal processor may be disconnected from the acoustic stimulator (via the detachable connector 195) so that the signal processor may be removed without disturbing the acoustic stimulator.

In general, a system incorporating an acoustic sensor as shown in fig. 9 may operate in the same manner as systems employing electrical stimulators and cochlear electrodes that replace acoustic stimulation with electrical stimulation only, as described elsewhere herein. The same modular benefits, including system maintenance and upgrades, and the ability to translate into a fully implantable system when the patient becomes fully developed, can similarly be achieved using an acoustic stimulation system. For example, the process illustrated in fig. 8 may be performed in an acoustic stimulation system simply by replacing the acoustic stimulator with an electrical stimulator and a cochlear electrode.

Some systems may incorporate a hybrid system that includes both an electrical stimulator and an acoustic stimulator in communication with a signal processor. In some such examples, the signal processor may be configured to perform electrical and/or acoustic stimulation according to a transfer function of the signal processor. In some instances, the type of stimulus used may depend on the input signal received by the signal processor. For example, in an exemplary embodiment, the frequency content of the input signal to the signal processor may specify the type of stimulus. In some cases, frequencies below the threshold frequency may be represented using one of electrical and acoustic stimulation, while frequencies above the threshold frequency may be represented using the other of electrical and acoustic stimulation. This threshold frequency may be adjusted based on the hearing profile of the patient. Using a limited frequency range may reduce the number of frequency domains and thereby reduce the number of contact electrodes on the cochlear electrode. In other instances, both electrical and acoustic stimulation may be performed for various frequencies, as opposed to a single threshold frequency defining which frequencies are both electrically and acoustically stimulated. In some such examples, the relative amounts of electrical and acoustic stimulation may be frequency-dependent. As described elsewhere herein, the signal processor transfer functions may be updated to meet the needs of the patient, including electrical stimulation and acoustic stimulation profiles.

With further reference to fig. 1 and 9, in some examples, the system may include a cut-off controller 104 that may be configured to wirelessly prevent the electrical stimulator 130 from stimulating cochlear tissue of the patient and/or prevent the acoustic stimulator 150 from stimulating the ossicular chain of the patient. For example, if the system fails or an uncomfortably large input sound results in an undesirable stimulation level, the user may use the cut-off controller 104 to interrupt stimulation from the stimulator 130. The shutdown controller 104 may be embodied in a variety of ways. For example, in some embodiments, shutdown controller 104 may be integrated into other external components, such as programmer 100. In some such examples, programmer 100 includes a user interface through which a user may select an emergency shutdown feature for interrupting stimulation. Additionally or alternatively, the shutdown controller 104 may be embodied as a separate component. The separate components may be used in situations where the patient may not have immediate access to the programmer 100. For example, the cut-off controller 104 may be implemented as a wearable component, such as a ring, bracelet, necklace, etc., that the patient may wear all or most of the time.

The cut-off controller 104 may communicate with the system to stop stimulation in a variety of ways. In some examples, the shutdown controller 104 includes a magnet, as in the processor and/or implantable battery and/or communication module 140, that is detectable by a sensor (e.g., a Hall-Effect sensor) implanted in the patient. In some such embodiments, the system may stop stimulation of the cochlear tissue or ossicular chain when the magnet is brought sufficiently close to the sensor.

After the stimulus is disabled using the cutoff controller 104, the stimulus may be re-enabled in one or more of a variety of ways. For example, in some embodiments, stimulation is re-enabled after a predetermined amount of time after stimulation is disabled. In other instances, the stimulus may be re-enabled using the shutdown controller 104. In some such instances, the patient brings the cut-off controller 104 within a first distance of a sensor (e.g., a magnetic sensor) to disable stimulation, and then removes the cut-off controller 104. Stimulation may then be re-enabled once the patient brings the cut-off controller 104 within a second distance from the sensor. In various embodiments, the first distance may be less than, equal to, or greater than the second distance. In still further embodiments, another device, such as a separate on-controller (not shown) or programmer 100, may be used to re-enable stimulation. Any combination of this re-enabling of stimulation may be used, as the programmer 100 or the shutdown controller 104 may alternatively be used to enable stimulation or to combine a minimum "off time before stimulation may be re-enabled using any other method.

In some embodiments, other actions may be taken, such as reducing the magnitude of the stimulation, as opposed to disabling the stimulation altogether. For example, in some embodiments, a cut-off sensor may be used to reduce the output signal by a predetermined amount (e.g., absolute amount, percentage, etc.). In other examples, switching off the sensor may affect the transfer function of the signal processor to reduce the magnitude of the stimulus in a customized manner, such as according to the frequency or other parameters of the input signal (e.g., from the middle ear sensor).

Referring back to fig. 1, as described elsewhere herein, an implantable battery and/or communication module may be used to provide power and/or data (e.g., processing instructions) to other system components through leads 190. Transmitting electrical signals through the body of a patient presents different challenges. For example, safety standards may limit the amount of current (particularly DC current) that can safely flow through a patient's body. In addition, the patient's body may act as an undesirable signal path from assembly to assembly (e.g., through contact with the housing or "can" of each assembly). Various systems and methods may be employed to improve the communication capabilities between system components.

Fig. 10A is a high-level electrical schematic diagram illustrating communication between an implantable battery and/or communication module and a signal processor. In the embodiment shown, the implantable battery and/or communication module includes circuitry that communicates with circuitry in the signal processor. Communication between circuitry in the implantable battery and/or communication module and the signal processor may be facilitated by leads (190) represented by lead transfer functions. The lead transfer function may include, for example, parasitic resistance and capacitance between the lead connecting the implantable battery and/or communication module and the signal processor and the patient's body and/or between two or more conductors comprising the lead (e.g., 191). The signals transmitted from the circuitry of the implantable battery and/or communication module to the circuitry in the signal processor may include power and/or data (e.g., processed data regarding the transfer function of the signal processor) that provides power for operating and/or stimulating system components (e.g., middle ear sensors, signal processors, electrical and/or acoustic stimulators, and/or cochlear electrodes).

As discussed elsewhere herein, the patient's body provides an electrical path between system components, such as the "can" of the implantable battery and/or communication module and the "can" of the signal processor. This path is shown in FIG. 10A by the path R_{Body part}Is shown. As a result, the patient's body may provide undesirable signal paths that may negatively affect communication between components. To address this issue, in some embodiments, the operational circuitry in each component may be substantially isolated from the component "canister" and thus from the patient's body. For example, as shown, resistance R_{Pot for storing food}Positioned between the circuitry and the "can" of both the implantable battery and/or communication module and the signal processor.

Although shown as R in each of the implantable battery and/or communication module and the signal processor_{Pot for storing food}It should be understood, however, that the actual values of the resistances between the circuitry and the respective "cans" of the different elements are not necessarily equal. In addition, R_{Pot for storing food}It need not contain only a resistor but may contain other components such as one or more capacitors, inductors, etc. Namely, R_{Pot for storing food}May represent an insulated circuit containing any kind of component that acts to increase the impedance between the circuitry within the component and the "can" of the component. Thus, R _{Pot for storing food}May represent the impedance between the operating circuitry of the assembly and the corresponding "can" and the patient's tissue. Isolating the circuitry from the "can" and the patient's body serves to similarly isolate the circuitry from the "can" of other components, thereby allowing each component to operate with reference to a substantially isolated component ground. This may eliminate undesirable communication and interference between system components and/or between system components and the patient's body.

For example, as described elsewhere herein, in some examples, an electrical stimulator may provide electrical stimulation to one or more contact electrodes on a cochlear electrode implanted in cochlear tissue of a patient. Fig. 10B illustrates an exemplary schematic diagram showing a cochlear electrode having a plurality of contact electrodes and fixedly or detachably connected to an electrical stimulator. As shown, cochlear electrode 1000 has four contact electrodes 1002, 1004, 1006, and 1008, but it should be understood that any number of contact electrodes is possible. As described elsewhere herein, an electrical stimulator may provide an electrical signal to one or more such contact electrodes in response to an output from a signal processor according to a signal processor transfer function and a received input signal.

Because each contact electrode 1002-1008 is in contact with the cochlear tissue of the patient, each contact electrode passes through the patient tissue, shown as R_{Body part}Is separate from the "canister" of the electrical stimulator (and the "canister" of other system components). Thus, if circuitry within various system components is coupled to the impedance of the component "can" (e.g., R)_{Pot for storing food}) Not high enough, the electrical signal may stimulate an undesired region of the patient's cochlear tissue. For example, stimulation intended for a particular contact electrode (e.g., 1002) may result in undesired stimulation of other contact electrodes (e.g., 1004, 1006, 1008), thereby reducing the overall efficacy of the system. Due to the patient's body, e.g. by passing R between the component circuitry and the corresponding "can_{Pot for storing food}Incorporating a conductive path between impedance minimization system components (e.g., a contact electrode to a cochlear electrode) may thus improve the ability to apply electrical stimulation to only a desired portion of the patient's body.

It is to be understood that the term R_{Body part}As used herein, generally refers to the resistance and/or impedance of patient tissue between various components, and not to specific values. Further, each depiction in the figures or R _{Body part}Not necessarily representing the same resistance and/or impedance as the other depictions.

Fig. 11A shows a high-level schematic diagram illustrating an exemplary communication configuration between an implantable battery and/or communication module, a signal processor, and a stimulator. In the example of fig. 11A, the implantable battery and/or communication module 1110 is in bi-directional communication with the signal processor 1120. For example, the implantable battery and/or communication module 1110 may transmit power and/or data signals 1150 to the signal processor 1120. In some instances, the power and data signals 1150 may be contained in a single signal generated in the implantable battery and/or communication module 1110 and may be transmitted to the signal processor 1120. Such signals may include, for example, digital signals transmitted at a particular clock rate, which may be adjustable in some embodiments, for example, by an implantable battery and/or communication module 1110.

In some embodiments, the signal processor 1120 may transmit information, such as feedback information and/or requests for more power, etc., to the implantable battery and/or communication module 1110 (e.g., 1151). In response, the implantable battery and/or communication module 1110 may adjust its output (e.g., magnitude, duty cycle, clock rate, etc.) to the signal processor 1120 to accommodate the received feedback (e.g., to provide more power, etc.). Thus, in some such instances, the implantable battery and/or communication module 1110 may transmit power and data to the signal processor 1120 (e.g., 1150), and the signal processor 1120 may transmit various data back to the implantable battery and/or communication module 1110 (e.g., 1151).

In some embodiments, similar communications may be implemented between the signal processor 1120 and the stimulator 1130, where the signal processor 1120 provides power and data to the stimulator 1130 (e.g., 1160) and in turn receives data from the stimulator 1130 (e.g., 1161). For example, the signal processor 1120 may be configured to output signals (e.g., power and/or data) to the stimulator 1130 (e.g., based on received input from a middle ear sensor or other device) via a similar communication protocol as implemented between the implantable battery and/or communication module 1110 and the signal processor 1120. Similarly, in some embodiments, the stimulator may be configured to provide a feedback signal to the signal processor, e.g. indicative of the performed stimulation procedure. Additionally or alternatively, the stimulator may provide diagnostic information such as electrode impedance and neuro-response telemetry or other biomarker signals.

Fig. 11B is a schematic diagram illustrating exemplary electrical communication between an implantable battery and/or communication module and a signal processor in a cochlear implant system according to some embodiments. In the embodiment shown, the implantable battery and/or communication module 1110 includes a signal generator 1112 configured to output a signal to the signal processor 1120 via a lead (e.g., 190). As described with respect to fig. 11A, in some examples, the signal generator 1112 is configured to generate both data and power signals (e.g., 1150) for communication with the signal processor 1120. In some embodiments, the signal generator 1112 generates digital signals for communication with the signal processor 1120. The digital signal from the signal generator 1112 may be transferred to the signal processor 1120 at a particular clock rate. In some examples, the signal is generated at about 30 kHz. In various examples, the data and power supply frequencies may range from about 100Hz to about 10MHz, and may be adjustable by a user, for example, in some examples.

In the embodiment shown, the implantable battery and/or communication module 1110 includes a controller in communication with the signal generator 1112. In some examples, the controller can adjust a communication parameter such as a clock rate of the signal generator 1112. In an exemplary embodiment, the controller and/or signal generator 1112 may be in communication with, for example, an external programmer of the patient (e.g., shown in fig. 1). The controller and/or signal generator 1112 may be configured to transmit data, such as updated firmware, transfer functions of the signal processor 1120, and/or the like, to the signal processor 1120 (e.g., 1151).

As shown, signal generator 1112 outputs the generated signals to amplifier 1190 and inverting amplifier 1192. In some examples, both amplifiers are unity gain amplifiers. In some examples that include digital signals, inverting amplifier 1192 may include a digital not gate. The outputs from amplifier 1190 and inverting amplifier 1192 are substantially opposite each other and are directed to signal processor 1120. In some embodiments, the relative nature of the signal output from the amplifiers 1190 and 1192 to the signal processor 1120 results in charge neutral communication between the implantable battery and/or communication module 1110 and the signal processor 1120 such that a net charge does not flow through the wearer.

In the shown example of fig. 11B, receive circuitry in signal processor 1120 includes rectifier circuit 1122 that receives signals (e.g., 1150) from amplifier 1190 and inverting amplifier 1192. Since the output of one of the amplifiers 1190 and 1192 will be high, the rectifier circuit 1122 may be configured to receive the relative signal from the amplifiers 1190 and 1192 and thereby generate the substantially DC power output 1123. In various embodiments, the DC power 1123 may be used to power various components, such as the signal processor 1120 itself, the middle ear sensor, electrical and/or acoustic stimulators, and the like. For example, rectifier circuit 1122 may include any known suitable circuitry components for rectifying one or more input signals, such as a diode rectifier circuit or a transistor circuit.

The implantable battery and/or communication module 1110 may transmit data to the signal processor 1120 as described elsewhere herein. In some embodiments, controller and/or signal generator 1112 is configured to encode data for transmission through output amplifiers 1190 and 1192. The signal processor 1120 may include a signal extraction module 1124 configured to extract a data signal 1125 from a signal (e.g., 1150) transmitted to the signal processor 1120 to generate a signal for use by the signal processor 1120. In some examples, the signal extraction module 1124 can decode signals encoded by the implantable battery and/or communication module 1110. Additionally or alternatively, the signal extraction module 1124 can extract the signal 1125 generated by the lead transfer function. In various examples, extracted signal 1125 may include, for example, an updated transfer function of signal processor 1120, a desired stimulation command, or other signal affecting the operation of signal processor 1120.

In the example shown, the signal processor 1120 includes a controller 1126 capable of monitoring DC power 1123 and signals 1125 received from the implantable battery and/or communication module 1110. The controller 1126 may be configured to analyze the received DC power 1123 and signal 1125 and determine whether the power and/or signal is sufficient. For example, the controller 1126 may determine from the transfer function of the signal processor 1120 that the DC power received by the signal processor 1120 for stimulating the cochlear electrode is insufficient, or that data from the implantable battery and/or communication module 1110 is not being transmitted at a desired rate. Thus, in some instances, the controller 1126 of the signal processor 1120 may communicate with the controller 1114 of the implantable battery and/or communication module 1110 and provide feedback regarding the received communication. Based on the received feedback from the controller 1126 of the signal processor 1120, the controller 1114 of the implantable battery and/or communication module 1110 may adjust various properties of the signal output by the implantable battery and/or communication module 1110. For example, the implantable battery and/or a controller of the communication module 1110 may adjust the clock rate of communications from the signal generator 1112 to the signal processor 1120.

In some systems, the efficiency of the transmission between the implantable battery and/or communication module 1110 and the signal processor 1120 is dependent on the clock rate of the transmission. Thus, in some examples, the implantable battery and/or communication module 1110 begins by transmitting at an optimized clock rate until the clock rate requested by the signal processor 1120 changes, such as to enhance data transmission (e.g., rate, resolution, etc.). In other cases, if more power is needed (e.g., the controller of the signal processor 1120 determines that the DC power is insufficient), the clock frequency may be adjusted to increase the transmission efficiency, and thus the magnitude 1120 of the signal received at the signal processor. It should be appreciated that adjusting the amount of power transmitted to the signal processor 1120 may include adjusting the magnitude of the signal output from the signal generator 1112 in addition to or instead of adjusting the clock rate. In some embodiments, e.g., with respect to fig. 11A-B, power and data may be transferred to the signal processor 1120, e.g., from the implantable battery and/or communication module 1110, at a rate of approximately 30kHz, and may be adjusted accordingly as needed and/or desired, e.g., by the signal processor 1120.

Fig. 12A is an alternative high-level schematic diagram illustrating an exemplary communication configuration between an implantable battery and/or communication module, a signal processor, and a stimulator. In the example of fig. 12A, the implantable battery and/or communication module 1210 provides a signal (e.g., 1250) to the signal processor 1220 over the first communication link and further communicates bi-directionally to provide additional signals (e.g., 1251) with the signal processor 1220. In the example of fig. 12A, the implantable battery and/or communication module 1210 can provide a power signal (e.g., 1250) to the signal processor 1220 over a communication link and additionally conduct bidirectional data communication 1251 with the signal processor 1220 over a second communication link. In some such examples, the power (1250) and data (1251) signals may each comprise digital signals. However, in some embodiments, the power and data signals are transmitted at different clock rates. In some examples, the clock rate of the data signal is at least one magnitude greater than the clock rate of the power signal. For example, in an exemplary embodiment, the power signal is transmitted at a clock rate of about 30kHz, while the data communication occurs at a clock rate of about 1 MHz. Similar to the embodiment described in fig. 11A, in some examples, the clock rate may be adjusted, for example, by an implantable battery and/or communication module 1210.

As described with respect to fig. 11A, in some embodiments, the signal processor 1220 may transmit information, such as feedback information and/or a request for more power, etc. (e.g., data signal 1251) to the implantable battery and/or communication module 1210. In response, the implantable battery and/or communication module 1210 may adjust the power and/or data (e.g., magnitude, duty cycle, clock rate, etc.) output to the signal processor 1220 to accommodate the received feedback (e.g., to provide more power, etc.).

In some embodiments, similar communications may be implemented between signal processor 1220 and stimulator 1230, where signal processor 1220 provides power and data to stimulator 1230 and in turn receives data from stimulator 1230. For example, the signal processor 1220 may be configured to output signal power signals (e.g., 1260) and data signals (e.g., 1261) to the stimulator 1230 (e.g., based on received inputs from middle ear sensors or other devices). This communication may be implemented by a similar communication protocol as implemented between the implantable battery and/or communication module 1210 and the signal processor 1220. In some examples, the power signal provided to the stimulator 1230 (e.g., 1260) is the same signal (e.g., 1250) received by the signal processor 1220 from the implantable battery and/or communication module 1210. Additionally, in some embodiments, stimulator 1230 may be configured to provide feedback signals, e.g., representative of the stimulation process performed, to signal processor 1220 (e.g., 1261).

Fig. 12B is an alternative schematic diagram illustrating exemplary electrical communication between an implantable battery and/or communication module 1210B and a signal processor 1220B in a cochlear implant system, similar to that shown in fig. 12A. In the illustrated embodiment of fig. 12B, the implantable battery and/or communication module 1210B includes a power signal generator 1211 and a separate signal generator 1212. The power signal generator 1211 and the signal generator 1212 are each configured to output a signal to the signal processor 1220b through a lead (e.g., 190). In some embodiments, power signal generator 1211 and signal generator 1212 each generate a digital signal for communication with signal processor 1220 b. In some such embodiments, the digital signal (e.g., 1250) from the power signal generator 1211 may be transferred to the signal processor 1220b at a power clock rate, while the digital signal (e.g., 1251b) from the signal generator 1212 may be transferred to the signal processor 1220b at a data clock rate that is different than the power clock rate. For example, in some configurations, power and data may be most efficiently and/or effectively transferred at different clock rates. In an exemplary embodiment, the power clock rate is about 30kHz and the data clock rate is about 1 MHz. Utilizing different and separately transmitted power and data signals having different clock rates may improve the transfer efficiency of power and/or data from the implantable battery and/or communication module 1210b to the signal processor 1220 b.

In the embodiment shown, the implantable battery and/or communication module 1210b includes a controller 1214 in communication with a power signal generator 1211 and a signal generator 1212. In some examples, controller 1214 can adjust communication parameters, such as clock rates or content of signal generator 1212 and/or power signal generator 1211. In an exemplary embodiment, the controller 1214 and/or the signal generator 1212 or the power signal generator 1211 can be in communication with, for example, an external programmer (e.g., shown in fig. 1) of the patient. The controller 1214 and/or the signal generator 1212 may be configured to transfer data, such as updated firmware, transfer functions of the signal processor 1220b, etc., to the signal processor 1220 b. Additionally or alternatively, controller 1214 may be configured to transmit signals, such as audio or other signals streamed or otherwise received from one or more external devices as described elsewhere herein.

As shown and similar to the example shown in fig. 11B, the power signal generator 1211 outputs the generated signals to the amplifier 1290 and the inverting amplifier 1292. In some examples, both amplifiers are unity gain amplifiers. In some examples that include digital signals, inverting amplifier 1292 may include a digital not gate. The outputs from amplifier 1290 and inverting amplifier 1292 are generally opposite one another and are directed to signal processor 1220 b. In the example shown, receive circuitry in signal processor 1220b includes rectifier circuit 1222 that receives signals from amplifier 1290 and inverting amplifier 1292. Since the output of one of the amplifiers 1290 and 1292 will be high, the rectifier circuit 1222 may be configured to receive the relative signals from the amplifiers 1290 and 1292 and thereby generate the substantially DC power output 1223.

In various embodiments, the DC power 1223 may be used to power various components, such as the signal processor 1220b itself, the middle ear sensor, the electrical and/or acoustic stimulator 1230, and the like. For example, rectifier circuit 1222 may include any known suitable circuitry components for rectifying one or more input signals, such as a diode rectifier circuit or a transistor circuit. In some embodiments, the signal from the power signal generator 1211 is generated at a clock rate (e.g., about 30kHz) that is optimal for transmitting power through the leads. In the illustrated example of fig. 12B, rectifier circuit 1222 may be arranged in parallel with a power line configured to deliver power signals to other components within the system, such as stimulator 1230. For example, in some embodiments, the same power signal (e.g., 1250) generated by power signal generator 1211 and output through amplifiers 1290 and 1292 may be similarly applied to stimulator 1230. In some such examples, stimulator 1230 includes a rectifier circuit 1222 similar to signal processor 1220b for extracting DC power from the power signal and the inverted power signal provided by amplifiers 1290 and 1292, respectively. In an alternative embodiment, the signal processor 1220B may similarly provide signals from the separate power signal generator 1211 to provide a power signal (e.g., at about 30kHz) to the stimulator 1230 similar to how power is provided from the implantable battery and/or communication module 1210B to the signal processor 1220B in fig. 12B.

In the example of fig. 12B, the signal generator 1212 outputs a data signal (e.g., 1251B) to the amplifier 1294 and the inverting amplifier 1296. In some examples, both amplifiers are unity gain amplifiers. In some examples that include digital signals, inverting amplifier 1296 may include a digital not gate. The outputs from amplifier 1294 and inverting amplifier 1296 are generally opposite one another and are directed to signal processor 1220 b.

As described elsewhere herein, in some embodiments, the controller 1214 and/or the signal generator 1212 are configured to encode data for transmission through the output amplifiers 1294 and 1296. Signal processor 1220b may include a signal extraction module 1224 configured to extract data from signal 1225 transmitted to signal processor 1220b to generate signal 1225 for use by signal processor 1220 b. In some examples, the signal extraction module 1224 is capable of decoding a signal encoded by the implantable battery and/or communication module 1210 b. Additionally or alternatively, the signal extraction module 1224 may extract a resulting signal 1225 generated by the lead transfer function. In various examples, the extracted signals may include, for example, updated transfer functions of signal processor 1220b, desired stimulation commands, or other signals that affect the operation of signal processor 1220 b.

In the example of fig. 12B, signal extraction module 1224 includes a pair of tri-state buffers 1286 and 1288 in communication with the signal output from signal generator 1212. The tri-state buffers 1286 and 1288 are shown having an "enable" (ENB) signal provided by the controller 1226 to control the operation of the tri-state buffers 1286 and 1288 to extract signals from the signal generator 1212. The signal from signal generator 1212 and buffered by tri-state buffers 1286 and 1288 is received by amplifier 1284, which may be configured to produce signal 1225 representing the signal generated by signal generator 1212.

In some examples, the communication of the signal generated at the signal generator 1212 may be communicated to the signal processor 1220b at a clock rate different from the clock rate of the signal generated by the power signal generator 1211. For example, in some embodiments, the power signal from the power signal generator 1211 is transmitted at approximately 30kHz, which may be a high efficiency frequency for transmitting power. However, in some examples, the signal from the signal generator 1212 is transmitted at a higher frequency than the signal from the power signal generator 1211, e.g., at about 1 MHz. Such high frequency data transmission may be useful for faster data transfer than is available at lower frequencies (e.g., the frequencies used to transmit the signals from the power signal generator 1211). Thus, in some embodiments, power and data may be communicated from the implantable battery and/or communication module 1210b to the signal processor 1220b at different frequencies over different communication channels.

Similar to the embodiment shown in fig. 11B, in the illustrated example of fig. 12B, the signal processor 1220B includes a controller 1226 in communication with an implantable battery and/or communication module 1210B. In some such embodiments, the controller 1226 in the signal processor 1220b can monitor the DC power 1223 and/or the signal 1225 received from the implantable battery and/or communication module 1210 b. The controller 1126 may be configured to analyze the received DC power 1223 and signal 1225 and determine whether the power and/or signal is sufficient. For example, the controller 1226 may determine from the transfer function of the signal processor 1220b that the DC power received by the signal processor 1220b for stimulating the cochlear electrode is insufficient, or that data from the implantable battery and/or communication module 1210b is not being transmitted at a desired rate. Thus, in some instances, the controller 1226 of the signal processor 1220b may communicate with the controller 1214 of the implantable battery and/or communication module 1210b and provide feedback regarding the received communications. Based on the received feedback from the controller 1226 of the signal processor 1220b, the controller 1214 of the implantable battery and/or communication module 1210b may adjust various properties of the signals output by the power signal generator 1211 and/or the signal generator 1212.

In the illustrated example of fig. 12B, the bi-directional communication signals 1251B between the implantable battery and/or communication module 1210B and the signal processor 1220B include signals from amplifiers 1294 and 1296 in one direction and communication from the controller 1226 to the controller 1214 in the other direction. It should be appreciated that a variety of communication protocols and techniques may be used to establish the bi-directional communication signal 1251b between the implantable battery and/or communication module 1210b and the signal processor 1220 b.

For example, in some embodiments, the implantable battery and/or communication module 1210b need not include amplifiers 1294 and 1296 and instead transmits a signal to the signal processor 1220b rather than an inverse thereof. In other examples, the signal processor includes amplifiers similar to 1294 and 1296 and outputs a signal and its inverse back to the implantable battery and/or communication module 1210 b. Additionally or alternatively, in some embodiments, the signal generator 1212 may be integral with the controller 1214 and/or the signal extraction module 1224 may be integral with the controller 1226, wherein the controllers 1214 and 1226 may be in bi-directional communication via the signal generator 1212 and/or the signal extraction module 1224. In general, the implantable battery and/or communication module 1210b and the signal processor 1220b may communicate bi-directionally for communicating data signals separate from the power signals provided by the power signal generator 1211.

As described, separate communication channels for power (e.g., 1250) and data (e.g., 1251b) may be used to provide both power and data from the implantable battery and/or communication module 1210b and the signal processor 1220 b. This may allow separate data and power clock rates to improve power transfer efficiency as well as data transfer efficiency and/or rate. Further, in some examples, if bi-directional communication (e.g., 1251b) between the implantable battery and/or communication module 1210b and the signal processor 1220b fails (e.g., due to a component failure, a connection failure, etc.), data from the implantable battery and/or communication module 1210b for communication may be encoded in the power signal (e.g., 1250) from the power signal generator 1211 and transmitted to the signal processor 1220 b. Thus, similar to the embodiment described with respect to fig. 11B, both power and data may be transmitted through the same signal.

In some instances, the signal extraction module 1224 may be configured to receive data received from the power signal generator 1211, for example, through an actuatable switch that may be actuated upon detection of a failure of the communication 1251 b. In other examples, the signal extraction module 1224 and/or the controller 1226 may generally monitor data from the power signal generator 1211 and identify when a signal received from the power signal generator 1211 contains a data signal encoded into the received power signal to determine when to consider including the data in the power signal.

Thus, in some embodiments, the configuration of fig. 12B may be implemented to establish efficient bidirectional communication between the implantable battery and/or communication module 1210B and the signal processor 1220B. The failure of the two-way communication 1251b may be identified manually and/or automatically. Upon detecting a failure of the bi-directional communication 1251B, the controller 1214 may encode data into the power signal output from the power signal generator 1211, and the power and data may be combined into a single signal, as described with respect to fig. 11B.

Fig. 12C is another alternative schematic diagram illustrating exemplary electrical communication between an implantable battery and/or communication module 1210C and a signal processor 1220C in a cochlear implant system, similar to that shown in fig. 12A. Similar to the embodiment of fig. 12B, in the illustrated embodiment of fig. 12C, the implantable battery and/or communication module 1210C includes a signal generator 1211 configured to output a signal to the signal processor 1220C through a lead (e.g., 190). In some embodiments, the power signal generator 1211 generates a digital signal (e.g., 1250) for transmission to the signal processor 1220c, for example, at a power clock rate. The power signal generator 1211 and corresponding amplifiers 1290, 1292, and rectifier circuit 1222 may operate similarly to that described with respect to fig. 12B to extract DC power 1223 and, in some examples, output a power signal to additional system components, such as stimulator 1230.

In the illustrated embodiment, the implantable battery and/or communication module 1210c includes a signal generator 1213 capable of providing data signals to the signal processor. In some embodiments, signal generator 1213 generates a digital signal for transmission to signal processor 1220 c. In some such embodiments, the digital signal (e.g., 1251c) from the signal generator 1213 may be transferred to the signal processor 1220b at a data clock rate that is different from the power supply clock rate. For example, as described elsewhere herein, in some configurations, power and data may be most efficiently and/or effectively transferred at different clock rates. In an exemplary embodiment, the power clock rate is about 30kHz and the data clock rate is about 1 MHz. Utilizing different and separately transmitted power and data signals having different clock rates may improve the transfer efficiency of power and/or data from the implantable battery and/or communication module 1210c to the signal processor 1220 c.

The embodiment of fig. 12C includes a controller 1215 in communication with a power signal generator 1211 and a signal generator 1213. In some examples, the controller 1215 can adjust communication parameters, such as the clock rate or content of the signal generator 1213 and/or the power signal generator 1211. In an exemplary embodiment, the controller 1215 and/or the signal generator 1213 or the power signal generator 1211 can be in communication with, for example, an external programmer (e.g., shown in fig. 1) of the patient. The controller 1215 and/or signal generator 1213 may be configured to transfer data, such as updated firmware, transfer functions of the signal processor 1220c, etc., to the signal processor 1220 c.

Similar to the example in fig. 12B, in the example of fig. 12C, the signal generator 1213 outputs a data signal (e.g., 1251) to the amplifier 1295 and the inverting amplifier 1297. In some examples, both amplifiers are unity gain amplifiers. In some examples, amplifiers 1295, 1297 comprise tri-state buffers. In some examples that include digital signals, inverting amplifier 1297 may include a digital not gate. The outputs from amplifier 1295 and inverting amplifier 1297 are generally opposite one another and are directed to signal processor 1220 c.

As described elsewhere herein, in some embodiments, the controller 1215 and/or signal generator 1213 is configured to encode data for transmission through the amplifiers 1295 and 1297. The signal processor 1220c may include a signal extraction module 1234 configured to extract data from the signal delivered to the signal processor 1220c to produce a signal for use by the signal processor 1220 c. In some examples, the signal extraction module 1234 can decode signals encoded by the implantable battery and/or communication module 1210 c. Additionally or alternatively, the signal extraction module 1234 may extract a signal resulting from a lead transfer function. In various examples, the extracted signals may include, for example, updated transfer functions of signal processor 1220c, desired stimulation commands, or other signals that affect the operation of signal processor 1220 c.

In the example of fig. 12C, similar to signal extraction module 1224 of fig. 12B, signal extraction module 1234 includes a pair of tri-state buffers 1287 and 1289 in communication with the signal output from signal generator 1213. The tri-state buffers 1287 and 1289 are shown having an "enable" (ENB) signal provided by the controller 1227 to control the operation of the tri-state buffers 1287 and 1289 to extract signals from the signal generator 1213. The signal from signal generator 1213, and buffered by tri-state buffers 1287 and 1289, is received by amplifier 1285, which may be configured to produce a signal representative of the signal generated by signal generator 1213.

As described elsewhere herein, in some examples, communication of the signal generated at the signal generator 1213 may be communicated to the signal processor 1220c at a clock rate that is different from the clock rate of the signal generated by the power signal generator 1211. For example, in some embodiments, the power signal from the power signal generator 1211 is transmitted at approximately 30kHz, which may be a high efficiency frequency for transmitting power. However, in some examples, the signal from the signal generator 1213 is transmitted at a higher frequency than the signal from the power signal generator 1211, e.g., at about 1 MHz. Such high frequency data transmission may be useful for faster data transfer than is available at lower frequencies (e.g., the frequencies used to transmit the signals from the power signal generator 1211). Thus, in some embodiments, power and data may be communicated from the implantable battery and/or communication module 1210c to the signal processor 1220c at different frequencies over different communication channels.

In the shown example of fig. 12C, the signal processor 1220C includes a signal generator 1217 and a controller 1227 in communication with the signal generator 1217. Similar to the operation of the signal generator 1213 and the amplifiers 1295 and 1299, the signal generator may be configured to generate output signals to buffers 1287 and 1289, which may be configured to output signals to the implantable battery and/or communication module 1210 c.

In some such embodiments, the controller 1227 in the signal processor 1220c can monitor the DC power 1223 and/or signals received from the implantable battery and/or communication module 1210 c. The controller 1126 may be configured to analyze the received DC power 1223 and signals and determine whether the power and/or signals are sufficient. For example, the controller 1227 may determine from the transfer function of the signal processor 1220c that the DC power received by the signal processor 1220c for stimulating the cochlear electrode is insufficient, or that data from the implantable battery and/or communication module 1210c is not being transmitted at a desired rate. Thus, in some examples, the controller 1227 of the signal processor 1220c causes the signal generator 1217 to generate a communication signal for transmission to the implantable battery and/or communication module 1210 c. Such signals may be used to provide feedback regarding signals received by the signal processor 1220c, such as DC power 1223.

In the example of fig. 12C, amplifiers 1295 and 1297 are shown as including tri-state amplifiers (e.g., tri-state buffers) that may be controlled by controller 1227. Similar to the configuration in the signal processor 1220c, the implantable battery and/or communication module 1210c includes a signal extraction module 1235 configured to extract data from the signal transmitted by the signal generator 1217 of the signal processor 1220c to the implantable battery and/or communication module 1210 c. Signal extraction module 1235 includes amplifiers 1295 and 1297 (e.g., tri-state buffers) in communication with the signal output from signal generator 1217. Signals from the signal generator 1217 received at the amplifiers 1295 and 1297 are received by an amplifier 1299, which may be configured to generate a signal representative of the signal generated by the signal generator 1217 to the controller 1215 of the implantable battery and/or communication module 1210. Thus, in some embodiments, the controller 1227 of the signal processor 1220c is configured to transmit data back to the implantable battery and/or communication module 1210a through the buffers 1287 and 1289.

As described with respect to other embodiments, the controller 1215 of the implantable battery and/or communication module 1210c may adjust various properties of the signals output by the power signal generator 1211 and/or the signal generator 1213 based on the received feedback from the controller 1227 of the signal processor 1220 c.

Thus, in the illustrated example of fig. 12C, the bi-directional communication signal 1251 between the implantable battery and/or communication module 1210C and the signal processor 1220C includes communication between different signal extraction modules 1235 and 1234. As shown, both the implantable battery and/or communication module 1210c and the signal processor 1220c include a controller (1215, 1227) that communicates with the signal generator (1213, 1217) to generate the output signal. The signal generators (1213, 1217) output signals through a tri-state amplifier that includes one inverting amplifier (1297, 1289) for communication across the bi-directional communication 1251c for receipt by another signal extraction module (1234, 1235).

Thus, in some embodiments, bidirectional communication 1251c between the implantable battery and/or communication module 1210c and the signal processor 1220c may be enabled by each of the implantable battery and/or communication module and the signal processor to receive and transmit data over substantially the same communication structure as the other. In some such examples, the implantable battery and/or communication module 1210c and the signal processor 1220c include data extraction modules 1235 and 1234 configured to output signals from the signal generator (e.g., by the signal generator 1213 or the signal generator 1217) and receive and extract both signals (e.g., by the amplifier 1285 and the amplifier 1299), respectively.

In the example of fig. 12C, amplifiers 1295 and 1297 comprise tri-state amplifiers that selectively output (e.g., via an "enable" control from controller 1215) the signal from signal generator 1213, and amplifier 1297 is shown as an inverting amplifier. As described above, in some examples, amplifiers 1295 and 1297 comprise tri-state buffers. Similarly, in tri-state buffers 1287 and 1289 that selectively output signals from signal generator 1217 (e.g., via an "enable" control from controller 1227), buffer 1289 is shown as an inverting amplifier. As described elsewhere herein, the transmitted signal and its inverse (e.g., via 1295 and 1297) allow communication between the implantable battery and/or communication module 1210c and the signal processor 1220c in the absence of a net flow of charge. Thus, bidirectional communication between the implantable battery and/or communication module 1210c and the signal processor 1220c may be performed without a net flow of charge between the components.

As described elsewhere herein, power from the power generator 1211 and data from the signal generator 1213 (and/or the signal generator 1217) may be transmitted at different clock rates to optimize power and data transfer. In some examples, if the data communication (e.g., through the two-way communication 1251c) fails, the controller 1215 can be configured to control the power generator 1211 to provide both the power and data signals through the amplifiers 1290 and 1292, e.g., as described with respect to fig. 11B.

Thus, in some embodiments, the configuration of fig. 12C may be implemented to establish efficient bidirectional communication between the implantable battery and/or communication module 1210 and the signal processor 1220. The failure of the two-way communication 1251 may be identified manually and/or automatically. Upon detecting the failure of the bidirectional communication 1251, the controller 1215 may encode data into the power signal output from the power signal generator 1211 and may combine the power and data into a single signal, as described with respect to fig. 11B.

As discussed elsewhere herein, there may be different safety standards regarding electrical communication within the patient's body. For example, safety standards may limit the amount of current (particularly DC current) that can safely flow through a patient's body. As shown in fig. 11B, 12B, and 12C, each of the illustrated communication paths between the implantable battery and/or communication module and the signal processor are coupled to an output capacitor. Capacitors positioned at the input and output of the implantable battery and/or communication module and signal processor may substantially prevent DC current from flowing therebetween while allowing AC signals to be transmitted.

As described elsewhere herein, in some embodiments, data communicated between the implantable battery and/or communication module and the signal processor (e.g., from the signal generator) is encoded. In some such instances, the encoding may be performed according to a particular data encoding method, such as an 8b/10b encoding scheme, to achieve DC balance in the transmitted signal. For example, in some embodiments, the data may be encoded such that the number of high and low bits at each clock signal transmitted between the components meets some criteria for preventing a charge of one polarity from building up on any of the capacitors. This encoding may minimize the total charge flowing between the implantable battery and/or communication module and the signal processor during communication.

Although described and illustrated as representing communication between an implantable battery and/or communication module and a signal processor, it should be understood that the communication configurations shown in fig. 10, 11A, 11B, 12A, 12B, and 12C may be implemented between any pair of devices that typically communicate with each other. For example, isolated circuitry (e.g., R) may be included in any of the system components (e.g., middle ear sensor, acoustic stimulator, electrical stimulator, etc.)_{Pot for storing food}) To effectively isolate the ground signal from each assembly from its respective tank. Similarly, an exemplary capacitive AC coupled with a DC blocking capacitor and DC balance encoded as described elsewhere herein may be incorporated as a communication interface between any two communication components.

As described above, data may be communicated from the implantable battery and/or communication module to the signal processor for a variety of reasons. In some examples, the data is transferred from an external component, such as the programmer shown in fig. 1, to the implantable battery and/or communication module. In an exemplary procedure, a programmer such as a clinician's computer may be used to communicate with a fully implantable system of a patient via a communication configuration as shown in fig. 11B, 12B, or 12C. For example, the programmer may communicate wirelessly (e.g., via bluetooth or other suitable communication technology) with the patient's implantable battery and/or communication module. Signals from the programmer may be sent from the implantable battery and/or communication module to the signal processor via the communication configuration shown in fig. 11B, 12B, or 12C.

During such procedures, the clinician may communicate with the signal processor and, in some cases, with other components through the signal processor. For example, the clinician may cause the signal processor to actuate the electrical and/or acoustic stimulator in various ways, such as using various electrical stimulation parameters, a combination of active contact electrodes, various acoustic stimulation parameters, and various combinations thereof. Changing the stimulation parameters in real-time may allow clinicians and patients to determine the effectiveness of different stimulation techniques on individual patients. Similarly, the clinician may communicate with the signal processor to update the transfer function. For example, a clinician may iteratively update the transfer function signal processors as each signal processor is tested for efficacy in a single patient. In some instances, the combination of stimulation parameters and signal processor transfer functions may be tested for customized system behavior for individual patients.

In some embodiments, various internal properties of the system may be tested. FOR example, various IMPEDANCE values, such as sensor IMPEDANCE or stimulator IMPEDANCE, may be tested, as described in U.S. patent publication No. 2015/0256945, entitled "TRANSDUCER IMPEDANCE MEASUREMENT FOR hearing assistance (TRANSDUCER IMPEDANCE MEASUREMENT FOR HEARING AID"), the relevant portions of which are incorporated herein by reference.

Additionally or alternatively, various characteristics of the individual leads may be analyzed. Fig. 12D is a high-level schematic diagram illustrating exemplary electrical communication between an implantable battery and/or communication module and a signal processor in a cochlear implant system, similar to that shown in fig. 12A. In the simplified example of fig. 12D, conductors 1201, 1202, 1203, and 1204 extend between the implantable battery and/or communication module 1210D and the signal processor 1220D. In some examples, such conductors are included in leads (e.g., lead 190) extending between the implantable battery and/or communication module 1210d and the signal processor 1220 d. In the example of fig. 12D, the implantable battery and/or communication module 1210D includes a controller 1205, and the signal processor 1220D includes a controller 1206. The implantable battery and/or other internal components of the communication module 1210d and the signal processor 1220d are not shown, but various configurations are possible, as shown in fig. 11B, 12B, or 12C.

In some embodiments, one or both of the controllers 1205, 1206 may be configured to apply test signals to one or more of the conductors 1201, 1202, 1203, 1204 to test one or more properties of such conductors. In an exemplary test procedure, a controller (e.g., 1205) may drive a signal (e.g., a sine wave or other shaped wave) across a conductor (e.g., 1201) and measure the current sent and the voltage sent by the current. From this information, the controller can determine the conductor impedance, including the integrity of the conductor (e.g., whether the conductor is broken). Similarly, the controller may be configured to ground the second conductor (e.g., 1202) while driving the test signal across the test conductor (e.g., 1201) in order to measure one or more electrical parameters (e.g., capacitance, impedance, etc.) between the two conductors.

During exemplary operation, the controller may be configured to apply a test signal to a first conductor (e.g., 1201) and ground a second conductor (e.g., 1202). The controller may be configured to apply test signals at a plurality of frequencies (e.g., perform a frequency sweep) and measure impedance and frequency between the first conductor and the second grounded conductor. In various examples, the controller may be configured to perform such testing using any two conductors 1201, 1202, 1203, 1204 to test for a baseline value (e.g., when the system is in a known operating condition) or to test for an expected value (e.g., to compare to an established baseline). In various embodiments, a controller in implantable battery and/or communication module 1210d (controller 1205) and/or a controller in signal processor 1220d (controller 1206) may perform grounding and/or applying test signals to one or more conductors.

In some embodiments, such a test process may be performed automatically, for example, according to a programmed schedule. Additionally or alternatively, such a test procedure may be initiated manually, for example, by the wearer or clinician through an external device, such as through a programmer (e.g., 100) or charger (e.g., 102). The results of such processes may be stored in an internal memory for later access and analysis, and/or may be output to an external device for viewing. In some instances, the results and/or warnings may be automatically output to an external device if one or more of the results sufficiently deviate from the baseline value. In various examples, a sufficient change from baseline for the trigger output may be based on a percentage change from baseline (e.g., greater than 1% deviation, greater than 5% deviation, greater than 10% deviation, etc. from baseline). Additionally or alternatively, sufficient variation includes changing some number of standard deviations from baseline (e.g., greater than one standard deviation, two standard deviations, etc.). In various embodiments, the amount of change that triggers the output result and/or alert may be adjustable. Additionally or alternatively, this amount may vary between different measurements.

In some embodiments, one or more actions may be performed in response to the results of this analysis. For example, in the exemplary embodiment described with respect to fig. 12B, if the test reveals an unexpected impedance (e.g., from amplifier 1294 or inverting amplifier 1296) on one of the signal conductors, such as an open circuit, the controller 1214 can be configured to alter the operation of the system. For example, the controller 1214 may be configured to adjust the output from the power generator 1211 to provide both a power signal and a data signal by the power generator 1211, as described with respect to the configuration in fig. 11B. In some instances, the controller 1214 may be configured to transmit a signal to an external device signaling a change in operation and/or alerting the wearer and/or clinician that one or more conductors may be damaged or otherwise inoperable.

Although shown as separate components connected by a lead (e.g., lead 180) in several embodiments (e.g., fig. 1, 9, 11A, 12A), in some examples, the processor (e.g., 120) and stimulator (e.g., 130) may be integrated into a single component, e.g., within a hermetically sealed housing. Fig. 13A shows an exemplary schematic representation of the processor and stimulator combined into a single housing. In the example of fig. 13A, processor/stimulator 1320 receives signal input from a sensor (e.g., middle ear sensor) through lead 1370 and power from a battery (e.g., an implantable battery and/or a communication module) through lead 1390. Processor/stimulator 1320 may include hubs 1322, 1324 for receiving leads 1370, 1390, respectively.

Processor/stimulator 1320 may be configured to receive input signals from the sensors, process the received input signals according to a transfer function, and output stimulation signals through electrodes 1326. The electrodes 1326 may include one or more contact electrodes (e.g., 1328) that contact the cochlear tissue of the wearer to provide electrical stimulation thereto, such as described with respect to fig. 10B.

Processor/stimulator 1320 of fig. 13 includes return electrode 1330 for providing a return path (e.g., 1332) for stimulation signals emitted from electrode 1326. Return electrode 1330 may be electrically coupled to a grounded portion of circuitry within processor/stimulator 1320 to complete a circuit including the circuitry within processor/stimulator 1320, electrode 1326, the cochlear tissue of the wearer, and ground. In some examples, return electrode 1330 comprises a conductive material that is in electrical communication with circuitry within processor/stimulator 1320, while the remainder of the housing of processor/stimulator 1320 is typically not electrically coupled with internal circuitry.

In some embodiments, the return electrode 1330 and the housing of the processor/stimulator 1320 comprise a conductive material. For example, in some examples, the housing comprises titanium and the return electrode 1330 comprises platinum or a platinum alloy. Needle hub 1324 may generally comprise a non-conductive biocompatible material such as a biocompatible polymer. Non-conductive needle hub 1324 may provide isolation between return electrode 1330 and the conductive housing of processor/stimulator 1320.

Although shown in fig. 13A as being positioned in power hub 1324 of processor/stimulator 1320, return electrode 1330 may generally be positioned anywhere on the outer surface of processor/stimulator 1320. In some instances, one or more redundant return electrodes may be included, for example, at or near the interface of the housing and the electrode 1326. In some instances, the return electrode may be positioned on the proximal end of the electrode 1326 itself. In some embodiments with multiple return electrodes (e.g., return electrode on the proximal ends of return electrode 1330 and electrode 1326), a switch may be used to select which return electrode to use. Additionally or alternatively, multiple return electrodes may be used simultaneously.

Fig. 13B shows a simplified cross-sectional view of the processor/stimulator shown in fig. 13A taken along line B-B. As shown in fig. 13B, processor/stimulator 1320 includes a housing having a first side 1319 and a second side 1321 and a return electrode 1330 embedded in the housing. The return electrode 1330 can comprise a conductive material, such as platinum, suitable for contact with the wearer's tissue. In the example shown, the return electrode 1330 wraps around both sides of the housing of the processor/stimulator 1320 such that the return electrode 1330 is coupled to the outer surface of the housing on the first side 1319 and the second side 1321.

This may facilitate implantation to either side of the wearer's anatomy, as in some cases only one side of the processor/stimulator is in electrical contact with the wearer's conductive tissue, while the other side is in contact with, for example, the wearer's skull, and does not easily provide a return path (e.g., 1332). Thus, a single processor/stimulator design may be implanted in either side of the wearer's anatomy while providing an adequate return path through return electrode 1330.

In various examples, return electrode 1330 can extend around a peripheral edge of processor/stimulator 1320, as shown in fig. 13B. In other examples, return electrode 1330 may comprise segments on either side of the housing and may be connected to each other inside the housing rather than by a wrap-around contact. Additionally, although shown embedded in the housing of the processor/stimulator 1320, in some examples, the return electrode 1330 may protrude outward from the housing. Return electrode 1330 can generally be any of a variety of shapes and sizes, while including electrical contact sections on opposite sides of the housing to enable usability on either side of the wearer's anatomy. In other embodiments, the return electrode may be positioned on only one side of the housing for customized right or left side implementations.

As discussed elsewhere herein, in various embodiments, the processor typically receives an input signal, processes the signal, and generates a stimulation signal that can be applied by an integrated stimulator (e.g., by a processor/stimulator as in fig. 13A and 13B) or a separate stimulator in communication with the processor (e.g., as described in fig. 1 and 9). In some such embodiments, the input signal received by the signal processor is generated by an implantable sensor, such as a middle ear sensor (e.g., as described with respect to fig. 4 and 5).

However, such sensors typically measure or otherwise receive some sort of stimulus that is converted into an output that is read and processed by a signal processor. For example, some middle ear sensors may produce different output signals for a given stimulus depending on factors such as variability of the wearer's inner ear anatomy and motion. Thus, the output of a sensor to a given input may not be predictable, particularly across a range of frequencies, when designing a system.

Fig. 14A is a schematic diagram illustrating an exemplary signal processing configuration for normalizing a stimulation signal and adapting to variability of the sensor frequency response. Fig. 14B shows exemplary gain versus frequency response curves for signals at various stages in a processing configuration. The "gain" associated with a particular frequency as used with respect to fig. 14B refers to the relationship (e.g., ratio) between the magnitude of the input stimulus received by the sensor and processor and the magnitude of the resulting signal at various stages of processing. In the example shown, processor/stimulator 1400 receives input signals 1405 from sensors.

As shown in fig. 14B, the gain is very uneven over the frequency distribution shown in the figure. For example, according to the example shown, a stimulus signal received at 1kHz at the sensor will result in a signal 1405 of a much larger magnitude than the same magnitude stimulus signal received at 10kHz at the sensor. This difference in frequency response may make signal processing difficult. Furthermore, this frequency response will typically vary from person to person, or over the course of the wearer's life, due to physical movement or anatomical changes of the sensor.

The input signal 1405 undergoes analog processing 1410 to produce an analog processed signal 1415. As shown in fig. 14B, the analog processing step 1410 improves the uniformity of gain across the frequency range because the analog processed signal 1415 provides a flatter frequency response curve compared to the input signal 1405. In some embodiments, the analog processing may include one or more filters and/or amplifiers generally configured to flatten the frequency response curve, as shown in fig. 14B. In some examples, analog processing component 1410 within processor/stimulator 1400 may be substantially identical across various implantable systems in order to provide first order correction of the frequency response. In other examples, simulation processing configuration 1410 may be customized for the wearer, e.g., based on known anatomical features, measurements, analysis, etc.

The analog processed signal 1415 undergoes a digital processing step 1420 to produce a digitally processed signal 1425. As shown in fig. 14B, analog processing step 1420 further improves gain uniformity across a frequency range because digitally processed signal 1425 provides a flatter frequency response curve compared to analog processed signal 1415. In some embodiments, digital processing 1420 may be configured to substantially level the frequency response to correct for remaining frequency response inconsistencies in analog processed signal 1415. For example, in some embodiments, after digital processing 1420, a stimulation signal of a given magnitude at a first frequency and a second frequency will result in a digitally processed signal 1425 having the same magnitude at the first frequency and the second frequency. Thus, digitally processed signal 1425 corresponds to a normalized stimulation signal, thereby reducing or eliminating variability occurring with different wearer anatomies and wearer motion and/or over time. Having a normalized frequency response across a large frequency range may simplify the evaluation of the efficacy of an implanted system, the programming of signal processor transfer functions, the evaluation of system operation, and the like. In some instances, a flat frequency response may enable the system to present electrical stimulation to the wearer at an appropriate intensity level, e.g., relative to the received external acoustic stimulus, independent of the frequency content of the external acoustic stimulus.

In some embodiments, the digital processing 1420 may be customized after system implantation via a calibration process. In an exemplary calibration process, a clinician or other user may provide, for example, a series of stimulation signals at multiple frequencies and with similar magnitudes to be "picked up" by a sensor that generates an input signal 1405 for each received signal. A clinician or other user may then sample the resulting analog processed signal 1415 and/or the initial digitally processed signal 1425 at multiple frequencies to determine the remaining non-uniformity of the gain across the frequency sweep. The digital processing 1420 may be established or updated to compensate for the non-uniformity in order to establish a substantially flat frequency response curve of the digitally processed signal 1425. In some examples, multiple signals having different frequencies are provided in turn and a magnitude response (e.g., gain) at each frequency is determined. After determining this magnitude response, the digital processing stage 1420 may be updated based on the response versus frequency to flatten the frequency response curve.

In an alternative process, a white noise signal to be "picked up" by the sensor may be provided. A transformation (e.g., Fast Fourier Transform (FFT)) of the signal may be performed in order to extract the frequency content of the signal. The extracted frequency content may be used to determine a magnitude response at each frequency, and the digital processing 1420 may be updated to flatten the frequency response similar to that described above.

In the example shown of fig. 14A, the digitally processed signal 1425 (e.g., having a uniform gain across a frequency range relative to the input signal received from the sensor) is subjected to a signal processor transfer function 1430 to generate a stimulation signal 1435. The stimulation signals 1435 may be received by a stimulator 1440, which may apply electrical signals 1445 to electrodes as described elsewhere herein.

In some examples, the digital processing step 1420 for providing a uniform frequency response may be incorporated into the transfer function 1430, where digital processing of the analog processed signal 1415 levels out both the frequency response and the generation of the stimulation signal (e.g., 1435) according to the programmed transfer function. Additionally or alternatively, as described elsewhere herein, in some examples, the stimulator 1440 may be located external to the processor rather than being combined into a single processor/stimulator assembly 1400.

As described elsewhere herein, while many of the examples show the middle ear sensor in communication with an implanted signal processor, in various embodiments one or more additional or alternative input sources may be included. For example, in some embodiments, a microphone may be implanted under the skin of the user and may be placed in communication with the signal processor (e.g., through a removable connector such as 171). The signal processor may receive an input signal from the implantable microphone and provide a signal to the stimulator based on the received input signal and the signal processor transfer function.

Additionally or alternatively, one or more system components may be configured to receive a broadcast signal for conversion into a stimulus signal. Fig. 15 is a schematic system diagram illustrating an implantable system configured to receive broadcast signals from a broadcaster. As shown in the example of fig. 15, broadcast source 1550 broadcasts signals over communication link 1560. Communication link 1560 may include communications over various communication protocols, such as Wi-Fi, Bluetooth, or other known data transfer protocols. Broadcast source 1550 may include any of a variety of components, such as a media source (e.g., television, radio, etc.), a communication device (e.g., telephone, smart phone, etc.), a telecoil or other broadcast system (e.g., in a live performance), or any other source of audio signals that may be transmitted to an implanted system or external components of an implanted system (e.g., a system programmer, etc.).

An implantable system comprising programmer 1500, implantable battery and/or communication module 1510, signal processor 1520, and stimulator 1530 may generally receive data from broadcast source 1550 through communication link 1560. In various embodiments, any number of components in the implantable system may include a receiving device, such as a telecoil, configured to receive the broadcast signal for eventual conversion to a stimulation signal.

For example, in some embodiments, programmer 1500 may include a telecoil relay configured to receive broadcast telecoil signals from broadcast source 1550. The programmer may be configured to then transmit a signal representative of the received broadcast signal to the implantable battery and/or communication module 1510 and/or the signal processor 1520, for example, via bluetooth communication. If communications are received from the programmer 1500 via the implantable battery and/or communications module 1510, the implantable battery and/or communications module 1510 may transmit a signal to a signal processor, such as described in any of fig. 11A, 11B, 12A, or 12C.

In some such embodiments, the signal processor 1520 may be configured to receive this signal from the implantable battery and/or communication module 1510 and output a stimulation signal to the stimulator 1530 based on the received signal and the signal processor transfer function. In other examples, the signal processor 1520 may include a telecoil repeater or other device capable of receiving broadcast signals from the broadcast source 1550. In some such embodiments, the signal processor 1520 processes the received signals according to a signal processor transfer function and outputs stimulation signals to the stimulator 1530.

In some embodiments, the signal processor 1520 may communicate (e.g., via the implantable battery and/or the communication module 1510) with a plurality of input sources, such as a combination of an implanted microphone, a middle ear sensor, and a broadcast source 1550. In some such instances, the signal processor may be programmed with a plurality of transfer function programs, each transfer function according to a respective input source. In such embodiments, the signal processor may identify which one or more input sources provide an input signal and process each such input signal according to the transfer function associated with its corresponding input source.

In some examples, signal processor 1520, which receives multiple input signals from a corresponding multiple input sources, effectively combines the signals when generating the stimulation signals to stimulator 1530. That is, in some embodiments, the input sources are combined to form a stimulation signal from the signal processor 1520. In some such instances, a user may be able to mix the various received input signals in any desired manner. For example, the user may choose to blend various different input streams, such as input from a middle ear sensor or other implantable device, signals received from an external device (e.g., a telecoil relay, a bluetooth connection such as a smartphone), and so forth. In an exemplary configuration, the user may choose to blend the two input sources equally, such that the stimulation signal is based on 50% of the first input source and 50% of the second input source.

Additionally or alternatively, the user may choose to effectively "mute" one or more input sources, such that the signal processor 1520 outputs a stimulation signal based on input signals received from un-muted sources. Similarly, a user may be able to select a single source from which to process a received input signal. For example, in some embodiments, the user may choose to have the signal received from broadcast source 1550 processed and converted to a stimulus signal while having the signal received from, for example, a middle ear sensor ignored.

In some instances, direct communication with a signal processor may be used to test the efficacy of a given signal processor transfer function and associated stimulation (e.g., acoustic or electrical) parameters. For example, a programmer may be used to disable input signals from a middle ear sensor or other input source and provide customized signals to the signal processor to simulate signals from the input source. The signal processor processes the received signal according to its transfer function and actuates the electrical and/or acoustic stimulator accordingly. The processor may be used to test a variety of customized "sounds" to determine the efficacy of a given patient's signal processor transfer function for each "sound".

FIG. 16 is a process flow diagram illustrating an exemplary process for establishing a preferred transfer function for a patient. The method may include connecting an external programmer to the implantable battery and/or communication module (step 1650). Connecting may include, for example, establishing a wireless connection (e.g., bluetooth communication) between the external programmer and the implantable battery and/or communication module. The external programmer may include any of a variety of components, such as a computer, a smart phone, a tablet computer, etc., capable of providing programming instructions to the implantable battery and/or communication module.

Once communication is established, if no signal processor transfer function is active (step 1652), a signal processor transfer function may be established (step 1654). If the transfer function has been activated, or after the transfer function is established (step 1654), a programmer may be used to input one or more analog "sounds" to the signal processor. This "sound" may be received and processed by a signal processor as if it were received from an input source such as a middle ear sensor. "Sound" may be, for example, a computer-generated signal designed to simulate various input signals, such as a range of frequencies, speech sounds, or other distinguishable sound characteristics.

The process may further include testing the efficacy of the signal processor transfer function (step 1658). This may include, for example, determining how well the patient responds to each sound of a given signal processor transfer function. In some instances, this may include ranking the transfer functions under test for each of the "sounds" and determining an overall score for the transfer function based on the scores associated with the one or more "sounds".

After testing the efficacy of the signal processor transfer functions, if all desired transfer functions are not tested (step 1660), the signal transfer functions may be updated (step 1654). One or more simulated "sounds" may be input to the signal processor (step 1656) and processed according to the updated transfer function, and the efficacy of the updated transfer function may be tested (step 1658). Once all desired transfer functions have been tested (step 1660), the user's signal processor transfer functions may be created or selected and implemented for the patient (step 1662). In some examples, the best transfer function of the tested transfer functions is selected based on user preferences, highest scores, or other metrics. In other examples, composite results from the tested transfer functions may be combined to create a customized transfer function for the patient.

In other instances, the pre-processing of the simulated "sound" may be performed outside the signal processor, e.g., in the field with a clinician or audiologist, as opposed to continuously updating the signal processor transfer function. For example, in an exemplary process, one or more simulated sounds may be pre-processed using processing software to create a simulated stimulation signal to be produced by a particular input signal processed through a particular transfer function. In some instances, such signals may be passed to a signal processor, for example, for applying stimulation signals directly to the wearer.

For example, communication with the stimulator may be performed directly by various system components, such as a programmer. In other examples, this communication may be performed by an implantable battery and/or a communication module and a signal processor. For example, in an exemplary embodiment, the pre-processed signal may be transmitted to the implantable battery and/or the communication module via wireless (e.g., bluetooth) communication. The implantable battery and/or communication module may communicate the preprocessed signals to a signal processor that may be configured with a unit transfer function. Thus, the signal processor only delivers the pre-processed signals to the stimulator for performing stimulation.

FIG. 17 is a process flow diagram illustrating an exemplary method of testing the efficacy of one or more sounds by means of a preprocessed signal using one or more transfer functions. In the method of FIG. 17, the sound may be loaded (step 1750) into, for example, an application or processing software capable of processing the received sound. In some instances, the sound may be an analog sound, such as a computer-generated signal representing a desired sound. In other examples, the sound may comprise recording an actual sound such as a human voice or other stimulus. The loaded sound may be pre-processed according to a transfer function to generate a stimulation signal (step 1752). For example, the pre-processing may be performed on a stand-alone workstation, a system programmer, or the like.

The method of fig. 17 further includes the step of applying a stimulation signal from the pre-processed sound to a stimulator of the implantable system (step 1754). As described elsewhere herein, this communication of the stimulation signal to the stimulator may be performed in a variety of ways, such as directly to the stimulator (e.g., from an external workstation, a user's programmer, etc.) or through a signal processor.

After applying the stimulation signal (step 1754), the method may further comprise the step of testing the efficacy of the stimulation signal (step 1756). This may include, for example, testing the user's understanding of the initial sound from the received stimulation signal, receiving a rating score from the user, or any other suitable way of quiescing the efficacy of the stimulation signal. Since the stimulation signal applied in step 1754 is based on the sound and the transfer function used for the pre-processing, testing the efficacy of the stimulation signal is similar to testing the efficacy of the transfer function for a given sound.

After testing the efficacy of the stimulus signal, it can be determined whether all analog transfer functions have been tested for a given sound (step 1758). If no test is performed, the method may comprise the steps of: the simulated transfer function is established or updated (step 1760) and the steps of pre-processing the sound to establish the stimulation signal (step 1752), applying the stimulation signal (step 1754) and testing the efficacy of the stimulation signal (step 1756) all according to the updated transfer function are repeated. Thus, a given sound may be processed according to multiple transfer functions, and multiple corresponding stimulation signals may be tested with respect to a given user. If all of the simulated transfer functions have been tested at step 1758, the process may include establishing a preferred processing for the sound (step 1762).

In some instances, the process of fig. 17 may be performed in real-time. For example, in some embodiments, a device in communication with a stimulator in an implantable system (e.g., directly through wireless communication with the stimulator or indirectly through a signal processor) may cycle through various analog transfer functions while pre-processing the sound signal prior to delivery to the user's system. In some such instances, after establishing a preferred processing technique (e.g., simulated transfer function) for a given sound (e.g., in step 1762), the user's signal processor transfer function may be updated to reflect the given user's preferred transfer function.

Additionally or alternatively, the process of fig. 17 may be repeated for a plurality of different sounds. In some embodiments, multiple sounds may be pre-processed according to multiple different simulated transfer functions, and the resulting generated stimulation signals may be stored in a database. The method of fig. 17 may be performed using a testing device such as a workstation, programmer, or the like, while testing the efficacy of various transfer functions with respect to various sounds of a user using a database of stimulation signals.

In some instances, this database may be used to fit a patient with a particular implant system. For example, stimulation signals generated by pre-processing various sounds may be delivered to a user's implantable stimulator having an implantable stimulator and cochlear electrodes to test the efficacy of the transfer function simulated in the pre-processing. In various instances, multiple generated stimulation signals associated with a given sound may be applied to the stimulator until a preferably simulated transfer function is established. In other examples, a stimulus signal representative of the generation of the plurality of sounds may be established for each of a plurality of transfer functions, such that each transfer function of the user may be tested for the plurality of sounds before another transfer function is tested.

Fig. 18 is a schematic representation of an exemplary database of pre-processed sound signals. As shown, the database is represented as a table with n rows corresponding to different sounds (sound 1, sound 2, … …, sound n) and m columns corresponding to different simulated transfer functions (simulated transfer function 1, simulated transfer function 2, … …, simulated transfer function m). As shown, at the intersection of each row (i) and each column (j), pre-processing the sound i with an analog transfer function j produces a stimulus signal (i, j). In some embodiments, a table of stimulus signals generated by the pre-processed sound as shown in fig. 18 may be stored in a database of pre-processed sound signals for user-fitted devices.

As discussed elsewhere herein, during various assembly processes, a sound (e.g., sound 1) may be selected from the database, and a plurality of different stimulation signals (e.g., stimulation signal (1,1), stimulation signal (1,2), …, stimulation signal (1, m)) may be transmitted to the implantable stimulator. This stimulation signal generally corresponds to the result of a sound (e.g., sound 1) pre-processed according to various simulated transfer functions (1-m). As described with respect to fig. 17, a preferred stimulation signal (and thus a preferred corresponding simulated transfer function) may be established for a given sound (e.g., sound 1). A similar process may be repeated for each sound in the database. In various examples, one or more signal processor transfer functions may be communicated to the signal processor based on the determined preferred simulated transfer function. For example, in some instances, the analog transfer function that is preferred in most sounds may be implemented as a signal processor transfer function. In other embodiments, the signal processor contains multiple transfer functions, and different transfer functions may be applied to different detected sounds according to the preferred transfer function for each sound.

In other exemplary assembly processes, a plurality of stimulation signals (e.g., stimulation signal (1,1), stimulation signal (2,1), …, stimulation signal (n,1)) corresponding to a single simulated transfer function (e.g., simulated transfer function 1) may be applied to the stimulator. This stimulation signal corresponds to a plurality of sounds that are pre-processed according to a single simulated transfer function. This can be used to test the efficacy of the selected transfer function. The process may be repeated for multiple simulated transfer functions (e.g., 2-m) to determine the best transfer function across the various sounds (e.g., sounds 1-n).

In general, a data set of stimulus signals generated by pre-processing sound signals through various transfer functions as shown in fig. 18 may be used to expedite testing of such transfer functions for a particular user. Pre-processing this sound allows the processing to be done before any assembly process, e.g. in a laboratory or on a workstation, and allows stimulation signals corresponding to different transfer functions to be applied efficiently to the user's stimulator without the need to update the signal processor. In addition, such pre-processing may allow testing of the efficacy of more advanced or computationally demanding processing techniques, even if the implanted signal processor has not yet effectively implemented such processing techniques (e.g., due to various hardware limitations). Testing the efficacy of such processing techniques may drive the evolution of processing methods and hardware capabilities, for example, in an effort to adopt more complex processing techniques in the future.

Various features and functions of the implantable system have been described herein. As described, in various embodiments, system operation may be adjusted based on communication with the implanted system from components located outside the body while the system remains implanted. In some embodiments, the system may include any number of external components capable of interfacing with the system in a variety of ways.

Fig. 19 is a schematic diagram illustrating possible communication between various system components according to some embodiments of a fully implantable system. In the embodiment shown, the implantable components of the system (outlined in dashed lines) include an implantable battery and/or communication module 1910, a signal processor 1920, and a stimulator 1930. Such implantable components may operate according to various examples as described herein to effectively stimulate a user (e.g., through electrical and/or acoustic stimulation) in response to received input signals.

The schematic illustration of fig. 19 includes a plurality of external devices capable of wirelessly interfacing with one or more of the implantable components, such as through a communication link 1925. Such devices may include a programmer 1900, a charger 1902, a smartphone/tablet 1904, a smart watch or other wearable technology 1906, and a key fob 1908. In some instances, such components may communicate with one or more implantable components via one or more communication protocols such as bluetooth, Zigbee, or other suitable protocols over a wireless communication link 1925. In various embodiments, different external devices may be capable of performing one or more functions associated with system operation. In some such embodiments, each external device is capable of performing the same functions as the other devices. In other examples, some external devices are capable of performing more functions than other devices.

For example, programmer 1900 may be capable of wirelessly interfacing with one or more implantable components to control various operating parameters of the implantable system. For example, in some embodiments, programmer 1900 may be configured to adjust a signal processor transfer function or select an operational profile (e.g., associated with a particular signal processor transfer function according to a particular user, environment, etc.). In some instances, programmer 1900 may be used to create a user profile, such as a preferred signal processor transfer function, as described elsewhere herein. Programmer 1900 may additionally or alternatively be used to turn the system on or off, adjust the volume of the system, receive input data, and stream input data to the system (e.g., implantable battery and/or communication module 1910). In some embodiments, programmer 1900 includes a display for displaying various information to a user. For example, the display may be used to indicate a mode of operation (e.g., loaded user profile), remaining power level, and so forth. In some such embodiments, the display may act as a user interface through which a user may adjust one or more parameters, such as volume, profile, input source, input mix, and the like.

In some embodiments, the charger 1902 may be used to charge one or more internal batteries or other power sources within the system, such as an implantable battery and/or the communication module 1910. In some examples, the charger 1902 may include the same functionality as the programmer 1900 including, for example, a display and/or a user interface. In some such embodiments, programmer 1900 and charger 1902 may be integrated into a single device.

In some embodiments, various external devices, such as a smartphone or tablet 1904 may include an application ("app") that may be used to interface with the implanted system. For example, in some embodiments, a user may communicate with the system through a smartphone or tablet 1904 (e.g., through link 1925) to adjust certain operating factors of the system using a predetermined app to provide an interface (e.g., through a visual interface of a display integrated into an external device). The app may help the user adjust various parameters such as volume, operating profile, on/off, etc. In some instances, the smartphone/tablet 1904 may be used to stream input signals to an implanted system, such as media or communications playing on the smartphone/tablet 1904.

In some systems, a smart watch or other wearable technology 1906 may interact with the system in a similar manner as the smartphone/tablet 1904. For example, a smart watch or other wearable technology 1906 may include an app similar to those operable on a smartphone/tablet computer for controlling various aspects of the implantable system, such as volume control, on/off control, and so forth.

In some embodiments, key fob 1908 may be used to perform basic functions with respect to an implanted system. For example, in some embodiments, key fob 1908 may be used to load/implement a particular operating profile associated with key fob 1908. Additionally or alternatively, key fob 1908 can function similarly to cut-off controller 104 of fig. 1 and can be used to quickly disable and/or mute the system. As described elsewhere herein, in some instances, the same means for disabling and/or muting the system (e.g., key fob 1908) may be used to enable and/or un-mute the system.

The schematic of fig. 19 further includes a broadcast source 1950 configured to broadcast a signal 1960 that may be received by one or more external devices and/or one or more implanted system components. Similar to broadcast source 1550 in fig. 15, broadcast source 1950 may be configured to transmit a signal that may become a stimulation signal for application by stimulator 1930. The broadcast signal 1960 may include, for example, a telecoil signal, a bluetooth signal, etc. In various embodiments, one or more external devices, such as programmer 1900, charger 1902, smartphone/tablet 1904, smart watch/wearable device 1906, and/or key fob 1908 may include components (e.g., telecoil relays) capable of receiving broadcast signals 1960. The external device may be further configured to transmit a signal representative of the received broadcast signal 1960 to the one or more implantable components to apply stimulation to the patient based on the broadcast signal 1960.

Additionally or alternatively, in some embodiments, one or more implantable system components, such as the implantable battery and/or communication module 1910, the signal processor 1920, and/or the stimulator 1930, can be configured to receive the broadcast signal 1960. Such components may be used to generate stimulation signals for application to a user by stimulator 1930 from received broadcast signals 1960.

As described, in some embodiments, various devices may communicate with components in an implantable system via a wireless communication protocol, such as bluetooth. Various data and signals may be communicated wirelessly, including control signals and streaming audio. However, in some cases, this wireless communication should be secured so that the system communicates only with those devices that the wearer desires. This may prevent undesired signals from being broadcast to the implanted device and/or unauthorized access to one or more adjustable device settings.

In some embodiments, the one or more implantable system components include a near field communication component configured to facilitate communication between the system and an external device only when in close proximity to the near field communication component. In some such instances, once near field communication is established, a pairing for longer range wireless communication (e.g., bluetooth) may be established. For example, in an exemplary embodiment, the charger and implantable battery and/or communication module may each contain near field communication components for establishing secure near field communication and subsequently pairing with each other for additional wireless communication.

Fig. 20 is a schematic diagram illustrating establishing secure wireless connections between various components in an implantable system. In the example shown, the charger 2010 is configured to communicate with an implantable battery and/or communication module 2020. The charger 2010 includes a wireless communication component 2016, such as a bluetooth link, that can facilitate communication between the charger 2010 and other devices. The charger 2010 further includes a near field communication component 2012, such as a coil, and a processor/memory component 2014 that can receive and transmit signals from and to the near field communication component 2012 and/or the wireless communication component 2016.

The implantable battery and/or communication module 2020 includes a wireless communication component 2026, such as a bluetooth link, that may facilitate communication between the charger 2010 and other devices. The implantable battery and/or communication module 2020 further includes a near field communication component 2022, such as a coil, and a processor/memory component 2024 that can receive and transmit signals from and to the near field communication component 2022 and/or wireless communication component 2026.

In some embodiments, the near field communication components 2012 and 2022 include coils capable of establishing near field wireless communication therebetween. In some embodiments, the coil may also be used to transfer power between the power source 2018 of the charger 2010 to the power source 2028 of the implantable battery and/or communication module 2020, for example to charge the power source 2028 in an implanted system for continued use. In various embodiments, power source 2018 and/or power source 2028 may include one or more batteries, capacitors (e.g., ultracapacitors), and/or other power storage devices that may store electrical energy and provide electrical energy to other components. In some embodiments, the power source 2018 in the charger 2010 may include an external or removable power source, such as a removable or replaceable battery and/or a power cord that may be plugged into a standard wall jack.

In some examples, the implantable battery and/or communications module 2020 is not capable of communicating with external components through the wireless communication component 2026 until such communication is first enabled. In such embodiments, enabling such communication is performed by the near field communications component 2022 to ensure that the device is not accidentally or undesirably paired with the implantable battery and/or communications module 2020.

In the exemplary embodiment of fig. 20, the numbers in the blocks illustrate an exemplary sequential process for establishing wireless communication between the charger 2010 and the implantable battery and/or communication module 2020. In the illustrated embodiment, the charger 2010 first establishes contact with the implantable battery and/or communication module 2020 through the near field communication components 2012, 2022. In various embodiments, this near field communication operates only within a very short distance, such as within two inches. This prevents other devices from accidentally or undesirably establishing near field communication with the implantable battery and/or communication module 2020. During performance of this step, the user may position the charger 2010 proximate to the pectoral region where the implantable battery and/or communication module 2020 is implanted to enable this communication. In some examples, after the charger 2010 is paired with the implantable battery and/or communication module 2020 through near field communications 2012, 2022, such devices may then communicate through wireless communications 2016, 2026.

In some embodiments, the external device 2030 (e.g., a smartphone or other audio/media source) may include a wireless communications component 2036 and a processor/storage 2034 capable of facilitating communication with the implantable battery and/or communications module 2020 (e.g., through the wireless communications component 2026), but may not include a near field communications component for pairing the external device 2030. Thus, in some instances, the paired charger 2010 may be configured to enable subsequent pairing of the implantable battery and/or communication module 2020 with the external device 2030.

The encircled numbers show an exemplary pairing order of the external device 2030 and the implantable battery and/or communication module 2020. The charger 2010 may communicate with the external device 2030 through the wireless communication components 2016, 2036, for example, to determine that a user wishes to pair the external device 2030 with the implantable battery and/or communication module 2020. The charger 2010 may then communicate with the implantable battery and/or communication module 2020 (e.g., via the wireless communication components 2016, 2026) to pair the implantable battery and/or communication module 2020 with the external device 2030 to enable subsequent wireless communication between the implantable battery and/or communication module 2020 and the external device 2030 (e.g., via the wireless communication components 2026, 2036).

In some examples, once the device is paired with the implantable battery and/or communication module 2020, the device may be used to subsequently pair additional devices with the implantable battery and/or communication module, as described above with respect to charger 2010. In other embodiments, only some devices include the ability to pair additional devices with the implantable battery and/or communication module 2020, such as the charger 2010 only. In still further examples, each device must pair with the implantable battery and/or communication module through a near field communication process (e.g., through the field communication component 2022) before a longer range wireless (e.g., bluetooth) communication can be established.

Additionally or alternatively, once the external device is paired with the implantable battery and/or communication module 2020, additional functionality may be performed using the external device (e.g., external device 2030). In some embodiments, the additional functionality may include adjusting a transfer function of the signal processor. In some examples, the external device includes or is otherwise in communication with one or more sensors and may be configured to update a transfer function of the signal processor based on one or more signals detected by the one or more sensors. In some such examples, one or more such sensors may include a microphone, a location sensor (e.g., GPS, location based on one or more available wireless networks, etc.), a clock, or other sensors known to one of ordinary skill in the art. In some embodiments, the external device (e.g., 2030) that includes or communicates with such one or more sensors includes a smartphone, a tablet, or a computer.

In embodiments where the external device contains or is in communication with a microphone, the external device may be configured to reprogram the signal processor based on information collected from the microphone that is representative of the acoustic environment. For example, the external device may be configured to identify background noise (e.g., low-end noise) and update the signal processor transfer function accordingly. In some such instances, the external device may be configured to reduce the gain of the low-end signal and/or emphasize other sounds or frequency ranges, such as speech or other sounds having higher frequencies. In some embodiments, a user may initiate a process of identifying background noise to adjust the operation of the signal processor through an external device, for example, through a user interface (e.g., a smartphone or a tablet computer touch screen).

In embodiments where the external device includes or is in communication with a position sensor and/or clock, the external device may reprogram the signal processor based on the detected position and/or time. For example, in an example embodiment, when the external device is located in a place where the loud sound is known (e.g., a mall or stadium), the external device may be configured to detect the location and automatically reprogram the signal processor to reduce background noise (e.g., a particular frequency or range of frequencies) and/or to reduce the overall gain associated with the transfer function. Similarly, in some instances, the external device may be configured to reprogram the signal processor to emphasize the frequency associated with the voice when located in a place (e.g., a movie theater) where the wearer may wish to specifically identify the voice.

In some instances, the transfer function may be updated to reduce the contribution of the identified background noise. In some embodiments, reducing the contribution of the identified background noise includes emphasizing signals having a frequency content between approximately 200Hz and 20 kHz. In some embodiments, updating the transfer function to reduce the contribution of the identified background noise includes emphasizing signals having a frequency content between approximately 300Hz and 8 kHz. Emphasizing signals within such frequency ranges may help emphasize human speech or other similar signals within a noisy environment.

Additionally or alternatively, the external device may be configured to reprogram the signal processor based on the determined time of day. For example, the external device may be configured to reduce the volume of all or most sounds when the wearer does not normally want to be disturbed (e.g., at night). In some instances, the wearer may additionally or alternatively, through an external device, temporarily reprogram the signal processor to adjust the transfer function of the signal processor (e.g., to reduce the volume) for a predetermined amount of time (e.g., 15 minutes, 1 hour, or 1 day).

In some examples, reprogramming the signal processor includes adjusting the transfer function to achieve the relative change (e.g., decrease the volume). In some cases, reprogramming the signal processor includes implementing a predefined transfer function in response to received data, such as position data indicating that the wearer is in a particular position. In some such instances, a plurality of preprogrammed transfer functions are stored in memory and may be implemented based on data acquired by one or more sensors of an external device.

In some embodiments, the external device may be configured to provide the input signal based on audio generated by the external device. For example, the external device may be a smartphone and may provide input signals to the wearer's implantable battery and/or communication module including audio from a phone call, text-to-speech audio (e.g., reading a text message or article aloud), and/or media audio (e.g., video, music, games, etc.). The implantable battery and/or communication module may be configured to relay the input signal to the signal processor for conversion by the signal processor into a corresponding stimulation signal.

Fig. 21 illustrates a process flow diagram showing an exemplary method for pairing a charger with an implanted system. The method includes turning on a charger (step 2100) and initiating a pairing process by the charger (step 2102). The charger may instruct the user to place and hold a communication coil associated with the charger over the implant (step 2104). When within range of the coil communication, the charger communicates with the implant (step 2106), for example, via the implantable battery and/or communication module. The charger may determine whether the pairing with the implant was successful (step 2108) and display to the user whether the pairing was successful (step 2110) or unsuccessful (step 2112).

Fig. 22 illustrates a process flow diagram showing an exemplary method for pairing another device with an implanted system using a paired charger. The method includes selecting an option for pairing a device with an implant on a charger (step 2200), turning on the desired device and placing it in pairing mode (step 2202). The implant determines the mateable devices and transmits a list of available devices to the charger (step 2204), which displays the list of available devices to the customer (step 2206). The user may select from the displayed list of devices to initiate pairing (step 2208). The charger and/or the selected device may determine whether the pairing was a successful step (step 2210). If the pairing is successful, a "pairing successful" message may be displayed by the charger and/or the newly paired device (step 2212). If the pairing is unsuccessful, a "pairing unsuccessful" message may be displayed on the charger (step 2214). For example, in some embodiments, after attempting to initiate pairing between the implant (e.g., by an implantable battery and/or communication module of the system) and another device (e.g., step 2208), if after a predetermined amount of time the charger does not receive an indication from the implant or the selected device confirming the pairing, the charger may determine that the pairing is unsuccessful, output a "pairing unsuccessful" message (step 2214), and stop attempting to establish the pairing.

In various examples, a device that may be paired with the implant (e.g., for communicating with the implantable battery and/or communication module) by a charger, such as by the method shown in fig. 22, may include a remote control, a smart device running an application for interfacing with the implant, a key fob, an audio streaming device, or other consumer electronics capable of wireless communication (e.g., bluetooth).

Referring back to fig. 20, in various embodiments, once a device (e.g., charger 2010, external device 2030, etc.) has been paired with the implantable battery and/or communication module 2020 for wireless communication, information associated with the pairing (e.g., device identifier, etc.) may be stored in one or more memory components (e.g., 2014, 2024, 2034) so that the pairing need not be performed again in the future. In some embodiments, one or more devices may be unpaired by the communication with the implantable battery and/or communication module 2020. For example, if the user no longer uses the device (e.g., discards, returns, gifts, etc.), the device may be used to disconnect from the implantable battery and/or communication module 2020. Additionally or alternatively, the device may automatically unpair if the device has not established wireless communication with the implantable battery and/or communication module 2020 within a certain amount of time since the last connection. For example, in an exemplary embodiment, if a device that is transmitting a bluetooth audio stream to an implanted system through an implantable battery and/or communication module is disconnected from the implantable battery and/or communication module for greater than 5 minutes, the device is unpaired from the implantable battery and/or communication module and must be re-paired for future use.

As described, in various embodiments, different external devices may interface with the implantable components to adjust the operation of the system in various ways. In some embodiments, not all components may be capable of performing the same function as other components. Fig. 23 is a graph illustrating various parameters that may be adjusted by each of various external devices according to some example systems. In the example of FIG. 23, an entry in the diagram containing an "X" represents a component configured to perform the corresponding function. For example, in the illustrated embodiment, only the charger is capable of performing an initial wireless pairing with the implanted system, as described with respect to fig. 20 and 21. In some such examples, the remaining devices that may be programmed for wireless communication with the implanted system are paired through a charger, as described with respect to fig. 22. Other examples are possible where different components contain different functionality than represented by the example of fig. 23, for example, where components other than or in addition to a charger may initiate wireless pairing with an implanted system.

In general, the modularity of such systems allows system modifications, such as repair, replacement, upgrade, and/or transition from a partially implantable system to a fully implantable system, to be performed with minimal interference with implanted system components. For example, the implanted cochlear electrode and electrical and/or acoustic stimulator may remain in place while other system components are implanted and/or replaced, thereby reducing the risk of additional procedures damaging the cochlear tissue of the patient. In addition, communication techniques as described herein may be used to help customize and/or optimize the signal processor transfer function for a particular patient, as well as enable the system to meet safety standards, provide sufficient power and data transfer rates between system components, and operate at high efficiency. It should be understood that although described herein generally with respect to implantable hearing systems, the described communication techniques may be used with various other implantable systems, such as various neuromodulation devices/systems, including, for example, pain management, spinal cord stimulation, brain stimulation (e.g., deep brain stimulation), and so forth.

In some embodiments, the system may communicate with external devices to assist in fitting and/or calibrating the implantable system. FIG. 24 shows an example configuration of interfacing devices configured to facilitate system calibration. As shown, an external device 2400 (e.g., a laptop, a PC, a smart phone, a tablet, a smart watch, etc.) communicates with the mounting hub 2402. The mounting hub 2402 contains or otherwise communicates with speakers 2404, which may output sounds based on commands from the mounting hub 2402.

In the example shown, the mounting hub 2402 includes a wireless communication interface 2406 (e.g., a bluetooth interface) that can communicate with the communication interface 2442 of the implantable battery and/or communication module 2440. In some examples, the mounting hub 2402 includes or is otherwise capable of interfacing with a near field communications component 2408 (e.g., a communications coil) to enable bluetooth communications (e.g., by the implantable battery and/or communications module 2440) between the mounting hub 2402 and an implanted system as described elsewhere herein. Additionally or alternatively, wireless (e.g., bluetooth) communication between the mounting hub 2402 and the implantable battery and/or communication module 2440 may be accomplished using another device (e.g., a charger).

The illustrated system of fig. 24 includes an implanted modular cochlear implant system that includes an implantable battery and/or communication module 2440, a signal processor 2420, a sensor 2410, a stimulator 2430, and a cochlear electrode 2416. Such components may be configured and arranged similarly to the various embodiments described herein, and may be configured to provide electrical signals from the stimulator 2430 through the cochlear electrode 2416 based on signals received at the signal processor from the sensor 2410.

During an exemplary calibration process, the mounting hub 2402 may be configured to output sound through the speaker 2404 and also transmit information about the sound (e.g., intensity, frequency content, etc.) to the implantable battery and/or communication module 2440 of the implantable system. The implantable system, e.g., via signal processor 2420, may be configured to compare the output of sensor 2410 (received at signal processor 2420) with the actual sound emitted from speaker 2404. This data may be repeated for a variety of sounds from the output from the speaker (e.g., various frequencies and/or magnitudes) and used to determine a relationship between the sound picked up from the sensor 2410 and the output from the sensor 2410 to the signal processor 2420. Based on this information, the transfer function of the signal processor 2420 may be calibrated so that the stimulation signal sent to the stimulator 2430 based on the output from the sensor 2410 accurately represents the sound from the environment. Additionally or alternatively, the information may be used to identify how effectively the sensor responds to various external acoustic stimuli, such as different frequencies, intensities, and the like. This information may be determined specifically for the wearer, as the sensor response may depend on various factors specific to the wearer and/or the positioning of the sensor.

In some embodiments, the mounting hub 2402 may be configured to output one or more sounds comprising a single frequency and/or a single intensity. For example, each sound may have signal frequency components at a certain intensity, such as various tones. Additionally or alternatively, the one or more sounds may include complex frequency and intensity components, such as sounds representing various beeps, words, noise, or other sounds known to one of ordinary skill in the art.

Although described as occurring in an implanted system (e.g., signal processor 2420), the calibration process may be similarly performed by the mounting hub 2402. For example, the speaker 2404 may output a sound based on instructions from the mounting hub 2402. The sensor 2410 may output a signal based on the sensor's response to sound emitted from the speaker 2404, and the signal processor 2420 may receive the signal from the sensor 2410 and output a stimulation signal to the stimulator 2430 based on the received signal and the signal processor transfer function.

In various examples, the implantable battery and/or communication module 2440 may be configured to receive signals from the sensor 2410, stimulation signals from the signal processor 2420, or any combination of signals representative of one or both of such signals. The implantable battery and/or communication module 2440 may then transmit one or more signals representing the output of the sensor 2410 and/or the signal processor 2420 to the mounting hub 2402 in response to the sound output from the speaker 2404. Comparison of the sound output from the speaker 2404 with the corresponding resulting signal in the implanted system may be performed by processing in the mounting hub 2402. Similar to that discussed above, this comparison may be used to determine a relationship between sound picked up from the sensor 2410 and the output from the sensor 2410 to the signal processor 2420. Based on this information, the transfer function of the signal processor 2420 may be calibrated so that the stimulation signal sent to the stimulator 2430 based on the output from the sensor 2410 accurately represents the sound from the environment. Additionally or alternatively, the information may be used to identify how effectively the sensor responds to various external acoustic stimuli, such as different frequencies, intensities, and the like. This information may be determined specifically for the wearer, as the sensor response may depend on various factors specific to the wearer and/or the positioning of the sensor.

As described, in various examples, external device 2400 can be used in conjunction with mounting hub 2402. For example, in some instances, the external device 2400 may provide processing and control capabilities for the processes described herein, and the mounting hub 2402 may act as an interface between the external device 2400 and the implanted system (e.g., by providing a speaker 2404, a wireless communication interface 2406, a near field communication component 2408, etc.).

In some embodiments, the features and/or functions of the mounting hub 2402 as described herein may be performed by an external device, such as by a laptop, PC, smartphone, tablet computer, or the like, including the various capabilities described with respect to the mounting hub. For example, the external device may include a speaker capable of outputting a desired sound according to a command from the external device, and a wireless communication interface for communicating with the implanted system, e.g., via the implantable battery and/or communication module 2440.

In some instances, the external device 2400 and/or the mounting hub 2402 can include a user interface in the form of an application on the external device. In such embodiments, the features and/or functions of the mounting hub 2402 may be performed by an application. For example, in some instances, the mounting hub may receive instructions for performing functions through an application running on external device 2400. In some such embodiments, the wearer and/or the physician may provide input through an application, for example, during various procedures described herein. In some embodiments, the wearer may receive sound from the mounting hub 2402 and provide an input indicating whether the sound was heard or not heard, whether the sound was too loud or too quiet, whether the sound was distinguishable from previous sounds, and/or other inputs through the application. In some examples, the implant system (e.g., via the mounting hub 2402 or the implantable battery and/or communication module 2440) may be configured to update the signal processor transfer function in response to such received input.

In some embodiments, the mounting hub 2402 and/or the external device 2400 can be configured to communicate with a remote facility, for example, with a physician such as an audiologist. In some such embodiments, the mounting hub 2402 and/or the external device 2400 includes a remote communication device 2407 configured to communicate with this remote facility, for example, over the internet. The remote communication device 2407 may communicate various information associated with the mounting hub 2402, the external device 2400, and the implanted cochlear implant to another device, such as a device used by an audiologist. Additionally or alternatively, the remote communication device 2407 may be configured to receive inputs from such additional devices, such as inputs related to features and/or functions performed by the mounting hub, the external device, and/or the implanted cochlear implant. For example, in some cases, an audiologist operating at a remote facility may trigger the mounting hub 2402 to output one or more predetermined sounds and/or perform one or more mounting functions. Additionally or alternatively, the audiologist may receive information such as how often the wearer used and/or updated the features of the cochlear implant system.

In an example embodiment, the physician may receive diagnostic information about any tests or other procedures performed by the external device 2400, the mounting hub 2402, and/or the implanted cochlear implant system via the remote communication device 2407. In some such instances, the physician may receive data regarding how often tests or other procedures are performed, the results of any performed tests or procedures, how often various devices are used (e.g., the mounting hub 2402), and/or any feedback regarding the use or availability of the implanted cochlear implant.

In some instances, a physician may initiate or perform various tests or other procedures by additional devices through the remote communication device 2407. In some embodiments, the features and/or functions of the mounting hub 2402 as described herein may be performed or initiated by a physician using additional means through the remote communication means 2407. In various instances, the physician may perform various features, such as providing one or more sounds through a speaker (e.g., 2404), performing a stapedial reflex test, or the like as described herein. In response to the provided one or more sounds from the speaker, the physician may receive one or more signals representative of the output of the sensor 2410 and/or the signal processor 2420. The comparison of the provided sound or sounds from the speaker with the corresponding resulting signals in the implanted system may be performed by the further apparatus and/or by a physician receiving this information by the further apparatus.

In some embodiments, the remote communication device 2407 may communicate with another device (e.g., at a remote facility of a physician) through a wireless connection (e.g., bluetooth, Wi-Fi, NFC, cellular network, internet access, etc.). While the remote communication device 2407 is depicted as communicating through the external device 2400, the remote communication device 2407 may additionally or alternatively communicate through the mounting hub 2402 or different components of the system. In various embodiments, this remote communication device may be integrated into the external device 2400 and/or the mounting hub 2402. In some embodiments, remote communication device 2407 and wireless communication interface 2406 may be integrated to facilitate communication with remote facilities and implantable systems. Alternatively, remote communication device 2407 and wireless communication interface 2406 may be separate or partially separate components.

Fig. 25 is a process flow diagram illustrating an example process for calibrating an implantable system. In some instances, one or more sensors (e.g., a sensor that contacts the incus, such as sensor 540 shown in fig. 5) may detect a physiological phenomenon known as the stapedial reflex, in which muscles of the middle ear contract in response to various stimuli, such as loud sounds or an expectation of loud sounds. In some instances, an implanted signal processor in communication with this sensor may identify the occurrence of a stapedial reflex based on the characteristic output, e.g., by pre-programmed signal identification or by a learning process in which the stapedial reflex is triggered and the response from the sensor is measured and learned.

The calibration process of fig. 25 involves applying an electrical stimulus of a predetermined intensity (step 2500) and measuring the physiological response by the middle ear sensor (step 2510). The measured physiological response can be used to detect whether a stapedial reflex has occurred (step 2520). If no stapedial reflex is detected, the intensity of the electrical stimulation is increased (step 2530), and a new intensity of electrical stimulation is applied (step 2500) and the physiological response is measured (step 2510). This process may be repeated before the stapedial reflex is detected at step 2520.

Once the stapedial reflex is detected, the intensity that caused the stapedial reflex can be mapped to a predetermined sound pressure level (step 2540). For example, in some instances, the lowest electrical strength determined to cause a detected stapedial reflex may be mapped to an input sound pressure of 100 dB. The method may include calibrating stimulation intensity as a function of sound pressure level based on a mapping of the intensity causing the stapedial reflex to a predetermined sound pressure level (step 2550).

The calibration process of fig. 25 may be initiated in a variety of ways. For example, in various embodiments, the process may be initiated by one or more components in communication with the implanted system, such as a programmer, charger, external device, mounting hub, and the like. This process may be performed during initial set-up and/or calibration after a period of system use.

Initiating the procedure with a fully implanted system and through wireless communication (e.g., by a programmer, an assembly hub, an external device, etc.) greatly simplifies the process of triggering and/or detecting the stapedial reflex. For example, utilizing a cochlear electrode (e.g., 2416) to induce a stapedial reflex and sensing the reflex using an implanted middle ear sensor eliminates the need for a tedious diagnostic device such as a tympanometric device for analyzing the stapedial reflex.

In some examples, the systems and processes described with respect to fig. 24 may be used in the calibration step discussed with respect to fig. 25. For example, in an illustrative example, the mounting hub 2402 of fig. 24 may cause the speaker 2404 to produce sound at a sound pressure level of 100dB while also communicating (e.g., via bluetooth communication) details (e.g., intensity, frequency, etc.) of the sound to the implantable battery and/or communication module 2440. The output of the sensor 2410 in response to the 100dB sound may be identified and associated with the lowest electrical stimulation intensity that caused the detected stapedial reflex. This process may be repeated for multiple frequencies to link various external acoustic stimuli (e.g., from speaker 2404) to specific electrical stimuli.

Several embodiments discussed herein relate generally to cochlear implant systems. As discussed herein, a cochlear implant system may include a cochlear electrode implanted into the cochlear tissue of a wearer, as well as various other components, such as an electrical stimulator, a signal processor, and a middle ear sensor. In some embodiments, a cochlear implant system includes an assembly implanted on one or both sides of a wearer. For example, the system may include components implanted on the left side of the wearer (e.g., for their left ear), on the right side of the wearer (e.g., for their right ear), or both.

Fig. 26 illustrates an example embodiment in which a cochlear implant system includes components implanted to both sides of a wearer (e.g., to both its right ear and its left ear). As shown, the cochlear implant system of fig. 26 includes a first subsystem including the first cochlear electrode 2616a, the first electrical stimulator 2630a, the first middle ear sensor 2610a, and the first signal processor 2620a, and a second subsystem including the second cochlear electrode 2616b, the second electrical stimulator 2630b, the second middle ear sensor 2610b, and the second signal processor 2620 b. The first subsystem and the second subsystem may be configured similarly to other cochlear implant systems discussed herein. In some embodiments, the first electrical stimulator 2630a and the first signal processor 2620a may be housed in a first housing with the first cochlear electrode 2616a extending from the first housing. Additionally or alternatively, the second electrical stimulator 2630b and the second signal processor 2620b may be housed in a second housing with the second cochlear electrode 2616b extending from the second housing.

The cochlear implant system of fig. 26 includes an implantable battery and/or communication module 2640. In some embodiments, the cochlear implant system may include multiple implantable batteries and/or communication modules, but are not shown in fig. 26. The implantable battery and/or communication module 2640 may be configured to adjust a first transfer function associated with the first signal processor 2620a and adjust a second transfer function associated with the second signal processor 2620 b.

In some such embodiments, the implantable battery and/or communication module 2640 may communicate with the first signal processor 2620a over a first lead 2670a and with the second signal processor 2620b over a second lead 2670 b. In some such embodiments, as shown in fig. 26, the first lead 2670a may be different from the second lead 2670 b.

Additionally or alternatively, the implantable battery and/or communication module 2640 may communicate with both the first and second signal processors 2620a and 2620b through a bifurcated lead 2675. In some such examples, the implantable battery and/or communication module 2640 may be configured to send output signals to each of the first and second signal processors 2620a and 2620b simultaneously through the bifurcated lead 2675. In some embodiments, the implantable battery and/or communication module 2640 provides the same output signal to both the first and second signal processors 2620a and 2620 b. The implantable battery and/or communication module 2640 may be configured to transmit an addressed output signal to the first and second signal processors 2620a and 2620b via the split lead 2675, wherein the addressed output signal includes address information specifying at least one of the first and second signal processors 2620a and 2620 b. In some such embodiments, the first and second signal processors 2620a and 2620b may be configured to detect address information and respond only to signals addressed by a particular signal processor. For example, in some instances, the first signal processor 2620a may not be affected by an output signal that includes addressing of address information that specifies the second signal processor 2620b instead of the first signal processor 2620 a. Similarly, the second signal processor 2620b may not be affected by an output signal including addressing of address information designating the first signal processor 2620a instead of the second signal processor 2620 b. Alternatively, the battery and/or communication module 2640 may pass the same signal or different signals to the first and second signal processors 2620a and 2620b without the bifurcated lead 2675, such as an embodiment with two separate outputs from the battery and/or communication module 2640.

As discussed herein, the implantable battery and/or the communication module may be configured to communicate with the signal processor to adjust a transfer function associated therewith. In some examples, the implantable battery and/or communication module 2640 may be configured to adjust a first transfer function of the first signal processor 2620a, a second transfer function of the second signal processor 2620b, or a combination of both, for example, in response to a received command. In such embodiments, the implantable battery and/or communication module 2640 may be configured to receive commands from an external device over a wireless communication interface (e.g., bluetooth, Wi-Fi, NFC, etc.).

In some embodiments, a cochlear implant system may receive a command to change a volume associated with the cochlear implant system. In some embodiments, the volume associated with a cochlear implant system may be the total volume or a volume of a particular frequency and/or pitch range (e.g., reducing background noise, emphasizing speech, an increase in volume from one source relative to another, etc.). In some examples, the implantable battery and/or communication module 2640 may be configured to adjust the relative volume of both the first transfer function and the second transfer function by about the same amount in response to a command to change the volume.

However, in some instances, one side of the wearer may have a different amount or type of hearing loss than the other side. In such instances, increasing the volume of the first transfer function that is the same as the second transfer function may not be correlated to the patient perceiving the same relative volume change on both sides. As such, the first and second transfer functions may be updated such that the patient perceives similar output changes by the first and second electrical stimulators 2630a and 2630b in response to a given stimulation.

In response to the command to change the volume, the implantable battery and/or communication module 2640 may be configured to determine an existing first transfer function associated with the first signal processor 2620a and determine an updated first transfer function based on the determined existing first transfer function and the received command. Additionally, the implantable battery and/or communication module 2640 may be configured to determine an existing second transfer function associated with the second signal processor 2620b and determine an updated second transfer function based on the determined existing second transfer function and the received command. In such embodiments, the updated first transfer function and the updated second transfer function may reflect changes in perceived volume as specified in the received command. The changes to the first and second transfer functions need not be the same, although resulting from the same received command.

For example, in some embodiments, in response to a command to change the volume, the implantable battery and/or communication module may be configured to separately change the volume associated with the first transfer function and the volume associated with the second transfer function. In some such embodiments, the adjustment to the first transfer function may reflect the same or different adjustment as the adjustment to the second transfer function. In an example embodiment, in response to receiving a command to change the volume, the implantable battery and/or communication module may be configured to adjust the volume of the first transfer function to be greater than or less than the second transfer function such that the wearer perceives more or less changes in the stimulation output by the first electrical stimulator 2630a as compared to the second electrical stimulator 2630 b.

The transfer functions associated with the individual signal processors may be updated differently in response to a common command (e.g., "increase volume") to accommodate the different hearing profiles associated with each subsystem. For example, in an example embodiment, the first and second subsystems may be programmed with different transfer functions based on, for example, the hearing profiles of the wearer in the left and right ears, the operation of the middle ear sensors in each of the first and second subsystems (which may behave differently based on, for example, the wearer's anatomy), and so forth. A command to "increase volume" may result in different adjustments to different transfer functions. For example, a first transfer function may increase the gain by 10% and a second transfer function may increase the gain by 20% over one or more frequency ranges. Each change may be determined, for example, based on a prescribed response to a given command based on an existing transfer function.

In some embodiments, a system comprising two different subsystems, as shown in fig. 26, may be used to perform the various functions described herein, such as detecting the stapedial reflex of the wearer. In an example embodiment, the acoustic stimulus may be provided to the first ear of the wearer, such as through an in-ear speaker (e.g., in communication with the mounting hub). The acoustic stimulation may be detected by a first middle ear sensor 2610, which may provide an input signal to a first signal processor 2620a programmed with a first transfer function and output a corresponding stimulation signal to a first electrical stimulator 2630 a. The first electrical stimulator 2630a may provide electrical stimulation to cochlear tissue of the wearer based on the stimulation signal.

The implantable battery and/or communication module 2640 may receive information from the second signal processor 2620b representative of the data received from the second middle ear sensor 2610 b. Generally, the stapedial reflex occurs in the inner ear on both sides of a person, even if a stimulus is applied to only a single ear. Accordingly, the implantable battery and/or communication module 2640 may be configured to detect a stapedial reflex triggered in the wearer's body based on information received from the second signal processor 2620b in response to a stimulus detected by the first middle ear sensor 2610 a.

In some embodiments, this phenomenon may be exploited to perform the various stapedial reflex procedures described herein. For example, the mounting hub may provide an increased intensity stimulus to a first ear of the wearer until the implantable battery and/or communication module detects a stapedial reflex in the other ear of the wearer. Similar to that described elsewhere herein, the intensity of the sound triggering the stapedial reflex may be used to calibrate the transfer function of the signal processor associated with the sensor used in the first ear. This process may be repeated for multiple frequencies and for another ear.

Various non-limiting embodiments have been described. These and other implementations are within the scope of the examples set forth below.

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