Physiological measurement management using prosthesis technology and/or other technologies

文档序号:788249 发布日期:2021-04-09 浏览:14次 中文

阅读说明:本技术 利用修复体技术和/或其它技术的生理测量管理 (Physiological measurement management using prosthesis technology and/or other technologies ) 是由 肯尼思·奥普林格 S·J·毛格 于 2019-11-01 设计创作,主要内容包括:一种医疗装置,其中所述医疗装置被配置成判定是否应开始数据收集活动,其中所述数据是与所述医疗装置的接受者相关联的生理数据。在示例性实施例中,所述医疗装置可以是修复体,例如植入式修复体,并且在其它实施例中,所述医疗装置与修复体不同。(A medical device, wherein the medical device is configured to determine whether a data collection activity should be initiated, wherein the data is physiological data associated with a recipient of the medical device. In an exemplary embodiment, the medical device may be a prosthesis, such as an implantable prosthesis, and in other embodiments, the medical device is distinct from the prosthesis.)

1. An apparatus, comprising:

a medical device, wherein the medical device is configured to determine whether a data collection activity should be initiated based on non-movement data associated with a recipient of the medical device, wherein the data is physiological data associated with the recipient of the medical device.

2. The apparatus of claim 1, wherein:

the medical device is a hearing prosthesis; and is

The hearing prosthesis is configured to evaluate a sound environment of the hearing prosthesis to determine whether the data collection activity should be initiated.

3. The apparatus of claim 1, wherein:

the medical device includes an external acoustic sensor.

4. The apparatus of claim 2, wherein:

the medical device includes an implantable acoustic sensor.

5. The apparatus of claim 1, wherein:

the medical device includes an implantable component configured to perform acoustic detection of the recipient's body.

6. The apparatus of claim 5, wherein:

the detection is a detection using an acoustic type signal.

7. The apparatus of claim 5, wherein:

the detection is of tissue directly using electrical stimulation.

8. The apparatus of claim 1, wherein:

the medical device is further configured to sense a phenomenon indicative of movement of the recipient; and is

The medical device is configured to evaluate the sensed phenomenon indicative of movement to determine whether the data collection activity should be initiated.

9. The apparatus of claim 1, wherein:

the data collection activity is data collection with an implanted electrode that is part of the medical device.

10. The apparatus of claim 1, wherein:

the medical device is configured to perform EEG monitoring.

11. The apparatus of claim 1, wherein the medical device is configured to:

obtaining data indicative of a type and/or amount of neuronal activity of a recipient of the medical device;

evaluating the obtained data; and is

A determination is made whether a data collection activity should be initiated based on the evaluation.

12. The apparatus of claim 1, wherein:

the medical device includes a first sensor system and a second sensor system;

the first sensor system is a sensor system for collecting data after the start of the data collection;

the second sensor system collects non-physiological data; and is

The medical device is configured to evaluate the collected non-physiological data to make a determination.

13. The apparatus of claim 1, wherein:

the medical device includes a classification system; and is

The medical device is configured to determine whether the data collection activity should be initiated based on a classification by the classification system of a physiological characteristic associated with the recipient and/or the recipient's environment.

14. The apparatus of claim 1, wherein:

the medical device is configured to determine and/or infer a status of a recipient of the medical device; and is

The medical device is configured to determine whether the data collection activity should be initiated based on a determination of the status of the recipient.

15. The apparatus of claim 1, wherein:

the medical device is configured to determine and/or infer an environment of the recipient; and is

The medical device is configured to determine whether the data collection activity should be initiated based on a determination of the environment of the recipient.

16. The apparatus of claim 1, wherein:

the medical device is configured to determine and/or infer the status of the recipient of the medical device and/or an environment of the medical device; and is

The medical device is configured to determine whether the data collection activity should be initiated based on a determination of the status of the recipient and/or an environment of the recipient.

17. The apparatus of claim 1, wherein:

the medical device includes an environment classification system; and is

The medical device is configured to determine whether the data collection activity should be initiated based on a classification of the environment by the classification system.

18. The apparatus of claim 1, wherein:

the data is EEG data and the non-movement data is non-EEG data.

19. The apparatus of claim 1, wherein:

the non-mobile data is biometric-based data.

20. The apparatus of claim 1, wherein:

the medical device is configured to determine whether to initiate active probing of the recipient.

21. The apparatus of claim 20, wherein:

determining whether to initiate active probing is based on the non-movement data associated with a recipient of the medical device.

22. The apparatus of claim 20, wherein:

the data obtained based on the active probing is the non-movement data associated with the recipient.

23. The apparatus of claim 20, wherein:

the data obtained based on the active probing is the physiological data.

24. The apparatus of claim 1, wherein:

the medical device is configured to identify the presence and/or absence of at least one of: at least in vivo noise, scalp EMG, eye movement, body temperature, body heart rate, body blood pressure, or user speech that meets or at least does not meet predetermined criteria; and is

Determining whether the data collection activity should be initiated based on the presence and/or absence of the identification.

25. The apparatus of claim 1, wherein:

the medical device is configured to identify the presence and/or absence of at least one of: ambient sound, ambient light, electromagnetic radiation or magnetic fields at least meeting or at least not meeting predetermined criteria; and is

Determining whether the data collection activity should be initiated based on the presence and/or absence of the identification.

26. The apparatus of claim 25, wherein:

the medical device is configured to assess at least one of the intensity, spectrum or fluctuations of the ambient sound and/or light and determine whether these aspects meet and/or do not meet predetermined criteria; and is

Determining whether the data collection activity should be initiated based on the presence and/or absence of the identification.

27. A system, comprising:

a first subsystem configured to sense a phenomenon associated with an individual;

a second subsystem configured to at least one of capture sound, capture light, or capture electromagnetic radiation; and

a third subsystem configured to at least one of:

analyzing output from at least the second subsystem and determining at least one of: whether to activate the first subsystem, or the level of activation of the second subsystem; or

Analyzing output from at least the second subsystem and the first subsystem and determining at least one of: whether to activate a fourth subsystem that stimulates the recipient, or a level of activation of the fourth subsystem.

28. The system of claim 27, wherein:

the first subsystem is an EEG monitor.

29. The system of claim 27, wherein:

the system is configured to at least analyze the output from at least the second subsystem and identify at least one of a location condition of the recipient or an activity in which the recipient is engaged or a state of the recipient; and is

The system is configured to make a determination based on the identification.

30. The system of claim 27, wherein:

the system includes the fourth subsystem; and is

The fourth subsystem is an electrotherapy system.

31. The system of claim 27, wherein:

the second subsystem is part of an environment classifier and outputs data indicative of a classification of an environment.

32. The system of claim 27, wherein:

the second subsystem is comprised in an at least partially implantable prosthesis.

33. The system of claim 27, wherein:

the first, second and third subsystems are part of an integrated prosthetic system.

34. The system of claim 27, wherein:

the third subsystem is further configured to identify whether the recipient is moving and/or quantify movement of the recipient based on the output from at least the second subsystem, and to determine one or more of the following based on the identification: whether to activate the first subsystem, the level of activation of the second subsystem, or the level of activation of a fourth subsystem that applies stimulation to the recipient.

35. The system of claim 27, wherein:

the third subsystem is configured to identify whether the recipient is in a sensory noisy environment and/or to quantify sensory noise in the noisy environment based on the output from at least the second subsystem, and to determine whether to activate the level of activation of the first subsystem or the second subsystem based on the identification.

36. The system of claim 27, wherein:

the phenomenon is a physiological phenomenon; and is

The third subsystem is configured to analyze outputs from at least the second subsystem and the first subsystem to determine the level of activation of the second subsystem and/or, if present, a level of activation of a fourth subsystem that applies stimulation to the recipient.

37. The system of claim 27, wherein:

the phenomenon is a physiological phenomenon; and is

The third subsystem is configured to, independently of any output from the first subsystem, if present, analyze the output of the second subsystem to determine whether to activate the activation level of the first subsystem or the second subsystem and/or, if present, apply a stimulus to the activation level of a fourth subsystem of the recipient.

38. A method, comprising:

obtaining, with a device of a recipient of a prosthesis, first data indicative of an occurrence of an event associated with the recipient, wherein the prosthesis is substantially stationary relative to a local location when the first data is obtained; and

determining, based on the obtained first data, whether to perform at least one of: performing a measurement involving the recipient, or disregarding second data involving the recipient.

39. The method of claim 38, wherein:

the measurements are high fidelity recordings; and is

Low fidelity recording has occurred when the decision action was taken.

40. The method of claim 38, wherein:

the measurements are high fidelity recordings;

a low fidelity recording is occurring at the time of the determination; and is

The decision action includes deciding to implement a high fidelity measurement and thus to transition from a low fidelity measurement to a high fidelity measurement.

41. The method of claim 38, wherein:

the determining action is performed remotely from the device of the recipient.

42. The method of claim 38, wherein:

performing, by the device, the determining action.

43. The method of claim 38, wherein:

the second data is also obtained by performing a measurement; and is

The measuring includes measuring a physiological characteristic of the recipient with an implantable device implanted in the recipient.

44. The method of claim 38, wherein:

the second data is also obtained by performing a measurement; and is

The measuring includes measuring a physiological characteristic of the recipient with a non-implantable device that is not implanted in the recipient.

45. The method of claim 38, wherein:

the first data is indicative of at least one of: an environment of the recipient, an activity in which the recipient is engaged, or a status of the recipient;

the method includes evaluating the first data and determining, based on the evaluation, that the environment, the activity, and/or the status indicates that the measured utility value is detrimental; and is

The determining act includes disregarding the second data based on the evaluating.

46. The method of claim 38, wherein:

the first data is obtained at a plurality of times in a first time period;

the determining is performed a plurality of times respectively for the correspondingly obtained first data;

the obtained first data comprises respective data indicative of a respective noisy environment, and the respective deciding of the deciding action comprises deciding not to perform a measurement related in time to the respective obtained first data and/or disregarding respective second data related in time to the respective obtained first data, respectively;

the obtained first data comprises respective data indicating that the noisy environment is no longer present, and the respective decision comprises deciding to implement the measurement temporally related to the respective obtained first data or not to disregard the second data temporally related to the respective obtained first data.

47. The method of claim 46, wherein:

the respective data indicative of a respective sensory noisy environment is respective data indicative of a respective sound noisy environment.

48. The method of claim 38, wherein:

the obtained first data includes first sub-data obtained during a first time period in which the recipient experiences a first classification of event occurrences associated with the recipient;

the obtained first data includes second sub-data obtained during a second time period after the first time period during which the recipient experiences a second classification of event occurrences associated with the recipient.

The determining includes:

performing a first determination that a measurement related in time to the first sub-data or a third sub-data included in the second data is not disregarded; and

stopping the measurement related in time to the second sub data or disregarding the second determination of the fourth sub data included in the second data.

49. The method of claim 48, wherein:

the event occurrence is a movement of the recipient;

the first classification of an event occurrence is that the recipient has made a non-significant movement; and is

The second classification of event occurrence is that the recipient has moved significantly.

50. The method of claim 48, wherein:

the event occurrence is exposure of the recipient to noise;

the first classification is that the recipient is not significantly exposed to noise; and is

The second classification of an event occurrence is an occurrence of significant exposure of the recipient to noise.

51. The method of claim 48, wherein:

the event occurrence is exposure of the recipient to visual noise;

the first classification is that the recipient is not significantly exposed to visual noise; and is

The second classification of an event occurrence is an occurrence of a significant exposure of the recipient to visual noise.

52. The method of claim 38, wherein:

performing the obtaining act using the hearing prosthesis component.

53. The method of claim 38, wherein:

the obtaining act is performed using a cochlear implant fully implantable hearing prosthesis implant component.

54. The method of claim 38, wherein:

the event occurrence is a location presence of the recipient; and is

The first data is based on a captured sound captured by the device of the recipient.

55. The method of claim 54, further comprising:

performing a sound scene classification procedure to evaluate the first data and make a determination that the location of the recipient is present.

56. The method of claim 38, wherein:

the event occurrence is a location presence of the recipient; and is

The first data is based on a captured sound captured by the device of the recipient.

Background

The present application claims priority of U.S. provisional application No. 62/754,776 entitled PHYSIOLOGICAL MEASUREMENT MANAGEMENT with PROSTHESIS TECHNOLOGY AND/OR OTHER TECHNOLOGY (PHYSIOLOGICAL MEASUREMENT MANAGEMENT using PROSTHESIS TECHNOLOGY AND/OR OTHER TECHNOLOGY), filed on day 11, 2 of 2018, the inventor of which is Kenneth opinger of the University of mackery, australia (macquare University), the entire contents of which are incorporated herein by reference in their entirety.

Background

Some people suffer from sensory disorders such as vision disorders, hearing disorders, hyposmia, and the like. With respect to hearing impairment, this can be attributed to many different causes, generally two types: conductive and neurogenic. Neurological hearing disorders are due to the loss or damage of hair cells in the cochlea that convert sound signals into nerve impulses. Various hearing prostheses are commercially available to provide individuals with a neurological hearing disorder with the ability to perceive sound. An example of a hearing prosthesis is a cochlear implant.

Conductive hearing impairment occurs when the normal mechanical path for providing sound to hair cells in the cochlea is obstructed, for example, by injury to the ossicular chain or ear canal. Individuals with conductive hearing impairment may retain some form of residual hearing because the hair cells in the cochlea may remain intact.

Individuals with hearing disorders often receive acoustic hearing aids. Conventional acoustic hearing aids rely on the principle of air conduction to transmit acoustic signals to the cochlea. In particular, hearing aids typically use an arrangement positioned in or on the ear canal or outer ear of the recipient to amplify sound received by the outer ear of the recipient. This amplified sound reaches the cochlea, causing the movement of perilymph and stimulating the auditory nerve.

Conductive hearing impairment situations can be handled by means of bone conduction devices. These devices use a mechanical actuator coupled to the skull to apply amplified sound compared to conventional hearing aids. Other types of devices, such as middle ear implants, may be used to induce hearing perception to address conductive hearing disorders.

In contrast to hearing aids that rely primarily on the principle of air conduction, certain types of hearing prostheses, commonly referred to as cochlear implants, convert received sound into electrical stimulation. Electrical stimulation is applied to the cochlea, which produces a perception of received sound.

Furthermore, often some people may be totally blind or legally blind. The retinal implant can provide stimuli to the recipient to induce vision perception. In some cases, retinal implants are intended to restore useful vision to people who lose their vision due to degenerative eye diseases such as Retinitis Pigmentosa (RP) or macular degeneration. In some cases, at least in some cases not mutually exclusive from the foregoing examples, a retinal implant is provided to provide at least a small amount of spatial and/or contextual perception to an otherwise invisible person.

Generally, there are three types of retinal implants available for restoring partial vision: pre-retinal implants (on the retina), sub-retinal implants (behind the retina) and suprachoroidal implants (above the vascular choroid) retinal implants provide low resolution images to the recipient by electrically stimulating surviving retinal cells. Such images may be sufficient to restore certain visual abilities, such as light perception and object recognition.

In addition, other types of sensory disorders include lack of somatic sensation and lack of chemical sensation. Thus, there may be somatosensory implants and chemosensory implants that may address such issues.

The various prostheses described above sometimes utilize sophisticated processing (e.g., sound processing, image processing, etc.) techniques to improve the evoked perception (hearing, vision, etc.) over what would otherwise be possible.

Many devices, such as medical devices that interface with recipients, have structural and/or functional features, where there is practical value in adjusting such features for individual recipients. One medical device in which there is practical value in making such adjustments is the cochlear implant described above. That is, there are other types of medical devices, such as other types of hearing prostheses, and other types of prostheses, such as retinal implants, where there is practical value in adapting such devices and prostheses to a recipient.

Disclosure of Invention

In an exemplary embodiment, there is a medical device, wherein the medical device is configured to determine whether a data collection activity should be initiated based on non-movement data associated with a recipient of the medical device, wherein the data is physiological data associated with the recipient of the medical device.

In an exemplary embodiment, there is a method comprising: obtaining, with a device of a recipient of a prosthesis, first data indicative of an occurrence of an event associated with the recipient, and determining, based on the obtained first data, whether to at least one of: performing a measurement involving the recipient, or disregarding (count) second data involving the recipient.

In an exemplary embodiment, there is a system comprising: a first subsystem configured to sense a phenomenon associated with an individual; a second subsystem configured to at least one of capture sound, capture light, or capture electromagnetic radiation; and a third subsystem configured to at least one of:

analyzing output from at least the second subsystem and determining at least one of: whether to activate the first subsystem, or the level of activation of the second subsystem; or

Analyzing output from at least the second subsystem and the first subsystem and determining at least one of: whether to activate a fourth subsystem that stimulates the recipient, or a level of activation of the fourth subsystem.

Drawings

Embodiments are described below with reference to the accompanying drawings, in which:

FIG. 1 is a perspective view of an exemplary hearing prosthesis, in which at least some of the teachings detailed herein are applicable;

FIG. 2 presents a functional block diagram of an example cochlear implant;

fig. 3A and 3B present exemplary systems according to some embodiments;

FIG. 4 presents exemplary external components;

figures 5 and 6 and 7 present schematic diagrams of some exemplary human monitoring systems;

FIG. 8 presents an exemplary sensory prosthesis;

FIGS. 9, 10, and 11 provide exemplary algorithms for an exemplary method;

FIG. 12 presents a functional diagram of an exemplary system; and

figures 13 through 16 present schematic diagrams of some exemplary human monitoring systems. .

Detailed Description

The teachings detailed herein are implemented in sensory prostheses, such as, in particular, hearing implants, and, in general, neurostimulation devices. Other types of sensory prostheses may include retinal implants. Thus, unless otherwise indicated, any teachings herein regarding sensory restorations correspond to disclosures applying these teachings for hearing implants/use in conjunction with hearing implants and for retinal implants/use in conjunction with retinal implants, as long as such is supported by the art. Furthermore, with respect to any teachings herein, unless otherwise indicated, the teachings correspond to disclosures utilizing these teachings in conjunction with cochlear implants, bone conduction devices (both active and passive transcutaneous bone conduction devices, as well as transcutaneous bone conduction devices), and middle ear implants, in whole or in part, as long as the art supports so. In particular, any teaching herein with respect to a particular sensory prosthesis corresponds to the disclosure of applying such teachings to/utilizing in conjunction with any of the above-described hearing prostheses, and vice versa. It follows that at least some of the teachings detailed herein may be implemented in a somatosensory implant and/or a chemosensory implant. Thus, any teachings herein regarding sensory prostheses correspond to disclosures utilizing/using these teachings in conjunction with a somatosensory implant and/or a chemical sensory implant.

Although the teachings detailed herein will be described to the greatest extent with respect to a hearing prosthesis, in light of the above, it should be noted that any disclosure herein with respect to a hearing prosthesis corresponds to a disclosure of another embodiment that utilizes the associated teachings with respect to any one of the other prostheses noted herein, whether a hearing prosthesis or a sensory prosthesis, such as a retinal prosthesis. In this regard, any disclosure herein with respect to eliciting hearing perceptions corresponds to disclosures in other embodiments that elicit other types of neural perceptions, such as visual/visual perceptions, tactile perceptions, olfactory perceptions, or taste perceptions, unless otherwise indicated and/or unless not supported by the art. Any disclosure herein of devices, systems and/or methods for or producing a final stimulation of an auditory nerve corresponds to a disclosure of similar stimulation of an optic nerve with similar components/methods/systems.

Fig. 1 is a perspective view of a cochlear implant, referred to as a cochlear implant 100, to which some of the embodiments detailed herein and/or variations thereof are applicable, implanted in a recipient. In some embodiments, cochlear implant 100 is part of system 10 that may contain external components, as will be described in detail below. Additionally, it should be noted that the teachings detailed herein are also applicable to other types of hearing prostheses, such as, by way of example only and not by way of limitation, bone conduction devices (percutaneous, active percutaneous, and/or passive percutaneous), direct acoustic cochlear stimulators, middle ear implants, and conventional hearing aids, among others. It should be noted in fact that the teachings detailed herein are also applicable to so-called multimode devices. In an exemplary embodiment, these multimodal devices apply both electrical and acoustic stimulation to a recipient. In exemplary embodiments, these multimode devices induce hearing perception through electrical hearing and bone conduction hearing.

In this regard, it should be appreciated that the techniques presented herein may also be used in conjunction with a variety of other medical devices that may benefit from setting variations based on the medical device location while providing a wide range of therapeutic benefits to a recipient, patient, or other user. For example, the techniques presented herein may be used with other hearing prostheses including acoustic hearing aids, bone conduction devices, middle ear hearing prostheses, direct acoustic stimulators, other electrically stimulated hearing prostheses (e.g., auditory brain stimulators), and the like. The techniques presented herein may also be used in conjunction with visual prostheses (i.e., biomimetic eyes), sensors, pacemakers, drug delivery systems, defibrillators, functional electrical stimulation devices, catheters, and the like. Thus, any disclosure herein with respect to one of these types of hearing prostheses corresponds to another of these types of hearing prostheses or any medical device in question, unless specified otherwise, or unless its disclosure is incompatible with a given device based on the state of the art. In at least some embodiments, the teachings detailed herein are applicable to partially and/or fully implantable medical devices that provide a wide range of therapeutic utility to a recipient, patient, or other user, such as hearing devices with implanted microphones, auditory brain stimulators, visual restorations (e.g., biomimetic eyes), sensors, and the like.

In view of the above, it will be appreciated that at least some embodiments and/or variations thereof detailed herein relate to human-worn sensation-complementary (complementary) medical devices (e.g., the hearing prosthesis of fig. 1, which complement hearing even in the absence of natural hearing, e.g., because of prior natural hearing degradation or lack of any natural hearing, e.g., from birth). It should be noted that at least some exemplary embodiments of some sensory assistive medical devices relate to conventional hearing aids that aid hearing in the presence of some natural hearing persistence, as well as visual restorations (those suitable for recipients with some natural vision as well as those without). Thus, the teachings detailed herein are applicable to any type of sensory assistive medical device for which the teachings detailed herein can be used in a practical manner. In this regard, the phrase sensory complementary medical device refers to any device used to provide a sensation to a recipient regardless of whether the natural sensation applicable is only partially impaired or entirely impaired or never actually present.

The recipient has an outer ear 101, a middle ear 105, and an inner ear 107. The components of outer ear 101, middle ear 105, and inner ear 107 are described below, followed by description of cochlear implant 100.

In a fully functional ear, outer ear 101 includes a pinna 110 and an ear canal 102. The sound pressure or sound wave 103 is collected by the pinna 110 and directed into and through the ear canal 102. A tympanic membrane 104 that vibrates in response to sound waves 103 is distal to the ear canal 102. This vibration is coupled to the oval or oval window 112 through the three bones of the middle ear 105, collectively referred to as the ossicles 106, and including the malleus 108, the incus 109, and the stapes 111. Bones 108, 109 and 111 of middle ear 105 serve to filter and amplify sound wave 103, thereby causing elliptical window 112 to articulate or vibrate in response to vibration of tympanic membrane 104. This vibration causes the perilymph within the cochlea 140 to generate fluid motion waves. This fluid movement in turn activates tiny hair cells (not shown) inside the cochlea 140. Activation of the hair cells causes appropriate nerve impulses to be generated and transmitted to the brain (also not shown) through the spiral ganglion cells (not shown) and the auditory nerve 114, where they are perceived as sound.

As shown, cochlear implant 100 includes one or more components that are temporarily or permanently implanted in the recipient. Shown in fig. 1 is cochlear implant 100 having an external device 142 that is part of system 10 (along with cochlear implant 100) that is configured to provide power to the cochlear implant as described below, wherein the implanted cochlear implant contains a battery that is charged from the power provided by external device 142.

In the illustrative arrangement of fig. 1, the external device 142 may include a power supply (not shown) disposed in the behind-the-ear (BTE) unit 126. The external device 142 also contains components of the transcutaneous energy transfer link known as external energy transfer components. The transcutaneous energy transfer link is used to transfer power and/or data to the cochlear implant 100. Various types of energy transfer, such as Infrared (IR), electromagnetic, capacitive, and inductive transfer, may be used to transfer power and/or data from external device 142 to cochlear implant 100. In the illustrative embodiment of fig. 1, the external energy transfer assembly includes an external coil 130 that forms part of an inductive Radio Frequency (RF) communication link. The external coil 130 is typically a wire antenna coil formed of multiple turns of electrically insulated single or multi-strand platinum or gold wire. The external device 142 also contains magnets (not shown) positioned within the turns of the external coil 130. It should be understood that the external devices shown in fig. 1 are merely illustrative, and that other external devices may be used with the embodiments.

Cochlear implant 100 includes an internal energy delivery assembly 132 positionable in a recess adjacent the temporal bone of recipient's pinna 110. As described in detail below, the internal energy transfer assembly 132 is a component of the transcutaneous energy transfer link and receives power and/or data from the external device 142. In the illustrative embodiment, the energy transfer link comprises an inductive RF link, and the internal energy transfer assembly 132 comprises a primary internal coil 136. The internal coil 136 is typically a wire antenna coil formed of multiple turns of electrically insulated single or multi-strand platinum or gold wire.

Cochlear implant 100 also includes a main implantable component 120 and an elongated electrode assembly 118. In some embodiments, the internal energy delivery assembly 132 and the primary implantable component 120 are hermetically sealed within a biocompatible housing. In some embodiments, the primary implantable component 120 contains an implantable microphone assembly (not shown) and a sound processing unit (not shown) to convert sound signals received by the implantable microphone in the internal energy transfer assembly 132 into data signals. That is, in some alternative embodiments, the implantable microphone assembly may be located in a separate implantable component (e.g., having its own housing assembly, etc.) that is in signal communication with the primary implantable component 120 (e.g., through a lead between the separate implantable component and the primary implantable component 120, etc.). In at least some embodiments, the teachings detailed herein and/or variations thereof may be used with any type of implantable microphone arrangement.

The primary implantable component 120 also contains a stimulator unit (also not shown) that generates electrical stimulation signals based on the data signals. The electrical stimulation signals are delivered to the recipient through the elongate electrode assembly 118.

The elongate electrode assembly 118 has a proximal end connected to the primary implantable component 120 and a distal end implanted in the cochlea 140. The electrode assembly 118 extends from the main implantable component 120 through the mastoid bone 119 to the cochlea 140. In some embodiments, the electrode assembly 118 may be implanted at least in the basal region 116, sometimes deeper. For example, electrode assembly 118 may extend toward the apical end of cochlea 140, referred to as the cochlea tip 134. In some cases, electrode assembly 118 may be inserted into cochlea 140 through cochleostomy 122. In other cases, a cochlear stoma may be formed by round window 121, oval window 112, promontory 123, or by the top turn 147 of cochlea 140.

Electrode assembly 118 includes a longitudinally aligned and distally extending array 146 of electrodes 148 disposed along the length thereof. As noted, the stimulator unit generates stimulation signals that are applied by the electrodes 148 to the cochlea 140, thereby stimulating the auditory nerve 114.

Thus, as seen above, various implantable devices rely on external components to provide certain functions and/or power. For example, a recipient of an implantable device may wear an external component that provides power and/or data (e.g., a signal representing sound) to the implanted portion to allow the implantable device to function. In particular, the implantable device may be devoid of batteries and may in fact be entirely dependent on an external power source that provides continuous power to the implantable device for functioning. Although the external power source may continuously supply power, the characteristics of the supplied power are not necessarily constant and may fluctuate. In addition, where the implanted device is an auditory prosthesis such as a cochlear implant, the implanted device may not have its own sound input device (e.g., microphone). Sometimes, it is practical to remove the outer part. For example, the recipient of the auditory prosthesis typically removes the external portion of the prosthesis while sleeping. Doing so can result in a loss of function of the implanted portion of the prosthesis, which can render the recipient unable to hear the ambient sound. This may be less practical and may cause the recipient to hear no sound while sleeping. The loss of functionality will also prevent the implanted portion from responding to a signal representing streaming content (e.g., music streamed from a telephone) or provide other functionality, such as providing tinnitus suppressing noise.

As detailed above, the external components that provide power and/or data may be worn by the recipient. When the wearable external device is worn by the recipient, the external device is typically in close proximity to and in close alignment with the implanted component. The wearable external device may be configured to operate under these conditions. Relatively speaking, in some cases, the unworn device may be generally remote from the implanted components and less closely aligned with the implanted components. This can create difficulties where the implantable device relies on an external device for power and data (e.g., where the implantable device does not have its own battery and microphone), and the external device may need to provide power and data continuously and consistently in order to achieve continuous and consistent functionality of the implantable device.

The techniques disclosed herein may be used to provide power and/or data to and/or retrieve data from an implantable device without the recipient wearing an external device. The techniques may overcome one or more challenges associated therewith. In an example, the disclosed technology can provide power and/or data to an implanted medical device through a system that includes a pillow or other headrest or other back cushion (body rest) component (mattress, blanket, etc.). The disclosed technology may be configured to provide power and data to an implantable medical device continuously and/or intermittently over a period of time (e.g., substantially the entire period of time that a recipient rests a head on a pillow). The characteristics of the continuously supplied power are not necessarily constant. For example, power may fluctuate because the efficiency of the link between the implant and the pillow may vary as the recipient's head moves, causing the proximity of the coils to vary. For example, a tank capacitor may be used to smooth the power supplied to the implanted electronics. The recipient of the implanted medical device typically removes his external device while sleeping, and during this time the pillow is typically placed in close proximity to the implanted prosthesis. In particular, the hearing implant is typically placed in close proximity to the ear of the recipient, and the person typically rests the head on a pillow, whereby one or both ears are proximate to the pillow. Thus, it may be practical to incorporate a pillow into a system for providing the functionality of a worn external device while a recipient of the implantable device is sleeping. For recipients of bilateral hearing implants, it may be sufficient that only one of the two devices is functional when used at night. For example, a first device closest to the pillow may receive sufficient power and/or data to function, while a second device further from the pillow may receive insufficient power and/or data to function.

Reference may be made herein to pillows or other headrests for simplicity, but the disclosed techniques may be used in connection with a variety of articles. Headrests may include, for example, pillows, cushions, pads, head supports, mattresses, and the like. Such articles may be covered (e.g., by a pillow case) or uncovered. Additionally, the disclosed external system components may be used in conjunction with any of a variety of systems in accordance with embodiments of the present technique. For example, in many embodiments, the techniques are used in conjunction with a conventional cochlear implant system. Fig. 1 depicts an exemplary cochlear implant system that may benefit from use in conjunction with the techniques disclosed herein.

Fig. 2 is a functional block diagram of a cochlear implant system 200 that may benefit from the use of a pillow system in accordance with certain examples of the technology described herein. The cochlear implant system 200 includes an implantable component 201 (e.g., the implantable component 100 of fig. 1) and an external device 240 (e.g., the external device 142 of fig. 1) configured to be implanted beneath a recipient's skin or other tissue 249.

The external device 240 may be configured as a wearable external device such that the external device 240 is worn by the recipient in close proximity to the implantable component, which may enable the implantable component 201 to receive power and stimulation data from the external device 240. As depicted in fig. 1, magnets may be used to facilitate operative alignment of the external device 240 with the implantable member 201. Where the external device 240 and the implantable component 201 are in close proximity, the transfer of power and data may be accomplished by using near-field electromagnetic radiation, and the components of the external device 240 may be configured for use in conjunction with the near-field electromagnetic radiation.

The implantable component 201 may include a transceiver unit 208, an electronics module 213, which may be a stimulator assembly of a cochlear implant, and an electrode assembly 254 (which may include an electrode contact array disposed on the lead 118 of fig. 1). The transceiver unit 208 is configured to transcutaneously receive power and/or data from the external device 240. As used herein, transceiver unit 208 refers to any collection of one or more components that form part of a transcutaneous energy transfer system. Further, the transceiver unit 208 may include or be coupled to one or more components that receive and/or transmit data or power. For example, an example includes a coil of a magnetic inductive arrangement coupled to the transceiver unit 208. Other arrangements are also possible, including antennas for alternative RF systems, capacitive plates, or any other practical arrangement. In an example, the data modulates an RF carrier or signal containing power. The transcutaneous communication link established by the transceiver unit 208 may use time interleaving of power and data over a single RF channel or band to transmit the power and data to the implantable component 201. In some examples, processor 244 is configured to cause transceiver unit 246 to interleave power and data signals, such as described in U.S. patent publication No. 2009/0216296 to meskeys. In this way, the data signal is modulated with the power signal, and a single coil may be used to transmit both power and data to the implanted component 201. Various types of energy transfer, such as Infrared (IR), electromagnetic, capacitive, and inductive transfer, may be used to transfer power and/or data from the external device 240 to the implantable member 201.

Aspects of the implantable component 201 may require a power source to provide functions such as receiving signals, processing data, or delivering electrical stimulation. The power source that directly powers the operation of various aspects of the implantable component 201 may be described as operating power. There are two exemplary ways in which the implantable component 201 may receive operating power: a power source (e.g., a battery) internal to the implantable component 201 or external to the implantable component. However, other methods or combinations of methods are possible. For example, the implantable component may have a battery, but still receive operating power from the external component (e.g., to maintain internal battery life when the battery is fully charged).

The internal power source may be a power storage element (not depicted). The power storage element may be configured for long term storage of power and may comprise, for example, one or more rechargeable batteries. Power may be received from an external source, such as external device 240, and stored in the power storage element for long term use (e.g., to charge a battery of the power storage element). The power storage element may then provide power to other components of the implantable component 201 over time as required for operation, without the need for an external power source. In this manner, power from the external source may be considered charging power rather than operating power, as power from the external power source is used to charge the battery (which in turn provides operating power) rather than directly powering aspects of the implantable component 201 that require power to operate. The power storage element may be a long-term power storage element configured to serve as a primary power source for the implantable component 201.

In some embodiments, the implantable component 201 receives operating power from the external device 240, and the implantable component 201 does not contain an internal power source (e.g., battery)/internal power storage device. In other words, the implantable component 201 is powered solely by the external device 240 or another external device that provides sufficient power to the implantable component 201 to allow the implantable component to operate (e.g., receive data signals and take action in response). The operating power may directly power the function of the device rather than charging the power storage element of the implantable component 201. In these examples, implantable component 201 may include an accompanying component that may store an electrical charge (e.g., a capacitor) or may store a small amount of power, such as a small battery (e.g., a motherboard CMOS battery) used to keep volatile memory powered or to power a clock. Such accessory components do not themselves have sufficient power to allow the implantable component to provide the primary function of the implantable component 201 (e.g., receive data signals and take action in response thereto, such as providing stimulation), and therefore cannot be said to provide operating power even though the accessory component is essential to the operation of the implantable component 201.

As shown, the electronics module 213 includes a stimulator unit 214 (which may correspond to the stimulator of fig. 1, for example). The electronic module 213 may also contain one or more other components for generating electrical stimulation signals 215 or controlling the delivery of electrical stimulation signals to a recipient. As described above with respect to fig. 1, a lead (e.g., the elongated lead 118 of fig. 1) may be inserted into a cochlea of a recipient. The lead may include an electrode assembly 254 configured to deliver the electrical stimulation signals 215 generated by the stimulator unit 214 to the cochlea.

In the example system 200 depicted in fig. 2, the external device 240 includes a sound input unit 242, a sound processor 244, a transceiver unit 246, a coil 247, and a power supply 248. The sound input unit 242 is a unit configured to receive sound input. The sound input unit 242 may be configured as a microphone (e.g., arranged to output audio data representative of the ambient sound environment), an electrical input (e.g., a receiver for a Frequency Modulation (FM) listening system), and/or another component for receiving sound inputs. The sound input unit 242 may be or comprise a mixer for mixing a plurality of sound inputs together.

Processor 244 is a processor configured to control one or more aspects of system 200, including converting sound signals received from sound input unit 242 into data signals and causing transceiver unit 246 to transmit power and/or data signals. The transceiver unit 246 may be configured to transmit or receive power and/or data 251. For example, the transceiver unit 246 may include circuit components that transmit power and data through the coil 247 (e.g., inductively). Data signals from the sound processor 244 may be transmitted to the implantable component 201 using the transceiver unit 246 for providing stimulation or other medical functions.

The transceiver unit 246 may include one or more antennas or coils, such as coil 247, for transmitting power or data signals. The coil 247 may be an electrically insulated single or multi-stranded wire antenna coil having a plurality of turns. The electrical insulation of the coil 247 may be provided by a flexible silicone molding. Various types of energy transfer, such as Infrared (IR), Radio Frequency (RF) electromagnetic, capacitive, and inductive transfer, may be used to transfer power and/or data from the external device 240 to the implantable member 201.

FIG. 3A depicts an exemplary system 210 according to an exemplary embodiment, comprising: a hearing prosthesis 100, which in an exemplary embodiment corresponds to the cochlear implant 100 detailed above; and a portable carry-on device (such as the portable handheld device seen in fig. 3A, a watch, a pocket device, etc.) 2401 in the form of a mobile computer having a display 2421. The system comprises a wireless link 230 between the portable handheld device 2401 and the hearing prosthesis 100. In an embodiment, prosthesis 100 is an implant (functionally represented by the dashed line of box 100 in fig. 3A) implanted in recipient 99.

In an exemplary embodiment, the system 210 is configured such that the hearing prosthesis 100 and the portable handheld device 2401 have a symbiotic relationship. In an exemplary embodiment, the symbiotic relationship is the ability to display data related to one or more functions of the hearing prosthesis 100, and in at least some cases, the ability to control the one or more functions. In an exemplary embodiment, this may be accomplished by the ability of the handheld 2401 to receive data from the auditory prosthesis 100 via the wireless link 230 (although in other exemplary embodiments, other types of links, such as wired links, etc., may be utilized). As will also be detailed below, this may be achieved by communicating with a geographically remote device that communicates with the hearing prosthesis 100 and/or the portable handheld device 2401 via a link, such as, by way of example only and not by way of limitation, an internet connection or a cellular telephone connection. In some such exemplary embodiments, system 210 may also include a geographically remote device as well. Also, additional examples of this aspect will be described in more detail below.

As noted above, in the exemplary embodiment, portable handheld device 2401 includes a mobile computer and display 2421. In an exemplary embodiment, the display 2421 is a touch screen display. In an exemplary embodiment, portable handheld device 2401 also has the functionality of a portable cellular telephone. In this regard, by way of example only and not by way of limitation, the device 2401 may be a smartphone, as is commonly referred to. That is, in the exemplary embodiment, portable handheld device 2401 includes a smartphone, again commonly referred to as a smartphone.

It should be noted that in some other embodiments, device 2401 need not be a computer device or the like. Which may be a lower technology recorder, or any device that may implement the teachings herein.

The phrase "mobile computer" includes devices configured to enable human-computer interaction, where the computer is expected to be transferred away from a stationary position during normal use. Also, in the exemplary embodiment, portable handheld device 2401 is a smart phone, as is commonly referred to. However, in other embodiments, less complex (or more complex) mobile computing devices may be utilized to implement the teachings detailed herein and/or variations thereof. In at least some embodiments, any devices, systems, and/or methods that may enable the teachings detailed herein and/or variations thereof to be practiced may be utilized. (As will be described in more detail below, in some cases, the device 2401 is not a mobile computer, but a remote device (remote from the hearing prosthesis 100. some of these embodiments are described below.)

In an exemplary embodiment, portable handheld device 2401 is configured to receive data from the hearing prosthesis and present some of a plurality of different interface displays on the display based on the received data. The exemplary embodiment will sometimes be described in terms of data received from the hearing prosthesis 100. It should be noted, however, that any disclosure that is equally applicable to data sent from handheld device 2401 to a hearing prosthesis is also encompassed by such disclosure (and vice versa) unless otherwise specified or otherwise incompatible with the relevant art.

It should be noted that in some embodiments, system 210 is configured such that cochlear implant 100 and portable device 2401 have a relationship. By way of example only, and not by way of limitation, in an exemplary embodiment, the relationship is the ability of the device 2401 to act as a remote microphone for the prosthesis 100 over the wireless link 230. Thus, the device 2401 may be a remote microphone. That is, in an alternative embodiment, device 2401 is a stand-alone recording/sound capture device.

It should be noted that in at least some exemplary embodiments, device 2401 corresponds to 2018Apple Watch commercially available in the United states from 9 months and 15 daysTMSeries 1 or series 2. In an exemplary embodiment, device 2401 corresponds to a Samsung Galaxy Gear commercially available in the United states since 2018, 9, 15TMAnd Gear 2. The device is programmed and configured to communicate with the prosthesis and/or to implement the teachings detailed herein.

In an exemplary embodiment, the telecommunications infrastructure may be in communication with the hearing prosthesis 100 and/or the device 2401. By way of example only, and not by way of limitation, a telecoil (telecoil)2491 or some other communication system (bluetooth, etc.) is used to communicate with the prosthesis and/or the remote device. Fig. 2B depicts an exemplary quasi-functional schematic diagram depicting communication between the external communication system 2491 (e.g., telecoil) and the hearing prosthesis 100 and/or the handheld device 2401 via links 277 and 279, respectively (note that fig. 3B depicts bi-directional communication between the hearing prosthesis 100 and the external audio source 2491 and between the handheld device and the external audio source 2491 — in alternative embodiments, the communication is only unidirectional (e.g., from the external audio source 2491 to the respective device)).

It should be noted that while some embodiments detailed herein are described in terms of utilizing external devices that are stationary or otherwise relatively immobile (e.g., devices integrated into, for example, a bed) or devices that may be in relatively easily movable objects (pillows, shirts, etc.) to communicate and/or power implanted components, it should be understood that these devices may also be powered by and/or communicate with their conventional external components. In this regard, fig. 4 depicts an exemplary external component 1440. The external component 1440 may correspond to the external component 142 of the system 10. As can be seen, external component 1440 includes a behind-the-ear (BTE) device 1426 that is connected by a cable 1472 to an exemplary headpiece 1478 that includes an external inductive coil 1458EX, which corresponds to the external coil of fig. 1. As shown, the outer member 1440 includes a headpiece 1478 that contains a coil 1458EX and a magnet 1442. This magnet 1442 interacts with the implanted magnet (or implanted magnetic material) of the implantable component to hold the headpiece 1478 to the recipient's skin. In an exemplary embodiment, the external component 1440 is configured to transcutaneously transmit magnetic data and/or transmit power to and/or receive magnetic data from an implantable component comprising an inductive coil via the coil 1458 EX. The coil 1458X is electrically coupled to a BTE device 1426 by a cable 1472. The BTE device 1426 can include at least some components such as external devices/components described herein.

Thus, in an exemplary embodiment, the external component 1440 may be used in conjunction with an implantable component, such as an implantable hearing prosthesis and/or an implantable retinal implant and/or an implantable sensory prosthesis, as detailed herein, wherein an implant coil is implanted near or in the head.

In some embodiments, there may be a practical value in measuring a physiological characteristic of a user with respect to any of the devices detailed herein and/or variations thereof. In the case of a cochlear implant, in an exemplary embodiment, electrically evoked compound action potentials in response to stimulating the cochlea may be measured. In another example, EEG of the patient/recipient is measured. Many physiological and environmental factors can affect the recording. It is beneficial to understand the factors when measuring the physiological characteristics of the user/recipient.

In an exemplary embodiment, there may be a sensor, such as an implantable or internal sensor, which may have utility in assisting, at least in part, in including a time period during which it is determined that it may be practical to take measurements of something associated with a person. By way of example only, and not by way of limitation, in embodiments where acoustic probing is performed (e.g., by utilizing any of the hearing prostheses disclosed herein that can accomplish this action, including conventional hearing aids, or by utilizing non-prosthetic devices, such as a smartphone or smart device's speaker, etc.) to obtain data related to the recipient based on a reaction or response to the probe or any other detectable utility phenomenon, for example, a microphone may be used to obtain data, which may be used to determine the presence of a certain environment directly and/or through latent variables, where the external noise is at and/or below a certain level such that the use of the acoustic probe and/or data produced by such use may be used with minimal efficacy (e.g., the person may hear the sound generated by the acoustic probe as well as the ambient noise). In an exemplary embodiment, acoustic detection is performed using acoustic-type signals and/or acoustic analog signals, while in other embodiments the acoustic signals are purely acoustic signals, while in other embodiments the acoustic-type signals do not include purely acoustic signals. In some embodiments, the detection is detection of tissue using electrical stimulation or the like.

In view of the above, there is an apparatus comprising a medical device, such as any of the medical devices disclosed herein, e.g. cochlear implants and/or conventional hearing aids above, or retinal implants, etc. In this exemplary embodiment, the medical device is configured to determine whether a data collection activity should be initiated, wherein the data is physiological data associated with a recipient of the medical device. In an exemplary embodiment, where the medical device is a hearing prosthesis, the hearing prosthesis is configured to evaluate a sound environment of the hearing prosthesis to determine whether a data collection activity should begin. By way of example only, and not by way of limitation, in an exemplary embodiment, a hearing prosthesis according to at least some teachings detailed herein is utilized in connection with data collection associated with recording electroencephalography (EEG) data. Indeed, in an exemplary embodiment, the hearing perception is induced using an acoustic transducer or any other sound creation or hearing perception inducing means available. By way of example only, and not by way of limitation, this may be accomplished using an implanted actuator, such as a bone conduction device or a middle ear implant. Additionally, this may be accomplished with cochlear implants, auditory brainstem implants, or auditory midbrain implants, among others. In an alternative embodiment, a conventional hearing aid may be used to induce a hearing sensation. In some embodiments, a combination of two or more of the foregoing devices may be used to induce hearing perception. Other devices may also be utilized. In an exemplary embodiment, the portable handheld device 2401 described above, or a noise or sound generating device designed and manufactured specifically for medical procedures, may be utilized. In an exemplary embodiment, the determination is made based on whether the recipient is moving, while in other embodiments, the movement is determined based on non-movement data/data unrelated to movement data (e.g., data not based on an accelerometer and/or output of a device determining that the recipient is moving, which is different from a device that may determine that the recipient has moved/is in a new location different from the previous case). In particular, "non-moving data," as used herein, means that the data is not related to movement, rather than meaning that the recipient is not moving.

In many cases, the teachings detailed herein will relate to implantable components and the like and/or prostheses. It should be noted that any disclosure herein of an implantable component corresponds to an alternative disclosure of an unimplanted device or component having the same or sufficiently effectively similar functionality as the implanted component. Further, any disclosure of a prosthesis herein corresponds to an alternative disclosure of a device or component that is not a prosthetic component. Any disclosure of a prosthesis herein corresponds to an alternative disclosure of a wearable or portable device. It should also be noted that any disclosure of the wearable or wearable device and/or prosthesis and/or implanted components corresponds to a disclosure of a stationary or semi-stationary device having this functionality. All of which are dependent on the art to which such is supported and are not in any way a clear limitation of what is detailed herein.

In many cases, implantable devices such as implantable electrodes are disclosed herein for use in monitoring physiological characteristics. Consistent with the above statements of the previous paragraph, any disclosure herein of an implanted component for measurement or sensory purposes also corresponds to an alternative disclosure of an apparatus and/or device for a component that is not implanted but has that function or otherwise supports such a function, which is likewise subject to the above limitations.

In this exemplary embodiment discussed, the generated sound or other stimulus that is otherwise used to induce a hearing perception is used to elicit a time-specific response in the brain, such as an EEG response. In this regard, sound or perceived sound may cause the brain to be stimulated and thus produce detectable/recordable brain waves, and data associated therewith may be analyzed, sometimes in real time, to assess the state of the human brain.

Fig. 5 provides an exemplary embodiment of an EEG system implanted in a recipient, where read/sense electrodes 1220 are arranged within the recipient's head and are in signal communication with coils 1210 via electrical leads. In this embodiment, the implanted device does not have recording/storage capability and requires the external device to receive signals from the implanted inductive coil 1210 in order to retrieve the signals therefrom in real time. Implantable components that convert electricity sensed by the sensor/read electrode into a signal transmitted by the inductive coil 1210 are not shown. In an exemplary embodiment, the sensor arrangement seen in fig. 5 is an implantable EEG sensor arrangement.

Fig. 6 depicts another arrangement of an implantable sensor arrangement that also includes a sensor/read electrode 1220 and leads. Here, in this embodiment, there is a housing 1330 containing circuitry configured to receive signals from the electrodes 1220 by the leads and record data therein or otherwise store data and allow the data to be periodically read from the external device when the external device is in signal communication with the implanted inductive coil 1210. Alternatively, and/or in addition, the circuitry is configured to periodically energize the inductive coil 1210, thereby providing data to the coil 1210, such that the coil generates an inductive signal, which in turn communicates with an external component that reads the signal and thus the data associated with the electrode. Thus, in at least some example embodiments, the implantable device is configured to stream the data. Additionally, in some embodiments, the data is not streamed, but instead is provided in bursts.

In at least some example embodiments, any arrangement that enables data associated with the read electrodes to be provided from inside the recipient to outside the recipient may be utilized. In this regard, conventional implantable EEG sensor arrangements may be obtained and modified to implement the teachings detailed herein and/or variations thereof.

It should be noted that some embodiments of the sensor arrangement of fig. 13 include an implanted battery or otherwise implanted power storage arrangement, while in other embodiments the arrangement does not explicitly resemble this arrangement to the embodiment of fig. 12.

In view of the above, it should be understood that in at least some exemplary embodiments, there are conventional implantable EEG and EKG sensor systems configured to communicate with external devices detailed herein (e.g., the device of fig. 4 or the above-described "pillow charger" or "bed charger", etc.). In an exemplary embodiment, the structure implanted in the recipient is identical to these conventional sensor systems, except that the structure has been modified to operate in the various modes detailed herein, e.g., by programming or by structural modification or by including logic circuitry, etc. That is, in an exemplary embodiment, the sensory systems of fig. 5 and 6 are used in combination with the pillow charger detailed above to communicate and/or power and/or charge. Any disclosure herein above detailed in relation to the use of a pillow charger in association with a hearing prosthesis also corresponds to the use of a pillow charger for data transfer and/or for powering and/or charging the sensor system of fig. 5 and 6, or any other sensor system detailed herein, just as any disclosure herein detailed in relation to a pillow charger with respect to a cochlear implant also corresponds to such disclosure in relation to an implanted middle ear prosthesis, DACI and active transcutaneous bone conduction device.

Returning to the features discussed above with respect to the EEG, in embodiments where the medical device is a hearing prosthesis and the hearing prosthesis is configured to evaluate the sound environment of the hearing prosthesis to determine whether a data collection activity should be initiated, the microphone of the hearing prosthesis, whether it is an external microphone or an implanted microphone or even a microphone that is not part of the hearing prosthesis itself but is usable to communicate with the hearing prosthesis, captures ambient sound. The prosthetic is configured to evaluate the ambient sound, or more precisely, to evaluate/analyze the data (signal data) output by the sound capture device (microphone) and to infer the current sound environment. By way of example only, and not by way of limitation, a signal-to-noise ratio may be developed or otherwise identified based on data from the microphone. The absolute/average sound levels may be derived based on data from the microphones, e.g. 77dB, 40dB, 100dB, etc. Using a predetermined algorithm or data embodied in a look-up table, a comparison may be made between the results of the analysis and predetermined data to determine a level of quietness or loudness, etc., of the environment based on the data. In this regard, in an exemplary embodiment, the hearing prosthesis may include a processor or logic or some other form of circuitry that may be used for the analysis described above.

In an exemplary embodiment, the apparatus/device herein is configured to identify the presence and/or absence of at least one of ambient sound, ambient light, electromagnetic radiation or a magnetic field that at least meets or at least does not meet predetermined criteria and to determine whether a data collection activity should be initiated based on the identified presence and/or absence, and/or to evaluate at least one of the intensity, spectrum or fluctuation of the ambient sound and/or light and determine whether these aspects meet and/or do not meet the predetermined criteria and to determine whether a data collection activity should be initiated based on the identified presence and/or absence.

The hearing prosthesis may determine, based on the analysis, whether a data collection activity should be initiated and/or whether the data should be disregarded, or otherwise provide output/data that may support such determination. In an exemplary embodiment, if the ambient sound is fluctuating such that the signal level varies by more than 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20dB, for example, within more or less than 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 4.5 or 5 seconds, for example, over a given period of time, the prosthesis may decide that data collection should not be initiated because, for example, the ambient sound may induce reactions in the brain, producing an EEG signal that would confound general activity of the brain that is not related to the ambient sound, thereby reducing the utility value of the EEG when analyzed for purposes of analysis (e.g., the signal amplitude would vary partially in response to the ambient sound, which may be sufficient to affect the utility value of the EEG response in terms of general activity of the EEG signal).

The hearing prosthesis may determine whether a data collection activity should begin based on the analysis. In another exemplary embodiment, if it is determined that the ambient sound is at a level of 100dB, the prosthesis may determine that data collection should not begin because in embodiments where a brain response is evoked using a sound source, it is believed that the recipient of the hearing prosthesis may not be able to hear the sound, or even if the recipient hears the sound or even otherwise distinguishes the sound from the ambient environment, the resulting EEG signal will not be practical when analyzed for purposes of analysis (e.g., the signal amplitude will only change slightly compared to the situation before data collection begins, or more accurately, before additional noise begins or action begins to evoke a hearing perception for purposes of stimulating the brain).

There are various devices, systems, and methods that enable an ambient acoustic environment to be analyzed. These aspects may be included in the hearing prosthesis by dedicated specific circuitry added to the hearing prosthesis or by modifying its existing circuitry (e.g., reprogramming an existing processor, etc.).

It should be noted that with respect to the configuration to evaluate the sound environment of the hearing prosthesis to determine whether a data collection activity should begin, in some embodiments, the hearing prosthesis is configured to subsequently begin a data collection activity. In this regard, in an exemplary embodiment, for example only and not by way of limitation, where probing is used, the external component 1440 may output sound from any one of the speaker/receiver devices associated therewith, such as in the case of a speaker in the ear canal with respect to a conventional hearing aid, or cause an implanted actuator to operate to induce a hearing perception, or cause an implanted cochlear implant electrode array or the like to provide stimulation to the cochlea to induce a hearing perception, or the like. Further, in an exemplary embodiment, the external component 1440 may be configured to communicate with the implant coil 1210 to extract data recorded or otherwise collected by the read electrodes 1220 or the like from the recipient. Thus, in the exemplary embodiment, external component 1440 is not configured to communicate as such. Alternatively, a separate device may be utilized to retrieve the data. In this regard, the means for retrieving data may be a component that is completely separate from the hearing prosthesis, or a medical device for evaluating the sound environment. Indeed, it should be noted that in some exemplary embodiments, even a hearing prosthesis is not used to induce a hearing perception or otherwise generate sound. In an exemplary embodiment, as noted above, a separate device may be utilized. That is, there may be practical value with respect to a combination device, at least with respect to a device that analyzes a sound environment and a device that causes a hearing perception to be evoked, thereby stimulating the brain.

In view of the above, it can be seen that in some embodiments, the hearing prosthesis does not necessarily participate in any affirmative actions associated with the data collection activity. In this regard, in an exemplary embodiment, the hearing prosthesis may output only data indicative of the results of the analysis. By way of example only, and not by way of limitation, in an exemplary embodiment, the prosthesis may indicate to the recipient a situation such as "is now a good time to perform brain monitoring," such as where the recipient is an active participant in a data collection activity. This may be simulated speech produced by the hearing prosthesis. In the case of an implantable hearing prosthesis, the simulated voice may be content that is audible only to the recipient. In an exemplary embodiment of this exemplary embodiment, the recipient may then affirmatively participate in the testing protocol. In an exemplary embodiment, the recipient may close the eyes and relax briefly. Or in addition, in an exemplary embodiment, the recipient may be affirmatively engaged in the test regimen and the data collection activity commenced when the recipient is in a suitable physical state and desires to conduct the test while producing sound or otherwise inducing hearing perception. This process may be as simple as the recipient closing his eyes (and affirming the detection of this activity by the measuring device) or the recipient saying "start bar" or similar event for a limited period of time starting from the above-mentioned notification from the hearing prosthesis. This may also be the recipient affirmatively pressing a button or the like on the external component, where the recipient may activate an application on the portable handheld electronic device 241 to conduct the test or the like. In at least some example embodiments, any apparatus, system, and/or method that may implement the teachings detailed herein may be utilized.

It should also be noted that, in at least some exemplary embodiments, the hearing prosthesis does not communicate with the recipient, at least not directly. Alternatively, in an exemplary embodiment, after evaluating the sound environment, the hearing prosthesis may communicate with a remote device, such as portable handheld electronic device 2401 detailed above, which may control the overall effort to cause the hearing prosthesis to cancel brain stimulation. That is, the hearing prosthesis may communicate with a remote device, such as a remote server or the like, that is physically remote from the site, which may control data collection activities and testing, etc.

Moreover, at least some example embodiments include integrated systems and/or semi-integrated systems, of which the hearing prosthesis is a part, that may perform at least one or more or all of the method acts detailed herein, or that have functions in one or more or all of the functions detailed herein.

Thus, it can be seen that in at least some exemplary embodiments, a medical device may be configured to perform EEG monitoring. In an exemplary embodiment, the data collection activity is EEG signal collection/recording/reading. As will be described in detail below, the data collection activity may alternatively be EKG signal collection/recording/reading. The data collection activity may also be a single action potential, multi-cell cluster recording, compound action potential, or other neural response. Other types of data collection activities may be utilized. In at least some example embodiments, any data collection activity that may have practical value in analyzing features associated with a recipient's body may be utilized.

Consistent with the embodiments detailed above in connection with EEG/EKG monitoring, in an exemplary embodiment the data collection activity is data collection with implanted electrodes as part of a medical device. It should be noted that in at least some example embodiments, electrodes in a cochlear electrode array may be utilized. These electrodes may be implanted in the cochlea or extra cochlear electrodes, and in some embodiments any electrode used to induce hearing perception may be used. As described above, the electrode(s) may also be an extra-cochlear electrode (e.g., a so-called ball electrode, or a flat plate electrode located on the receiver stimulator of a cochlear implant, etc.) for return in monopolar stimulation. These may also be additional electrodes added to the cochlear implant electrode array, such as the arranged electrodes seen in fig. 5, which are integrated or otherwise in communication with the cochlear implant.

Like these, fig. 7 presents an exemplary embodiment of a modified version of the fig. 6 embodiment detailed above. In this embodiment, presented in functional conceptual terms (e.g., coil 1201 and housing 1330 would be part of an integrated assembly), the cochlear implant is represented as a cochlear implant electrode array represented by an "X". This is an example of how a cochlear implant electrode array may be integrated with an EEG reading electrode device. In this embodiment, the housing 1330 may contain implanted circuitry and components of a cochlear implant electrode array that may be modified to have functionality for EEG reading purposes or, alternatively, may also contain separate circuitry in the housing for EEG reading purposes.

It should also be noted that fig. 7 conceptually represents a different type of hearing prosthesis than a cochlear implant. The middle ear actuator may be represented by an "X" or the implanted actuator of the bone conduction device may be represented by an "X" and the housing 1330 may contain circuitry to control the implanted actuator, while also containing circuitry housed in the housing that may enable EEG readings.

It should also be noted that in at least some example embodiments, housing 1330 can contain a speech processor or the like, such as would be implanted in the case of a fully implantable hearing prosthesis.

Returning to the features associated with sound, as can be seen, in at least some example embodiments, the prosthesis (or other medical device) may include an acoustic sensor. In an exemplary embodiment, the acoustic sensor may be an implantable/implantable acoustic sensor and/or may be an external acoustic sensor. In some embodiments, this may be a microphone or the like. In some embodiments, this implanted acoustic sensor may be used to obtain data associated with the sound environment of the hearing prosthesis, as noted above. It should be noted that the utilization of an implanted acoustic sensor may have practical value in capturing body noise and the like. Indeed, in some embodiments, the features captured in the body noise monitoring can be indicative of the physiological state of the user. Such features may be indicative of resting levels or stress levels or postprandial digestion stages, and may have value in determining whether it is an appropriate time to take the measurement. Similarly, the amplitude of the body noise may have a temporal characteristic or be sufficiently high to make the above-described test less practical than otherwise. That is, in at least some example embodiments, not only are characteristics such as temporal fluctuations, spectral shapes, or amplitudes of ambient sounds determined and utilized to determine whether to conduct a test, but characteristics such as temporal fluctuations, spectral shapes, and amplitudes of body sounds are also determined and utilized to determine whether to conduct a test.

It follows that, in at least some exemplary embodiments, the medical device includes an implantable component configured to perform acoustic detection using an acoustic sensor.

In some embodiments, the probing may be active probing. In some embodiments, the data obtained based on active probing is non-movement data associated with the recipient, and in some embodiments, the data is physiological data, and in some embodiments, the probing is movement data. Thus, at least some of the determinations may be a determination of whether to initiate active probing, and in some embodiments, such determinations may be based on non-movement data associated with a recipient of the medical device.

In some embodiments, the non-movement data is biologically based data. In some embodiments, the data (whether it is non-mobile data or not) may be non-biologically based data.

It should also be noted that in an exemplary embodiment, the medical device may contain only one sensor system, which may be used to collect both physiological and non-physiological data. In an exemplary embodiment, the data obtained based on active probing as detailed herein is physiological data.

It should also be noted that the teachings detailed herein are not limited to utilizing only a sound capture device to obtain data upon which the determinations and/or analyses detailed herein are based. In this regard, in an exemplary embodiment, there is a medical device configured to obtain data indicative of a type and/or amount of neuronal activity of a recipient of the medical device and evaluate the obtained data. Consistent with other embodiments detailed herein, the device may also be configured to determine whether a data collection activity should be initiated based on the evaluation. With respect to the ability to obtain data indicative of the type and/or amount of neuronal activity of the recipient, this may be performed using the apparatus of fig. 6 or fig. 7, or the like. Alternatively, and/or in addition, electrodes in a cochlear implant electrode array may be utilized. In some embodiments, the same electrodes may be used to obtain data indicative of the type and/or amount of neuronal activity used for data collection. In other embodiments, the electrodes are separate electrodes. Indeed, according to the teachings detailed above with respect to some embodiments, the medical device is not a device performing data collection activities (while in other embodiments it is a device performing data collection activities).

It should also be noted that the electrodes are not necessarily used to obtain data indicative of the type and/or amount of neuronal activity. Any means for achieving this may be utilized. Additionally, it should be noted that although the embodiments disclosed herein relate to implantable electrodes for obtaining data, in some embodiments, non-implantable or semi-implantable electrodes may be utilized. In at least some example embodiments, any apparatus, system, and/or method capable of carrying out the basic teachings detailed herein may be used.

By way of example only, and not by way of limitation, in an exemplary embodiment, electrodes may be utilized to detect whether an auditory portion of the brain is stimulated. In this regard, this may be a potential variable indicating whether the recipient is in an environment sufficiently quiet for the acoustic stimulus described above. In fact, the amount of sound in the environment is a potential variable indicating whether the recipient is in a state in which the above-described acoustic stimulation can be performed in a manner that will produce a practical value with respect to the collected data. In any case, for example, the electrodes in the cochlear implant electrode array can be used to assess the type and/or amount of neuronal activity in the recipient, which may be an indication that the recipient is in a sound environment, or an indication that the recipient is developing brain functions that do not contribute to practical value from any data collected. Also, in at least some example embodiments, components associated with the ability to obtain data indicative of the type and/or amount of neuronal activity of the recipient may be integrated into any of the prostheses detailed herein.

It should be noted that some other embodiments may include obtaining data associated with a visual cortex. In this exemplary embodiment, the electrodes may be used to acquire data associated with visual cortical activity. By way of example only, and not by way of limitation, read electrodes may be used to determine the level and/or number of neurons excited (similar to the way auditory cortex is analyzed in at least some exemplary embodiments).

The more neurons that fire, whether auditory or visual cortex, may indicate the level of stimulation applied to the recipient at a given time. The medical device may be configured to analyze data obtained by the medical device indicative of the number of neurons fired, etc., or any other underlying indicia that may have a practical value, and to determine whether to initiate data collection activity, etc., based on the analysis.

In view of the foregoing, it can be seen that in at least some exemplary embodiments, the medical device includes a plurality of sensor systems. For example, a medical device according to the teachings detailed herein may include a first sensor system and a second sensor system. The first sensor system may be a sensor system to collect data after data collection begins. This may be any of the read electrodes, etc., detailed herein. The second sensor system may collect non-physiological data. For example, the second sensor may collect ambient sound in the recipient's environment according to the teachings detailed above. According to the above embodiments, the medical device is configured to evaluate the collected non-physiological data to determine whether a data collection activity should be initiated. In at least some example embodiments, the medical device is configured to evaluate the collected non-physiological data in the absence/without regard to any data that may be collected by the first sensor system. As a corollary, in at least one exemplary embodiment, the second sensor system is configured to collect only non-physiological data. In other embodiments, the second sensor system is configured to collect both. Additionally, in an exemplary embodiment, the medical device may use two sensor systems together to make the determination.

Thus, in some embodiments, there may be a medical device comprising a first sensor system for collecting data after the start of data collection and a second sensor system that collects non-physiological data, and configured to evaluate the collected non-physiological data to make one or more determinations as detailed herein.

While the above embodiments have focused on the second sensor system collecting sound or otherwise capturing sound, in some alternative embodiments, the second sensor system may be a sensor system collecting light. By way of example only, and not by way of limitation, ambient light may be a potential variable indicative of brain stimulation or the like. Accordingly, embodiments include capturing light and evaluating the amount and/or content of light to make the above-described determination as to whether a data collection activity should begin. In exemplary embodiments, the optical sensor may be located at a hearing prosthesis, for example on a behind-the-ear device, or on a button sound processor, or otherwise located on and outside of an ear device, etc. Indeed, in an exemplary embodiment, a light sensor of the portable handheld device 2401 may be utilized. In this regard, embodiments enable the hand-held device to communicate a signal indicative of the amount of light to the prosthesis or other medical device, and the medical device may analyze the signal to make the determination. As can the microphone of the portable handheld device 2401.

While the above embodiments have focused on capturing and evaluating the amount of light present in at least some instances, by way of example only and not by way of limitation, the second sensor system may capture video images or the surrounding environment, analyze these images to determine if certain features are present, and determine if measurements should be taken. For example, the features may be a determination of the presence of other people in the vicinity of the user, or may be a determination of a stationary physical environment.

It should be noted that in some embodiments, the medical devices detailed herein above may be configured to determine and/or infer a state of a recipient of the medical device and/or an environment of the medical device (and/or the environment of the recipient — both of which are not necessarily mutually exclusive), and determine whether a data collection activity should be initiated based on the determination of the state of the recipient. The function associated with the determination may be implemented by, for example, monitoring the recipient's brain waves and determining that the recipient is, for example, sleeping. The functionality associated with the inference may be implemented by, for example, monitoring ambient sounds for noise indicative of sleep and/or the absence of noise indicative of the recipient being asleep, at least for a specified time period at a specified time location. Alternatively, the prosthesis may be configured to determine and/or infer that the recipient is in, for example, an exercise state or a physical activity state. Another possible state may be a high concentration state. In some embodiments, any one or more of the states may be a state in which data collection activity may produce data that is less practical than otherwise. That is, in some embodiments, there may be utility in collecting data in states that are associated with those states, as the data is particularly needed. Additionally, this may be as simple as attempting to avoid waking up a recipient that utilizes a sound-based test.

In at least some example embodiments, the medical device is configured to receive information indicative of a recipient status. In an exemplary embodiment, this may be accomplished by real-time input to the medical device by another device, such as a handheld device. Indeed, in an exemplary embodiment, the recipient may speak into the handheld device, thereby indicating its status. A recipient may activate an activation in which the recipient may enter their status, such as by pressing an icon indicating ease, happiness, mania, worsening, tiredness, mania, sexual arousal, never wanting to see another woman or man, etc., additional icons may include the ability to enter the recipient's current activities (exercise, reading, fishing, working, driving in poor traffic conditions, etc.). It should also be noted that instead of or in addition to using icons, a voice system may be utilized to receive data. That is, the medical device may also be utilized in a manner that skips a handheld device. For example, a microphone of a hearing prosthesis may be utilized, wherein the recipient merely indicates his happiness, etc. Additionally, it should be noted that latent variables may also be used to infer any of the above scenarios. For example, the sound capture device of the prosthesis may capture sounds of the recipient complaining about her boss, shouting, etc., indicating that the recipient is in a less happy state. The repeated horn sounds may indicate that the recipient is in a traffic environment. A sound indicating a description of the degree of attractiveness of another person may indicate the arousal (or the degree of unappealing of the person, etc.) described above. In any case, the medical device is configured in one way or another to receive input indicative of one or more of the above-mentioned contexts. The medical device may be configured to receive these inputs and evaluate the inputs, and determine whether a data collection activity should be initiated. Thus, embodiments include utilizing non-latent variables.

It should also be noted that, in at least some example embodiments, the medical device may be configured to identify the geographic location of the recipient and/or the environment in which the recipient is located. This can be done using GPS technology and/or computer aided location means on e.g. a smart phone or the like. This can also be done using the above scenarios such as sound capture (horn equivalent to traffic, long typed sound indicating work, etc.). In fact, many hearing prostheses incorporate advanced scene classification systems and algorithms. These systems and algorithms are used to analyze a sound environment and, based on the analysis, adjust the hearing restoration to better present sounds associated with the environment, rather than other background situations that are more practical for other environments. Here, instead of adjusting the hearing restoration, the basic result of the sound environment analysis is used to infer the environmental condition of the recipient. It should also be noted that the visual means may be used to infer the environmental condition of the recipient. In this regard, advanced image processing may be used to determine a given location of a recipient, and so on. This can be done with a small camera located on the hearing prosthesis or on the medical device or, for example, on the portable handheld device 2401 as detailed above. Thus, in some embodiments, an event occurrence refers to the presence of a recipient's location (e.g., at a casino, soccer stadium, workplace, etc.). Further, in an exemplary embodiment, the first data is based on a captured sound captured by the recipient's device. Further, the camera may be used to collect data to assess other things, such as the condition of the recipient (a "self-timer" may be taken, and the image recognition software may determine whether the recipient is "healthy as usual," and based on that determination other determinations may be made, etc.).

In an exemplary context, there may be a utility value in determining, for example, whether the recipient is at a casino or the like. Collecting data may be impractical when a recipient rides a roller coaster. Accordingly, based on the obtained data associated with the recipient's environment, data collection may or may not begin.

In an exemplary scenario, there may be a utility value in determining the tertiary environmental factors through the above analysis. For example, the geographic location and camera (to determine whether the person is outside or inside the vehicle, or in the vehicle, etc.) are utilized in the environment of the user to determine atmospheric pressure, ambient temperature, humidity, wind energy characteristics, any weather characteristics that may be practical (wind, rain, sun, night, day, etc.), and so forth. All of which can be used to evaluate whether to perform the measurement and/or disregard the measurement, etc.

Thus, in an exemplary embodiment, the medical device includes an environment classification system. The medical device may be configured to determine whether a data collection activity should be initiated based on the classification of the environment by the classification system. In some other embodiments, other types of classification systems are used, and thus in some embodiments, the medical device includes a classification system, and the medical device is configured to determine whether a data collection activity should be initiated based on a classification by the classification system of physiological and/or non-physiological characteristics associated with the recipient and/or the recipient's environment.

Still referring to the method 900 consistent with the above embodiments, in an exemplary embodiment, the first data may indicate movement of the recipient, and the second data may be any EEG measurement that may be performed and/or performed by an implanted component implanted in the recipient. In this regard, there may be practical value in acquiring EEG measurements or otherwise evaluating EEG measurements acquired while the recipient is stationary, as the measurements may be more indicative of the underlying phenomena associated with brain signals than if the recipient was moving. Indeed, in this regard, in some embodiments, an action is taken when the recipient is stationary or moving and/or when the prosthesis is stationary or moving (where the term differences are not mutually exclusive). In some embodiments, the prosthesis and/or the recipient are locally stationary, meaning that the prosthesis and/or the recipient are not moving relative to their surroundings (e.g., the recipient may sit still in an office, or may sit in a car driving on a very smooth road, but the recipient sits still in a car). In some embodiments, the recipient and/or the restoration are globally stationary, which would preclude the recipient from being in a moving car, even on a smooth road, etc. In some embodiments, the event for evaluating or otherwise determining whether to perform a measurement or disregard a measurement occurs differently than if the recipient was actually stationary. In this regard, the event occurrence may be something that occurs whether the recipient is stationary or not. Alternatively, the event occurrence may be a delta of a stationary condition of the recipient. Indeed, this is consistent with the teachings herein, where multiple data may be used as a basis for implementing or disregarding measurements. For example, if the accelerometer data indicates that the prosthesis is stationary, but other data indicates that the recipient is emotionally disturbed or in a noisy environment, etc., the test may not be started or the data may be ignored, although the recipient is stationary. It should also be noted that in some embodiments, the presence of a stationary condition may be determined without an accelerometer. For example, the recipient may enter data that the recipient is stationary (e.g., by answering questions on the device and selecting a yes/no prompt). Further, in some embodiments, the determination may be made without sensor input regarding the recipient's movement and/or without data indicative of the recipient's movement, and various actions herein may be taken if the recipient is stationary according to any of the contexts herein. That is, in some embodiments, the teachings herein may be performed even in the absence of a positive and/or direct determination that the recipient is stationary.

At a possibly more basic level, the medical device may be configured to sense a phenomenon indicative of movement of the recipient. In some embodiments, such data collection may be less practical when collected during movement of the recipient, which movement may indicate at least little physical activity. That is, in some embodiments, the phenomenon indicative of movement may be an amount of movement associated with the recipient. For example, for scenarios where data is collected while the recipient is walking rather than running, at least some data collection activities may be practical. Thus, in an exemplary embodiment, the medical device is configured to sense a phenomenon indicative of movement of the recipient, and to evaluate the sensed phenomenon indicative of movement to determine whether a data collection activity should be initiated.

It is briefly noted that at least some example embodiments cause any one or more or all of the method acts and/or functions detailed herein to be performed by a medical device. In exemplary embodiments, one or more or all of the method acts and/or functions detailed herein are performed generally by a prosthesis, and in particular, for example, by a hearing prosthesis or a retinal prosthesis. That is, in some embodiments, one or more of the method acts detailed herein and/or functions detailed herein may be performed by a non-medical device under a non-prosthetic device, wherein data indicative of the method acts or functions or results thereof is communicated to the medical device such that other ones of the functions dependent upon such data may be performed.

Fig. 9 presents an exemplary flow diagram of an exemplary method, method 900, that includes a method act 910 that includes an act of obtaining, with a device of a recipient, first data indicative of an occurrence of an event associated with the recipient of the prosthesis. The recipient's device may be a prosthetic device that the recipient has received. The recipient's device may be an implantable prosthetic device or an external prosthetic device. Further, the recipient's device need not be a prosthetic device. Alternatively, it may be some form of medical device of the recipient. Furthermore, in an exemplary embodiment, the recipient's device itself may not even be a medical device. By way of example only, and not by way of limitation, it may be the portable handheld electronic device 2401 detailed above. More information on this is provided below.

Method 900 also includes a method act 920 that includes determining, based on the obtained first data, whether to at least one of: perform a measurement involving the recipient, or disregard second data involving the recipient. In an exemplary embodiment, the first data indicates at least one of an environment of the recipient, an activity in which the recipient is engaged, or a status of the recipient, by way of example only. Consistent with the teachings detailed above, the environment may be a noisy environment, a harsh environment (playground, etc.), an automotive environment, a traffic environment, a space environment that is all children, etc. Also consistent with the teachings detailed above, the activity in which the recipient participates may be exercise, driving, reading, sleeping, etc. The status of the recipient may be worsening or happy or binge or excited, etc.

The obtained first data may be obtained by any device herein, such as any prosthesis herein or a medical device herein or a remote device, such as a portable handheld device or the like. Alternatively, and/or in addition, the decision action, method action 920, may be performed by a device remote from the recipient, such as by a geographically remote server or the like. That is, method act 920 may be performed with another device, e.g., a hearing prosthesis, remote from the recipient, where the device used to perform method 910 may be a dedicated EEG monitoring device as noted above. Additionally, in an exemplary embodiment, the device used to perform method act 920 may be the portable handheld device 2401 detailed above, while the device used to perform method act 910 may be a prosthesis, such as a hearing prosthesis, or any other medical device, and thus one device remote from the other device. Relatively speaking, decision action method act 920 may be performed by an apparatus for obtaining first data that is the subject of method 910. Likewise, such devices may be implemented with any of the integrated devices detailed herein and/or variations thereof.

In view of the above, the measuring of method act 920 includes measuring physiological characteristic(s) of the recipient with an implantable device implanted in the recipient. In this regard, in exemplary embodiments where the obtained second data is also obtained by performing measurements, at least in some exemplary embodiments, both measurements associated with the possible permutations of method act 920 include measuring a physiological characteristic of the recipient with an implantable device implanted in the recipient.

Fig. 10 presents an exemplary flow chart of an exemplary method, method 1000 comprising method act 1010, which comprises performing method 900. Method 1000 also includes a method act 1020 that includes evaluating the first data and determining, based on the evaluation, that the environmental, activity, and/or status indication is detrimental to the measured utility value. By way of example again, the environment may be a noisy environment in situations where sound is to be used to stimulate brain activity. The activity may be that the recipient is exercising or at a casino or the like, wherein the activity causes the recipient's brain to behave in such a way that the recorded EEG signals will not be practical due to overall stimulation. In an exemplary embodiment, for example, where a man reveres a woman it finds appealing, the recipient's state will be excited, and the brain wave pattern of a man in such state is likely to be suppressed, enhanced, or skewed in some way, which is only the case. In an exemplary embodiment, the determining act of method act 1020 may include disregarding the second data based on the evaluating. Also, in exemplary embodiments where a noisy environment exists and the test is performed with prosthesis-induced hearing perceptions, the resulting data will be skewed or may not be available, for example, because the recipient may not react to the prosthesis-induced hearing perceptions and/or the prosthesis-induced hearing perceptions are overwhelmed by the ambient noise. Indeed, if the recipient is unable to perceive sound, the data obtained will be like any other data obtained without sound, all other things being equal.

Briefly, with regard to disregarding the second data, there is a context in which the first data is collected regardless of the activity or environmental state of the recipient. In this regard, there are some types of sensory systems that have access to sufficient power and/or processing power and/or data collection working elements so that the system can collect data continuously, possibly continuously or semi-continuously. In at least some example embodiments, this provides a practical value on the premise that more data is better than less data. However, the opposite concept is that more data containing more bad data is less practical than less data containing less bad data. Of course, there is practical value for more data containing more good data and less bad data. In view of this, it can be seen that the teachings detailed herein can be used to achieve any desired combination. Regarding the neglect, this concept is: you have a lot of data that contains a lot of bad data because the system that collects the second data collects it in an ambiguous way at a certain rate or for the collected data is good or bad. However, with efficacy in accordance with the teachings of the present application, the collected data may be correlated in some manner with the first data (in time, numerically, etc.), and then subsequently (or in real time) evaluated whether the first data justifies disregarding the second data. For example, if the data was collected when the recipient was emotionally distracted for various reasons, this second data may prove to disregard the first data. This is in contrast to the system or you deciding that the second data indicates that the first data should not be collected in the first instance.

In view of the foregoing, it can be seen that the options for implementing the teachings detailed herein are broad and bulky. The innovations according to the present application enable the healthcare community to obtain various options that heretofore did not exist at all, at least in terms of practical implementation.

In particular, example embodiments of disregarding may include disregarding various amounts of the first data based solely on the second data. An exemplary embodiment of the disregarding may be deleting various amounts of the first data based on the second data. An exemplary embodiment of the disregarding may be to take further action to verify or otherwise further analyze the first data, which would otherwise not occur in other circumstances with respect to the second data. By way of example only, and not by way of limitation, in the event that the recipient is very excited, the first data collected during this may indicate a high likelihood of epilepsy or the like due to brain activity, but because the method/system "knows" that this data was collected during excitation, the recipient (or some other caregiver) may not be automatically alerted of an impending seizure, but instead increase the monitoring frequency and/or monitoring duration and/or increase the span or duration, etc. This is in contrast to the first data indicating that epilepsy may be about to occur, where the second data indicates that the recipient is relaxed. In such a scenario, the first data would not be ignored, any alert could be automatically issued without waiting for a moment, and so on. I.e. the first data is never ignored. In this regard, the notion of disregard may be a relative notion of processing data and other times or under other collection schemes.

As will be understood from the foregoing, at least some embodiments are implemented with a hearing prosthesis such as a cochlear implant. In this regard, the cochlear implant induces hearing perception based on captured ambient sounds. Thus, a noisy environment will produce noise that is perceived by the recipient, as well as electrical artifacts (artifacts) from electrical stimulation of the cochlea. In some embodiments, the medical device may be configured to stop supplying the recipient with ambient environmental noise such that no sound is perceived and no electrical artifacts are recorded in the signal measurements in the system 1. In another embodiment, the background noise representation is stopped, and then an electrical probe is activated, which is the sound used for the test. This may even enable at least some testing in environments that would otherwise be harmful to the data obtained. Thus, in an exemplary embodiment, in a variation of the method acts detailed herein, upon analyzing the obtained first data, a decision may be made to implement a measurement involving the recipient, but in a controlled manner in which the sound of the surrounding environment is blocked by the prosthesis. That is, method act 920 may be accompanied by a modification that further includes preventing inducement of hearing perceptions based on ambient sounds during the test. Alternatively, the only hearing perception induced is based on the test sound, for example in case an acoustic probe is used.

In an exemplary embodiment, the data that is the subject of the methods herein is non-EEG data and/or non-EKG data.

In an exemplary embodiment, the medical device may be configured to notify the recipient that there will be a period of time during which the recipient cannot hear the surrounding environment. Thus, the recipient will be alerted. In an exemplary embodiment, the medical device may be configured to ask or otherwise request input to the recipient as to whether such event occurrence is appropriate for the recipient. In some embodiments, the medical device may be designed to require a positive input by the recipient to continue, while in other embodiments the medical device does not continue only if the recipient overrules the medical device.

The method 900 may have practical value in determining whether to expedite measurements or recordings, etc., from basic recording/measurement schemes to more complex or processor-intensive or data-intensive things. In this regard, the data recording characteristic of a given medical device or hearing prosthesis may periodically obtain the first data at a given rate and/or in a given amount that is less than an amount that may occur during a period of greater interest or during an event associated with the recipient, such as a seizure or pre-seizure. Thus, in an exemplary embodiment of method 900, the following scenario may exist: the method includes performing a low fidelity recording, and then after deciding to perform a measurement involving the recipient, the medical device performs a high fidelity recording. Indeed, in the exemplary embodiment, even in the case where no decision is made to implement a measurement, a low fidelity recording may have occurred at the time the decision action was taken. In this regard, method act 920 may involve deciding to change from a low fidelity recording to a high fidelity recording. Method act 920 can also involve determining not to change from low fidelity recording to high fidelity recording, only maintaining low fidelity recording work.

Thus, in the exemplary embodiment of method 900, the measurement is a high fidelity recording, while a low fidelity recording occurs at the time of the decision. Decision action method action 920 includes deciding to implement a high fidelity measurement and thus transition from a low fidelity measurement to a high fidelity measurement.

Still referring to method 900, the get action method act 910 is performed with the hearing prosthesis component. This is different from using a hearing prosthesis. In this regard, there are devices and systems developed or otherwise manufactured from components removed from the hearing prosthesis design. In this regard, there are devices corresponding to, for example, cochlear implants that are configured to perform method 900 and variations thereof. Additionally, some devices are not cochlear implants themselves, but use components of cochlear implants or other implants/prostheses, such as FDA approved/approved products, such as the FDA approved/approved cochlear implant up to 2018, 9/1.

For example, the microphone component and the sound capture device and/or the scene classification algorithm and/or the sound level detection/identification device, etc. may be used in devices that are not themselves hearing prostheses. Alternatively, these means may be used to obtain the first data and/or to analyze the first data. Additionally, in an exemplary embodiment, the means for obtaining and/or analyzing the first data is also used elsewhere for hearing restoration purposes, e.g., to ultimately induce a hearing perception with a hearing restoration, at the same time and/or contemporaneously with the act of obtaining the first data. In this regard, embodiments include utilizing components in a hearing prosthesis for non-hearing repair purposes. Thus, there are methods that involve using those components in a hearing prosthesis, while the design of those components, or components having exactly the same given features and/or parts and/or structures, etc., are used in a non-hearing prosthesis device to implement at least some of the teachings detailed herein.

It should also be noted that noise cancellation techniques may be used to determine the ambient/environmental noise. For example, many hearing prostheses may incorporate noise cancellation devices. The operation of these noise cancellation devices may be analyzed or otherwise evaluated to determine the amount of noise in the ambient environment. Likewise, the teachings detailed herein may relate to the use of FDA-approved components of hearing prosthesis devices for non-hearing perception inducing purposes, in fact to determine or otherwise identify the occurrence of other events. In particular, the above-described human noise system or noise cancellation system may never be used to induce a hearing perception. That is, consistent with the teachings detailed above, there are devices, systems, and methods that include a hearing prosthesis component and/or methods that are utilized in conjunction with a hearing prosthesis that would otherwise be used to induce a hearing sensation that is not induced based on its use.

It follows that, in at least some exemplary embodiments, the devices, systems, and/or methods disclosed herein relating to hearing prosthesis technology and/or retinal implant/biomimetic eye technology are used in persons without hearing and/or vision disorders or sensory disorders. In exemplary embodiments, the device systems and/or methods disclosed herein are associated with hearing restoration technology and/or retinal implants/biomimetic eyes or any one or more of the above-described senses as explained under the american handicapped act on the date as regulations and laws by 2018, 9, 15. That is, the person associated with the methods and apparatus herein is one that is not considered by law to have a given sensory disability. That is, according to this act, this person would not be considered to have vision or hearing disabilities that comply with the united states laws. This is not to say that if the person does not otherwise feel disabled, then the person is not disabled according to the act. That is, there is no particular sensory disability with respect to a given person.

Nor does it imply that the disabled person cannot utilize the teachings detailed herein. That is, the teachings detailed herein may be applied at 100% and cover people for sensory soundness.

In an exemplary embodiment, the teachings detailed herein are performed for persons or related persons who are not quorum and/or are not quorum blind according to the U.S. law and/or state of california laws that are current and explained as early as 2018, 9, 15.

In an exemplary embodiment, for artifact engineers who can correspond to 50 percent by 9/15 in 2018, such personnel being persons 20, 30, 40, 50, 60, and/or 70 years old (artifact personnel, not personnel of the subject of the method), it performs the teachings detailed herein for people who live in the united states at 9/15 days 2018 and/or for indigenous births residing in the united states, of any race or gender, male or female (in some embodiments, US military manuals for human factor engineering may be applicable, also for those existing at 9/15 days 2018), who are deemed to hear sounds of 500, 750, 1000, 1250, 1500, 1750, 2000, 2500, 3000, 3500, 4000, 5000, 6000, 7000, 8000, 9000, 10,000, 12,500, 15,000, 16,000, 17,000, 18,000, and/or 19,000Hz in a manner that is deemed audible.

It should furthermore be noted that the persons belonging to the subject of the method and/or the persons using the device may be persons with hearing and/or vision abilities as of 2018, 9, 15, as of the policy implemented in the state of california or the federal of pennsylvania, so that the healthcare system used by Aetna or Blue Cross-Blue Shield Personal Choice or Boeing Company (Boeing Company) in their philadelphia plant for the vast majority of non-exempt uses will not reimburse the hearing restoration of the persons, since the employees will have poor hearing.

Referring back to the external device of fig. 4, the device may be used in conjunction with the exemplary EEG system and/or EKG system disclosed herein. Indeed, in exemplary embodiments where the implanted coil of an EKG system such as that detailed herein is located on the upper torso, e.g., at the top of the chest, it is possible to utilize external device 1440 and such systems by snaking lead wire 1472 down through a person's shirt collar or the like to the person's chest or shoulder. That is, in an alternative embodiment, a dedicated external device dedicated to the EKG system may be utilized, where, for example, the non-coil portion (e.g., the equivalent of the BTE component 1426) is worn like a pendant on a chain of the person's neck, and the coil is magnetically adhered to the coil within the body. Furthermore, an off-the-ear (OTE) device may be used, wherever located, it may be a single unit located above the coil. This device may not be on a pendant, but instead may be held to the recipient by a magnet or the like.

Also, in some embodiments, the external device is substantially an external device to a hearing prosthesis, whether the hearing prosthesis is a cochlear implant, a middle ear implant, a bone conduction device, or a conventional hearing aid. In some embodiments, this external device is used for people without hearing problems, according to the above. Additionally, in at least some embodiments, such an external device is used in a manner that does not involve the use of the device itself to induce hearing perception or vision perception or sensory perception, or the like, with the possible exception of using the device for testing purposes.

Embodiments include components that utilize a hearing prosthesis or hearing prosthesis based at least on one or two or more days, at least for purposes unrelated to measurement, in a manner that does not induce a hearing perception, if not always. The same is true for other types of sensory prostheses, for example, optical prostheses, so-called biomimetic eyes. In this regard, in exemplary embodiments, there are methods that include utilizing a device having a sound processor or otherwise configured for sound processing that may be used to induce hearing perception if the device is used in a hearing prosthesis. There are also methods that involve the use of devices with sound processor technology, such as noise cancellation and/or human noise cancellation or detection features, etc., that can be used to accomplish this when used in hearing prostheses. In these methods, the device is used during a period lasting at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 200, 250, 300, 350, 400, 500, 600, 700, 800, 900, or 1000 hours or days, but not for inducing a hearing perception or a vision perception or a sensory perception, again, except for doing so to obtain a measurement. Thus, there may be a method comprising: the basic processing component, if not all components, of the hearing prosthesis performs any one or more of the actions detailed herein, with or without the presence of output components (receiver/speaker, actuators, electrodes), to accomplish things unrelated to the evoked hearing perceptions. This may also be the case for retinal implants (which may or may not have electrodes) where the matter is done/the device is utilized to do something unrelated to the induction of light perception.

In an exemplary embodiment, according to some embodiments, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95 or 100% of the device components are components found in hearing prostheses manufactured by at least one hearing prosthesis manufacturing company in the world on said date, based on the cost of a given point in time supporting the homogeneous comparison. In some exemplary embodiments, the above percentages are for: components relating to one or more of: determining whether a data collection activity should be initiated and/or data obtained for such determination, and/or determining whether collected data should be disregarded and/or data obtained for such determination; and/or means for obtaining the aforementioned first data, the first data indicating an event occurrence associated with the recipient and/or to determine whether to at least one of perform the measurement or disregard the measurement; and/or components of the second subsystem and/or the third subsystem. In an exemplary embodiment, the percentages exclude software, while in other embodiments, the percentages include software.

Consistent with the above, in at least some example embodiments, the obtaining act, act 910, and/or any analysis associated with data obtained by the act may be performed using a cochlear implant fully implantable hearing prosthesis implant component. Also, the idea is to disassemble or otherwise use an existing given design originally developed for hearing restorations for non-hearing restorative purposes.

As noted above, there may be practical value in utilizing sound scene classification, etc., with respect to the first data of the evaluation method action 910. Accordingly, fig. 11 presents an exemplary flow diagram of an exemplary method, method 1100 including method acts 1110, which relate to performing method 900. Method 1100 also includes a method act 1120 that involves performing a sound scene classification procedure to evaluate the first data and make a determination as to the presence of the recipient's location. Thus, in at least some example embodiments, method act 1120 occurs between method act 910 and method act 920. In this regard, it should be noted that any method acts detailed herein may be performed in any order relative to any other method acts detailed herein, provided that the art enables such diseases to be otherwise identified. Thus, the order in which a given method action is presented, as detailed herein, does not necessarily correspond to the actual order in which those method actions are to be performed. That is, in other embodiments, this is the order in which those method acts will be performed.

Sound scene classification is a technique developed and perfected by the college Limited, sydney, australia. In some cases, sound scene classification may be used as a latent variable to determine any number of things, such as location, activity in which the recipient is engaged, or even the status of the recipient. By way of example only, and not by way of limitation, a sound scene consisting of loud rock music or political review television programming may be a latent variable indicating that the recipient may be more defending than listening to elevator music, listening to weather reports, or silence. In an exemplary embodiment, there is an utilization of a sound Scene Classification system as disclosed in U.S. patent application publication No. 20170359659 entitled Advanced Scene Classification For Prosthesis (Advanced Scene Classification For Prosthesis) filed by Alex Von Brasch, australian inventor, 2016, 9.

In an exemplary embodiment of method 900, the first data obtained in method act 910 is obtained at a plurality of times over a first time period. By way of example only, and not by way of limitation, the first data may be collected every X seconds or minutes, less than or greater than X seconds or minutes, wherein X equals 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 260, 270, 280, 290, 300, 400, 1600, 600, 1200, 1400, 1200, 1400, 3000, 1200, 3000, 1200, 700, 3000, 5, 6, 7, 8, 86400, 9, 10, 12.5, 15, 17.5, 20, 25, 30, or more tens of thousands, or any value or range of values therebetween in 0.01 second increments (e.g., 25, 22.3, 5 to 30.22 seconds, etc.).

It should also be noted that the first data may be collected at nine even intervals, such as every five seconds in some cases, and every 10 seconds in other cases, etc., and further noted that in some embodiments, consistent with the teachings detailed above, for any of the above time periods, data collection may be suspended due to various circumstances that may occur that may indicate that the data collection will produce data that includes data that is less practical than that collected for other time periods. It should also be noted that in some embodiments, data collection may be increased to a rate that falls within any of the above values or variations thereof, depending on the context.

In any case, the obtained first data is obtained at a plurality of times in the first cycle. It should also be noted that the first time period may correspond to any of the values of X seconds or minutes detailed above, including any range of values therebetween.

It is also noted that the plurality of times can correspond to greater than, less than, or equal to Y times, where Y is 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 45, 50, 55, 60, 65, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 275, 300, 350, 400, 450, 500, 550, 600, 650, 700, 800, 900, 1000, 1250, 1500, 1750, 2000, 2500, 3000, 3500, 4000, 4500, 5000, 6000, 7000, 8000, 9000, 1, 1.1, 1.2, 1.4, 1.5, or more values in increments or ranges of any value therebetween.

Additionally, in the exemplary embodiment, the determining act of method act 920 is performed a plurality of times, respectively, for the respective obtained first data. The plurality may be equal to any value of Y or any value of Y minus Z as detailed above, wherein Z is equal to 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 45, 50, 55, 60, 65, 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200, 210, 220, 230, 240, 250, 275, 300, 350, 400, 450, 500, 550, 600, 650, 700, 800, 900, 1000, 1250, 1500, 1750, 2000, 2500, 3000, 3500, 4000, 4500, 5000, 6000, 7000, 8000, 9000, 1, 1.1, 1.2, 1.4, 1.5.4, 1.5.5.4.4.4.4.4.4.4.4.4.4.4.4.4.4.4.4.4.4.4.4.4.4.4.4.4.4.4.

Additionally, in some embodiments, the obtained first data comprises corresponding data indicative of a sensory noisy environment. The sensory noisy environment is not limited to a sound noisy environment. This may also be due to visual stimuli. Indeed, unlike acoustic noise, visual noise may be a feature associated with biomimetic eye and retinal implants and the like, in particular, the phrase "noise" and the phrase "noisy" as used herein always correspond to acoustic noise without modifiers. The phrase "sensory noise" and variations thereof is a generic covering, for example, various visual and acoustic noises. Thus, in an exemplary embodiment, the data indicative of a sensory noisy environment may in some embodiments be data indicative of a sound noisy environment. In particular, visual noise is considered, which may also be detrimental or otherwise disadvantageous to accurate measurements, or which may otherwise affect or otherwise skew measurements. Any type of sensory stimulus equivalent to acoustic noise intended to affect the measurements taken in embodiments herein may produce a sensory noisy environment.

In fact, this presents another point. One practical value of the teachings detailed herein is to identify situations where the recipient or individual is experiencing "sensory overload". In at least some exemplary embodiments, the sensory overload may be the worst case with respect to the obtained measurements in at least some exemplary embodiments, because, at least in some embodiments, this will skew the data to the greatest extent, and thus most likely result in false positives or false negatives, this is, at least in part, the goal of some embodiments of the teachings detailed herein (identifying false positives and/or false negatives, and/or identifying false related data and/or false unrelated data, and/or avoiding false positives and/or false negatives, or more precisely, avoiding data collection that includes data that would cause false positives and/or false negatives and/or data that would include false related data and/or false unrelated data, etc., the teachings detailed herein may, in some embodiments, be used to do any one or more of the above). Accordingly, embodiments also include identifying a sensory overload environment with respect to an action associated with obtaining the first data, and proceeding accordingly based on such identification or lack of identification.

Moreover, the respective determination of act 920 includes determining not to perform a measurement related in time to the respective obtained first data and/or disregard the respective second data related in time to the respective obtained first data, respectively. Further, in some embodiments, the obtained first data comprises respective data indicating that the noisy environment is no longer present, and the respective determining comprises deciding to perform a measurement related in time to the respective obtained first data or not to disregard second data related in time to the respective obtained first data.

Further, with respect to the above, in the exemplary embodiment, the obtained first data includes first sub-data obtained during a first time period in which the recipient is experiencing a first classification of event occurrences associated with the recipient. Additionally, the obtained first data may include second sub-data obtained during a second time period after the first time period during which the recipient is experiencing a second classification of event occurrences associated with the recipient. In one suitable embodiment, the determining act 920 includes a first determination that a measurement related to the first sub-data is performed or a third sub-data included in the second data is not ignored, and a second determination that a measurement related to the second sub-data is stopped or a fourth sub-data included in the second data is ignored.

For example, where the event occurrence is a movement of a recipient, a first classification of event occurrences may be non-significant movements of the recipient and a second classification of event occurrences may be occurrences of significant movements of the recipient. Thus, in embodiments where the occurrence of significant movement of the recipient is deemed something that would seriously affect such measurements, the decision action in method action 920 may include a first decision to implement a measurement that is temporally related to the first child data. This is because the classification of an event occurrence is an insignificant movement of the recipient. Therefore, the measured value is likely to be a good measured value or a measured value having a practical value, and the acquisition of the measured value should be continued. With respect to embodiments in which the measurement is obtained without regard to the occurrence of an event associated with the recipient of the prosthesis, wherein the measurement is effectively disregarded, decision act 920 may comprise not disregarding the third child data contained in the second data. For example, the second data may be EEG measurements taken during the first and second time periods and periods before and/or after. Accordingly, the EEG measurement values acquired in the first time period will correspond to the third subdata, and will therefore not be ignored because of the classification.

In addition, the determining operation in the operation 920 may further include the second determination described above, which is a determination to stop the measurement temporally related to the second sub-data. This is because the second category of event occurrences is significant movement of the recipient. Thus, the measurement is likely to be of less good value or of less practical value, at least as compared to a measurement that would be obtained if the recipient were not moving. With respect to embodiments in which the measurement is obtained without regard to the occurrence of an event associated with the recipient of the prosthesis, wherein the measurement is actually disregarded, decision act 920 may comprise disregarding fourth sub-data contained in the second data. For example, the second data may be EEG measurements taken over a period of the first and second time periods, and before and/or after, etc. The EEG measurement values acquired in the second time period will correspond to the fourth subdata and will therefore be disregarded because of the classification.

It should be noted that while the above exemplary embodiments have been described in terms of non-significant and significant movements, other embodiments include other scenarios, such as non-significant distraction and significant distraction, non-significant excitement and significant excitement (which may extend to any kind of excitement type that may be practical), non-significant anger and significant anger, non-significant fatigue and significant fatigue, and so forth. It should also be noted that the occurrence of an event associated with a recipient may be, for example, the recipient being at work, at a casino, driving in a traffic environment, relaxing, sleeping, etc., in accordance with various other aspects disclosed herein. Thus, the classification may be grouped into two or more groups (more see "more" below), one group being classified as something that helps in obtaining good measurements, while the other group is something that does not help in obtaining good measurements, and the above method will therefore be implemented with appropriate modifications.

With respect to "more" of the phrase "two or more groups," there may be a third classification or a fourth classification, and so on. The third classification may be "in the middle". This may trigger the start of data collection, which is then considered for later disregard. This pertains to a scheme where the method starts collecting data or does not collect data according to the first and second classification triggers, respectively. Both the third and fourth classifications may be "in the middle," where the third classification does not cause the data to be ignored if other features are present, and the fourth classification causes the data to be ignored if other features are present.

Another point is set forth above. It should be noted that the start of data collection and the act of disregarding data are not mutually exclusive. In other words, the actions detailed above may exist separately. For example, a method may include starting collection of data and then subsequently disregarding the data. The method may include starting collection of data and not disregarding some of the data but disregarding other portions of the data. Methods may include collecting data all the time, and ignoring some of the data but not other portions, etc. Any arrangement that will provide a practical value may be utilized in at least some example embodiments.

Referring back to the embodiment that utilizes sound to induce brain responses or even in embodiments where sound is not used to this point but only noise can skew the measurements, in an exemplary embodiment the first classification is that the recipient is not significantly exposed to noise (acoustic noise, according to the conventional case detailed above, where the use of noise without modifiers corresponds to acoustic noise), and the second classification of event occurrences is the occurrence of significant exposure of the recipient to noise. Additionally, as will be appreciated from the above, some embodiments may include utilizing visual stimuli to induce brain responses, or even in embodiments where visual stimuli such as light are not used to achieve this, but only light and/or visual stimuli may skew the measurements, in exemplary embodiments where the event occurrence is a recipient's exposure to visual noise, the first classification is that the recipient is not significantly exposed to visual noise, and the second classification of the event occurrence is that the recipient is significantly exposed to visual noise. Any other type of sensory noise that may affect the measurement may also be considered. The scent may be one. The tactile input may be another. The electromagnetic field may be another. The temperature may again be one. Wind may be yet another. The air pressure may also be one. The taste is also. With respect to the latter, the latent variable may be used to determine or otherwise determine whether the recipient is eating or chewing, and so forth. In this regard, a human noise algorithm may be utilized in lieu of and/or in addition to its typical operation of removing human noise from a signal, in which case, removing non-human noise from a signal, for obtaining data indicative of such action, and inferring or inferring that the recipient is eating or drinking or the like by processing the data as a latent variable. In such exemplary embodiments, the teachings detailed herein may be such that no measurement is acquired, or the data is ignored accordingly, when the recipient is eating or chewing or drinking. The same is said to be the other way round. Thus, exemplary embodiments include devices, such as medical devices, such as prostheses, that are configured to identify or detect the occurrence of human noise, otherwise evaluate the human noise, and use this as a basis for initiating or not initiating a measurement or disregarding or not disregarding a measurement value, and the like. Accordingly, embodiments include a prosthesis configured to detect human body noise. In an exemplary embodiment, the human noise cancellation algorithm may be analyzed during its operation to determine the amount of human noise present, or the type of human noise, etc. Thus, embodiments include a modified hearing prosthesis where the basic processor or circuitry for human noise cancellation, etc., is also used to extract data for the purpose of determining the occurrence of things that may affect taste. For example, the amount of cancellation in a given frequency may be indicative of human noise. Noise detected at certain frequencies by an implanted accelerometer or the like may be used to identify the occurrence of such human noise. This may also be the case in terms of amplitude, etc. Any device, system, and/or method that can utilize modifications of the human noise detection and/or cancellation techniques in the prior art to implement the teachings detailed herein to determine whether a recipient is eating or drinking or chewing or smoking, etc., can be used in at least some example embodiments.

In an exemplary embodiment, the apparatus detailed herein may be configured to identify the presence and/or absence of at least one of: at least in vivo noise that meets or at least does not meet predetermined criteria (e.g., using any of the human noise cancellation and/or noise detection devices, systems, and/or methods commercially available in the united states and/or approved by the FDA as of day 10, 31 of 2018), scalp EMG, eye movement, body temperature, body heart rate, body blood pressure, or user speech; and determining whether a data collection activity should be initiated based on the presence and/or absence of the identification.

In some embodiments, the first data is based on a sound captured by a device of the recipient also in case the event occurrence is the presence of a location of the recipient. Also, in an exemplary embodiment, a scene classification may be used to identify that the location exists.

Embodiments include systems that may have practical value. For example, referring now to fig. 12, there may be a system 1210 comprising a first subsystem 1220 configured to sense a phenomenon associated with an individual, a second subsystem 1230 configured to at least one of capture sound, capture light, or capture electromagnetic radiation, and a third subsystem 1240 configured to at least one of: (i) analyzing output from at least the second subsystem and determining at least one of: whether to activate the level of activation of the first subsystem or the second subsystem; or (ii) analyze output from at least the second subsystem and the first subsystem and determine at least one of: whether to activate a fourth subsystem that stimulates the recipient, or a level of activation of the fourth subsystem. Fig. 12 presents a system 1210 in which various subsystems are enclosed in dashed lines. This is because in some embodiments, system 1210 is a single integrated device that includes all three subsystems, while in other embodiments, the subsystems are separate devices and/or two subsystems are in separate devices from the device of the third subsystem, or even each subsystem may have subsystems dispersed across multiple devices, and in some embodiments, some devices may include subsystems from different systems. An exemplary embodiment utilizing captured electromagnetic radiation may be a device that can discern whether an external coil is in use, where the presence or absence of such a condition may determine whether to conduct a test and/or disregard the test results, etc. In another embodiment, such a condition may indicate a location of the recipient, which may also be used to make various determinations detailed herein, at least in part.

In particular, referring back to fig. 3A and 3B, it can be seen that in at least some example embodiments, any one or more of the functions detailed herein can be performed by the prosthesis and/or by the handheld electronic device, and/or remotely by communicating with a telecoil or the like. In this regard, in exemplary embodiments, various determinations and/or detections that may be inferred from such measurements may be performed by separate components other than the component making the measurement and/or other than the component determining that the measurement should be taken or should not be ignored, etc. Unless otherwise indicated, any method acts disclosed herein and/or any functions disclosed herein may be performed by any one or more of the devices disclosed herein, as supported by the art.

According to the teachings detailed above, in an exemplary embodiment, the first subsystem is an EEG monitor. Again, this may be a stand-alone subsystem as detailed above, or may be integrated with other medical device systems/subsystems, such as a hearing prosthesis system/subsystem. In an exemplary embodiment, the subsystem may be an EKG monitor, as will be described below. In at least some embodiments, any device that may have practical value in monitoring a phenomenon associated with a recipient may be utilized.

Also, consistent with various teachings herein, in at least some embodiments, system 1210 is configured to at least analyze output from at least a second subsystem and identify at least one of: a location condition of the recipient, an activity in which the recipient is engaged, or a status of the recipient. The system 210 is also configured to make the determination based on the identification. Likewise, it is contemplated that there may be circumstances in which it is more practical to collect and/or obtain data than other data collected at other times, and the teachings detailed herein may enable identification of a given circumstance, or at least provide an indicator that one circumstance exists, etc. another circumstance may be more convenient.

In an exemplary embodiment of the system of fig. 12, the system is configured to at least analyze output from at least a second subsystem and identify at least one of: a location condition of the recipient, or an activity in which the recipient is engaged, or a status of the recipient. Further, the system may be configured to make the determination based on the identification. In this regard, it should be noted that the embodiment disclosed in fig. 12 presents bi-directional communication between all subsystems. It should be noted that in some embodiments, there is only one-way communication between one or more or all of the subsystems. Furthermore, in some embodiments, there may be subsystems that do not communicate with each other in one way or another. Any drug arrangement between subsystems that can implement the teachings detailed herein can be utilized, provided that such is of practical value.

In the embodiment variant of fig. 12, the system may comprise a fourth subsystem. In an exemplary embodiment, the fourth subsystem may be an electrotherapy system. In this regard, in at least some example embodiments, one or more existing systems may be used to assess whether conditions associated with a recipient exist, such conditions indicating an impending seizure or the like. Based on this determination, the fourth subsystem may participate in attempts to avoid or otherwise mitigate the effects of epilepsy. In an exemplary embodiment, the fourth subsystem may be integrated with other subsystems according to other teachings herein. Alternatively, the fourth subsystem may be a separate device with respect to a device containing one or more or all of the other subsystems. In other embodiments, other types of stimulation applying devices may be utilized in addition to the electrotherapy system.

In at least some example embodiments, the second subsystem is part of an environment classifier and outputs data indicative of the environment classification. Also, in some embodiments, environmental classifiers known for use in the hearing repair field and/or retinal implant portion may be used in whole or in part as part of the second subsystem.

In some embodiments, the second subsystem is comprised in an at least partially implantable prosthesis, while in other embodiments, this is not the case. Additionally, according to the teachings detailed above, in at least some example embodiments, the first, second, and third subsystems are part of an integrated prosthetic system and/or part of an integrated medical device, and in some embodiments, this is also the case with respect to the fourth subsystem and/or other subsystems, which may include a stimulation system configured to stimulate or otherwise apply some form of energy to a recipient to achieve some medical treatment. In at least some example embodiments, one or more of the subsystems detailed herein may or may not be integrated into a device relative to any one or more other subsystems.

In some embodiments, the third subsystem is further configured to identify whether the recipient is moving and/or quantify the recipient's movement based on the output from the at least second subsystem, and to determine one or more of the following based on the identification: whether to activate the first subsystem, the level of activation of the second subsystem, or the level of activation of a fourth subsystem that applies stimulation to the recipient (which includes whether to activate). Also, as detailed above, in some cases, the teachings detailed herein relate to the intentional omission of data or measurements in certain situations. Regarding the issue of the level of activation of the second subsystem, in an exemplary embodiment the second subsystem is part of a system used as or being a sensory prosthesis. In some embodiments, there may be a utility value in relation to limiting the amount of stimulation associated with the recipient's environment. For example, if it appears that the recipient may be developing towards epilepsy, it may be practical to reduce the amount of acoustic noise that the recipient is receiving and/or applying to the recipient. That is, in some embodiments, the goal is not necessarily to reduce stimulation for therapeutic purposes, but to reduce stimulation for measurement purposes. In this regard, if a sound probe or the like is utilized, wherein using such a probe in a quiet environment has practical value, the system may manually reduce the amount of ambient sound heard by the recipient through utilization of the second subsystem. With respect to the fourth subsystem, this may be a system specifically dedicated to applying stimulation to a recipient for medical purposes such as shock therapy, or any other system that may have practical value.

In some embodiments, the third subsystem is configured to identify whether the recipient is in a sensory noisy environment and/or quantify sensory noise in the noisy environment based on the output from the at least second subsystem, and determine whether to activate the activation level of the first subsystem or the second subsystem based on the identification. Also, according to the above, the noise may be light noise or sound noise or smell noise or the like. In some embodiments, the phenomenon sensed by the first subsystem is a physiological phenomenon. Further, the third subsystem is configured to analyze outputs from at least the second subsystem and the first subsystem to determine an activation level of the second subsystem and/or, if present, an activation level of a fourth subsystem that applies stimulation to the recipient. In some embodiments, the phenomenon sensed by the first subsystem is a physiological phenomenon.

Additionally, also in some embodiments where the phenomenon sensed by the first subsystem is a physiological phenomenon, the third subsystem is configured to analyze the output from at least the second subsystem to determine whether to activate the level of activation of the first subsystem or the second subsystem or, if present, apply a stimulus to the level of activation of a fourth subsystem of the recipient, independent of any output from the first subsystem, if present, based on the identification.

Additionally, while the embodiments detailed above have referred to the possibility of disregarding or otherwise not acquiring measurements, it should also be noted that in some other embodiments the frequency of measurement acquisition and/or the amount of measurement acquisition, etc., may actually increase according to a given context. By way of example only, and not by way of limitation, it is mentioned above that the measurements may include EKG measurements. In an exemplary embodiment, this may be practical in determining that the recipient is exercising or engaged in an activity or an event that may increase heart attacks, etc., and thus the number of measurements may be increased after a given subsystem determines that the recipient is engaged in such an activity.

It should also be noted that while the above trend focuses on increasing or decreasing or disregarding or focusing on measurements in a semi-binary manner, it should also be noted that some embodiments may include focusing more on a given measurement. Also, in examples where the system determines that the recipient is starting exercise, this may provide an indication to a healthcare professional or the like to more closely monitor the measurement. In an exemplary embodiment, this may indicate that the measurements should be evaluated and/or monitored in real-time rather than later (later for data collection purposes or otherwise to analyze trends). Indeed, the automated monitoring and/or analysis system may even be implemented based on determinations associated with input implemented by a given sub-component based on indications of the recipient's activities and/or environment, etc. In addition, the hold content (holds) can be adjusted accordingly. Also, according to the concept, in the case where the recipient starts exercising, measurement value abnormalities that would otherwise be possibly ignored will be unlikely to be ignored after it is determined that the recipient is exercising, because there may be a greater chance of a heart attack, or the like. In at least some example embodiments, any data evaluation and/or manipulation process that may be utilized in a practical manner based on a given decision detailed herein may be used.

It should be noted that phrase recipients are sometimes utilized herein. Unless otherwise indicated, any disclosure herein referring to a recipient corresponds to an equivalent disclosure of a person, whether or not the person is the recipient of the prosthesis, and vice versa, as long as the art supports so.

In an exemplary embodiment, one or more devices and/or systems and/or subsystems, and the like and variations thereof, disclosed herein comprise a processor, which may be a standard microprocessor supported by software or firmware or the like programmed to perform one or more of the acts and functions herein. The processor may include input and/or output connections. By way of example only and not limitation, in an exemplary embodiment, the microprocessor may have access to a look-up table or the like having data and/or may compare characteristics of the input signal and compare those characteristics to characteristics in the look-up table and make a determination regarding the input signal, and thus a determination or the like, by the relevant data in the look-up table associated with those characteristics. Numerical analysis algorithms may be programmed in a processor or the like to implement the teachings herein.

It should be noted that the teachings detailed herein may be implemented in any processor-based device capable of implementing the teachings herein. In an exemplary embodiment, the teachings detailed herein may be implemented by adapting circuitry or otherwise providing programming to a given processor to modify a sensory prosthesis, such as a hearing prosthesis or an optical prosthesis. Further, an internet of things based approach may be utilized. Additionally, the various components and systems and subsystems may be networked such that some acts and/or functions detailed herein are performed by components that are remotely located from other components and/or by components that are geographically remote from other components. Thus, the teachings detailed herein may be implemented with the internet or a land-line based device or a wireless communication system such as a cellular telephone communication system. Any of the prostheses and/or medical devices detailed herein may correspond to a wearable or portable device. Likewise, these wearable or carried-on devices may have a processor programmed to receive input and/or provide output to implement the teachings detailed herein. In some embodiments, a programmed personal computer and/or laptop and/or personal handheld device, such as a smartphone or smartwatch, etc., may be used to perform at least some of the functions and method acts detailed herein.

Many of the embodiments detailed above focus on devices that are implanted in the head or otherwise include an inductive coil located in the head. Indeed, the embodiments detailed above have generally focused on hearing prostheses such as cochlear implants (although it should be noted that in at least some other exemplary embodiments, the hearing prostheses are DACI prostheses and/or middle ear hearing prostheses and/or active transcutaneous bone conduction device hearing prostheses, all of which contain an implanted radio frequency coil, such as a coil in the form of an inductive coil or any other coil that can enable the teachings detailed herein, or a radio frequency antenna, or any other device that can enable communication-any disclosure of cochlear implants herein corresponds to that in an alternative embodiment with respect to one of the other aforementioned hearing prostheses). Some other embodiments may be embodiments that include implantable components implanted elsewhere than in the head. By way of example only, and not by way of limitation, in exemplary embodiments there may be a heart monitor and/or a cardiac stimulator (pacemaker), such as, by way of example only, but not limitation, the arrangement seen in fig. 13. As can be seen, the heart monitor includes a plurality of sensor/read electrodes 720 connected to an inductive coil 710 by leads 730. In this embodiment, the implanted device does not have recording/storage capabilities and requires the external device to receive signals from the implanted inductive coil 710 in order to retrieve the signals therefrom in real time. Implantable components that convert electricity sensed by the sensor/read electrode into a signal transmitted by inductive coil 710 are not shown. In an exemplary embodiment, the sensor arrangement seen in fig. 7 is an implanted EKG sensor arrangement. Fig. 14 depicts another arrangement of an implantable sensor arrangement that also includes a sensor/read electrode 720 and a lead 730. Here, in this embodiment, there is a housing 830 containing circuitry configured to receive signals from the electrodes 720 by the leads and record data therein or otherwise store data and allow the data to be periodically read from an external device when the external device is in signal communication with the implanted inductive coil 710. Alternatively, and/or in addition, the circuitry is configured to periodically energize the inductive coil 710, providing data to the coil 710, causing the coil to generate an inductive signal, which in turn communicates with an external component that reads the signal and thus the data associated with the electrode. Thus, in at least some example embodiments, the implantable device is configured to stream the data. Additionally, in some embodiments, the data is not streamed, but instead is provided in bursts.

In at least some example embodiments, any arrangement that enables data associated with the read electrodes to be provided from inside the recipient to outside the recipient may be utilized. In this regard, conventional implantable EKG sensor arrangements may be obtained and modified to implement the teachings detailed herein and/or variations thereof.

It should be noted that some embodiments of the sensor arrangement of fig. 14 include an implanted battery or otherwise implanted power storage arrangement, while in other embodiments the arrangement does not explicitly resemble this arrangement to the embodiment of fig. 13.

In view of the above, it can be seen that the above measurements may also correspond to EKG measurements, and so on. In this regard, there may be practical value in determining whether the recipient is exercising or the like in order to ignore or otherwise not even monitor (or, for example, more carefully and more frequently monitor EKG measurements).

Fig. 15 presents another exemplary embodiment of an implantable device that may be used to obtain measurements that may be suitable for use in some embodiments of the teachings detailed herein. With respect to implantable devices, fig. 15 provides an exemplary functional arrangement of an implantable device 1540 configured to transcutaneously communicate with the external device of fig. 14 or a similar device through an inductive field. Implantable component 1540 may correspond to the implantable component of system 10 of fig. 1. Alternatively, and/or in addition, the implantable component of fig. 15 may representatively correspond to implantable components of an EEG embodiment or an EKG embodiment or a retinal implant embodiment. As can be seen, the external component 1540 includes an implantable housing 1526 connected by a cable 1572 to an exemplary implanted coil apparatus 1578 including an implanted inductive coil 1558IM corresponding in this exemplary embodiment to the external coil of fig. 1, where fig. 15 represents the cochlear implant of fig. 1. As shown, implantable component 1540 includes an implantable inductive communication assembly including coil 1558IM and magnet 1542. This magnet 1152 interacts with an external magnet of the implantable component to hold the headpiece 1478 to the recipient's skin. In an exemplary embodiment, implantable component 1540 is configured to transcutaneously transmit magnetic data through coil 1558IM and/or receive magnetic data from an external component that includes an inductive coil as detailed above and/or receive power. The coil 1558IM is electrically coupled to the housing 1526 by a cable 1572. Housing 1526 may contain, for example, at least some of the implantable components of fig. 1, such as a stimulator of a cochlear implant, where such components are represented by the embodiment of fig. 15.

Implantable component 1540 also includes a stimulation component, which as seen includes leads that extend from housing 1526, ultimately to electrodes 1520. In the embodiment of fig. 15 representing an implantable component of a cochlear implant, the electrode 1520 and functionally associated lead represent an electrode assembly of the cochlear implant, but it is important to note that in a real cochlear implant, the electrode 1520 would be supported by a carrier member, rather than "free" as shown. That is, in an exemplary embodiment, fig. 15 may represent the EEG and/or EKG system detailed above, where electrodes 1520 are read/sense electrodes. Additionally, in an exemplary embodiment, the implantable component of fig. 15 may represent a retinal implant. It should also be noted that in an exemplary embodiment, the electrodes 1520 are replaced by mechanical actuators, and thus the embodiment of fig. 15 represents an active transcutaneous bone conduction device and/or a middle ear implant, or the like.

In this regard, fig. 15 is presented for conceptual purposes to represent how the external component of fig. 4 communicates with the implanted component. Similar to these, in an exemplary embodiment, the magnet of the external component is magnetically aligned with the magnet of the implantable component, thus aligning the external coil with the implanted coil. This may have practical value because aligning the coils relative to the case of misalignment of the coils provides efficiency. By way of example only, and not by way of limitation, in an exemplary embodiment the magnets are disk magnets with north and south poles aligned with the axis of rotation of the disk. In this regard, the magnets need to align the magnetic fields with each other, and thus by utilizing the structure of the external component and/or the implantable component (e.g., the silicone body) to hold the respective coils at a predetermined controlled distance from the respective magnets, the coils will become aligned with each other as the magnets become aligned with each other. Fig. 16 depicts the manner in which the respective magnets are aligned with each other with respect to their north and south poles. As can be seen, the two magnets are aligned about an axis. This has the effect of aligning the respective coils.

Thus, in an exemplary embodiment, implantable component 1540 can be used in conjunction with an external component of a hearing prosthesis, and/or an external component of a retinal implant, and/or an external component of a sensory prosthesis, as detailed herein.

Exemplary embodiments include an implantable EEG monitor or another type of monitor having an internal power source operating in two different modes of operation. One mode is for daytime use, where the recipient is awake and/or active. The daytime mode may cause the implanted component to operate autonomously without any external components, but in some embodiments, the implantable component may also operate with external components in the daytime mode. Consistent with the teachings detailed above, the daytime mode may be such that the implanted components receive power only from the implanted battery or other power source implanted within the recipient. In this exemplary embodiment, the implant monitors and/or stores data, such as EEG and/or EKG data, during the daytime operating mode. Additionally, in at least some example embodiments, during the daytime mode of operation, the implantable component may analyze the data and may determine whether an alert should be provided to the recipient based on the data. In an exemplary embodiment, the alert is provided using all components implanted in the recipient according to the teachings detailed herein.

It should be noted that in some embodiments, where there is a day or night mode, the teachings detailed herein may be used to transition the device from one mode to another based on data obtained by a second subsystem or the like.

The teachings detailed herein may be applicable to the management or monitoring of populations susceptible to epilepsy. In this regard, epileptic seizures may be infrequent, with seizures separated by months. Diagnosis requires that at least one seizure be captured. Many patients remain undiagnosed or misdiagnosed due to the lack of long-term monitoring. As can be seen, EEG data capture can be provided prior to and/or during epilepsy using the teachings detailed herein. Accordingly, some exemplary methods encompass practicing the details herein with respect to methods of treating and/or monitoring epilepsy.

It should be noted that while the embodiments detailed herein focus on electrical detection/monitoring/analysis (ECE/EEG), other embodiments relate to detecting/monitoring, analyzing changes in the chemical composition of a substance in the body. By way of example only, and not by way of limitation, fig. 16 provides a schematic illustration of an implantable component 1740 configured to monitor bodily fluid chemistry. In this regard, there is a housing 1726 containing a processor or the like programmed to analyze data via signals from the blood capture device 1720. The blood capture device 1720 is configured to capture blood and/or analyze the blood to assess its chemistry. By way of example only, and not by way of limitation, the implantable component 1740 may be a blood glucose implantable monitor that directly or indirectly monitors blood to determine its glucose content. The captured blood is then analyzed by the device 1726.

It should also be noted that in an exemplary embodiment, the implantable component 1740 may be a new drug analyzer. By way of example only, and not by way of limitation, the implantable component 1740 may be configured or otherwise programmed to analyze blood chemistry to assess the effectiveness of a new drug.

As noted above, it should be noted that, in at least some exemplary embodiments, EEG systems can be used to assess blood glucose levels and/or new drug efficacy. In this regard, there may be a use scenario in which there is a new drug introduction, and the assessment protocol for new drug introduction includes brain monitoring, wherein the brain monitoring includes applying EEG monitoring. At least some of the exemplary embodiments detailed herein provide for the implementation of continuous monitoring, and this may have great utility for new drug assessment.

Briefly, it is noted that hypoglycemia (low blood glucose content) can be detected by a three-level monitoring method of EEG analysis. To maximize utility value, the implantable components can be monitored continuously and over time.

Traditionally, a problem associated with monitoring the above phenomenon is that if data is to be streamed in real-time or semi-real-time, external components are required. Also, typically the outer component is a head-worn outer component. However, during sleep or epileptic seizures, this component is often removed or dropped. Thus, the teachings detailed herein may provide for the streaming and/or recording of data in the complete absence of traditional external components used with implants.

It is particularly noted that, in at least some exemplary embodiments, the implantable device is not a hearing prosthesis of the type understood by those skilled in the art. In this regard, merely because the device induces a hearing perception does not mean that it is a hearing prosthesis. As used herein, the phrase hearing prosthesis means that the device is configured to capture sound and induce a hearing perception based on the captured sound. In particular, teachings detailed herein that utilize hearing perception to provide instructions to a recipient do not require a captured sound. In this regard, the implantable components are pre-programmed and/or pre-configured to induce only a limited number of hearing perceptions regardless of the environment.

That is, in at least some exemplary embodiments, the teachings detailed herein may be combined with, or even limited to, a hearing prosthesis. In this regard, in an exemplary embodiment, the implantable component is an implantable component of a hearing prosthesis that includes a tissue stimulator that provides the indication.

In an exemplary embodiment, the implantable component includes a tissue stimulator providing the indication. The tissue stimulator may be part of a device that, among other functions, provides the following functions: (i) stimulating tissue to provide the indication (e.g., the system may be an EEG monitor, an EKG monitor, a bodily fluid monitor, a drug efficacy monitor, etc.); and (ii) if the implantable component is configured to provide a hearing restoration function, stimulating the tissue to provide a hearing perception based on the external stimulus. The external stimulus comprises sound captured by a sound capture device, streaming audio to the hearing prosthesis, etc.

In an exemplary embodiment, the implantable component is part of a body monitoring device configured to monitor aspects of the recipient's body, wherein the implantable component is configured to evaluate the monitored aspects and determine whether an aspect is outside of given parameters, and upon such determination, provide an indication to the recipient, wherein the indication is an indication that the aspect is outside of the given parameters. Also, as detailed above, in an exemplary embodiment, the EEG monitor monitors signals for potential epilepsy or the like. The implantable component may analyze the signal in real time or near real time and alert the recipient if the signal indicates potential epilepsy by providing an indication that would be an alert that epilepsy may be about to occur.

Fig. 8 presents in general exemplary embodiments of neural and retinal prostheses and their environments of use, and in particular, components thereof that may be used in whole or in part in some teachings herein. In some embodiments of retinal prostheses, a retinal prosthesis sensor-stimulator 10801 is positioned proximate to the retina 11001. In an exemplary embodiment, photons entering the eye are absorbed by a microelectronic array of sensor-stimulator 10801 that is hybridized with a glass piece 11201 containing, for example, an embedded microwire array. The glass may have a curved surface that conforms to a radius within the retina. Sensor-stimulator 10801 may include a microelectronic imaging device, which may be made of thin silicon containing integrated circuitry that converts incident photons into electronic charges.

The image processor 10201 is in signal communication with the sensor-stimulator 10801 via a cable 10401 that extends through the surgical incision 10601 in the wall of the eye (although in other embodiments, the image processor 10201 is in wireless communication with the sensor-stimulator 10801). The image processor 10201 processes the input to the sensor-stimulator 10801 and provides a control signal back to the sensor-stimulator 10801 so that the device can provide a processed output to the optic nerve. That is, in an alternative embodiment, the processing is performed by a component that is proximate to or integrated with the sensor-stimulator 10801. The charge generated by the conversion of the incident photons is converted into a proportional amount of electron current that is input to the nearby retinal cell layer. The cells fire and a signal is sent to the optic nerve, thus initiating visual perception.

The retinal prosthesis may comprise an external device disposed in a behind-the-ear (BTE) unit or in a pair of glasses, or any other type of component that may have practical value. The retinal prosthesis may include an external light/image capture device (e.g., located in/on a BTE device or a pair of glasses, etc.), while as noted above, in some embodiments, a sensor-stimulator 10801 captures light/images, which is implanted in the recipient.

To make the disclosure compact, any disclosure of a microphone or sound capture device herein corresponds to a similar disclosure of a light/image capture device, such as a charge coupled device. It follows that any disclosure herein of a stimulator unit that generates electrical stimulation signals or otherwise energizes tissue to induce hearing perception corresponds to a similar disclosure of a stimulator device for retinal prostheses. Any disclosure herein of a sound processor or processing of captured sounds, etc., corresponds to a similar disclosure of a light processor/image processor having similar functionality of a retinal prosthesis and processing captured images in a similar manner. Indeed, any disclosure of an apparatus for a hearing prosthesis herein corresponds to a disclosure of an apparatus for a retinal prosthesis with similar functionality of a retinal prosthesis. Any disclosure herein of placing a hearing prosthesis corresponds to a disclosure of placing a retinal prosthesis using a similar action. Any disclosure herein of a method of using or operating a hearing prosthesis or otherwise functioning in conjunction with a hearing prosthesis corresponds to a disclosure herein of using or operating a retinal prosthesis or otherwise functioning in conjunction with a retinal prosthesis in a similar manner.

An exemplary system includes one or more exemplary devices that can implement the teachings detailed herein, which in at least some embodiments can utilize automation, as will now be described in the context of an automated system. That is, exemplary embodiments encompass performing, at least in part, in an automated or semi-automated manner, one or more or all of the methods detailed herein, and variations thereof, using any of the teachings herein.

It should also be noted that any disclosure of a device and/or system detailed herein also corresponds to a disclosure of providing the device and/or system in other ways and/or utilizing the device and/or system.

It should also be noted that any disclosure herein of any process of making an otherwise provided device corresponds to a disclosure of the device and/or system thus produced. It should also be noted that any disclosure of any device and/or system herein corresponds to a disclosure of a method of producing or otherwise providing or otherwise manufacturing such a device and/or system.

Any embodiment or any feature disclosed herein may be combined with any one or more or other embodiments and/or other features disclosed herein unless explicitly indicated and/or unless not otherwise supported by the art. Any embodiment or any feature disclosed herein may be specifically excluded from use in combination with any one or more other embodiments and/or other features disclosed herein unless such combination is specifically indicated and/or unless such exclusion is not supported by the art.

Any functions or method acts detailed herein correspond to the disclosure doing so in an automated or semi-automated manner.

While various embodiments of the present invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the spirit and scope of the invention.

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