IMPLANTABLE COCHLEAR SYSTEM HAVING INTEGRATED COMPONENT AND LEAD CHARACTERISTICS - Patent application

Abstract

To provide a cochlear implant system.SOLUTION: Cochlear implant systems include a signal processor programmed with a transfer function and configured to receive an input signal and output a stimulation signal based on the received input signal and transfer function. The systems can include an implantable battery and / or communication module in communication with the signal processor. The implantable battery and / or communication module can be configured to interface with and update the transfer function of the signal processor. The implantable battery and / or communication module can communicate with one or more external devices, and can facilitate calibration and normalization of the system. Digital and / or analog filtering can be used to compensate for nonuniformity of system behavior across entire frequency ranges. A single implantable battery and / or communication module can provide power and data to a plurality of signal processors implanted as parts of individual subsystems.SELECTED DRAWING: Figure 9

Description

[Technical field]

[0001] Related Applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 808,634, filed February 21, 2019, the contents of which are incorporated herein by reference. [Background technology]

[0002] A cochlear implant is an electronic device that can be surgically implanted at least partially into the cochlea, the hearing organ of the inner ear, to improve a patient's hearing. Cochlear implants can include components that are worn externally by the patient and components that are implanted internally in the patient.

[0003] The external components may include a microphone, a processor, and a transmitter. A cochlear implant may detect sounds via an ear-level microphone that transmits these sounds to a wearable processor. Some processors may be worn behind the patient's ear. Electronic signals from the processor may be sent to a transmitting coil worn externally behind the ear of the implant. The transmitting coil may send signals to an implant receiver located under the patient's scalp.

[0004] The internal components may include a receiver and one or more electrodes. Some cochlear implants may include additional processing circuitry between the internal components. The receiver can direct signals to one or more electrodes implanted within the cochlea. Responses to these signals are transmitted along the auditory nerve to the brain's cortex, where they are interpreted as sound.

[0005] Some cochlear implants are fully implanted and include a mechanism for measuring sound similar to a microphone, signal processing electronics, and a means for directing the signal to one or more electrodes implanted within the cochlea. Fully implanted cochlear implants typically do not include a transmit or receive coil.

[0006] The internal components of such cochlear implant systems typically require power to operate. Thus, a power supply is typically included along with the other internal components. However, the performance of such power supplies often degrades over time, and the power supply may need to be replaced. Additionally, processing circuitry technology continues to advance rapidly. As processing technology improves over time, the processing technology of the implanted processing circuitry may become outdated. Thus, there may be times when it is advantageous to replace / upgrade the processing circuitry.

[0007] However, such replacement procedures can be challenging: the location of the implanted internal components is not the most amenable to surgical procedures and they tend not to heal completely after the numerous incisions. Additionally, replacement of some components, such as the signal processor, requires the removal and reintroduction of components, such as electrical leads, into the patient's cochlear tissue, which can cause tissue damage and negatively impact the effectiveness of the cochlear stimulation.

[0008] Additionally, various challenges exist for communicating electrical signals through the patient's body. For example, safety standards can limit the amount of electrical current (especially DC current) that can safely flow through the patient's body. Additionally, the patient's body can act as an undesirable signal path between different components within the body (e.g., via contact with the housing or "can" of each component). This can lead to reduced signal strength or undesirable communication or interference between components. In some cases, the electrical signals can even stimulate undesirable areas of the patient's cochlear tissue, hindering the effectiveness of the cochlear implant. Summary of the Invention [Problem to be solved by the invention]

[0009] Some aspects of the present disclosure are generally directed to a cochlear implant system. Such a system may include a cochlear electrode, a stimulator in electrical communication with the cochlear electrode, an input source, and a signal processor. The signal processor may be configured to receive an input signal from the input source and output a stimulation signal to the stimulator based on the received input signal and a transfer function of the signal processor. [Means for solving the problem]

[0010] In some examples, the signal processor and the implantable battery and / or communication module may be electrically coupled via a plurality of conductors, for example, to communicate data and / or provide power between the components. In some such embodiments, the signal processor and / or the implantable battery and / or communication module may be configured to ground a first conductor of the plurality of conductors and apply a test signal to a second conductor of the plurality of conductors. The signal processor and / or the implantable battery and / or communication module may be configured to measure one or more electrical parameters of the first conductor, the second conductor, and / or the first conductor and the second conductor. In some embodiments, applying such a test signal may include sequentially applying a plurality of signals, with each of the signals having a different frequency, and determining an impedance between the first conductor and the second conductor as a function of frequency. Additionally or alternatively, in some examples, measuring the one or more electrical parameters includes determining whether the second conductor is intact.

[0011] In some embodiments, the signal processor and the implantable battery and / or communication module may be coupled via a first lead having a first conductor, a second conductor, a third conductor, and a fourth conductor. In some such examples, the implantable battery and / or communication module may be configured to generate a power signal, an inverted power signal, a data signal, and an inverted data signal. The implantable battery and / or communication module may communicate the power signal, the inverted power signal, the data signal, and the inverted data signal to the signal processor via the first conductor, the second conductor, the third conductor, and the fourth conductor, respectively, of the first lead. The power signal and the data signal may be provided at similar or different clock rates.

[0012] The implantable battery and / or communications module may be configured to perform one or more characterization processes to determine one or more characteristics of the first conductor, the second conductor, the third conductor, and / or the fourth conductor. In some examples, performing the one or more characterization processes includes determining an impedance versus frequency relationship between the two conductors. Additionally or alternatively, in some examples, performing the one or more characterization processes includes measuring a current transmitted through the test conductors, measuring a voltage at which the current was transmitted through the test conductors, and determining an impedance of the test conductors.

[0013] Some aspects of the present disclosure are generally directed to a cochlear implant system. Such a system may include a cochlear electrode, a stimulator in electrical communication with the cochlear electrode, an input source, and a signal processor. The signal processor may be configured to receive an input signal from the input source and output a stimulation signal to the stimulator based on the received input signal and a transfer function of the signal processor.

[0014] In some examples, the signal processor and stimulator can be integrated into a single hermetically sealed housing, with the cochlear electrodes extending from the single hermetically sealed housing. In some examples, the single hermetically sealed hose includes a return electrode coupled to an exterior surface thereof. In some such examples, the return electrode extends between a first side of the housing and a second side of the housing opposite the first side.

[0015] In some embodiments, the housing comprises a conductive material and includes a header comprising a non-conductive material, such as a biocompatible polymer, In some such embodiments, the non-conductive material of the header provides electrical insulation between the return electrode and the conductive housing.

[0016] Some aspects of the present disclosure are generally directed to a cochlear implant system. Such a system may include a cochlear electrode, a stimulator in electrical communication with the cochlear electrode, an input source, and a signal processor. The signal processor may be configured to receive an input signal from the input source and output a stimulation signal to the stimulator based on the received input signal and a transfer function of the signal processor.

[0017] In some examples, the signal processor includes an analog processing stage and a digital processing stage. In some such examples, the signal processor is configured to receive an input signal from an input source and input the received input signal to the analog processing stage to generate an analog processed signal. The signal processor can input the analog processed signal to the digital processing stage to generate a digital processed signal. In some examples, the signal processor is configured such that the digital processed signal corresponds to a normalized stimulus signal that has reduced gain variation across a range of frequencies and compensates for variations in the frequency response of the middle ear sensor.

[0018] In some embodiments, the analog and / or digital processing stages can be adjusted to normalize a frequency response of the combined analog and digital processing stages, in some examples, normalizing the frequency response to make the ratio of the digitally processed signal to the corresponding received stimulus signal approximately constant across multiple frequencies or frequency ranges.

[0019] Some aspects of the present disclosure relate to a method for compensating for variations in a middle-ear sensor, in some examples, the method includes receiving a stimulation signal via the middle-ear sensor, and generating an input signal based on the stimulation signal via the middle-ear sensor, the method includes applying an analog filter to the generated input signal to generate an analog filtered signal, and applying a digital filter to the generated analog filtered signal to generate a digital filtered signal.

[0020] In some examples, the method includes measuring a frequency response of the digitally filtered signal and / or the analog filtered signal with respect to the input signal, and adjusting the digital filter to normalize the frequency response of the digitally filtered signal with respect to the stimulation signal. In some examples, such a method further includes applying a plurality of stimulation signals to the middle ear sensor having known frequency content. In some such examples, measuring the frequency response of the digitally filtered signal with respect to the stimulation signal is performed for each of the plurality of stimulation signals.

[0021] Some aspects of the present disclosure are generally directed to a cochlear implant system. Such a system may include a cochlear electrode, a stimulator in electrical communication with the cochlear electrode, an input source, and a signal processor. The signal processor may be configured to receive an input signal from the input source and output a stimulation signal to the stimulator based on the received input signal and a transfer function of the signal processor.

[0022] In some embodiments, the implant system includes a short-range communication device for communicating via a first wireless communication protocol and a wireless communication device for communicating via a second wireless communication protocol. In some such examples, the short-range wireless communication device and the wireless communication device are included in the implantable battery and / or the communication module.

[0023] In some embodiments, the system includes an external device having an external short-range wireless communication device configured to wirelessly communicate with the implanted short-range wireless communication device via a first wireless communication protocol, the external device can include an external wireless communication device configured to wirelessly communicate with the implanted wireless communication device via a second wireless communication protocol.

[0024] Communication between the external wireless communication device and the implanted wireless communication device via the second wireless communication protocol may be enabled by first establishing communication between the implanted near-field communication device and the external near-field communication device via the first wireless communication protocol. In an exemplary embodiment, Bluetooth wireless communication between the implanted system and the external device may be established by enabling Bluetooth communication via near-field wireless communication.

[0025] In some embodiments, an external device that wirelessly communicates with the implanted system over a second wireless communication protocol can enable wireless communication between the implanted system and a second external device over the second wireless communication protocol, for example, in one example, a Bluetooth-paired external device can be used to enable Bluetooth communication with another external device.

[0026] In some examples, the external device can provide voice and / or data to the implant system via the second wireless communication protocol. In some embodiments, or more external devices can interface with the implanted system by providing an input signal to trigger stimulation of the wearer's cochlear tissue, such as streaming audio data, a wake-up alarm, etc. Additionally or alternatively, in some examples, an external device can be used to interface with the implanted system, such as by adjusting one or more settings of the system.

[0027] In some embodiments, the external device includes one or more sensors, such as a location sensor, an ambient sound sensor, and the like. In some such examples, the external device may be in communication with the implantable battery and / or the communication module, and the implantable battery and / or the communication module may be configured to update a transfer function of the signal processor in response to information determined from the one or more sensors. Having the implantable battery and / or the communication module update the transfer function may include providing sensor data to the implantable battery and / or the communication module, and the implantable battery and / or the communication module updates the transfer function based on the received data, or the external device determines that the transfer function should be updated based on data received from the sensor. Updating the transfer function may include adjusting one or more settings (gain settings, filter settings, etc.) or may include implementing a predetermined transfer function. In one example, the external device includes a GPS sensor, and the external device and / or the implantable battery and / or the communication module is configured to update the transfer function to a predetermined transfer function associated with a particular location based on detecting the predetermined location.

[0028] Additionally or alternatively, in some examples, the external device includes an ambient sound sensor, and updating the transfer function may include attenuating frequencies outside a typical human speech range to reduce background noise and emphasize speech. In some examples, updating the transfer function includes attenuating frequencies based on frequency content of the detected ambient sound.

[0029] Some aspects of the present disclosure are generally directed to a cochlear implant system. Such a system may include a cochlear electrode, a stimulator in electrical communication with the cochlear electrode, an input source, and a signal processor. The signal processor may be configured to receive an input signal from the input source and output a stimulation signal to the stimulator based on the received input signal and a transfer function of the signal processor.

[0030] In some examples, the system can include an external hub having a speaker and a wireless communication interface. The external hub can be configured to communicate wirelessly with the implantable battery and / or the communication module. The external hub can be further configured to output a predetermined acoustic signal and communicate information regarding the predetermined acoustic signal to the implantable battery and / or the communication module via wireless communication.

[0031] In some embodiments, the implantable battery and / or communication module is configured to receive information from the external hub regarding the acoustic signal output from the speaker of the external hub. The implantable battery and / or communication module can analyze the information regarding the acoustic signal and the information received from the signal processor representing the received input signal resulting from the sound output from the external hub. The implantable battery and / or communication module can determine a relationship between the acoustic signal output from the speaker of the external hub and the resulting input signal generated via the input source. In some such examples, the implantable battery and / or communication module can be configured to update a transfer function of the signal processor in response to the determined relationship.

[0032] In some examples, the input source comprises a middle-ear sensor and the speaker of the outer ear hub comprises an in-ear speaker. In some such examples, the implantable battery and / or communication module may be configured to receive information from the signal processor representative of an input signal output from the middle-ear sensor in response to the received stimulus and detect the wearer's acoustic reflex based on the information received from the signal processor. The external hub may be configured to provide an acoustic signal via the in-ear speaker at a first intensity and to increase the intensity over time, and the implantable battery and / or communication module may be configured to determine an intensity that elicits the acoustic reflex. The implantable battery and / or communication module may update a transfer function of the signal processor based on such determined intensity.

[0033] Some aspects of the present disclosure are generally directed to a cochlear implant system. In some examples, the cochlear implant system can include a first subsystem including a first cochlear electrode, a first stimulator, a first input source, and a first signal processor. The first input source can be configured to receive a first stimulation signal and generate a first input signal. The first signal processor can be configured to receive a first signal from the first input source and output the first stimulation signal to the first stimulator based on the first input signal and a first transfer function associated with the first signal processor.

[0034] Some such systems include a second subsystem including a second cochlear electrode, a second stimulator, a second input source, and a second signal processor, similar to the first subsystem. The second input source may be configured to receive a second stimulation signal and generate a second input signal. The second signal processor may be configured to receive a second signal from the second input source and output a second stimulation signal to the second stimulator based on the second input signal and a second transfer function associated with the second signal processor. In some embodiments, the wearer may have the first subsystem implanted proximate to the first ear and the second subsystem implanted proximate to the second ear.

[0035] The system may include an implantable battery and / or a communication module in communication with both the first and second signal processors. The implantable battery and / or communication module may be configured to provide power to both the first and second signal processors. Additionally or alternatively, the implantable battery and / or communication module may be configured to communicate data to and / or receive data from each of the first and / or second signal processors. In various embodiments, the implantable battery and / or communication module may communicate with each of the first and second signal processors via separate leads or by a bifurcated lead.

[0036] In some examples, the implantable battery and / or communication module may be configured to update a transfer function associated with each of the first and second signal processors. In examples having separate leads connecting the implantable battery and / or communication module and each signal processor, the implantable battery and / or communication module may communicate a signal to each respective signal processor to update the transfer function associated therewith. In some examples, such as examples in which both the first and second signal processors are in communication with the implantable battery and / or communication module via a bifurcated lead, the implantable battery and / or communication module may communicate an addressed signal to both signal processors. The addressed signal may include address information designating one of the signal processors as the desired recipient of the signal. Each signal processor may be configured to respond only to signals that designate it.

[0037] In some examples, the implantable battery and / or communications module can receive commands, such as commands to adjust the volume of the system. In some such examples, the implantable battery and / or communications module can be configured to update the transfer function of each signal processor based on an existing transfer function of each respective signal processor, since each subsystem can operate differently and independently from one another. [Brief description of the drawings]

[0038] [Figure 1] 1 shows a schematic diagram of a fully implantable cochlear implant system. [Diagram 2] 1 shows a fully implantable cochlear implant. [Figure 3A] FIG. 2 is an exemplary diagram illustrating communication with a signal processor. [Figure 3B] FIG. 2 is an exemplary diagram illustrating communication with a signal processor. [Figure 4]1 illustrates an exemplary middle ear sensor embodiment for use in conjunction with a patient's anatomical features. [Diagram 5] 1 illustrates an exemplary middle ear sensor embodiment for use in conjunction with a patient's anatomical features. [Figure 6] 1 illustrates a diagram of an exemplary removable connector. [Figure 7] 1 illustrates an exemplary cochlear implant system in a patient who is not fully physically developed, such as a child. [Figure 8] FIG. 1 is a process flow diagram illustrating an exemplary process for installing and / or updating an implantable cochlear implant system in a patient. [Figure 9] FIG. 1 is a schematic diagram illustrating an exemplary implantable system including an acoustic stimulator. [Figure 10A] FIG. 1 is a high level electrical schematic diagram showing communication between an implantable battery and / or communication module and a signal processor. [Figure 10B] FIG. 1 shows an exemplary schematic diagram illustrating a cochlear electrode having multiple contact electrodes and connected either fixedly or removably to an electrical stimulator. [Figure 11A] FIG. 1 shows a high level schematic diagram illustrating an exemplary communication arrangement between an implantable battery and / or communication module, a signal processor, and a stimulator in an exemplary cochlear implant system. [Figure 11B] FIG. 1 is a schematic diagram illustrating exemplary electrical communications between an implantable battery and / or communications module and a signal processor in a cochlear implant system, according to some embodiments. [Figure 12A] FIG. 13 is an alternative high level schematic diagram illustrating an exemplary communication configuration between an implantable battery and / or communication module, a signal processor, and a stimulator. [Figure 12B] FIG. 12B is an alternative schematic diagram illustrating exemplary electrical communications between an implantable battery and / or communications module and a signal processor in a cochlear implant system similar to that shown in FIG. 12A. [Figure 12C]FIG. 12B is another alternative schematic diagram illustrating exemplary electrical communications between an implantable battery and / or communications module and a signal processor in a cochlear implant system similar to that shown in FIG. 12A. [Figure 12D] FIG. 12B is a high level schematic diagram illustrating exemplary electrical communications between an implantable battery and / or communications module and a signal processor in a cochlear implant system similar to that shown in FIG. 12A. [Figure 13A] FIG. 1 shows an exemplary schematic diagram of a processor and stimulator combined in a single housing. [Figure 13B] 13B shows a simplified cross-sectional view of the processor / stimulator shown in FIG. 13A taken along line BB. [Figure 14A] FIG. 1 is a schematic diagram illustrating an exemplary signal processing configuration for adapting to variations in sensor frequency response. [Figure 14B] 4 shows exemplary gain vs. frequency response curves of a signal at various stages in a processing arrangement. [Figure 15] FIG. 1 is a process flow diagram illustrating an exemplary process for establishing a preferred transfer function for a patient. [Figure 16] FIG. 1 is a process flow diagram illustrating an exemplary process for establishing a preferred transfer function for a patient. [Figure 17] FIG. 1 is a process flow diagram illustrating an exemplary method for testing the effectiveness of one or more sounds using one or more transfer functions through a preprocessed signal. [Figure 18] FIG. 2 is a schematic diagram of an exemplary database of preprocessed sound signals. [Figure 19] FIG. 1 is a schematic diagram illustrating possible communications between various system components according to some embodiments of a fully implantable system. [Figure 20] FIG. 1 is a schematic diagram illustrating the establishment of a secure wireless connection between various components of the implantable system. [Figure 21] FIG. 1 shows a process flow diagram illustrating an exemplary method for pairing a charger with an implanted system. [Figure 22]FIG. 1 shows a process flow diagram illustrating an exemplary method for pairing another device with an implanted system using a paired charger. [Figure 23] 1 is a chart illustrating various parameters adjustable by each of various external devices. [Figure 24] 1 illustrates an example configuration of an interface device configured to assist in system calibration. [Diagram 25] FIG. 1 is a process flow diagram illustrating an exemplary process for calibrating an implanted system. [Figure 26] FIG. 1 illustrates an exemplary embodiment in which a cochlear implant system includes components implanted on both sides of a wearer (e.g., both the right and left ears). DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0039] FIG. 1 shows a schematic diagram of a fully implantable cochlear implant system. The system of FIG. 1 includes a middle ear sensor 110 in communication with a signal processor 120. The middle ear sensor 110 can be configured to detect incoming sound waves, for example, using the patient's ear structure. The signal processor 120 can be configured to receive signals from the middle ear sensor 110 and generate an output signal based thereon. For example, the signal processor 120 can be programmed with instructions to output a particular signal based on the received signal. In some embodiments, the output of the signal processor 120 can be calculated using an equation based on the received input signal. Alternatively, in some embodiments, the output of the signal processor 120 can be based on a look-up table or other programmed (e.g., in memory) correspondence between input and output signals from the middle ear sensor 110. Although not necessarily explicitly based on a function, the relationship between the input to the signal processor 120 (e.g., from the middle ear sensor 110) and the output of the signal processor 120 is referred to as the transfer function of the signal processor 120.

[0040] The system of FIG. 1 further includes a cochlear electrode 116 implanted in the patient's cochlear tissue. The cochlear electrode 116 is in electrical communication with an electrical stimulator 130, which can be configured to provide an electrical signal to the cochlear electrode 116 in response to an input signal received by the electrical stimulator 130. In some examples, the cochlear electrode 116 is fixedly attached to the electrical stimulator 130. In other examples, the cochlear electrode 116 is removably attached to the electrical stimulator 130. As shown, the electrical stimulator 130 is in communication with a signal processor 120. In some embodiments, the electrical stimulator 130 provides an electrical signal to the cochlear electrode 116 based on an output signal from the signal processor 120.

[0041] In various embodiments, the cochlear electrode 116 may include any number of contact electrodes in electrical contact with different portions of the cochlear tissue. In such embodiments, the electrical stimulator 130 may be configured to provide electrical signals to any number of such contact electrodes to stimulate the cochlear tissue. For example, in some embodiments, the electrical stimulator 130 is configured to activate different contact electrodes or combinations of contact electrodes of the cochlear electrode 116 in response to different input signals received from the signal processor 120. This helps the patient distinguish between different input signals.

[0042] During exemplary operation, the middle ear sensor 110 detects audio signals using characteristics of the patient's ear anatomy, for example, as described elsewhere herein and in U.S. Patent Publication No. 2013 / 0018216, which is incorporated herein by reference in its entirety. The signal processor 120 can receive such signals from the middle ear sensor 110 and generate an output to the electrical stimulator 130 based on a transfer function of the signal processor 120. The electrical stimulator 130 can then stimulate one or more contact electrodes of the cochlear electrode 116 based on the signals received from the signal processor 120.

[0043] 2, an embodiment of a fully implanted cochlear implant is shown. The device in this embodiment includes a processor 220 (e.g., a signal processor), a sensor 210, a first lead 270 connecting the sensor 210 to the processor 220, and a combination lead 280 attached to the processor 220, the combination lead 280 including both a ground electrode 217 and a cochlear electrode 216. The illustrated processor 220 includes a housing 202, a coil 208, a first female receptacle 271 and a second female receptacle 281 for inserting the leads 270 and 280, respectively.

[0044] In some embodiments, the coil 208 can receive power and / or data from an external device, including, for example, a transmit coil (not shown). Some such examples are described in U.S. Patent Publication No. 2013 / 0018216, which is incorporated by reference. In other examples, the processor 220 is configured to receive power and / or data from other sources, such as an implantable battery and / or communication module as shown in FIG. 1. Such a battery and / or communication module can be implanted, for example, in the patient's chest to provide sufficient space for a larger device (e.g., a relatively large battery) for extended operation (e.g., longer battery life). Additionally, if the battery eventually needs to be replaced, the replacement procedure can be performed multiple times in the patient's chest without certain vascularization issues that may occur near the location of the cochlear implant. For example, in some cases, repeating the procedure (e.g., replacing the battery) near the cochlear implant can reduce the ability of the skin in that area to heal after the procedure. Placing a replaceable component, such as a battery, in the chest can facilitate the replacement procedure while reducing the risk of such issues.

[0045] 3A and 3B are exemplary diagrams illustrating communication with a signal processor. For example, referring to FIGS. 3A and 3B, a processor 320 includes a housing 302, a coil 308, and a generic lead 380 is shown. The lead 380 is removable and can be attached to the processor 320 by inserting the male connector 382 of the generic lead 380 into any available female receptacle, shown here as 371 or 381. FIG. 3A shows the processor 320 with the generic lead 380 removed. FIG. 3B shows the processor 320 with the generic lead 380 attached. The male connector 382 is replaceable and acts as a seal to prevent or minimize fluid migration into the processor 320.

[0046] 4 and 5 show exemplary middle ear sensor embodiments for use in conjunction with patient anatomical features. Referring to FIG. 4, a fully implantable cochlear implant sensor 410 embodiment is shown, where the sensor 410 is in contact with the malleus 422. The sensor may include a cantilever 432 within a sensor housing 434. The sensor 410 may communicate with a processor 420 by at least two wires 436 and 438, which may form a first lead (e.g., 270). Both wires may be made of a biocompatible material, but not necessarily the same biocompatible material. Examples of such biocompatible materials may include tungsten, platinum, palladium, and the like. In various embodiments, one or both of the wires 436 and 438 may be coated with a coating and / or disposed within a casing, as described in U.S. Patent Application Publication No. 2013 / 0018216, which is incorporated by reference.

[0047] The illustrated cantilever 432 includes at least two ends, with at least one end in operative contact with the tympanic membrane or one or more bones of the ossicular chain. The cantilever 432 may be a laminate of at least two layers of material. The material used may be piezoelectric. One example of such a cantilever 432 is a piezoelectric bimorph, which is well known in the art (see, for example, U.S. Pat. No. 5,762,583). In one embodiment, the cantilever is made of two layers of piezoelectric material. In another embodiment, the cantilever is made of three or more layers of piezoelectric material. In yet another embodiment, the cantilever is made of three or more layers of piezoelectric and non-piezoelectric materials.

[0048] The sensor housing 434 of the sensor 410 may be made of a biocompatible material. In one embodiment, the biocompatible material may be titanium or gold. In another embodiment, the sensor 410 may be similar to sensors described, for example, in U.S. Pat. No. 7,524,278 to Madsen et al., or available sensors such as those used in the ESTEEM™ implant (Envoy Medical, Corp., St. Paul, Minn.). In alternative embodiments, the sensor 410 may be an electromagnetic sensor, an optical sensor, or an accelerometer. Accelerometers are known in the art, for example, as described in U.S. Pat. No. 5,540,095.

[0049] Referring to FIG. 5, an embodiment of a fully implantable cochlear implant sensor 510 is shown. Also shown are portions of the subject's anatomy, including at least the malleus 522, incus 524, and stapes 526 of the middle ear 528, and the cochlea 548, oval window 546, and round window 544 of the inner ear 542, if the subject is anatomically normal. Here, the sensor 510 is in contact with the incus 524. The sensor 510 of this embodiment can be as described for the embodiment of sensor 410 shown in FIG. 4. Additionally, although not shown in the drawings, the sensor 510 may be in operative contact with the tympanic membrane or stapes, or any combination of the tympanic membrane, malleus 522, incus 524, or stapes 526.

[0050] 4 and 5 show exemplary middle ear sensors for use in the systems described herein. However, other middle ear sensors can be used, such as sensors using microphones or other sensors capable of receiving inputs corresponding to detected sounds and outputting corresponding signals to the signal processor. Additionally or alternatively, the system can include other sensors configured to output signals representative of sounds received at or near the user's ear, such as microphones or other acoustic pickups located at the user's outer ear or implanted subcutaneously in the user. Such devices can serve as input sources to the signal processor, for example, such that the signal processor receives input signals from the input sources and generates and outputs one or more stimulus signals according to the received input signals and the signal processor transfer function.

[0051] 1, the signal processor 120 is shown as being in communication with the middle ear sensor 110, the electrical stimulator 130, and the implantable battery and / or communication module 140. As described elsewhere herein, the signal processor 120 can receive input signals from the middle ear sensor 110 and / or other input sources and output signals to the electrical stimulator 130 for stimulating the cochlear electrode 116. The signal processor 120 can receive data (e.g., process data to establish or update a transfer function of the signal processor 120) and / or power from the implantable battery and / or communication module 140. In some embodiments, the signal processor 120 can communicate with such components via inputs as shown in FIG.

[0052] In some embodiments, the implantable battery and / or communication module 140 can communicate with external components, such as the programmer 100 and / or the battery charger 102. The battery charger 102 can wirelessly charge the battery in the implantable battery and / or communication module 140 when in proximity to the implantable battery and / or communication module 140 in the patient's chest region. Such charging can be accomplished using, for example, inductive charging. The programmer 100 can be configured to wirelessly communicate with the implantable battery and / or communication module 140 via any suitable wireless communication technology, such as Bluetooth, Wi-Fi, etc. In some examples, the programmer 100 can be used to update system firmware and / or software. In an exemplary operation, the programmer 100 can be used to communicate an updated transfer function of the signal processor 120 to the implantable battery and / or communication module 140. In various embodiments, the programmer 100 and the charger 102 can be separate devices or can be integrated into a single device.

[0053] 1, the signal processor 120 is connected to the middle ear sensor 110 via a lead 170. In some embodiments, the lead 170 can provide communication between the signal processor 120 and the middle ear sensor 110. In some embodiments, the lead 170 can include multiple insulated conductors that provide multiple communication channels between the middle ear sensor 110 and the signal processor 120. The lead 170 can include a coating, such as an electrically insulating sheath, to minimize any conduction of electrical signals to the patient's body.

[0054] In various embodiments, one or more communication leads may be removable so that communication between two components can be severed to electrically and / or mechanically isolate such components. For example, in some embodiments, the lead 170 includes a removable connector 171. The removable connector 171 can facilitate decoupling of the signal processor 120 and the middle ear sensor 110. FIG. 6 shows a diagram of an exemplary removable connector. In the illustrated example, the removable connector 671 includes a male connector 672 and a female connector 673. In the illustrated example, the male connector 672 includes a plurality of insulated electrical contacts 682, and the female connector 673 includes a corresponding plurality of electrical contacts 683. When the male connector 672 is inserted into the female connector 673, the contacts 682 are in electrical contact with the contacts 683. Each corresponding pair of contacts 682, 683 can provide a separate communication channel between the components connected via the removable connector 671. In the illustrated example, four communication channels are possible, but it will be understood that any number of communication channels are possible. Additionally, although shown as circumferentially extending individual contacts 683, other configurations are possible.

[0055] In some embodiments, male connector 672 and female connector 673 are attached to the ends of leads 692, 693, respectively. Such leads may extend from components of an implantable cochlear system. For example, with reference to FIG. 1, in some embodiments, lead 170 may include a first lead having one of a male (e.g., 672) or female (e.g., 673) connector and extending from the middle ear sensor 110, and a second lead having the other of the male or female connector and extending from the signal processor 120. The first and second leads may be connected with a removable connector 171 to facilitate communication between the middle ear sensor 110 and the signal processor 120.

[0056] In other examples, a portion of the removable connector 171 may be integrated into one of the middle ear sensor 110 and the signal processor 120 (e.g., as shown in FIG. 3). For example, in an exemplary embodiment, the signal processor 120 may include a female connector (e.g., 673) integrated into the housing of the signal processor 120. The lead 170 may extend completely from the middle ear sensor 110 and terminate in a corresponding male connector (e.g., 672) for insertion into the female connector of the signal processor 120. In yet another embodiment, the lead (e.g., 170) may include a connector at each end that is configured to removably connect with a connector integrated into each of the components in communication. For example, the lead 170 may include two male connectors, two female connectors, or one male and one female connector for removably connecting with corresponding connectors integral to the middle ear sensor 110 and the signal processor 120. Thus, the lead 170 may include two or more removable connectors.

[0057] A similar communication configuration can be established for the removable connector 181 of the lead 180, which facilitates communication between the signal processor 120 and the stimulator 130, and the removable connector 191 of the lead 190, which facilitates communication between the signal processor 120 and the implantable battery and / or communication module 140. The leads (170, 180, 190) can include pairs of leads with corresponding connectors extending from each piece of communication equipment, or the connectors can be incorporated into any one or more of the communication components.

[0058] In such a configuration, each of the electrical stimulator 130, signal processor 120, middle ear sensor 110, and battery and / or communication module may each be enclosed in a housing, such as a hermetically sealed housing comprising a biocompatible material. Such components may include feedthroughs that provide communication to internal components enclosed in the housing. The feedthroughs may provide electrical communication to the components via leads extending from the housing and / or connectors integrated into the components.

[0059] In a modular configuration such as that shown in FIG. 1, various components can be accessed (e.g., for upgrades, repairs, replacement, etc.) separately from other components. For example, as signal processor 120 technology improves (e.g., improvements in size, processing speed, power consumption, etc.), the signal processor 120 implanted as part of a system can be removed and replaced independently of the other components. In an exemplary procedure, the implanted signal processor 120 can be disconnected from the electrical stimulator 130 by disconnecting the removable connector 181, from the middle ear sensor 110 by disconnecting the removable connector 171, and from the implantable battery and / or communication module 140 by disconnecting the removable connector 191. Thus, the signal processor 120 can be removed from the patient while other components such as the electrical stimulator 130, the cochlear electrodes 116, the middle ear sensor 110, and the battery and / or communication module can remain in place with the patient.

[0060] After the old signal processor is removed, the new signal processor can be connected to the electrical stimulator 130, the middle ear sensor 110, and the implantable battery and / or communication module 140 via the removable connectors 181, 171, and 191, respectively. Thus, the signal processor (e.g., 120) can be replaced, repaired, upgraded, or any combination thereof, without affecting other system components. This can, among other things, reduce the risk, complexity, duration, and recovery time of such procedures. In particular, the cochlear electrode 116 can be left in place within the patient's cochlea while other system components can be adjusted, reducing trauma to the patient's cochlear tissue.

[0061] Such modularity of the system components may be particularly advantageous when replacing the signal processor 120 as described above. Because processor technology continues to improve and is likely to continue to improve significantly in the future, the signal processor 120 is likely to be a candidate for significant upgrades and / or replacements during the patient's lifetime. Additionally, in embodiments such as the embodiment shown in FIG. 1, the signal processor 120 communicates with many system components. For example, as shown, the signal processor 120 communicates with each of the electrical stimulator 130, the middle ear sensor 110, and the implantable battery and / or communication module 140. Removably connecting such components to the signal processor 120 (e.g., via removable connectors 181, 171, and 191) allows replacement of the signal processor 120 without disturbing any other components. Thus, in the event of an available signal processor 120 upgrade and / or signal processor 120 failure, the signal processor 120 may be disconnected and removed from the other system components.

[0062] While there are many advantages to a replaceable signal processor 120, the modularity of other system components may be similarly advantageous, for example, to upgrade any system component. Similarly, if a system component (e.g., middle ear sensor 110) fails, the component may be disconnected (e.g., via removable connector 171) from the rest of the system and replaced without disturbing the remaining system components. In another example, even the rechargeable battery included in implantable battery and / or communication module 140 may eventually wear out and require replacement. The implantable battery and / or communication module 140 may be replaced or accessed (e.g., to replace the battery) without disturbing other system components. Additionally, as discussed elsewhere herein, when the implantable battery and / or communication module 140 is implanted in the patient's chest region, as in the illustrated example, such a procedure may leave the patient's head untouched and eliminate unnecessarily frequent access of the subcutaneous tissue.

[0063] Although various components are described herein as being removable, in various embodiments, one or more components configured to communicate with each other may be integrated into a single housing. For example, in some embodiments, the signal processor 120 may be integrally formed with the stimulator 130 and the cochlear electrode 116. For example, in an exemplary embodiment, the processing and stimulation circuitry of the signal processor 120 and the stimulator 130 may be integrally formed as a single unit within a housing coupled to the cochlear electrode. The cochlear electrode and the signal processor / stimulator may be implanted during an initial procedure and operate as a single unit.

[0064] In some embodiments, the integrated signal processor / stimulator / cochlear electrode component is not removed from the patient due to potential damage to the cochlear tissue in which the cochlear electrodes are implanted, but system upgrades are still possible. For example, in some embodiments, the modular signal processor may be implanted alongside and communicate with the integrated signal processor / stimulator component. In some such examples, the integrated signal processor may include a built-in bypass that allows a later-implanted signal processor to interface directly with the stimulator. Additionally or alternatively, the modular signal processor may communicate with the integrated signal processor, which may be programmed with a single transfer function. Thus, in some such embodiments, signals from the modular signal processor may pass through the integrated signal processor essentially unaltered, such that the modular signal processor effectively controls the actions of the integrated stimulator. Thus, in various embodiments, there are hardware and / or software solutions for upgrading an integrally attached signal processor that may be difficult or dangerous to remove.

[0065] Another advantage of a modular cochlear implant system such as that shown in FIG. 1 is the ability to implant different system components in patients at different times. For example, infants and children are not typically suitable for a fully implantable system such as that shown in FIG. 1. Instead, such patients are typically candidates to wear a conventional cochlear implant system. For example, FIG. 7 illustrates an exemplary cochlear implant system in a patient who is not fully physically developed, such as a child. The system includes a cochlear electrode 716 implanted in the cochlear tissue of the patient. The cochlear electrode 716 of FIG. 7 can include many of the characteristics of the cochlear electrodes described herein. The cochlear electrode 716 can be in electrical communication with an electrical stimulator 730, which can be configured to stimulate portions of the cochlear electrode 716 in response to an input signal, as described elsewhere herein. The electrical stimulator 730 can receive an input signal from a signal processor 720.

[0066] In some cases, components such as middle ear sensors are not compatible with patients who are not fully physically developed. For example, various dimensions within a growing patient's anatomy, such as spacing between anatomical structures or between locations on the anatomical structures (e.g., attachment points of devices), may change as the patient grows, thereby potentially rendering middle ear sensors, which are highly sensitive to movement, ineffective. Similarly, an underdeveloped patient may not be able to support an implantable battery and / or communication module. Thus, the signal processor 720 may be in communication with a communication device for communicating with components external to the patient. Such a communication component may include, for example, a coil 708, shown as connected to the signal processor 720 via a lead 770. The coil 708 may be used to receive data and / or power from a device external to the user. For example, a microphone or other audio sensing device (not shown) may be in communication with the external coil 709, which is configured to transmit data to the coil 708 implanted in the patient. Similarly, a power source (e.g., a battery) may be coupled to the external coil 709 and configured to provide power to the implanted components via the implanted coil 708. Additionally, processed data (e.g., transfer function updates of the signal processor 720) may also be communicated from the external coil 709 to the implanted coil 708. Although generally discussed using the coil 708, it will be appreciated that communication between the external and implanted components (e.g., the signal processor 720) may be performed using other communication techniques, such as various forms of wireless communication. As shown, in the embodiment of FIG. 7, the signal processor 720 is coupled to the coil 708 via a lead 770 and a removable connector 771. Thus, the coil 708 is separate from the signal processor 720 and may be removed without disturbing the signal processor 720.

[0067] When the patient is fully developed, e.g., until the patient can safely accommodate the middle ear sensor and the implantable battery and / or communication module, the coil 708 can be removed and the remaining components of the fully implantable system can be implanted. That is, as the patient develops, the cochlear implant system (e.g., of FIG. 7) can be upgraded to a fully implantable cochlear implant system (e.g., of FIG. 1). In some examples, a patient is considered fully developed when the patient reaches 18 years of age or another predetermined age. Additional or alternative criteria can be used, such as when various anatomical sizes or determined developmental states are achieved.

[0068] 8 is a process flow diagram illustrating an exemplary process for installing and / or updating an implantable cochlear implant system in a patient. A cochlear electrode can be implanted in communication with the patient's cochlear tissue, and an electrical stimulator can be implanted in communication with the cochlear electrode (step 850). A signal processor can be implanted in the patient (step 852). As described elsewhere herein, the signal processor can be connected to the electrical stimulator via a detachable connector (step 854). In examples where the signal processor is integrally formed with one or more components, such as the stimulator and cochlear electrode, steps 850, 852, and 854 can be combined into a single step that includes implanting the cochlear electrode, stimulator, and signal processor components.

[0069] When the process of Figure 8 is performed, it can be determined whether the patient is considered sufficiently developed (step 856). If not, a coil (or other communication device) as described with respect to Figure 7 can be implanted (step 858). The coil can be connected to a signal processor via a detachable connector (step 860), and the cochlear implant can operate in conjunction with external components such as a microphone, an external power source and a coil (step 862).

[0070] However, if the patient is or has developed sufficiently (step 856), additional components may be implanted in the patient. For example, the method may include implanting a middle ear sensor (step 864) and connecting the middle ear sensor to a signal processor via a removable connector (step 866). Additionally, the method may include implanting a battery and / or a communication module (step 868) and connecting the battery and / or the communication module to the signal processor via a removable connector (step 870). If the patient is sufficiently developed after wearing a partially external device as described with respect to FIG. 7 and steps 858-862, the method may include removing various previously implanted components. For example, a coil such as that implanted in step 858 may be disconnected and removed during the procedure of implanting the middle ear sensor (step 864).

[0071] The process of Fig. 8 may be embodied in a method for fitting an implantable hearing system to a patient. Such a method may include implanting a first system (e.g., the system of Fig. 7) in a patient of a first age. This may include, for example, performing steps 850-562 of Fig. 8. The method may further include removing some components (e.g., coils) of the first system and implanting not yet implanted components of a second system (e.g., the system of Fig. 1) when the patient reaches a second age greater than the first age, e.g., via steps 864-870 of Fig. 8.

[0072] For example, transitioning from the system of FIG. 7 to the system of FIG. 1 via the process of FIG. 8 can have several advantages. From a patient preference standpoint, some patients may prefer a system that is fully implanted and does not require wearable external components. Additionally, an implanted battery and / or communication module that communicates with the signal processor via the lead 190 (and detachable connector 191) can relay power and / or data to the signal processor much more efficiently when compared to an external device such as a coil.

[0073] Such modular systems offer distinct advantages over previous implantable or partially implantable cochlear implant systems. Previous systems generally include several components contained in a single housing that is implanted in the patient. For example, the functions of a signal processor, electrical stimulator, and sensor may be encapsulated in a single complex component. If such aspects of the components fail, which is more likely with increasing complexity, the entire module must be replaced. In contrast, in a modular system such as that shown in FIG. 1, individual components may be replaced while other components remain in place. Additionally, such systems, including, for example, inter-coil power and / or data communication through the patient's skin, are also generally less efficient than internal connections, such as through the lead 190. Modular systems such as those shown in FIGS. 1 and 7 also allow for a smooth transition from a partially implantable system for a patient not yet fully developed, to a fully implantable system once the patient is fully developed.

[0074] Although often described herein as using an electrical stimulator to stimulate the patient's cochlear tissue via a cochlear electrode, in some examples, the system may additionally or alternatively include an acoustic stimulator. The acoustic stimulator may include, for example, a transducer (e.g., a piezoelectric transducer) configured to provide mechanical stimulation to the patient's ear structure. In an exemplary embodiment, the acoustic stimulator may be configured to stimulate one or more portions of the patient's ossicular chain via amplified vibrations. The acoustic stimulator may include any suitable acoustic stimulator, such as those found in the ESTEEM™ implant (Envoy Medical Corp., St. Paul, Minn.), or as described in U.S. Patent Nos. 4,729,366, 4,850,962, and 7,524,278, and U.S. Patent Publication No. 2010 / 0042183, each of which is incorporated herein by reference in its entirety.

[0075] 9 is a schematic diagram illustrating an exemplary implantable system including an acoustic stimulator. The acoustic stimulator may be implanted in proximity to a patient's ossicular chain and may communicate with a signal processor via a lead 194 and a removable connector 195. The signal processor may be behave as described elsewhere herein and may be configured to cause acoustic stimulation of the ossicular chain via the acoustic stimulator in response to input signals from the middle-ear sensor according to a transfer function of the signal processor.

[0076] The acoustic stimulator of Figure 9 can be used similarly to the electrical stimulator as described elsewhere herein. For example, the acoustic stimulator can be mechanically coupled to the patient's ossicular chain once the system is implanted, and can be coupled to a signal processor via leads 194 and a removable connector 195. As with the systems described elsewhere herein for electrical stimulators, if the signal processor needs to be replaced or repaired, the signal processor can be disconnected from the acoustic stimulator (via the removable connector 195), allowing it to be removed without disrupting the acoustics.

[0077] In general, a system incorporating an acoustic sensor such as that shown in FIG. 9 can be operated in the same manner as the systems described elsewhere herein that use an electrical stimulator and cochlear electrodes that use only electrical stimulation instead of acoustic stimulation. The same modularity benefits, including system maintenance and upgrades, and the ability to convert to a fully implantable system when the patient is sufficiently developed, can be similarly realized using an acoustic stimulation system. For example, the process shown in FIG. 8 can be performed in an acoustic stimulation system by using an electrical stimulator and cochlear electrodes instead of an acoustic stimulator.

[0078] Some systems may include hybrid systems that include both electrical and acoustic stimulators in communication with a signal processor. In some such examples, the signal processor may be configured to stimulate electrically and / or acoustically according to a transfer function of the signal processor. In some examples, the type of stimulation used may depend on the input signal received by the signal processor. For example, in an exemplary embodiment, the frequency content of the input signal to the signal processor may dictate the type of stimulation. In some cases, frequencies below a threshold frequency may be represented using one of electrical and acoustic stimulation, and frequencies above the threshold frequency may be represented using the other of electrical and acoustic stimulation. Such threshold frequencies may be adjustable based on the patient's hearing profile. Using a limited range of frequencies may reduce the number of frequency regions on the cochlear electrodes, and therefore the number of contact electrodes. In other examples, various frequencies may be stimulated electrically and acoustically, rather than a single threshold frequency that defines which frequencies are stimulated electrically and acoustically. In some such examples, the relative amounts of electrical and acoustic stimulation may depend on frequency. As described elsewhere herein, the signal processor transfer function may be updated to meet the needs of the patient, including the electrical and acoustic stimulation profiles.

[0079] With further reference to FIGS. 1 and 9, in some examples, the system may include a shutoff controller 104 that may be configured to wirelessly stop the electrical stimulator 130 from stimulating the patient's cochlear tissue and / or the acoustic stimulator 150 from stimulating the patient's ossicles. For example, if the system is malfunctioning or an uncomfortably loud input sound causes an undesirable level of stimulation, a user may use the shutoff controller 104 to stop stimulation from the stimulator 130. The controller 104 may be embodied in a variety of ways. For example, in some embodiments, the shutoff controller 104 may be integrated into other external components, such as the programmer 100. In some such examples, the programmer 100 includes a user interface through which a user may select an emergency shutoff function to stop stimulation. Additionally or alternatively, the shutoff controller 104 may be embodied as a separate component. This may be useful in situations where the patient may not have ready access to the programmer 100. For example, the shutoff controller 104 may be implemented as a wearable component that the patient may wear all or most of the time, such as a ring, bracelet, necklace, etc.

[0080] The shutoff controller 104 can communicate with the system to stop stimulation in a variety of ways. In some examples, the shutoff controller 104 includes a magnet that is detectable by a processor and / or an implantable battery and / or a sensor (e.g., a Hall effect sensor) implanted in the patient, such as the communication module 140. In some such embodiments, when the magnet is brought sufficiently close to the sensor, the system can stop stimulation of the cochlear tissue or ossicular chain.

[0081] After disabling the stimulation using the shut-off controller 104, the stimulation can be re-enabled over one or more of a variety of methods. For example, in some embodiments, the stimulation is re-enabled after a predetermined time after it is disabled. In other examples, the shut-off controller 104 can be used to re-enable the stimulation. In some such examples, the patient brings the shut-off controller 104 within a first distance of a sensor (e.g., a magnetic sensor) to disable the stimulation, and then removes the shut-off controller 104. The stimulation can then be re-enabled when the patient brings the shut-off controller 104 within a second distance of the sensor. In various embodiments, the first distance can be less than, equal to, or greater than the second distance. In yet another embodiment, the stimulation can be re-enabled using a separate turn-on controller (not shown) or another device such as the programmer 100. Alternatively, any combination of such re-enabling of the stimulation can be used, such as combining a minimum "off" time before enabling the stimulation using either the programmer 100 or the shut-off controller 104, or using any other method.

[0082] In some embodiments, rather than disabling the stimulation entirely, other actions may be taken, such as reducing the magnitude of the stimulation. For example, in some embodiments, a shutoff sensor may be used to reduce the signal output by a predetermined amount (e.g., an absolute amount, a percentage, etc.). In other examples, the shutoff sensor may affect the transfer function of the signal processor to reduce the magnitude of the stimulation in a customized manner depending on the frequency or other parameters of the input signal (e.g., from a middle-ear sensor).

[0083] Referring back to FIG. 1, as described elsewhere herein, an implantable battery and / or communication module may be used to provide power and / or data (e.g., processing instructions) to other system components via lead 190. Communicating electrical signals through a patient's body presents various challenges. For example, safety standards may limit the amount of current (especially DC current) that can safely flow through the patient's body. Additionally, the patient's body may act as an undesirable signal path from component to component (e.g., via contact with the housing or "can" of each component). Various systems and methods may be employed to improve communication capabilities between system components.

[0084] FIG. 10A is a high level electrical schematic diagram showing communication between an implantable battery and / or communication module and a signal processor. In the illustrated embodiment, the implantable battery and / or communication module includes circuitry that communicates with circuitry in the signal processor. Communication between the circuitry in the implantable battery and / or communication module and the signal processor can be facilitated by a lead (190) represented by a lead transfer function. The lead transfer function can include, for example, parasitic resistance and capacitance between the lead connecting the implantable battery and / or communication module and the signal processor and the patient's body and / or between two or more conductors (e.g., 191) that make up the lead. Signals communicated from the circuitry of the implantable battery and / or communication module to the circuitry in the signal processor include power provided to operate system components (e.g., middle ear sensor, signal processor, electrical and / or acoustic stimulator, and / or cochlear electrodes) and / or data (e.g., processed data related to the transfer function of the signal processor).

[0085] As discussed elsewhere herein, the patient's body provides an electrical pathway between system components such as the implantable battery and / or communications module "can" and the signal processor "can." This pathway is illustrated in FIG. 10A as R Body The patient's body may therefore provide undesirable signal paths that may adversely affect communication between components. To address this, in some embodiments, the operational circuitry of each component may be substantially isolated from the component "can," and thus the patient's body. For example, as shown, resistor R Can is positioned between the circuitry and the implantable battery and / or "can" of both the communications module and the signal processor.

[0086] R in each of the implantable battery and / or communication module and the signal processor Can Although shown as R, it will be understood that the actual values ​​of resistance between the circuit and each "can" of different elements are not necessarily equal. Can does not have to be purely resistive, but can contain other components, e.g., one or more capacitors, inductors, etc. That is, R Can R can represent an isolation circuit that includes any of a variety of components that function to increase the impedance between the circuitry within the component and the "can" of the component. Thus, R Can represents the impedance between the operating circuit of a component and its respective "can" and the patient's tissue. Isolating the circuit from the "can" and the patient's body serves to similarly isolate the circuit from the "can" of other components, allowing each component to operate with reference to the substantially isolated component's ground. This can eliminate undesirable communication and interference between system components and / or between system components and the patient's body.

[0087] For example, as described elsewhere herein, in some examples, the electrical stimulator can provide electrical stimulation to one or more contact electrodes on a cochlear electrode implanted in the patient's cochlear tissue. FIG. 10B shows an exemplary schematic diagram illustrating a cochlear electrode having multiple contact electrodes and fixedly or removably connected to an electrical stimulator. As shown, the cochlear electrode 1000 has four contact electrodes 1002, 1004, 1006, and 1008, although it will be understood that any number of contact electrodes is possible. As described elsewhere herein, the electrical stimulator can provide electrical signals to one or more such contact electrodes in response to an output from a signal processor according to its transfer function and a received input signal.

[0088] Since each of the contact electrodes 1002-1008 is in contact with the patient's cochlear tissue, each of them has a Body As shown in Figure 1, the system is isolated from the "can" of the electrical stimulator (and the "cans" of other system components) through the impedance of the patient's tissue. Therefore, it is necessary to ensure that the circuits within the various system components have a sufficiently high impedance (e.g., R Can ), the electrical signal may stimulate undesired areas of the patient's cochlear tissue. For example, stimulation targeted to a particular contact electrode (e.g., 1002) may result in undesired stimulation of other contact electrodes (e.g., 1004, 1006, 1008), reducing the overall effectiveness of the system. Thus, R Can Minimizing the conductive paths between system components through the patient's body (e.g., to the contact electrodes of the cochlear electrode), such as by incorporating impedance between the component circuitry and the corresponding "can" via, can improve the ability to apply electrical stimulation to only desired portions of the patient's body.

[0089] R Body It will be understood that the term R is used generally herein to describe the resistance and / or impedance of the patient's tissue between various components and does not refer to a specific value. Further, each depiction in the figures or RBody do not necessarily represent the same resistance and / or impedance values ​​as others.

[0090] FIG. 11A shows a high level schematic diagram illustrating an example communication configuration between an implantable battery and / or communication module, a signal processor, and a stimulator. In the example of FIG. 11A, the implantable battery and / or communication module 1110 is in bidirectional communication with the signal processor 1120. For example, the implantable battery and / or communication module 1110 can communicate power and / or data signals 1150 to the signal processor 1120. In some examples, the power and data signals 1150 can be included in a single signal that is generated in the implantable battery and / or communication module 1110 and transmitted to the signal processor 1120. Such a signal can include, for example, a digital signal transmitted at a particular clock rate, which in some embodiments is adjustable via the implantable battery and / or communication module 1110, for example.

[0091] In some embodiments, the signal processor 1120 can communicate information (e.g., 1151) to the implantable battery and / or communications module 1110, such as feedback information and / or a request for more power. The implantable battery and / or communications module 1110 can, in response, adjust the output (e.g., amplitude, duty cycle, clock rate, etc.) to the signal processor 1120 to accommodate the received feedback (e.g., to provide more power, etc.). Thus, in some such examples, the implantable battery and / or communications module 1110 can communicate power and data (e.g., 1150) to the signal processor 1120, which can communicate various data back to the implantable battery and / or communications module 1110 (e.g., 1151).

[0092] In some embodiments, similar communications may be implemented between the signal processor 1120 and the stimulator 1130, with the signal processor 1120 providing power and data to the stimulator 1130 (e.g., 1160) and receiving data back from the stimulator 1130 (e.g., 1161). For example, the signal processor 1120 may be configured to output signals (e.g., power and / or data) to the stimulator 1130 (e.g., based on inputs received from a middle ear sensor or other device) via a communication protocol similar to that implemented between the implantable battery and / or communication module 1110 and the signal processor 1120. Similarly, in some embodiments, the stimulator may be configured to provide feedback signals to the signal processor, e.g., representative of the stimulation process performed. Additionally or alternatively, the stimulator may provide diagnostic information, such as electrode impedance and neural response telemetry or other biomarker signals.

[0093] FIG. 11B is a schematic diagram illustrating an exemplary electrical communication between an implantable battery and / or communication module and a signal processor in a cochlear implant system, according to some embodiments. In the illustrated embodiment, the implantable battery and / or communication module 1110 includes a signal generator 1112 configured to output a signal to a signal processor 1120 via a lead (e.g., 190). As described with respect to FIG. 11A, in some examples, the signal generator 1112 is configured to generate both a data signal and a power signal (e.g., 1150) for communication with the signal processor 1120. In some embodiments, the signal generator 1112 generates a digital signal for communication with the signal processor 1120. The digital signal from the signal generator 1112 can be communicated to the signal processor 1120 at a particular clock rate. In some examples, the signal is generated at about 30 kHz. In various examples, the data and power frequencies can range from about 100 Hz to about 10 MHz, and in some examples can be adjustable by a user, for example.

[0094] In the embodiment shown, the implantable battery and / or communication module 1110 includes a controller in communication with the signal generator 1112. In some examples, the controller can adjust communication parameters, such as a clock rate of the signal generator 1112. In an exemplary embodiment, the controller and / or signal generator 1112 can be in communication with, for example, a patient external programmer (e.g., as shown in FIG. 1). The controller and / or signal generator 1112 can be configured to communicate (e.g., 1151) data to the signal processor 1120, such as updated firmware, transfer functions of the signal processor 1120, etc.

[0095] As shown, the signal generator 1112 outputs a generated signal to an amplifier 1190 and an inverting amplifier 1192. In some examples, both amplifiers are unity gain amplifiers. In some examples involving digital signals, the inverting amplifier 1192 may include a digital NOT gate. The outputs from the amplifier 1190 and the inverting amplifier 1192 are generally the opposite of one another and are directed to the signal processor 1120. In some embodiments, the opposite nature of the signals output from the amplifiers 1190 and 1192 to the signal processor 1120 results in charge neutral communication between the implantable battery and / or communication module 1110 and the signal processor 1120 such that no net charge flows through the wearer.

[0096] 11B, the receiving circuit of the signal processor 1120 comprises a rectifier circuit 1122 that receives a signal (e.g., 1150) from an amplifier 1190 and an inverting amplifier 1192. As the output of one of the amplifiers 1190 and 1192 goes high, the rectifier circuit 1122 can be configured to receive an opposite signal from the amplifiers 1190 and 1192 and generate a substantially DC power output 1123 therefrom. In various embodiments, the DC power 1123 can be used to power various components such as the signal processor 1120 itself, a middle ear sensor, an electrical and / or acoustic stimulator, etc. The rectifier circuit 1122 can include any known suitable circuit components for rectifying one or more input signals, such as, for example, a diode rectifier circuit or a transistor circuit.

[0097] As described elsewhere herein, the implantable battery and / or communication module 1110 can communicate data to the signal processor 1120. In some embodiments, the controller and / or signal generator 1112 is configured to encode data for transmission via the output amplifiers 1190 and 1192. The signal processor 1120 can include a signal extraction module 1124 configured to extract a data signal 1125 from a signal (e.g., 1150) communicated to the signal processor 1120 to generate a signal used by the signal processor 1120. In some examples, the signal extraction module 1124 can decode a signal encoded by the implantable battery and / or communication module 1110. Additionally or alternatively, the signal extraction module 1124 can extract a signal 1125 resulting from a lead transfer function. In various examples, the extracted signal 1125 can include, for example, an updated transfer function for the signal processor 1120, a desired stimulation command, or other signal that affects the operation of the signal processor 1120.

[0098] In the illustrated example, the signal processor 1120 includes a controller 1126 that can monitor the DC power 1123 and the signal 1125 received from the implantable battery and / or communication module 1110. The controller 1126 can be configured to analyze the received DC power 1123 and signal 1125 and determine whether the power and / or signal is sufficient. For example, the controller 1126 may determine that the signal processor 1120 is receiving insufficient DC power to stimulate the cochlear electrodes according to a transfer function of the signal processor 1120 or that data from the implantable battery and / or communication module 1110 is not being communicated at a desired rate. Thus, in some examples, the controller 1126 of the signal processor 1120 can communicate with the controller 1114 of the implantable battery and / or communication module 1110 to provide feedback regarding the received communications. Based on feedback received from the controller 1126 of the signal processor 1120, the controller 1114 of the implantable battery and / or communications module 1110 can adjust various characteristics of the signal output by the implantable battery and / or communications module 1110. For example, the controller of the implantable battery and / or communications module 1110 can adjust a clock rate of communications from the signal generator 1112 to the signal processor 1120.

[0099] In some systems, the efficiency of transmission between the implantable battery and / or communication module 1110 and the signal processor 1120 depends on the clock speed of the transmission. Thus, in some examples, the implantable battery and / or communication module 1110 starts by transmitting at an optimized clock rate until a change in the clock rate is requested via the signal processor 1120, e.g., to enhance data transmission (e.g., rate, resolution, etc.). In other examples, if more power is needed (e.g., if the controller of the signal processor 1120 determines that DC power is insufficient), the clock rate can be adjusted to improve the efficiency of transmission and thus the magnitude of the signal received at the signal processor 1120. It will be appreciated that in addition to or instead of adjusting the clock rate, adjusting the amount of power transmitted to the signal processor 1120 may include adjusting the magnitude of the signal output from the signal generator 1112. In some embodiments, for example, with reference to Figures 11A-B, power and data can be communicated, for example, from the implantable battery and / or communications module 1110 to the signal processor 1120 at a rate of about 30 kHz, and conditioned therefrom, for example, by the signal processor 1120, as needed and / or desired.

[0100] FIG. 12A is an alternative high-level schematic diagram illustrating an exemplary communication configuration between an implantable battery and / or communication module, a signal processor, and a stimulator. In the example of FIG. 12A, the implantable battery and / or communication module 1210 provides a signal (e.g., 1250) to the signal processor 1220 via a first communication link and is in bidirectional communication (e.g., 1251) to provide an additional signal with the signal processor 1220. In the example of FIG. 12A, the implantable battery and / or communication module 1210 can provide a power signal (e.g., 1250) to the signal processor 1220 via a communication link and is otherwise in bidirectional data communication (1251) with the signal processor 1220 via a second communication link. In some such examples, the power signal (1250) and the data signal (1251) can each include a digital signal. However, in some embodiments, the power signal and the data signal are transmitted at different clock rates. In some examples, the clock rate of the data signal is at least an order of magnitude greater than the clock rate of the power signal. For example, in an exemplary embodiment, power signals are communicated at a clock rate of about 30 kHz, while data communications occur at a clock rate of about 1 MHz. As with the embodiment described in FIG. 11A, in some examples, the clock rate may be adjustable, for example, via the implantable battery and / or the communications module 1210.

[0101] 11A, in some embodiments, the signal processor 1220 can communicate information, such as feedback information and / or a request for more power (e.g., data signal 1251), to the implantable battery and / or communications module 1210. In response, the implantable battery and / or communications module 1210 can adjust the power and / or data (e.g., amplitude, duty cycle, clock rate, etc.) output to the signal processor 1220 to accommodate the received feedback (e.g., to provide more power, etc.).

[0102] In some embodiments, similar communications may be implemented between the signal processor 1220 and the stimulator 1230, with the signal processor 1220 providing power and data to the stimulator 1230 and receiving data back from the stimulator 1230. For example, the signal processor 1220 may be configured to output a signal power signal (e.g., 1260) and a data signal (e.g., 1261) to the stimulator 1230 (e.g., based on input received from a middle ear sensor or other device). Such communications may be implemented via a similar communications protocol as implemented between the implantable battery and / or communication module 1210 and the signal processor 1220. In some examples, the power signal (e.g., 1260) provided to the stimulator 1230 is the same signal (e.g., 1250) received by the signal processor 1220 from the implantable battery and / or communication module 1210. Additionally, in some embodiments, the stimulator 1230 can be configured to provide to the signal processor 1220 a feedback signal (eg, 1261) representative of, for example, the stimulation process performed.

[0103] FIG 12B is an alternative schematic diagram illustrating exemplary electrical communication between an implantable battery and / or communication module 1210b and a signal processor 1220b in a cochlear implant system similar to that shown in FIG 12A. In the illustrated embodiment of FIG 12B, the implantable battery and / or communication module 1210b includes a power signal generator 1211 and a separate signal generator 1212. The power signal generator 1211 and the signal generator 1212 are each configured to output a signal to the signal processor 1220b via a lead (e.g., 190). In some embodiments, the power signal generator 1211 and the signal generator 1212 each generate a digital signal for communication with the signal processor 1220b. In some such embodiments, the digital signal from the power signal generator 1211 (e.g., 1250) can be communicated to the signal processor 1220b at a power clock rate, and the digital signal from the signal generator 1212 (e.g., 1251b) can be communicated to the signal processor 1220b at a data clock rate that is different from the power clock rate. For example, in some configurations, power and data can be most effectively and / or efficiently communicated at different clock rates. In an exemplary embodiment, the power clock rate is about 30 kHz and the data clock rate is about 1 MHz. By utilizing different separately communicated power and data signals having different clock rates, the efficiency of the transfer of power and / or data from the implantable battery and / or communication module 1210b to the signal processor 1220b can be increased.

[0104] In the illustrated embodiment, the implantable battery and / or communication module 1210b includes a controller 1214 in communication with the power signal generator 1211 and the signal generator 1212. In some examples, the controller 1214 can adjust communication parameters, such as clock rates or contents, of the signal generator 1212 and / or the power signal generator 1211. In an exemplary embodiment, the controller 1214 and / or the signal generator 1212 or the power signal generator 1211 can communicate with, for example, a patient's external programmer (e.g., as shown in FIG. 1). The controller 1214 and / or the signal generator 1212 can be configured to communicate data to the signal processor 1220b, such as updated firmware, signal processor 1220b transfer functions, etc. Additionally or alternatively, the controller 1214 can be configured to transmit signals, such as audio or other signals streamed or otherwise received from one or more external devices, as described elsewhere herein.

[0105] As shown, and similar to the example shown in FIG. 11B, the power signal generator 1211 outputs a generated signal to an amplifier 1290 and an inverting amplifier 1292. In some examples, both amplifiers are unity gain amplifiers. In some examples involving digital signals, the inverting amplifier 1292 can include a digital NOT gate. The outputs from the amplifier 1290 and the inverting amplifier 1292 are generally opposite each other and are directed to the signal processor 1220b. In the example shown, the receiver circuit of the signal processor 1220b comprises a rectifier circuit 1222 that receives signals from the amplifier 1290 and the inverting amplifier 1292. The rectifier circuit 1222 can be configured to receive opposite signals from the amplifiers 1290 and 1292 and generate a substantially DC power output 1223 therefrom, as the output of one of the amplifiers 1290 and 1292 is high.

[0106] In various embodiments, the DC power 1223 can be used to power various components such as the signal processor 1220b itself, the middle ear sensor, the electrical and / or acoustic stimulator 1230, etc. The rectifier circuit 1222 can include any known suitable circuit components for rectifying one or more input signals, such as, for example, a diode rectifier circuit or a transistor circuit. In some embodiments, the signal from the power signal generator 1211 is generated at a clock rate (e.g., about 30 kHz) optimal for transmitting power through the lead. In the illustrated example of FIG. 12B, the rectifier circuit 1222 can be placed in parallel with a power line configured to communicate the power signal to other components in the system, such as, for example, the stimulator 1230. For example, in some embodiments, the same power signal (e.g., 1250) generated from the power signal generator 1211 and output through the amplifiers 1290 and 1292 can be similarly applied to the stimulator 1230. In some such examples, the stimulator 1230 includes a rectifier circuit 1222 similar to the signal processor 1220b for extracting DC power from the power signal and the inverted power signal provided by the amplifiers 1290 and 1292, respectively. In alternative embodiments, the signal processor 1220b can similarly provide a signal from a separate power signal generator 1211 to provide a power signal to the stimulator 1230 (e.g., at about 30 kHz) similar to the way power is provided to the signal processor 1220b from the implantable battery and / or communications module 1210b in FIG.

[0107] In the example of Figure 12B, the signal generator 1212 outputs a data signal (e.g., 1251b) to an amplifier 1294 and an inverting amplifier 1296. In some examples, both amplifiers are unity gain amplifiers. In some examples involving digital signals, the inverting amplifier 1296 may include a digital NOT gate. The outputs from the amplifier 1294 and the inverting amplifier 1296 are generally the inverse of each other and are directed to a signal processor 1220b.

[0108] As described elsewhere herein, in some embodiments, the controller 1214 and / or the signal generator 1212 are configured to encode data for transmission via the output amplifiers 1294 and 1296. The signal processor 1220b can include a signal extraction module 1224 configured to extract data from a signal 1225 communicated to the signal processor 1220b to generate a signal 1225 used by the signal processor 1220b. In some examples, the signal extraction module 1224 can decode a signal encoded by the implantable battery and / or the communication module 1210b. Additionally or alternatively, the signal extraction module 1224 can extract a resultant signal 1225 resulting from a lead transfer function. In various examples, the extracted signal can include, for example, an updated transfer function for the signal processor 1220b, a desired stimulation command, or other signals that affect the operation of the signal processor 1220b.

[0109] 12B example, the signal extraction module 1224 includes a pair of tri-state buffers 1286 and 1288 in communication with the signal output from the signal generator 1212. The tri-state buffers 1286 and 1288 are shown as having an "enable" (ENB) signal provided by the controller 1226 to control operation of the tri-state buffers 1286 and 1288 to extract the signal from the signal generator 1212. The signal from the signal generator 1212, buffered by the tri-state buffers 1286 and 1288, is received by an amplifier 1284, which can be configured to generate a signal 1225 representative of the signal generated by the signal generator 1212.

[0110] In some examples, communication of signals generated by the signal generator 1212 can be communicated to the signal processor 1220b at a clock rate different than the clock rate of the signals generated by the power signal generator 1211. For example, in some embodiments, the power signal from the power signal generator 1211 is transmitted at about 30 kHz, which may be an efficient frequency for transmitting power. However, in some examples, the signal from the signal generator 1212 is transmitted at a higher frequency than the signal from the power signal generator 1211, e.g., at about 1 MHz. Such high frequency data transmission may be useful for faster data transfer than is available at lower frequencies (e.g., frequencies for transmitting signals from the power signal generator 1211). Thus, in some embodiments, power and data can be communicated from the implantable battery and / or communication module 1210b to the signal processor 1220b over different communication channels at different frequencies.

[0111] Similar to the embodiment shown in FIG. 11B, in the illustrated example of FIG. 12B, the signal processor 1220b includes a controller 1226 in communication with the implantable battery and / or communication module 1210b. In some such embodiments, the controller 1226 in the signal processor 1220b can monitor the DC power 1223 and / or the signal 1225 received from the implantable battery and / or communication module 1210b. The controller 1126 can be configured to analyze the received DC power 1223 and the signal 1225 and determine whether the power and / or signal is sufficient. For example, the controller 1226 may determine that the signal processor 1220b is receiving insufficient DC power to stimulate the cochlear electrodes according to a transfer function of the signal processor 1220b, or that data from the implantable battery and / or communication module 1210b is not being communicated at a desired rate. Thus, in some examples, the controller 1226 of the signal processor 1220b can communicate with the controller 1214 of the implantable battery and / or communications module 1210b to provide feedback regarding the received communications. Based on the feedback received from the controller 1226 of the signal processor 1220b, the controller 1214 of the implantable battery and / or communications module 1210b can adjust various characteristics of the signals output by the power signal generator 1211 and / or the signal generator 1212.

[0112] 12B, the bidirectional communication signals 1251b between the implantable battery and / or communications module 1210b and the signal processor 1220b include signals from the amplifiers 1294 and 1296 in one direction and communications from the controller 1226 to the controller 1214 in the other direction. It will be appreciated that a variety of communication protocols and techniques can be used in establishing the bidirectional communication signals 1251b between the implantable battery and / or communications module 1210b and the signal processor 1220b.

[0113] For example, in some embodiments, the implantable battery and / or communication module 1210b need not include amplifiers 1294 and 1296, but instead transmits a signal and not its inverse to the signal processor 1220b. In other examples, the signal processor includes amplifiers similar to 1294 and 1296 and outputs the signal and its inverse to the implantable battery and / or communication module 1210b. Additionally or alternatively, in some embodiments, the signal generator 1212 can be integral with the controller 1214, and / or the signal extraction module 1224 can be integral with the controller 1226, and the controllers 1214 and 1226 can communicate bidirectionally via the signal generator 1212 and / or the signal extraction module 1224. In general, the implantable battery and / or communication module 1210b and the signal processor 1220b can communicate bidirectionally to communicate a data signal separate from the power signal provided by the power signal generator 1211.

[0114] As described, separate communication channels for power (e.g., 1250) and data (e.g., 1251b) can be used to provide both power and data from the implantable battery and / or communications module 1210b and the signal processor 1220b. This can allow for separate data and power clock rates to improve power transmission efficiency as well as data transmission efficiency and / or rate. Furthermore, in some examples, if bidirectional communication (e.g., 1251b) between the implantable battery and / or communications module 1210b and the signal processor 1220b fails (e.g., due to component failure, connection failure, etc.), data for communication from the implantable battery and / or communications module 1210b can be encoded in the power signal (e.g., 1250) from the power signal generator 1211 and transmitted to the signal processor 1220b. Thus, similar to the embodiment described with respect to FIG. 11B, both power and data can be transmitted over the same signal.

[0115] In some examples, the signal extraction module 1224 can be configured to receive data received from the power signal generator 1211 via, for example, an actuatable switch that can be actuated upon a detected failure of communication 1251b. In other examples, the signal extraction module 1224 and / or the controller 1226 can generally monitor data from the power signal generator 1211 and identify when the signal received from the power signal generator 1211 includes a data signal encoded in the received power signal to determine when to consider the power signal to include data.

[0116] Thus, in some embodiments, the configuration of FIG. 12B can be implemented to establish efficient bidirectional communication between the implantable battery and / or communication module 1210b and the signal processor 1220b. Faults in the bidirectional communication 1251b can be identified manually and / or automatically. Upon detecting a fault in the bidirectional communication 1251b, the controller 1214 can encode data into the power signal output from the power signal generator 1211, and the power and data can be combined into a single signal as described with respect to FIG. 11B.

[0117] FIG. 12C is another alternative schematic diagram illustrating exemplary electrical communication between an implantable battery and / or communication module 1210c and a signal processor 1220c in a cochlear implant system similar to that shown in FIG. 12A. Similar to the embodiment of FIG. 12B, in the illustrated embodiment of FIG. 12C, the implantable battery and / or communication module 1210c includes a power signal generator 1211 configured to output a signal to the signal processor 1220c via a lead (e.g., 190). In some embodiments, the power signal generator 1211 generates a digital signal (e.g., 1250) for communication with the signal processor 1220c, for example, at a power clock rate. The power signal generator 1211 and corresponding amplifiers 1290, 1292, as well as the rectifier circuit 1222, can operate similarly to that described with respect to FIG. 12B to extract DC power 1223 and, in some examples, output a power signal to further system components, such as a stimulator 1230.

[0118] In the illustrated embodiment, the implantable battery and / or communication module 1210c includes a signal generator 1213 that can provide a data signal to the signal processor. In some embodiments, the signal generator 1213 generates a digital signal for communication with the signal processor 1220c. In some such embodiments, the digital signal (e.g., 1251c) from the signal generator 1213 can be communicated to the signal processor 1220b at a data clock rate that is different from the power clock rate. For example, as described elsewhere herein, in some configurations, power and data can be most effectively and / or efficiently communicated at a variety of different clock rates. In an exemplary embodiment, the power clock rate is about 30 kHz and the data clock rate is about 1 MHz. By utilizing different separately communicated power and data signals having different clock rates, the efficiency of the transfer of power and / or data from the implantable battery and / or communication module 1210c to the signal processor 1220c can be increased.

[0119] The embodiment of FIG. 12C includes a controller 1215 in communication with the power signal generator 1211 and the signal generator 1213. In some examples, the controller 1215 can adjust communication parameters such as clock rates or contents of the signal generator 1213 and / or the power signal generator 1211. In an exemplary embodiment, the controller 1215 and / or the signal generator 1213 or the power signal generator 1211 can communicate with, for example, a patient's external programmer (e.g., as shown in FIG. 1). The controller 1215 and / or the signal generator 1213 can be configured to communicate data to the signal processor 1220c, such as updated firmware, signal processor 1220c transfer functions, etc.

[0120] Similar to the example of FIG. 12B, in the example of FIG. 12C, the signal generator 1213 outputs a data signal (e.g., 1251) to an amplifier 1295 and an inverting amplifier 1297. In some examples, both amplifiers are unity gain amplifiers. In some examples, the amplifiers 1295, 1297 include tri-state buffers. In some examples involving digital signals, the inverting amplifier 1297 may include a digital NOT gate. The outputs from the amplifier 1295 and the inverting amplifier 1297 are generally the inverse of each other and are directed to a signal processor 1220c.

[0121] As described elsewhere herein, in some embodiments, the controller 1215 and / or the signal generator 1213 are configured to encode data for transmission via the amplifiers 1295 and 1297. The signal processor 1220c can include a signal extraction module 1234 configured to extract data from signals communicated to the signal processor 1220c to generate signals used by the signal processor 1220c. In some examples, the signal extraction module 1234 can decode signals encoded by the implantable battery and / or the communication module 1210c. Additionally or alternatively, the signal extraction module 1234 can extract signals resulting from a lead transfer function. In various examples, the extracted signals can include, for example, an updated transfer function for the signal processor 1220c, a desired stimulation command, or other signals that affect the operation of the signal processor 1220c.

[0122] 12B, the signal extraction module 1234 includes a pair of tri-state buffers 1287 and 1289 in communication with the signal output from the signal generator 1213. The tri-state buffers 1287 and 1289 are shown as having an "enable" (ENB) signal provided by the controller 1227 to control operation of the tri-state buffers 1287 and 1289 to extract the signal from the signal generator 1213. The signal from the signal generator 1213, buffered by the tri-state buffers 1287 and 1289, is received by an amplifier 1285, which can be configured to generate a signal representative of the signal generated by the signal generator 1213.

[0123] As described elsewhere herein, in some examples, communication of signals generated by the signal generator 1213 can be communicated to the signal processor 1220c at a different clock rate than the clock rate of the signals generated by the power signal generator 1211. For example, in some embodiments, the power signal from the power signal generator 1211 is transmitted at approximately 30 kHz, which may be an efficient frequency for transmitting power. However, in some examples, the signal from the signal generator 1213 is transmitted at a higher frequency than the signal from the power signal generator 1211, e.g., at approximately 1 MHz. Such high frequency data transmission may be useful for faster data transfer than is available at lower frequencies (e.g., frequencies for transmitting signals from the power signal generator 1211). Thus, in some embodiments, power and data can be communicated from the implantable battery and / or communication module 1210c to the signal processor 1220c over different communication channels at different frequencies.

[0124] 12C, the signal processor 1220c includes a signal generator 1217 and a controller 1227 in communication with the signal generator 1217. Similar to the operation of the signal generator 1213 and the amplifiers 1295 and 1299, the signal generator can be configured to generate output signals to buffers 1287 and 1289, which can be configured to output signals to the implantable battery and / or the communication module 1210c.

[0125] In some embodiments, the controller 1227 in the signal processor 1220c can monitor signals received from the DC power 1223 and / or the implantable battery and / or the communication module 1210c. The controller 1126 can be configured to analyze the received DC power 1223 and signals and determine whether the power and / or signals are sufficient. For example, the controller 1227 may determine that the signal processor 1220c is receiving insufficient DC power to stimulate the cochlear electrodes according to the transfer function of the signal processor 1220c, or that data from the implantable battery and / or the communication module 1210c is not being communicated at a desired rate. Thus, in some examples, the controller 1227 of the signal processor 1220c causes the signal generator 1217 to generate and transmit a communication signal to the implantable battery and / or the communication module 1210c. Such a signal can be used to provide feedback regarding signals received by the signal processor 1220c, such as the DC power 1223.

[0126] In the example of FIG. 12C, the amplifiers 1295 and 1297 are shown as including tri-state amplifiers (e.g., tri-state buffers) controllable by the controller 1227. Similar to the configuration of the signal processor 1220c, the implantable battery and / or communication module 1210c includes a signal extraction module 1235 configured to extract data from signals communicated from the signal generator 1217 of the signal processor 1220c to the implantable battery and / or communication module 1210c. The signal extraction module 1235 includes amplifiers 1295 and 1297 (e.g., tri-state buffers) in communication with signals output from the signal generator 1217. Signals from the signal generator 1217 that are received at the amplifiers 1295 and 1297 are received by the amplifier 1299, which can be configured to generate a signal representative of the signal generated by the signal generator 1217 to the controller 1215 of the implantable battery and / or communication module 1210. Thus, in some embodiments, the controller 1227 of the signal processor 1220c is configured to communicate data back to the implantable battery and / or the communication module 1210a via buffers 1287 and 1289.

[0127] As described with respect to other embodiments, based on feedback received from the controller 1227 of the signal processor 1220c, the controller 1215 of the implantable battery and / or communication module 1210c can adjust various characteristics of the signals output by the power signal generator 1211 and / or the signal generator 1213.

[0128] Thus, in the illustrated example of FIG. 12C, the bidirectional communication signal 1251 between the implantable battery and / or communication module 1210c and the signal processor 1220c includes communication between the different signal extraction modules 1235 and 1234. As shown, both the implantable battery and / or communication module 1210c and the signal processor 1220c include controllers (1215, 1227) that communicate with signal generators (1213, 1217) to generate output signals. The signal generators (1213, 1217) output signals via tri-state amplifiers including one inverting amplifier (1297, 1289) for communication via the bidirectional communication 1251c for reception by the other signal extraction module (1234, 1235).

[0129] Thus, in some embodiments, bidirectional communication 1251c between the implantable battery and / or communications module 1210c and the signal processor 1220c can be enabled by each of the implantable battery and / or communications modules transmitting and receiving data via substantially the same communications structure as the other. In some such examples, the implantable battery and / or communications module 1210c and the signal processor 1220c each include a data extraction module 1235 and 1234 configured to both output a signal from a signal generator (e.g., via signal generator 1213 or signal generator 1217) and receive and extract a signal (e.g., via amplifier 1285 and amplifier 1299).

[0130] In the example of FIG. 12C, amplifiers 1295 and 1297 include tri-state amplifiers that selectively output a signal from signal generator 1213 (e.g., via an "enable" control from controller 1215), with amplifier 1297 shown as an inverting amplifier. As described, in some examples, amplifiers 1295 and 1297 include tri-state buffers. Similarly, of tri-state buffers 1287 and 1289 that selectively output a signal from signal generator 1217 (e.g., via an "enable" control from controller 1227), buffer 1289 is shown as an inverting amplifier. As described elsewhere herein, communicating a signal and its inverse (e.g., via 1295 and 1297) allows communication between implantable battery and / or communication module 1210c and signal processor 1220c with no net charge flow. Thus, bidirectional communication between implantable battery and / or communication module 1210c and signal processor 1220c can be performed with no net charge flow between the components.

[0131] As described elsewhere herein, power from power generator 1211 and data from signal generator 1213 (and / or signal generator 1217) can be communicated at different clock rates to optimize power and data transfer. In some examples, if data communication (e.g., via bidirectional communication 1251c) fails, controller 1215 can be configured to control power generator 1211 to provide both power and data signals via amplifiers 1290 and 1292, for example, as described with respect to FIG.

[0132] 12C may be implemented to establish efficient bidirectional communication between the implantable battery and / or communication module 1210 and the signal processor 1220. Faults in the bidirectional communication 1251 may be identified manually and / or automatically. Upon detecting a fault in the bidirectional communication 1251, the controller 1215 may encode data into the power signal output from the power signal generator 1211, and the power and data may be combined into a single signal as described with respect to FIG.

[0133] As described elsewhere herein, different safety standards may exist with respect to electrical communication within a patient's body. For example, safety standards may limit the amount of current (particularly DC current) that can safely flow through a patient's body. As shown in Figures 11B, 12B, and 12C, each of the illustrated communication paths between the implantable battery and / or communication module and the signal processor is coupled to an output capacitor. The capacitors positioned at the input and output of the implantable battery and / or communication module and the signal processor may substantially block DC current from flowing therebetween while allowing communication of AC signals.

[0134] As described elsewhere herein, in some embodiments, data communicated between the implantable battery and / or communication module and the signal processor (e.g., from the signal generator) is encoded. In some such examples, the encoding can be performed according to a particular data encoding method, such as an 8b / 10b encoding scheme, to achieve DC balance in the communicated signal. For example, in some embodiments, the data is encoded such that the number of most significant and least significant bits communicated between the components at each clock signal meets certain criteria to prevent charge of a single polarity from accumulating on any of the capacitors. Such encoding can minimize the total charge flowing between the implantable battery and / or communication module and the signal processor during communication.

[0135] Although described and illustrated as representing communication between an implantable battery and / or a communication module and a signal processor, the communication configurations as shown in Figures 10, 11A, 11B, 12A, 12B, and 12C may be implemented with any pair of devices in general communication with each other. For example, an isolation circuit (e.g., R Can ) can be included in any of the system components (e.g., middle ear sensor, acoustic stimulator, electrical stimulator, etc.) to effectively isolate the ground signal from each component from its respective can. Similarly, an exemplary capacitive AC coupling with DC blocking capacitors and DC balancing encoding as described elsewhere herein can be incorporated as the communication interface between any two communicating components.

[0136] As described, data can be communicated from the implantable battery and / or communication module to the signal processor for a variety of reasons. In some examples, the data is data communicated from an external component, such as a programmer, to the implantable battery and / or communication module, as shown in FIG. 1. In an exemplary process, a programmer, such as a clinician's computer, can be used to communicate with the patient's fully implanted system via a communication configuration such as shown in FIG. 11B, 12B, or 12C. For example, the programmer can communicate wirelessly (e.g., via Bluetooth or other suitable communication technology) with the patient's implantable battery and / or communication module. Signals from the programmer can be transmitted from the implantable battery and / or communication module to the signal processor via the communication configuration of FIG. 11B, 12B, or 12C.

[0137] During such a process, the clinician can communicate with the signal processor and, in some cases, with other components via the signal processor. For example, the clinician can cause the signal processor to operate the electrical and / or acoustic stimulator in various ways, such as using various electrical stimulation parameters, combinations of active contact electrodes, various acoustic stimulation parameters, and various combinations thereof. By varying the stimulation parameters in real time, the clinician and the patient can determine the effectiveness of various stimulation techniques for an individual patient. Similarly, the clinician can communicate with the signal processor to update the transfer function. For example, the clinician can iteratively update the transfer function signal processor while testing the effectiveness of each for an individual patient. In some examples, combinations of stimulation parameters and signal processor transfer functions can be tested for customized system operation for an individual patient.

[0138] In some embodiments, various internal characteristics of the system can be tested, for example, various impedance values ​​such as sensor impedance and stimulator impedance, as described in commonly assigned U.S. Patent Publication No. 2015 / 0256945, entitled "TRANSDUCER IMPEDANCE MEASUREMENT FOR HEARING AID," the relevant portions of which are incorporated herein by reference.

[0139] Additionally or alternatively, various characteristics of the individual leads can be analyzed. Figure 12D is a high-level schematic diagram illustrating an example of electrical communication between an implantable battery and / or communication module and a signal processor in a cochlear implant system similar to that shown in Figure 12A. In the simplified example of Figure 12D, conductors 1201, 1202, 1203, and 1204 extend between the implantable battery and / or communication module 1210d and the signal processor 1220d. In some examples, such conductors are included in a lead (e.g., lead 190) that extends between the implantable battery and / or communication module 1210d and the signal processor 1220d. In the example of Figure 12D, the implantable battery and / or communication module 1210d includes a controller 1205, and the signal processor 1220d includes a controller 1206. The implantable battery and / or other internal components of the communications module 1210d and signal processor 1220d are not shown, but may be in various configurations as shown in Figures 11B, 12B, or 12C.

[0140] In some embodiments, one or both of the controllers 1205, 1206 can be configured to apply a test signal to one or more of the conductors 1201, 1202, 1203, 1204 to test one or more characteristics of such conductors. In an exemplary testing process, the controller (e.g., 1205) can drive a signal (e.g., a sine wave or other shaped wave) across a conductor (e.g., 1201) and measure the current transmitted and the voltage at which the current is transmitted. From this information, the controller can determine the conductor impedance, including the integrity of the conductor (e.g., whether the conductor is broken). Similarly, the controller can be configured to drive a test signal (e.g., 1201) across the test conductor while grounding a second conductor (e.g., 1202) to measure one or more electrical parameters between the two conductors (e.g., capacitance, impedance, etc.).

[0141] During an exemplary operation, the controller can be configured to apply a test signal to a first conductor (e.g., 1201) and ground a second conductor (e.g., 1202). The controller can be configured to apply the test signal at multiple frequencies (e.g., perform a frequency sweep) and measure the impedance versus frequency between the first conductor and the second grounded conductor. In various examples, the controller can be configured to perform such tests using any two conductors 1201, 1202, 1203, 1204, to test for a baseline value (e.g., when the system is in a known operating state) or to test for an expected value (e.g., to compare to an established baseline). In different embodiments, the controller (controller 1205) of the implantable battery and / or communication module 1210d and / or the controller (controller 1206) within the signal processor 1220d can perform grounding of one or more conductors and / or apply a test signal to one or more conductors.

[0142] In some embodiments, such a testing process can be performed automatically, e.g., according to a programmed schedule. Additionally or alternatively, such a testing process can be manually initiated, e.g., by the wearer or clinician, via an external device, such as a programmer (e.g., 100) or a charger (e.g., 102). The results of such a process can be stored in an internal memory for later access and analysis, and / or output to an external device for viewing. In some examples, results and / or warnings can be automatically output to an external device when one or more results deviate sufficiently from the baseline value. In various examples, sufficient variation from the baseline to trigger an output can be based on a percentage variation from the baseline (e.g., more than 1% deviation from the baseline, more than 5% deviation, more than 10% deviation, etc.). Additionally or alternatively, sufficient variation includes a certain number of standard deviations of variation from the baseline (e.g., more than one standard deviation, more than two standard deviations, etc.). In various embodiments, the amount of variation that triggers the output of a result and / or warning is adjustable. Additionally or alternatively, such amount can vary between different measurements.

[0143] In some embodiments, one or more actions may be performed in response to the results of such an analysis. For example, in the exemplary embodiment described with respect to FIG. 12B, if the test reveals an unexpected impedance (e.g., from amplifier 1294 or inverting amplifier 1296) in one of the signal conductors, such as an open circuit, the controller 1214 may be configured to modify the operation of the system. For example, the controller 1214 may be configured to adjust the output from the power generator 1211 to provide both a power signal and a data signal from the power generator 1211, as described with respect to the configuration of FIG. 11B. In some examples, the controller 1214 may be configured to send a signal to an external device signaling such a change in operation and / or alerting the wearer and / or clinician that one or more conductors may be damaged or otherwise inoperable.

[0144] While shown in some embodiments (e.g., Figs. 1, 9, 11A, 12A) as separate components connected by leads (e.g., lead 180), in some examples the processor (e.g., 120) and stimulator (e.g., 130) can be integrated into a single component, for example, in a hermetically sealed housing. Fig. 13A shows an exemplary schematic diagram of a processor and stimulator combined in a single housing. In the example of Fig. 13A, the processor / stimulator 1320 receives signal input from a sensor (e.g., a middle ear sensor) via lead 1370 and receives power from a battery (e.g., an implantable battery and / or a communication module) via lead 1390. The processor / stimulator 1320 can include headers 1322, 1324 for receiving the leads 1370, 1390, respectively.

[0145] The processor / stimulator 1320 can be configured to receive input signals from the sensors, process the received input signals according to a transfer function, and output stimulation signals via the electrodes 1326. The electrodes 1326 can include one or more contact electrodes (e.g., 1328) that contact and provide electrical stimulation to the wearer's cochlear tissue, for example, as described with respect to FIG.

[0146] The processor / stimulator 1320 of FIG. 13 includes a return electrode 1330 to provide a return path (e.g., 1332) for the stimulation signal emitted from the electrode 1326. The return electrode 1330 can be electrically coupled to a ground portion of a circuit within the processor / stimulator 1320 to complete a circuit including the circuit within the processor / stimulator 1320, the electrode 1326, the wearer's cochlear tissue, and ground. In some examples, the return electrode 1330 includes a conductive material in electrical communication with the circuit within the processor / stimulator 1320, while the remainder of the housing of the processor / stimulator 1320 is generally not electrically coupled to the internal circuitry.

[0147] In some embodiments, the return electrode 1330 and the housing of the processor / stimulator 1320 comprise conductive materials. For example, in some instances, the housing comprises titanium, while the return electrode 1330 comprises platinum or a platinum alloy. The header 1324 may generally comprise a non-conductive biocompatible material, such as a biocompatible polymer. The non-conductive header 1324 may provide insulation between the return electrode 1330 and the conductive housing of the processor / stimulator 1320.

[0148] Although shown in FIG. 13A as being positioned on the power header 1324 of the processor / stimulator 1320, in general the return electrode 1330 may be positioned anywhere on the exterior surface of the processor / stimulator 1320. In some examples, one or more redundant return electrodes may be included, for example, at or near the interface of the housing and the electrode 1326. In some examples, the return electrode may be positioned at the proximal end of the electrode 1326 itself. In some embodiments having multiple return electrodes (e.g., the return electrode 1330 and a return electrode at the proximal end of the electrode 1326), a switch may be used to select which return electrode to use. Additionally or alternatively, multiple return electrodes may be used simultaneously.

[0149] FIG 13B shows a simplified cross-sectional view of the processor / stimulator shown in FIG 13A along line BB. As shown in FIG 13B, the processor / stimulator 1320 includes a housing having a first side 1319 and a second side 1321, and a return electrode 1330 embedded in the housing. The return electrode 1330 may include a conductive material suitable for contact with the wearer's tissue, such as platinum. In the example shown, the return electrode 1330 wraps around both sides of the housing of the processor / stimulator 1320 such that the return electrode 1330 is coupled to an exterior surface of the housing on the first side 1319 and the second side 1321.

[0150] This facilitates implantation on either side of the wearer's anatomy, since in some cases only one side of the processor / stimulator electrically contacts the wearer's conductive tissue, while the other side contacts, for example, the wearer's skull and does not easily provide a return path (e.g., 1332). Thus, a single processor / stimulator design can be implanted on either side of the wearer's anatomy while still providing an adequate return path via the return electrode 1330.

[0151] In various examples, the return electrodes 1330 can extend around the peripheral edge of the processor / stimulator 1320, as shown in FIG. 13B. In other examples, the return electrodes 1330 can include sections on either side of the housing and can be connected to each other within the housing rather than via wraparound contacts. Additionally, while shown as embedded in the housing of the processor / stimulator 1320, in some examples the return electrodes 1330 can protrude outwardly from the housing. The return electrodes 1330 can generally be any of a variety of shapes and sizes while including electrical contact sections on opposite sides of the housing to provide for usability on either side of the wearer's anatomy. In other embodiments, the return electrodes can be positioned only on one side of the housing for customized right or left side implementation.

[0152] As described elsewhere herein, in various embodiments, the processor generally receives an input signal, processes the signal, and generates a stimulation signal, which may be applied via an integrated stimulator (e.g., via a processor / stimulator such as in FIGS. 13A and 13B) or via a separate stimulator in communication with the processor (e.g., as shown in FIGS. 1 and 9). In some such embodiments, the input signal received via the signal processor is generated by an implantable sensor, such as a middle-ear sensor (e.g., as described with respect to FIGS. 4 and 5).

[0153] However, such sensors often measure or otherwise receive some stimulus that is converted into an output that is read and processed by a signal processor. For example, some middle ear sensors may generate different output signals for a given stimulus depending on various factors, such as the anatomy of the wearer's inner ear and variations in movement. Thus, the output of a sensor for a given input may not be predictable during system design, especially across frequency ranges.

[0154] FIG. 14A is a schematic diagram illustrating an exemplary signal processing configuration for normalizing a stimulation signal and accommodating variability in sensor frequency response. FIG. 14B illustrates an exemplary gain vs. frequency response curve of a signal at various stages in the processing configuration. As used with respect to FIG. 14B, the "gain" associated with a particular frequency refers to the relationship (e.g., ratio) between the magnitude of the input stimulation received by the sensor and processor and the magnitude of the resulting signal at various stages of processing. In the illustrated example, a processor / stimulator 1400 receives an input signal 1405 from a sensor.

[0155] As shown in FIG. 14B, the gain is very non-uniform across the distribution of frequencies shown in the plot. For example, according to the example shown, a stimulus signal received at the sensor at 1 kHz will result in a much larger magnitude in the signal 1405 compared to the same magnitude stimulus signal received at the sensor at 10 kHz. Such a mismatch in frequency response can make signal processing difficult. Furthermore, such frequency responses may generally vary from person to person or over the wearer's lifetime due to physical movement or anatomical changes of the sensor.

[0156] The input signal 1405 undergoes analog processing 1410 to generate an analog processed signal 1415. As shown in FIG. 14B, the analog processed signal 1415 provides a flatter frequency response curve than the input signal 1405, so the analog processing step 1410 improves gain consistency across the frequency range. In some embodiments, the analog processing can include one or more filters and / or amplifiers that are typically configured to flatten the frequency response curve, as shown in FIG. 14B. In some examples, the analog processing components 1410 in the processor / stimulator 1400 can be substantially the same across various implantable systems to provide first order correction of the frequency response. In other examples, the analog processing configuration 1410 can be customized for the wearer, for example, based on known anatomical features, measurements, analysis, etc.

[0157] The analog processed signal 1415 undergoes a digital processing step 1420 to generate a digitally processed signal 1425. As shown in FIG. 14B, the digital processing step 1420 further improves the consistency of gain across the frequency range, as the digitally processed signal 1425 provides a flatter frequency response curve than the analog processed signal 1415. In some embodiments, the digital processing 1420 can be configured to substantially flatten the frequency response to correct for inconsistencies in the remaining frequency response of the analog processed signal 1415. For example, in some embodiments, after the digital processing 1420, a stimulation signal of a given magnitude at a first frequency and a second frequency results in a digitally processed signal 1425 having the same magnitude at the first and second frequencies. Thus, the digitally processed signal 1425 corresponds to a normalized stimulation signal, reducing or eliminating variations associated with different wearer anatomies and wearer movement and / or changes over time. Having a normalized frequency response over a wide frequency range can simplify evaluation of the effectiveness of the implanted system, programming the transfer function of the signal processor, evaluation of system operation, etc. In some examples, a flat frequency response can enable the system to present electrical stimuli to the wearer at an appropriate intensity level, for example, with respect to a received external acoustic stimulus, regardless of the frequency content of the external acoustic stimulus.

[0158] In some embodiments, the digital processing 1420 can be customized via a calibration process after the system is implanted. In an exemplary calibration process, a clinician or other user may provide a series of stimulation signals having similar amplitudes, for example, at multiple frequencies to be "picked up" by the sensor to generate an input signal 1405 for each received signal. The clinician or other user may then sample the resulting analog processed signal 1415 and / or the initial digitally processed signal 1425 at multiple frequencies to determine any remaining non-uniformity in gain across the frequency sweep. The digital processing 1420 may be established or updated to compensate for the non-uniformity to establish a substantially flat frequency response curve in the digitally processed signal 1425. In some examples, multiple signals having different frequencies are provided in sequence and the magnitude response (e.g., gain) at each frequency is determined. After determining such magnitude response, the digital processing stage 1420 may be updated based on the response versus frequency relationship to flatten the frequency response curve.

[0159] In an alternative process, a white noise signal can be provided to be "picked up" by the sensor. A transformation of the signal (e.g., a Fast Fourier Transform, or FFT) can be performed to extract the frequency components of the signal. The extracted frequency components can be used to determine the magnitude response at each frequency, and the digital processing 1420 can be updated to flatten the frequency response in a similar manner as above.

[0160] 14A, a digitally processed signal 1425 (e.g., having a uniform gain across a frequency range with respect to the input signal received from the sensor) is processed according to a signal processor transfer function 1430 to generate a stimulation signal 1435. The stimulation signal 1435 can be received by a stimulator 1440, which can apply an electrical signal 1445 to the electrodes as described elsewhere herein.

[0161] In some examples, a digital processing step 1420 to provide a flat frequency response can be incorporated into the transfer function 1430, and the analog processed signal 1415 is digitally processed to both flatten the frequency response and generate the stimulation signal (e.g., 1435) according to a programmed transfer function. Additionally or alternatively, as described elsewhere herein, in some examples, the stimulator 1440 can be located external to the processor rather than being combined as a single processor / stimulator component 1400.

[0162] As described elsewhere herein, while many examples show a middle-ear sensor in communication with an implanted signal processor, various embodiments can include one or more additional or alternative input sources. For example, in some embodiments, a microphone can be implanted under the user's skin and placed in communication with the signal processor (e.g., via a removable connector such as 171). The signal processor can receive an input signal from the implanted microphone and provide a signal to a stimulator based on the received input signal and a transfer function of the signal processor.

[0163] Additionally or alternatively, one or more system components can be configured to receive a broadcast signal for conversion to a stimulation signal. FIG. 15 is a schematic system diagram illustrating an implantable system configured to receive a broadcast signal from a broadcast device. As shown in the example of FIG. 15, a broadcast source 1550 broadcasts a signal over a communication link 1560. The communication link 1560 can include communication over various communication protocols, such as Wi-Fi, Bluetooth, or other known data transmission protocols. The broadcast source 1550 can include any of a variety of components, such as a media source (e.g., television, radio, etc.), a communication device (e.g., telephone, smartphone, etc.), a telecoil or other broadcast system (e.g., at a live performance), or any other audio signal source that can be transmitted to the implanted system or to an external component of the implanted system (e.g., a system programmer, etc.).

[0164] An implantable system, including a programmer 1500, an implantable battery and / or communications module 1510, a signal processor 1520, and a stimulator 1530, can generally receive data from a broadcast source 1550 via a communications link 1560. In various embodiments, any number of components within the implantable system can include a receiving device, such as a telecoil, configured to receive the broadcast signal for eventual conversion into a stimulation signal.

[0165] For example, in some embodiments, the programmer 1500 can include a telecoil relay configured to receive a broadcast telecoil signal from a broadcast source 1550. The programmer can be configured to subsequently communicate a signal representing the received broadcast signal to the implantable battery and / or communications module 1510 and / or signal processor 1520, e.g., via Bluetooth communication. If a communication is received from the programmer 1500 via the implantable battery and / or communications module 1510, the implantable battery and / or communications module 1510 can communicate a signal to the signal processor, e.g., as described in any of FIGs. 11A, 11B, 12A, or 12C.

[0166] In some such embodiments, the signal processor 1520 can be configured to receive such signals from the implantable battery and / or communication module 1510 and output a stimulation signal to the stimulator 1530 based on the received signal and a transfer function of the signal processor. In other examples, the signal processor 1520 can include a telecoil relay or other device that can receive a broadcast signal from the broadcast source 1550. In some such embodiments, the signal processor 1520 processes the received signal according to the transfer function of the signal processor and outputs a stimulation signal to the stimulator 1530.

[0167] In some embodiments, the signal processor 1520 can communicate (e.g., via an implantable battery and / or communication module 1510) with multiple input sources, such as, for example, a combination of an implanted microphone, a middle-ear sensor, and a broadcast source 1550. In some such examples, the signal processor can be programmed with multiple transfer functions, each according to a respective input source. In such embodiments, the signal processor can identify which one or more input sources are providing an input signal and process each such input signal according to the transfer function associated with the corresponding input source.

[0168] In some examples, the signal processor 1520, which receives multiple input signals from corresponding multiple input sources, effectively combines the signals when generating the stimulation signal to the stimulator 1530. That is, in some embodiments, the input sources are combined to form the stimulation signal from the signal processor 1520. In some such examples, the user may be able to mix the various received input signals in any desired manner. For example, the user may choose to blend various different input streams, such as inputs from a middle-ear sensor or other implanted device, signals received from an external device (e.g., a telecoil relay, Bluetooth connection to a smartphone, etc.). In an exemplary configuration, the user may choose to blend the two input sources equally, such that the stimulation signal is based 50% on the first input source and 50% on the second input source.

[0169] Additionally or alternatively, a user may select to effectively "mute" one or more input sources, causing the signal processor 1520 to output a stimulation signal based on input signals received from unmuted sources. Similarly, a user may be able to select a single source for processing received input signals. For example, in some embodiments, a user may select to process and convert signals received from a broadcast source 1550 into stimulation signals, and to ignore signals received from, for example, a middle-ear sensor.

[0170] In some examples, direct communication with the signal processor can be used to test the effectiveness of a given signal processor's transfer function and associated stimulation (e.g., acoustic or electrical) parameters. For example, a programmer can be used to disable an input signal from a middle-ear sensor or other input source and provide a customized signal to the signal processor to simulate a signal from the input source. The signal processor processes the received signal according to its transfer function and activates the electrical and / or acoustic stimulators accordingly. The processor can be used to test various customized "sounds" to determine the effectiveness of a particular patient's signal processor's transfer function for each "sound."

[0171] 16 is a process flow diagram illustrating an exemplary process for establishing a preferred transfer function for a patient. The method can include connecting an external programmer to the implantable battery and / or communication module (step 1650). The connection can include, for example, establishing a wireless connection (e.g., Bluetooth communication) between the external programmer and the implantable battery and / or communication module. The external programmer can include any of a variety of components capable of providing programming instructions to the implantable battery and / or communication module, such as a computer, smartphone, tablet, etc.

[0172] Once communication is established, if there is no active signal processor transfer function (step 1652), a signal processor transfer function may be established (step 1654). If a transfer function is already active, or after a transfer function is established (step 1654), a programmer may be used to input one or more simulated "sounds" into the signal processor. Such "sounds" may be received and processed in the signal processor as if they were received from an input source, such as a middle-ear sensor. The "sounds" may be computer-generated signals designed to simulate various input signals, such as, for example, ranges of frequencies, phonetic sounds, or other identifiable sound characteristics.

[0173] The process may further include testing the effectiveness of the signal processor's transfer functions (step 1658). This may include, for example, determining how well the patient responds to each sound when a particular signal processor transfer function is provided. In some examples, this may include evaluating the transfer function under test for each "sound" and determining an overall score for the transfer functions based on the scores associated with one or more "sounds."

[0174] After testing the effectiveness of the signal processor's transfer functions, if all desired transfer functions have not been tested (step 1660), the signal transfer function may be updated (step 1654). One or more simulated "sounds" may be input to the signal processor (step 1656) and processed according to the updated transfer function, and the effectiveness of the updated transfer function may be tested (step 1658). Once all desired transfer functions have been tested (step 1660), a signal processor's transfer function for the user may be created or selected and implemented on the patient (step 1662). In some examples, the best of the tested transfer functions is selected based on user preference, highest score, or other metric. In other examples, composite results from the tested transfer functions may be combined to create a customized transfer function for the patient.

[0175] In other examples, rather than continually updating the transfer function of the signal processor, the simulated "sounds" can be pre-processed outside of the signal processor, e.g., on-site with a clinician or audiologist. For example, in an exemplary process, one or more simulated sounds can be pre-processed using processing software to establish a simulated stimulus signal that results from a particular input signal that is processed through a particular transfer function. In some examples, such a signal can be forwarded to a signal processor, e.g., for application of the stimulus signal directly to a wearer.

[0176] Communication to the stimulator can be performed directly from various system components, such as, for example, a programmer. In other examples, such communication can be performed via an implantable battery and / or communication module and a signal processor. For example, in an exemplary embodiment, the pre-processed signal can be communicated to the implantable battery and / or communication module via wireless (e.g., Bluetooth) communication. The implantable battery and / or communication module can communicate the pre-processed signal to the signal processor, which can be configured with a single transfer function. Thus, the signal processor simply passes the pre-processed signal to the stimulator to perform stimulation.

[0177] FIG. 17 is a process flow diagram illustrating an exemplary method of testing the effectiveness of one or more sounds using one or more transfer functions via a preprocessed signal. In the method of FIG. 17, for example, the sounds can be loaded into an application or processing software that can process the received sounds (step 1750). In some examples, the sounds can be simulated sounds, such as computer-generated signals representing the desired sounds. In other examples, the sounds can include recordings of actual sounds, such as a human voice or other stimuli. The loaded sounds can be preprocessed according to the transfer functions to generate a stimulus signal (step 1752). The preprocessing can be performed, for example, on a stand-alone workstation, a system programmer, or the like.

[0178] The method of Figure 17 further includes applying a stimulation signal from the preprocessed sound to a stimulator of the implanted system (step 1754). As described elsewhere herein, such communication of the stimulation signal to the stimulator can be performed in a variety of ways, such as directly to the stimulator (e.g., from an external workstation, a user's programmer, etc.) or via a signal processor.

[0179] Upon applying the stimulation signal (step 1754), the method may further include testing the effectiveness of the stimulation signal (step 1756). This may include, for example, testing the user's understanding of an initial sound from the received stimulation signal, receiving an evaluation score from the user, or other suitable methods of resting the effectiveness of the stimulation signal. Because the stimulation signal applied in step 1754 is based on the sounds and transfer functions used for pre-processing, testing the effectiveness of the stimulation signal is similar to testing the effectiveness of a transfer function for a given sound.

[0180] After testing the effectiveness of the stimulation signal, it may be determined whether all simulated transfer functions have been tested for the given sound (step 1758). If not, the method may include establishing or updating a simulated transfer function (step 1760) and repeating the steps of preprocessing the sound to establish a stimulation signal (step 1752), applying the stimulation signal (step 1754), and testing the effectiveness of the stimulation signal (step 1756) according to all updated transfer functions. Thus, a given sound may be processed according to multiple transfer functions, and multiple corresponding stimulation signals may be tested for a given user. If all simulated transfer functions have been tested at step 1758, the process may include establishing a preferred treatment for the sound (step 1762).

[0181] In some examples, the process of Figure 17 can be performed in real time. For example, in some embodiments, a device in communication with a stimulator in an implanted system (e.g., directly via wireless communication with the stimulator or indirectly via a signal processor) can cycle through various simulated transfer functions while preprocessing the sound signal before communication to the user system. In some such examples, after establishing a preferred processing technique (e.g., simulated transfer function) for a given sound (e.g., in step 1762), the transfer function of the user's signal processor can be updated to reflect the preferred transfer function for the given sound.

[0182] Additionally or alternatively, the process of Figure 17 can be repeated for multiple different sounds. In some embodiments, the multiple sounds can be pre-processed according to multiple different simulated transfer functions, and the resulting stimulus signals can be stored in a database. A testing device, such as a workstation, programmer, etc., can be used to perform the method of Figure 17, using the database of stimulus signals to test the effectiveness of various transfer functions for various sounds on a user.

[0183] In some examples, such a database can be used to match a user to a particular implant system. For example, stimulation signals generated by pre-processing a plurality of sounds can be communicated to an implanted stimulator of a user having an implanted stimulator and a cochlear electrode to test the effectiveness of the pre-processed simulated transfer functions. In various examples, the plurality of generated stimulation signals associated with a given sound can be applied to the stimulator until a preferred simulated transfer function is established. In other examples, generated stimulation signals representing a plurality of sounds can be established for each of a plurality of transfer functions, so that each transfer function can be tested for a user for a plurality of sounds before testing another transfer function.

[0184] FIG. 18 is a schematic diagram of an exemplary database of preprocessed audio signals. As shown, the database is represented as a table with n rows corresponding to various sounds (sound 1, sound 2, ... sound n) and m columns corresponding to different simulated transfer functions (simulated transfer function 1, simulated transfer function 2, ... simulated transfer function m). As shown, preprocessing sound i with simulated transfer function j at the intersection of each row (i) and each column (j) results in a stimulus signal (i, j). In some embodiments, a table such as the stimulus signal generated from the preprocessed sounds shown in FIG. 18 can be stored in the database of preprocessed audio signals for device fitting for a user.

[0185] As described elsewhere herein, in various fitting processes, a sound is stored in a database (e.g., sound 1), and multiple different stimulation signals (e.g., stimulation signal (1,1), stimulation signal (1,2), ..., stimulation signal (1,m)) can be communicated to the implanted stimulation device. Such stimulation signals generally correspond to the result of a sound (e.g., sound 1) being preprocessed according to various simulated transfer functions (1-m). As described with respect to FIG. 17, a preferred stimulation signal (and thus a preferred corresponding simulated transfer function) can be established for a given sound (e.g., sound 1). A similar process can be repeated for each sound in the database. In various examples, one or more signal processor transfer functions can be communicated to the signal processor based on the determined preferred simulated transfer function. For example, in some examples, a preferred simulated transfer function of most of the sounds can be implemented as the transfer function of the signal processor. In other embodiments, the signal processor can include multiple transfer functions and apply different transfer functions to different detected sounds depending on the preferred transfer function for each sound.

[0186] In another exemplary fitting process, multiple stimulus signals (e.g., stimulus signal (1, 1), stimulus signal (2, 1), ..., stimulus signal (n, 1)) corresponding to a single simulated transfer function (e.g., simulated transfer function 1) can be applied to the stimulator. Such stimulus signals correspond to multiple sounds that are preprocessed according to the single simulated transfer function. This can be used to test the effectiveness of a selected transfer function. This process can be repeated for multiple simulated transfer functions (e.g., 2 through m) to determine the optimal transfer function across a range of sounds (e.g., sounds 1 through n).

[0187] In general, a database of stimulation signals generated by preprocessing audio signals through various transfer functions as shown in FIG. 18 may be useful to facilitate testing of such transfer functions for a particular user. Such preprocessing of sounds may allow processing to be performed, for example, in a lab or workstation prior to the fitting process, and may efficiently apply stimulation signals corresponding to the various transfer functions to the user's stimulator without requiring updates to the signal processor. Additionally, such preprocessing may allow more advanced or computationally demanding processing techniques to be tested for effectiveness, even if such processing techniques may not yet be effectively implemented by the implanted signal processor (e.g., due to various hardware limitations). Testing the effectiveness of such processing techniques may, for example, facilitate the evolution of processing methods and hardware capabilities to employ more complex processing techniques in the future.

[0188] Various features and functions of the implantable system are described herein. As described, in various embodiments, system operation may be coordinated based on communications with the implanted system from components located outside the body while the system remains implanted. In some embodiments, the system may include any number of external components that may interface with the system in a variety of ways.

[0189] 19 is a schematic diagram illustrating possible communications between various system components according to some embodiments of a fully implantable system. In the illustrated embodiment, the implanted components of the system (outlined in dashed lines) include an implantable battery and / or communications module 1910, a signal processor 1920, and a stimulator 1930. Such implanted components can operate according to various examples described herein to effectively stimulate a user (e.g., via electrical and / or acoustic stimulation) in response to received input signals.

[0190] The schematic diagram of FIG. 19 includes multiple external devices that can wirelessly interface with one or more of the implanted components, for example, via communication links 1925. Such devices can include a programmer 1900, a charger 1902, a smartphone / tablet 1904, a smart watch or other wearable technology 1906, and a fob 1908. In some examples, such components can communicate with one or more implantable components via one or more communication protocols over wireless communication links 1925, such as Bluetooth, Zigbee, or other suitable protocols. In various embodiments, different external devices can perform one or more functions associated with system operation. In some such embodiments, each external device can perform the same functions as other devices. In other examples, some external devices can perform more functions than other devices.

[0191] For example, the programmer 1900 may be capable of wirelessly interfacing with one or more implantable components to control various operating parameters of the implanted system. For example, in some embodiments, the programmer 1900 may be configured to adjust a signal processor transfer function or select an operating profile (e.g., associated with a particular signal processor transfer function depending on a particular user, environment, etc.). In some examples, the programmer 1900 may be used to establish a user profile, such as a preferred signal processor transfer function, as described elsewhere herein. The programmer 1900 may additionally or alternatively be used to turn the system on or off, adjust the volume of the system, and receive and stream input data to the system (e.g., the implantable battery and / or the communication module 1910). In some embodiments, the programmer 1900 includes a display for displaying various information to the user. For example, the display may be used to indicate the operating mode (e.g., loaded user profile), remaining power level, etc. In some such embodiments, the display may function as a user interface through which the user may adjust one or more parameters, such as volume, profile, input source, input mix, etc.

[0192] In some embodiments, the charger 1902 can be used to charge one or more internal batteries or other power sources within the system, such as an implantable battery and / or a communications module 1910. In some examples, the charger 1902 can include the same functionality as the programmer 1900, including, for example, a display and / or a user interface. In some such embodiments, the programmer 1900 and the charger 1902 can be integrated into a single device.

[0193] In some embodiments, various external devices, such as the smartphone or tablet 1904, can include applications ("apps") that can be used to interface with the implanted system. For example, in some embodiments, a user can communicate with the system (e.g., via link 1925) via the smartphone or tablet 1904 to adjust certain operating factors of the system using a predefined app and provide an interface (e.g., a visual interface via a display integrated into the external device). The app can assist the user in adjusting various parameters such as volume, operating profile, on / off, etc. In some examples, the smartphone / tablet 1904 can be used to stream input signals to the implanted system, such as media or communications that are played on the smartphone / tablet 1904.

[0194] In some systems, a smartwatch or other wearable technology 1906 can interact with the system in a manner similar to the smartphone / tablet 1904. For example, the smartwatch or other wearable technology 1906 can include apps similar to those operable on a smartphone / tablet to control the operation of various aspects of the implanted system, such as volume control, on / off control, etc.

[0195] In some embodiments, the fob 1908 can be used to perform basic functions with respect to the implanted system. For example, in some embodiments, the fob 1908 can be used to load / implement a particular operational profile associated with the fob 1908. Additionally or alternatively, the fob 1908 can function similarly to the shutoff controller 104 of FIG. 1 and can be used to quickly disable and / or mute the system. As described elsewhere herein, in some examples, the same device (e.g., the fob 1908) used to disable and / or mute the system can also be used to enable and / or unmute the system.

[0196] The schematic diagram of FIG. 19 further includes a broadcast source 1950 configured to broadcast a signal 1960 receivable via one or more external devices and / or one or more implanted system components. Similar to the broadcast source 1550 of FIG. 15, the broadcast source 1950 can be configured to emit a signal that can be converted into a stimulation signal for application by the stimulator 1930. The broadcast signal 1960 can include, for example, a telecoil signal, a Bluetooth signal, etc. In various embodiments, one or more external devices, such as the programmer 1900, the charger 1902, the smartphone / tablet 1904, the smartwatch / wearable device 1906, and / or the fob 1908, can include a component (e.g., a telecoil relay) that can receive the broadcast signal 1960. The external device can be further configured to communicate a signal to one or more implanted components representing the received broadcast signal 1960 to apply stimulation to the patient based on the broadcast signal 1960.

[0197] Additionally or alternatively, in some embodiments, one or more implanted system components, such as the implantable battery and / or communication module 1910, the signal processor 1920, and / or the stimulator 1930, can be configured to receive the broadcast signal 1960. Such components can be used to generate a stimulation signal for application to the user via the stimulator 1930 in accordance with the received broadcast signal 1960.

[0198] As described, in some embodiments, various devices can communicate with components within the implanted system via wireless communication protocols such as Bluetooth. Various data and signals can be communicated wirelessly, including control signals and streaming audio. In some cases, however, such wireless communication should be secure so that the system communicates only with devices desired by the wearer. This can prevent unwanted signals from being broadcast to the implanted device or unauthorized access to one or more adjustable device settings.

[0199] In some embodiments, one or more implanted system components include a short-range wireless communication component configured to facilitate communication between the system and an external device only when in close proximity to the short-range wireless communication component. In some such examples, once short-range wireless communication is established, pairing for longer-range wireless communication (e.g., Bluetooth) can be established. For example, in an exemplary embodiment, the charger and the implantable battery and / or communication module each include a short-range wireless communication component for establishing secure short-range wireless communication and subsequently pairing with each other for additional wireless communication.

[0200] 20 is a schematic diagram illustrating establishing a secure wireless connection between various components in an implantable system. In the illustrated example, a charger 2010 is configured to communicate with an implantable battery and / or a communication module 2020. The charger 2010 includes a wireless communication component 2016, such as a Bluetooth link, that can facilitate communication between the charger 2010 and other devices. The charger 2010 further includes a near-field wireless communication component 2012, such as a coil, and a processor / memory component 2014 that can receive signals from and communicate signals to the near-field wireless communication component 2012 and / or the wireless communication component 2016.

[0201] The implantable battery and / or communications module 2020 includes a wireless communication component 2026, such as a Bluetooth link, that can facilitate communications between the charger 2010 and other devices. The implantable battery and / or communications module 2020 further includes a near field communication component 2022, such as a coil, and a processor / memory component 2024 that can receive signals from and communicate signals to the near field communication component 2022 and / or the wireless communication component 2026.

[0202] In some embodiments, the near field communication components 2012 and 2022 include coils capable of establishing near field communication therebetween. In some embodiments, the coils can be used to transfer power between the power source 2018 of the charger 2010 to the implantable battery and / or power source 2028 of the communication module 2020, for example, to charge the power source 2028 in the implanted system for continued use. In various embodiments, the power source 2018 and / or power source 2028 can include one or more batteries, capacitors (e.g., supercapacitors), and / or other power storage devices capable of storing and providing electrical energy to other components. In some embodiments, the power source 2018 of the charger 2010 can include an external or removable power source, such as a removable or replaceable battery and / or a power cord that can be plugged into a standard wall outlet.

[0203] In some examples, the implantable battery and / or communications module 2020 cannot communicate with external components via the wireless communications component 2026 until such communications is first enabled. In such embodiments, enabling such communications is performed via the near-field wireless communications component 2022 to ensure that devices are not accidentally or undesirably paired with the implantable battery and / or communications module 2020.

[0204] In the exemplary embodiment of FIG. 20, the numbers in the square boxes indicate an exemplary sequential process for establishing wireless communication between the charger 2010 and the implantable battery and / or communication module 2020. In the illustrated embodiment, the charger 2010 first establishes contact with the implantable battery and / or communication module 2020 via the near-field wireless communication components 2012, 2022. In various embodiments, such near-field wireless communication only operates within a very short distance, such as within 2 inches. This prevents other devices from accidentally or undesirably establishing near-field wireless communication with the implantable battery and / or communication module 2020. During this step, the user may position the charger 2010 in close proximity to the chest area in which the implantable battery and / or communication module 2020 will be implanted to enable such communication. In some examples, after pairing the charger 2010 with the implantable battery and / or communication module 2020 via near-field wireless communication 2012, 2022, such devices can then communicate via wireless communication 2016, 2026.

[0205] In some embodiments, the external device 2030 (e.g., a smartphone or other audio / media source) may include a wireless communication component 2036 and a processor / memory 2034 that can facilitate communication with the implantable battery and / or communications module 2020 (e.g., via the wireless communication component 2026), but may not include a near-field communication component for pairing the external device 2030. Thus, in some examples, the paired charger 2010 may be configured to enable subsequent pairing of the implantable battery and / or communications module 2020 with the external device 2030.

[0206] The circled reference numbers indicate an example pairing sequence between the external device 2030 and the implantable battery and / or communication module 2020. The charger 2010 can communicate with the external device 2030 via the wireless communication components 2016, 2036 to determine, for example, that a user desires to pair the external device 2030 with the implantable battery and / or communication module 2020. The charger 2010 can then communicate with the implantable battery and / or communication module 2020 (e.g., via the wireless communication components 2016, 2026) to pair the implantable battery and / or communication module 2020 with the external device 2030 and enable subsequent wireless communication between the implantable battery and / or communication module 2020 and the external device 2030 (e.g., via the wireless communication components 2026, 2036).

[0207] In some examples, once a device has been paired with the implantable battery and / or communications module 2020, it can be used to subsequently pair additional devices to the implantable battery and / or communications module, as described above with respect to the charger 2010. In other embodiments, only some devices, e.g., only the charger 2010, include the capability to pair additional devices with the implantable battery and / or communications module 2020. In yet another example, all devices must be paired with the implantable battery and / or communications module via a short-range wireless communication process (e.g., via the field communications component 2022) before long-range wireless (e.g., Bluetooth) communications can be established.

[0208] Additionally or alternatively, once the external device is paired with the implantable battery and / or communication module 2020, the external device (e.g., external device 2030) may be used to perform additional functions. In some embodiments, the additional functions may include adjusting a transfer function of a signal processor. In some examples, the external device may include or otherwise communicate with one or more sensors and be configured to update the transfer function of the signal processor based on one or more signals detected via the one or more sensors. In some such examples, one or more such sensors may include a microphone, a location sensor (e.g., GPS, location based on one or more available wireless networks), a clock, or other sensors known to those skilled in the art. In some embodiments, the external device (e.g., 2030) that includes or communicates with such one or more sensors includes a smartphone, tablet, or computer.

[0209] In embodiments in which the external device includes or communicates with a microphone, the external device can be configured to reprogram the signal processor based on information collected from the microphone that represents the acoustic environment. For example, the external device can be configured to identify background noise (e.g., low-end noise) and update the transfer function of the signal processor accordingly. In some such examples, the external device can be configured to reduce the gain of low-end signals and / or emphasize other sounds or frequency ranges, such as speech or other sounds with higher frequencies. In some embodiments, a user can initiate the process of identifying background noise to adjust the operation of the signal processor via the external device, for example, via a user interface (e.g., a touch screen on a smartphone or tablet).

[0210] In embodiments in which the external device includes or is in communication with a location sensor and / or a clock, the external device may reprogram the signal processor based on the detected location and / or time. For example, in an exemplary embodiment, when the external device is located in a location known to be noisy (e.g., a mall or sports stadium), the external device may be configured to detect its location and automatically reprogram the signal processor to reduce background noise (e.g., a particular frequency or frequency range) and / or reduce the overall gain associated with the transfer function. Similarly, in some examples, when the external device is located in a location where the wearer specifically wants to recognize speech (e.g., a movie theater), the external device may be configured to reprogram the signal processor to emphasize frequencies associated with speech.

[0211] In some examples, the transfer function may be updated to reduce the contribution of the identified background noise. In some embodiments, reducing the contribution of the identified background noise comprises enhancing signals having frequency components between about 200 Hz and 20 kHz. In some such examples, updating the transfer function to reduce the contribution of the identified background noise includes enhancing signals having frequency components between about 300 Hz and 8 kHz. Enhancement of signals in such frequency ranges may be useful for enhancing human speech and other similar signals in a noisy environment.

[0212] Additionally or alternatively, the external device can be configured to reprogram the signal processor based on the determined time of day. For example, the external device can be configured to lower the volume of all or most sounds when the wearer generally does not want to be disturbed (such as at night). In some examples, the wearer may additionally or alternatively reprogram the signal processor via the external device to adjust the transfer function of the signal processor (e.g., reduce the volume) for a predetermined time (e.g., 15 minutes, 1 hour, or 1 day).

[0213] In some examples, reprogramming the signal processor includes adjusting a transfer function to effect a relative change (e.g., reducing volume). In some cases, reprogramming the signal processor includes implementing a predefined transfer function in response to received data, such as position data indicating the wearer is in a particular position. In some such examples, multiple preprogrammed transfer functions can be stored in memory and implemented based on data obtained via one or more sensors of the external device.

[0214] In some embodiments, the external device can be configured to provide input signals based on audio generated by the external device. For example, the external device can be a smartphone and can provide input signals to the wearer's implantable battery and / or communication module including audio from a phone, text-to-speech audio (e.g., reading a text message or article out loud), and / or media audio (e.g., videos, music, games, etc.). The implantable battery and / or communication module can be configured to relay the input signals to a signal processor for conversion by the signal processor into a corresponding stimulation signal.

[0215] FIG. 21 shows a process flow diagram illustrating an exemplary method for pairing a charger with an implanted system. The method includes turning on the charger (step 2100) and initiating a pairing process via the charger (step 2102). The charger can prompt the user to place and hold a communication coil associated with the charger over the implant (step 2104). When within range of coil communication, the charger communicates with the implant (step 2106), e.g., via an implantable battery and / or a communication module. The charger determines whether pairing with the implant was successful (step 2108) and indicates to the user whether pairing was successful (step 2110) or not (step 2112).

[0216] FIG. 22 shows a process flow diagram illustrating an exemplary method for pairing another device with an implanted system using a paired charger. The method includes selecting an option to pair a device to an implant on the charger (step 2200) and turning on the desired device and putting it into pairing mode (step 2202). The implant determines devices available for pairing and communicates the list of available devices to the charger (step 2204), and the charger displays the list of available devices to the user (step 2206). The user can select from the displayed list of devices to initiate pairing (step 2208). The charger and / or the selected device can determine if the pairing is successful (step 2210). If the pairing is successful, a "pairing successful" message can be displayed via the charger and / or the newly paired device (step 2212). If the pairing is unsuccessful, a "pairing not successful" message can be displayed on the charger (step 2214). For example, in some embodiments, if, after a predetermined time period after attempting to initiate pairing between the implant and another device (e.g., via the system's implantable battery and / or communications module) (e.g., step 2208), the charger does not receive an indication from either the implant or the selected device confirming the pairing, the charger may determine that the pairing was not successful, output a "pairing not successful" message (step 2214), and stop attempting to establish the pairing.

[0217] In various examples, devices that can be paired to the implant via a charger (e.g., to communicate with the implantable battery and / or communications module) such as via the method shown in FIG. 22 can include remotes, smart devices running applications for interfacing with the implant, fobs, audio streaming devices, or other consumer electronic products capable of wireless communication (e.g., Bluetooth).

[0218] With reference to FIG. 20, in various embodiments, once a device (e.g., charger 2010, external device 2030, etc.) is paired with the implantable battery and / or communications module 2020 for wireless communication, information associated with the pairing (e.g., device identifier, etc.) can be stored in one or more memory components (e.g., 2014, 2024, 2034) so ​​that the pairing does not need to be performed again in the future. In some embodiments, one or more devices can be unpaired from communication with the implantable battery and / or communications module 2020. For example, if the device is no longer being used by a user (e.g., discarded, returned, given away, etc.), the device can be used to disconnect from the implantable battery and / or communications module 2020. Additionally or alternatively, if the device has not established wireless communication with the implantable battery and / or communications module 2020 within a certain time since the last connection, the device can automatically unpair. For example, in an exemplary embodiment, if a device transmitting a Bluetooth audio stream to an implanted system via the implantable battery and / or communications module is disconnected from the implantable battery and / or communications module for more than five minutes, the device will be unpaired from the implantable battery and / or communications module and must be re-paired for future use.

[0219] As described, in various embodiments, different external devices can interface with the implanted components to coordinate the operation of the system in various ways. In some embodiments, not all components can perform the same functions as other components. FIG. 23 is a chart illustrating various parameters adjustable by each of various external devices according to some exemplary systems. In the example of FIG. 23, chart entries containing an "X" represent components that are configured to perform the corresponding function. For example, in the illustrated embodiment, only the charger can perform the initial wireless pairing with the implanted system, as described with respect to FIGS. 20 and 21. In some such examples, the remaining devices that can be programmed for wireless communication with the implanted system are paired via the charger, as described with respect to FIG. 22. Other examples are possible in which different components include different functions than those represented by the example of FIG. 23, e.g., components other than or in addition to the charger can initiate wireless pairing with the implanted system.

[0220] In general, the modularity of such systems allows system modifications, such as repairs, replacements, upgrades of system components, and / or transitions from a partial to a fully implantable system, to be performed with minimal disturbance to the implanted system components. For example, cochlear implant electrodes and electrical and / or acoustic stimulators can remain in place while other system components are implanted and / or replaced, reducing the risk of additional procedures damaging the patient's cochlear tissue. Additionally, the communication techniques described herein can be used to help customize and / or optimize the signal processor transfer function for a particular patient, as well as to ensure that the system meets safety standards, provides adequate power and data transfer rates between system components, and operates with high efficiency. Although generally described herein with respect to implantable hearing systems, it will be appreciated that the communication techniques described can be used with a variety of other implantable systems, such as various neuromodulation devices / systems, including, for example, pain management, spinal cord stimulation, brain stimulation (e.g., deep brain stimulation), and the like.

[0221] In some embodiments, the system can communicate with an external device to assist in fitting and / or calibrating the implanted system. Figure 24 shows an example configuration of an interface device configured to assist in system calibration. As shown, an external device 2400 (e.g., a laptop, PC, smartphone, tablet, smartwatch, etc.) communicates with a fitting hub 2402. The fitting hub 2402 includes or otherwise communicates with a speaker 2404 that can output sound based on commands from the fitting hub 2402.

[0222] In the illustrated example, the fitting hub 2402 includes a wireless communication interface 2406 (e.g., a Bluetooth interface) that can communicate with a communication interface 2442 of an implantable battery and / or communication module 2440. In some examples, the fitting hub 2402 can include or otherwise interface with a near-field wireless communication component 2408 to enable Bluetooth communication between the fitting hub 2402 and the implanted system (e.g., via the implantable battery and / or communication module 2440), as described elsewhere herein. Additionally or alternatively, another device (e.g., a charger) can be used to enable wireless (e.g., Bluetooth) communication between the fitting hub 2402 and the implantable battery and / or communication module 2440.

[0223] The illustrated system of Figure 24 includes an implanted modular cochlear implant system including an implantable battery and / or communication module 2440, a signal processor 2420, a sensor 2410, a stimulator 2430, and a cochlear electrode 2416. Such components may be configured and arranged similarly to various embodiments described herein and may be configured to provide an electrical signal from the stimulator 2430 via the cochlear electrode 2416 based on a signal received at the signal processor from the sensor 2410.

[0224] During an exemplary calibration process, the fitting hub 2402 can be configured to output sound via the speaker 2404 and also communicate information about the sound (e.g., intensity, frequency content, etc.) to the implantable battery and / or communication module 2440 of the implanted system. The implanted system can be configured, for example, via the signal processor 2420, to compare the output of the sensor 2410 (received at the signal processor 2420) to the actual sound emitted from the speaker 2404. This data can be repeated for multiple sounds (e.g., various frequencies and / or amplitudes) from the output from the speaker and can be used to determine a relationship between the sound picked up from the sensor 2410 and the output from the sensor 2410 to the signal processor 2420. Based on this information, the transfer function of the signal processor 2420 can be calibrated so that the stimulation signal transmitted to the stimulator 2430 based on the output from the sensor 2410 accurately represents the sound from the environment. Additionally or alternatively, this information can be used to identify how effectively the sensor responds to various external acoustic stimuli of different frequencies, intensities, etc. This information may be determined specifically for a wearer, as the response of the sensor may depend on a variety of factors specific to the wearer and / or the positioning of the sensor.

[0225] In some embodiments, the fitting hub 2402 may be configured to output one or more sounds that include a single frequency and / or a single intensity. For example, each sound may have signal frequency components of various intensities, such as tones. Additionally or alternatively, the one or more sounds may include complex frequency and intensity components, such as sounds representing various beeps, words, noises, or other sounds known to those skilled in the art.

[0226] Although described as occurring at the implanted system (e.g., signal processor 2420), the calibration process may similarly be performed via the fitting hub 2402. For example, the speaker 2404 may output sounds based on instructions from the fitting hub 2402. The sensor 2410 may output signals based on the sensor response to sounds emitted from the speaker 2404, and the signal processor 2420 may receive signals from the sensor 2410 and output stimulation signals to the stimulator 2430 based on the received signals and a transfer function of the signal processor.

[0227] In various examples, the implantable battery and / or communication module 2440 can be configured to receive signals from the sensor 2410, stimulation signals from the signal processor 2420, or any combination of signals representative of one or both of such signals. The implantable battery and / or communication module 2440 can then communicate one or more signals representative of the output of the sensor 2410 and / or the signal processor 2420 to the fitting hub 2402 in response to the sound output from the speaker 2404. A comparison between the sound output from the speaker 2404 and the corresponding resulting signal in the implanted system can be performed via processing in the fitting hub 2402. Similar to what was discussed above, this comparison can be used to determine a relationship between the sound picked up from the sensor 2410 and the output from the sensor 2410 to the signal processor 2420. Based on this information, the transfer function of the signal processor 2420 can be calibrated so that the stimulation signal transmitted to the stimulator 2430 based on the output from the sensor 2410 accurately represents the sound from the environment. Additionally or alternatively, this information can be used to identify how effectively the sensor responds to various external acoustic stimuli of different frequencies, intensities, etc. Because the response of the sensor can depend on a variety of factors specific to the wearer and / or the positioning of the sensor, this information can be determined specifically for the wearer.

[0228] As described, in various examples, the external device 2400 can be used in conjunction with a fitting hub 2402. For example, in some examples, the external device 2400 can provide the processing and control functions of the processes described herein, and the fitting hub 2402 can act as an interface between the external device 2400 and the implanted system (e.g., by providing a speaker 2404, a wireless communication interface 2406, a near-field wireless communication component 2408, etc.).

[0229] In some embodiments, the features and / or functions of the fitting hub 2402 described herein can be performed via an external device, such as a laptop, PC, smartphone, tablet, etc., that includes various functions described with respect to the fitting hub. For example, the external device can include a speaker that can output a desired sound according to commands from the external device, as well as a wireless communication interface for communicating with the implanted system, e.g., via an implantable battery and / or a communication module 2440.

[0230] In some examples, the external device 2400 and / or the fitting hub 2402 may include a user interface in the form of an application on the external device. In such embodiments, features and / or functions of the fitting hub 2402 may be executed via the application. For example, in some examples, the fitting hub may receive instructions to execute functions via an application running on the external device 2400. In some such embodiments, the wearer and / or physician may provide input via the application, for example, during various processes described herein. In some embodiments, the wearer may receive sounds from the fitting hub 2402 and provide input via the application indicating whether the sound was heard or not heard, whether it was too loud or too quiet, whether it was distinguishable or indistinguishable from a previous sound, and / or other input. In some examples, the implant system (e.g., via the fitting hub 2402 or the implantable battery and / or communication module 2440) may be configured to update a transfer function of the signal processor in response to such received input.

[0231] In some embodiments, the fitting hub 2402 and / or the external device 2400 may be configured to communicate with a remote facility, e.g., a physician, such as an audiologist. In some such embodiments, the fitting hub 2402 and / or the external device 2400 includes a remote communication device 2407 configured to communicate with such remote facility, e.g., via the Internet. The remote communication device 2407 may communicate various information associated with the fitting hub 2402, the external device 2400, and the implanted cochlear implant to additional devices, such as devices used by an audiologist. Additionally or alternatively, the remote communication device 2407 may be configured to receive inputs from such additional devices, such as inputs related to features and / or functions performed by the fitting hub, the external device, and / or the implanted cochlear implant. For example, in some cases, an audiologist operating at a remote facility may trigger the fitting hub 2402 to output one or more predefined sounds and / or perform one or more fitting functions. Additionally or alternatively, the audiologist may receive information such as how frequently the wearer uses and / or updates the functionality of the cochlear implant system.

[0232] In an exemplary implementation, the physician can receive diagnostic information regarding any tests or other processes performed by the external device 2400, the fitting hub 2402, and / or the implanted cochlear implant system via the remote communication device 2407. In some such examples, the physician may receive data regarding the frequency with which tests or other processes are performed, the results of the tests or processes performed, the frequency with which various devices (e.g., the hub 2402) are used, and / or any feedback regarding the use or ease of use of the implanted cochlear implant.

[0233] In some examples, the physician can initiate or perform various tests or other processes from the additional device via the telecommunication device 2407. In some embodiments, features and / or functions of the fitting hub 2402 can be performed or initiated by the physician using the additional device via the telecommunication device 2407 as described herein. In various examples, the physician can perform various functions, such as providing one or more sounds via a speaker (e.g., 2404) and performing an accipiter reflex test, as described herein. The physician can receive one or more signals representing the output of the sensor 2410 and / or the signal processor 2420 in response to the one or more sounds provided by the speaker. A comparison of the one or more sounds provided by the speaker and the corresponding resulting signals in the implanted system can be performed by the additional device and / or by the physician receiving such information via the additional device.

[0234] In some embodiments, the remote communication device 2407 can communicate with additional devices (e.g., at the physician's remote facility) via a wireless connection (e.g., Bluetooth, Wi-Fi, NFC, cellular network, Internet access, etc.). Although the remote communication device 2407 is shown communicating via the external device 2400, the remote communication device 2407 can additionally or alternatively communicate via the fitting hub 2402, or a different component of the system. In various embodiments, such a remote communication device can be integrated into the external device 2400 and / or the fitting hub 2402. In some embodiments, the remote communication device 2407 and the wireless communication interface 2406 can be integrated together to facilitate communication with the remote facility and the implanted system. Alternatively, the remote communication device 2407 and the wireless communication interface 2406 can be separate or partially separate components.

[0235] 25 is a process flow diagram illustrating an exemplary process for calibrating an implanted system. In some examples, one or more sensors (e.g., sensors contacting the incus, such as sensor 540 shown in FIG. 5) can detect a physiological phenomenon known as stapedius reflex, in which muscles in the middle ear contract in response to various stimuli, such as a loud sound or the anticipation of a loud sound. In some examples, an implanted signal processor in communication with such sensors can recognize the occurrence of an stapedius reflex based on a characteristic output, for example, via preprogrammed signal recognition or via a learning process, in which the stapedius reflex is triggered and the response from the sensor is measured and learned.

[0236] The calibration process of Figure 25 includes applying an electrical stimulus at a predetermined intensity (step 2500) and measuring a physiological response via a middle-ear sensor (step 2510). The measured physiological response can be used to detect whether an acoustic reflex has occurred (step 2520). If an acoustic reflex is not detected, the intensity of the electrical stimulus is increased (step 2530), an electrical stimulus at the new intensity is applied (step 2500), and the physiological response is measured (step 2510). This process can be repeated until an acoustic reflex is detected in step 2520.

[0237] Once the acoustic reflex is detected, the intensity that elicited the acoustic reflex may be mapped to a predetermined sound pressure level (step 2540). For example, in some instances, the lowest electrical intensity determined to elicit a detected acoustic reflex may be mapped to an input sound pressure of 100 dB. The method may include calibrating the stimulus intensity as a function of sound pressure level based on the mapping of the intensity that elicits the acoustic reflex to the predetermined sound pressure level (step 2550).

[0238] The calibration process of Figure 25 can be initiated in a variety of ways. For example, in various embodiments, the process can be initiated by one or more components in communication with the implanted system, such as a programmer, charger, external device, fitting hub, etc. Such a process can be performed during initial fitting and / or calibration after a period of use of the system.

[0239] Utilizing a fully implanted system and initiating the process via wireless communication (e.g., from a programmer, fitting hub, external device, etc.) greatly simplifies the process of triggering and / or detecting the acoustic reflex. For example, utilizing a cochlear electrode (e.g., 2416) to trigger the acoustic reflex and an implanted middle ear sensor to sense the reflex eliminates the need for cumbersome diagnostic equipment such as tympanometry equipment to analyze the acoustic reflex.

[0240] In some examples, the system and process described with respect to FIG. 24 can be used with the calibration steps described with respect to FIG. 25. For example, in an illustrative example, the fitting hub 2402 of FIG. 24 can cause the speaker 2404 to generate a sound having a sound pressure level of 100 dB while also communicating (e.g., via Bluetooth communication) details of the sound (e.g., intensity, frequency, etc.) to the implantable battery and / or communication module 2440. The output of the sensor 2410 responsive to the 100 dB sound can be identified and associated with the lowest electrical stimulus intensity that elicits a detected acoustic reflex. Such a process can be repeated for multiple frequencies to link various external acoustic stimuli (e.g., from the speaker 2404) to specific electrical stimuli.

[0241] Some embodiments discussed herein generally relate to cochlear implant systems. As discussed herein, a cochlear implant system may include a cochlear implant implanted in the cochlear tissue of a wearer, as well as various other components, such as an electrical stimulator, a signal processor, and a middle-ear sensor. In some embodiments, the cochlear implant system includes components implanted on one or both sides of the wearer. For example, the system may include components implanted on the left side of the wearer (e.g., for the left ear), the right side of the wearer (e.g., for the right ear), or both.

[0242] FIG. 26 illustrates an example embodiment in which a cochlear implant system includes components implanted on both sides of a wearer (e.g., both right and left ears). As shown, the cochlear implant system of FIG. 26 includes a first subsystem including a first cochlear electrode 2616a, a first electrical stimulator 2630a, a first middle ear sensor 2610a, and a first signal processor 2620a, and a second subsystem including a second cochlear electrode 2616b, a second electrical stimulator 2630b, a second middle ear sensor 2610b, and a second signal processor 2620b. The first and second subsystems can be configured similarly to other cochlear implant systems discussed herein. In some embodiments, the first electrical stimulator 2630a and the first signal processor 2620a can be housed in a first housing with the first cochlear electrode 2616a extending from the first housing. Additionally or alternatively, the second electrical stimulator 2630b and the second signal processor 2620b may be housed in a second housing with a second cochlear electrode 2616b extending from the second housing.

[0243] The cochlear implant system of Figure 26 includes an implantable battery and / or communication module 2640. In some embodiments, the cochlear implant system may include multiple implantable battery and / or communication modules, not shown in Figure 26. The implantable battery and / or communication module 2640 may be configured to adjust a first transfer function associated with the first signal processor 2620a and adjust a second transfer function associated with the second signal processor 2620b.

[0244] In some such embodiments, the implantable battery and / or communication module 2640 can communicate with the first signal processor 2620a via the first lead 2670a and with the second signal processor 2620b via the second lead 2670b. In some such embodiments as shown in FIG. 26, the first lead 2670a can be different from the second lead 2670b.

[0245] Additionally or alternatively, the implantable battery and / or communication module 2640 can communicate with both the first signal processor 2620a and the second signal processor 2620b via the branched lead 2675. In some such examples, the implantable battery and / or communication module 2640 can be configured to simultaneously transmit an output signal to each of the first signal processor 2620a and the second signal processor 2620b via the branched lead 2675. In some embodiments, the implantable battery and / or communication module 2640 provides the same output signal to both the first signal processor 2620a and the second signal processor 2620b. The implantable battery and / or communication module 2640 can be configured to communicate an addressed output signal to the first signal processor 2620a and the second signal processor 2620b via the branched lead 2675, the addressed output signal comprising address information designating at least one of the signal processor 2620a and the second signal processor 2620b. In some such embodiments, the first signal processor 2620a and the second signal processor 2620b can be configured to detect address information and respond only to signals that address the particular signal processor. For example, in some instances, the first signal processor 2620a may not be affected by an addressed output signal that includes address information that designates the second signal processor 2620b, but not the first signal processor 2620a. Similarly, the second signal processor 2620b may not be affected by an addressed output signal that includes address information that designates the first signal processor 2620a, but not the second signal processor 2620b. Alternatively, the battery and / or communication module 2640 can communicate either the same or different signals to the first signal processor 2620a and the second signal processor 2620b without the branch lead 2675, such as an embodiment having two separate outputs from the battery and / or communication module 2640.

[0246] As discussed herein, the implantable battery and / or communication module can be configured to communicate with the signal processor to adjust a transfer function associated therewith. In some examples, the implantable battery and / or communication module 2640 can be configured to adjust a first transfer function of the first signal processor 2620a, a second transfer function of the second signal processor 2620b, or a combination of the two, for example, in response to a received command. In such an embodiment, the implantable battery and / or communication module 2640 can be configured to receive commands from an external device via a wireless communication interface (e.g., Bluetooth, Wi-Fi, NFC, etc.).

[0247] In some embodiments, the cochlear implant system can receive a command to change a volume associated with the cochlear implant system. In some embodiments, the volume associated with the cochlear implant system can be an overall volume or a volume of a particular range of frequencies and / or tones (e.g., reducing background noise, accentuating speech, increasing volume from one source to another). In some examples, the implantable battery and / or communication module 2640 can be configured to adjust the relative volumes of both the first transfer function and the second transfer function by approximately the same amount in response to a command to change the volume.

[0248] However, in some instances, a wearer may have a different amount or type of hearing loss on one side than on the other. In such instances, increasing the volume of the first transfer function in the same manner as the second transfer function may not correlate with the patient perceiving the same relative volume change on both sides. Thus, the first transfer function and the second transfer function may be updated such that in response to a given stimulus, the patient perceives a similar change in output via the first electrical stimulator 2630a and the second electrical stimulator 2630b.

[0249] In response to a command to change the volume, the implantable battery and / or communication module 2640 may be configured to determine an existing first transfer function associated with the first signal processor 2620a and determine an updated first transfer function based on the determined existing first transfer function and the received command. Additionally, the implantable battery and / or communication module 2640 may be configured to determine an existing second transfer function associated with the second signal processor 2620b and determine an updated second transfer function based on the determined existing second transfer function and the received command. In such an embodiment, the updated first transfer function and the updated second transfer function may reflect a change in the perceived volume defined in the received command. However, the changes to the first transfer function and the second transfer function, although resulting from the same received command, need not be the same.

[0250] For example, in some embodiments, in response to a command to change the volume, the implantable battery and / or communications module can be configured to individually change a volume associated with the first transfer function and a volume associated with the second transfer function. In some such embodiments, the adjustment to the first transfer function may reflect the same or different adjustment as the adjustment to the second transfer function. In an exemplary embodiment, in response to receiving a command to change the volume, the implantable battery and / or communications module can be configured to adjust the volume of the first transfer function more or less than the second transfer function, such that the wearer perceives a greater or lesser change in stimulation output via the first electrical stimulator 2630a than the second electrical stimulator 2630b.

[0251] The transfer functions associated with the individual signal processors can be updated differently in response to a common command (e.g., "turn up the volume") to accommodate the various hearing profiles associated with each subsystem. For example, in an exemplary embodiment, the first and second subsystems can be programmed with different transfer functions based on, for example, the wearer's hearing profile at the left and right ears, the operation of middle-ear sensors in each of the first and second subsystems (which may operate differently based on the wearer's anatomy), etc. A "turn up the volume" command may result in different adjustments to the different transfer functions. For example, the first transfer function may increase the gain by 10% and the second transfer function may increase the gain by 20% in one or more frequency ranges. Each change can be determined based on, for example, a prescribed response to a given command based on the existing transfer functions.

[0252] In some embodiments, a system including two different subsystems as shown in FIG. 26 can be used to perform various functions described herein, such as detecting the wearer's stapedial reflex. In an exemplary embodiment, acoustic stimulation can be provided to the wearer's first ear, such as via an in-ear speaker (e.g., in communication with a fitting hub). The acoustic stimulation can be detected via a first middle-ear sensor 2610, which can provide an input signal to a first signal processor 2620a programmed with a first transfer function and output a corresponding stimulation signal to a first electrical stimulator 2630a. The first electrical stimulator 2630a can provide electrical stimulation to the wearer's cochlear tissue based on the stimulation signal.

[0253] The implantable battery and / or communication module 2640 can receive information from the second signal processor 2620b representing the data received from the second middle ear sensor 2610b. Generally, the acoustic reflex occurs in both inner ears of a person even if the stimulus is applied to only one ear. Thus, the implantable battery and / or communication module 2640 can be configured to detect an acoustic reflex triggered in the wearer based on information received from the second signal processor 2620b in response to the stimulus detected by the first middle ear sensor 2610a.

[0254] In some embodiments, this phenomenon can be utilized to implement the various stapedius reflex processes described herein. For example, the fitting hub can provide stimulation of increasing intensity to a first ear of the wearer until an implanted battery and / or communication module detects an stapedius reflex in the wearer's other ear. As described elsewhere herein, the intensity of the sound that triggered the stapedius reflex can be used to calibrate the transfer function of a signal processor associated with a sensor used at the first ear. Such a process can be repeated for multiple frequencies and the other ear.

[0255] Various non-limiting embodiments have been described. These and other examples are within the scope of the claims recited below. The invention disclosed in this specification includes the following aspects. <Aspect 1> 1. A cochlear implant system comprising: A cochlear electrode; a stimulator in electrical communication with the cochlear electrode; a signal processor in communication with the stimulator; an input source in communication with the signal processor; an implantable battery and / or communication module configured to provide power to the signal processor; and a plurality of conductors electrically coupling the signal processor and the implantable battery and / or communication module; The signal processor and / or the implantable battery and / or the communication module, grounding a first conductor of the plurality of conductors; applying a test signal to a second conductor of the plurality of conductors; and measuring one or more electrical parameters of the first conductor, the second conductor, and / or between the first conductor and the second conductor. <Aspect 2> 2. The cochlear implant system of claim 1, wherein applying the test signal to the second conductor comprises applying a plurality of signals in succession, each of the plurality of signals having a different frequency. <Aspect 3> 3. The cochlear implant system of claim 2, wherein measuring the one or more electrical parameters comprises measuring an impedance between the first conductor and the second conductor as a function of frequency. <Aspect 4> 4. The cochlear implant system of claim 3, further comprising comparing the measured impedance as a function of frequency to a baseline measurement of impedance as a function of frequency. <Aspect 5> 2. The cochlear implant system of claim 1, wherein measuring the one or more electrical parameters includes determining whether the second conductor is intact. <Aspect 6> 1. A cochlear implant system comprising: A signal processor; an implantable battery and / or communication module; a first lead comprising a first conductor, a second conductor, a third conductor, and a fourth conductor, coupling the signal processor and the implantable battery and / or communication module; the implantable battery and / or communication module is configured to generate a power signal, an inverted power signal, a data signal, and an inverted data signal, and communicate the power signal, the inverted power signal, the data signal, and the inverted data signal, respectively, to the signal processor via the first conductor, the second conductor, the third conductor, and the fourth conductor of the first lead; The cochlear implant system, wherein the implantable battery and / or the communications module and / or the signal processor are configured to perform one or more characterization processes to determine one or more characteristics of the first conductor, the second conductor, the third conductor, and / or the fourth conductor. <Aspect 7> 7. The cochlear implant system of claim 6, wherein the power signal and the inverted power signal are communicated at a first clock rate and the data signal and the inverted data signal are communicated at a second clock rate, the second clock rate being higher than the first clock rate. <Aspect 8> 8. The cochlear implant system of claim 7, wherein performing the one or more characterization processes includes determining integrity of the third conductor and / or the fourth conductor. <Aspect 9> The cochlear implant system of claim 8, wherein if the third conductor and / or the fourth conductor are found to be faulty, the implantable battery and / or communications module is configured to communicate the data signal to the signal processor at the first clock rate via one of the first conductor or the second conductor and communicate the inverted data signal to the signal processor at the first clock rate via the other of the first conductor and the second conductor. <Aspect 10> 7. The cochlear implant system of claim 6, wherein performing the one or more characterization processes includes grounding one of the first conductor, the second conductor, the third conductor, or the fourth conductor, and applying test signals at multiple frequencies to different ones of the first conductor, the second conductor, the third conductor, or the fourth conductor. <Aspect 11> 11. The cochlear implant system of claim 10, wherein performing the one or more characterization processes includes determining an impedance versus frequency relationship between two conductors. <Aspect 12> performing the one or more characterization processes driving a test signal through a test conductor, the test conductor being one of the first conductor, the second conductor, the third conductor, or the fourth conductor; measuring a current transmitted through the test conductor; and measuring a voltage at which the current is transmitted through the test conductor. <Aspect 13> 13. The cochlear implant system of claim 12, wherein performing the one or more characterization processes further comprises determining an impedance of a test conductor. <Aspect 14> The cochlear implant system of embodiment 6, wherein performing the one or more characterization processes includes measuring one or more electrical parameters of one or more of the first conductor, the second conductor, the third conductor, and the fourth conductor, and comparing the one or more measured electrical parameters to corresponding one or more baseline parameters. <Aspect 15> The cochlear implant system of claim 14, wherein the implantable battery and / or communications module is configured to output a measurement and / or a warning if one or more of the one or more measured electrical parameters deviate from the corresponding one or more baseline parameters by more than a predetermined threshold. <Aspect 16> 1. A method for determining one or more characteristics of at least one conductor in a cochlear implant system, comprising: grounding a first conductor, the first conductor being connected between an implantable battery and / or a communication module of the cochlear implant system and a signal processor of the cochlear implant system; applying a test signal to a second conductor, the second conductor being connected between the implantable battery and / or communication module and the signal processor; and determining one or more characteristics of at least one of the first conductor and the second conductor. <Aspect 17> 17. The method of claim 16, wherein applying the test signal to the second conductor includes applying a plurality of test signals, each of the plurality of test signals having a different frequency component. <Aspect 18> 18. The method of embodiment 17, wherein determining one or more characteristics of at least one of the first conductor and the second conductor includes determining an impedance versus frequency relationship between the first conductor and the second conductor. <Aspect 19> 20. The method of embodiment 18, further comprising comparing the determined impedance versus frequency relationship between the first conductor and the second conductor to a baseline impedance versus frequency relationship. <Aspect 20> 20. The method of embodiment 19, further comprising outputting a measurement and / or an alert if the determined impedance versus frequency relationship deviates from a baseline measurement of impedance versus frequency by more than a predetermined threshold. <Aspect 21> 17. The method of embodiment 16, wherein determining one or more characteristics of at least one of the first conductor and the second conductor includes determining whether the second conductor is intact. <Aspect 22> 1. A cochlear implant system comprising: A cochlear electrode; a stimulator in electrical communication with the cochlear electrode; a sensor configured to receive a stimulus signal and generate an input signal based on the received stimulus signal; a signal processor in communication with the stimulator and the sensor, the signal processor being programmed with a transfer function; receiving the input signal from the sensor; outputting a stimulation signal to the stimulator based on the received input signal and the transfer function; A cochlear implant system, wherein the stimulator and the signal processor are integrated into a single hermetically sealed housing, and the cochlear electrodes extend from the single hermetically sealed housing. <Aspect 23> 23. The cochlear implant system of claim 22, wherein the single hermetically sealed housing comprises an outer surface having a first side and a second side generally opposite the first side, and a return electrode coupled to the outer surface on both the first side and the second side. <Aspect 24> 24. The cochlear implant system of claim 23, wherein the single hermetically sealed housing is configured to be implanted on either the right or left side of the wearer. <Aspect 25> 24. The cochlear implant system of embodiment 23, further comprising a plurality of return electrodes. <Aspect 26> 24. The cochlear implant system of claim 23, wherein the signal processor is configured to output the stimulation signal to one or more contact electrodes on the cochlear electrode, the one or more contact electrodes contacting and providing electrical stimulation to cochlear tissue of the wearer. <Aspect 27> 27. The cochlear implant system of claim 26, wherein the return electrode is electrically connected to an internal circuit of the single hermetically sealed housing. <Aspect 28> 28. The cochlear implant system of claim 27, wherein the return electrode comprises platinum or a platinum alloy. <Aspect 29> 28. The cochlear implant system of claim 27, wherein the single hermetically sealed housing comprises a conductive material. <Aspect 30> 30. The cochlear implant system of claim 29, wherein the unitary hermetically sealed housing comprises titanium. <Aspect 31> 30. The cochlear implant system of claim 29, wherein the single hermetically sealed housing includes a first header comprising a non-conductive material, the first header providing electrical insulation between the return electrode and the single hermetically sealed housing. <Aspect 32> 32. The cochlear implant system of claim 31 , wherein the first header comprises a biocompatible polymer. <Aspect 33> 32. The cochlear implant system of claim 31, further comprising an implantable battery and / or communication module that communicates with the signal processor via a first connector, the first connector interfacing with the single hermetically sealed housing via the first header. <Aspect 34> a second header comprising a non-conductive material; the sensor is in communication with the signal processor via a second connector; 32. The cochlear implant system of claim 31 , wherein the second connector interfaces with the single hermetically sealed housing via the second header. <Aspect 35> 23. The cochlear implant system of claim 22, wherein the sensor comprises a middle-ear sensor or a microphone. <Aspect 36> 1. A signal processing unit for a cochlear implant system, comprising: a housing defining an interior enclosed by the housing and an exterior, the exterior of the housing having a first side and a second side, the second side being opposite the first side; a cochlear electrode extending from the interior of the housing, through the housing, and extending away from the housing; a signal processor contained within the housing and programmed with a transfer function and configured to receive an input signal from a source representative of a received audio signal, and to process the received input signal in accordance with the transfer function to generate a stimulus signal; a stimulator within the housing and configured to receive the stimulation signal from the signal processor and to output an electrical signal to the cochlear electrode corresponding to the received stimulation signal; a return electrode connected to the first side of the exterior of the housing. <Aspect 37> A signal processing unit as described in aspect 36, wherein the return electrode is connected to both the first side and the second side of the exterior of the housing. <Aspect 38> 38. The signal processing unit of embodiment 37, wherein the return electrode comprises platinum or a platinum alloy. <Aspect 39> 39. The signal processing unit of embodiment 38, wherein the housing comprises titanium. <Aspect 40> the housing includes a header; the cochlear electrodes extend from the interior defined by the housing through the header to the exterior of the signal processing unit; 40. The signal processing unit of embodiment 39, wherein the header comprises a non-conductive material. <Aspect 41> 41. The signal processing unit of embodiment 40, wherein the header comprises a polymer. <Aspect 42> The signal processing unit of aspect 36, wherein the cochlear electrode comprises a plurality of stimulating electrodes, and the electrical signal includes a plurality of electrical signals, each of the plurality of electrical signals being applied to a unique one of the plurality of stimulating electrodes. <Aspect 43> 1. A cochlear implant system comprising: A cochlear electrode; a stimulator in electrical communication with the cochlear electrode; a middle ear sensor configured to receive a stimulation signal and generate an input signal based on the received stimulation signal; a signal processor in communication with the stimulator and the middle ear sensor, the signal processor having an analog processing stage and a digital processing stage and programmed with a transfer function; receiving the input signal from the middle ear sensor; inputting the received input signal to the analog processing stage and processing the received input signal through the analog processing stage to generate an analog processed signal; inputting the analog processed signal into the digital processing stage and processing the received analog processed signal through the digital processing stage to generate a digital processed signal, the digital processed signal corresponding to a normalized stimulus signal having reduced gain variation across a range of frequencies and compensating for variations in the frequency response of the middle ear sensor; and outputting a stimulation signal to the stimulator based on the digitally processed signal and the transfer function. <Aspect 44> 44. The cochlear implant system of claim 43, wherein processing the received input signal through the analog processing stage includes flattening a frequency response curve of the received input signal. <Aspect 45> 45. The cochlear implant system of claim 44, wherein the analog processing stage comprises one or more filters and / or amplifiers. <Aspect 46> 44. The cochlear implant system of claim 43, wherein the stimulator and the signal processor are integrated into a single hermetically sealed housing and the cochlear electrodes extend from the single hermetically sealed housing. <Aspect 47> 47. The cochlear implant system of claim 46, wherein the single hermetically sealed housing comprises an outer surface having a first side and a second side generally opposite the first side, and a return electrode coupled to the outer surface on both the first side and the second side. <Aspect 48> 44. The cochlear implant system of claim 43, wherein the signal processor is configured to apply the transfer function to the generated digitally processed signal to generate the stimulation signal. <Aspect 49> 44. A cochlear implant system as described in embodiment 43, wherein the digital processing stage is adjustable to calibrate the signal processor to the middle ear sensor. <Aspect 50> The cochlear implant system of aspect 49 further includes an external device in communication with the signal processor, the external device configured to receive the digitally processed signal generated by the signal processor and adjust the digital processing stage to modify the frequency response of the digital processing stage. <Aspect 51> The cochlear implant system of embodiment 50, further comprising an implantable battery and / or a communication module configured to communicate with the signal processor and to wirelessly communicate with the external device to facilitate communication between the external device and the signal processor. <Aspect 52> The signal processor includes: receiving a broad spectrum input signal that includes a plurality of frequencies and corresponds to the broad spectrum stimulus signal received at the middle ear sensor; 44. The cochlear implant system of embodiment 43, configured to: determine the frequency responses of the analog processing stage and the digital processing stage. <Aspect 53> 53. The cochlear implant system of claim 52, wherein the signal processor is configured to adjust the digital processing stage to normalize the frequency response of the combined analog and digital processing stages based on a fast Fourier transform of the broad spectrum stimulation signal and / or the broad spectrum input signal. <Aspect 54> A cochlear implant system as described in aspect 43, wherein the signal processor is configured to receive a plurality of input signals representing a stimulation signal each having a unique frequency component and to determine the frequency responses of the analog processing stage and the digital processing stage. <Aspect 55> 55. The cochlear implant system of claim 54, wherein the signal processor is further configured to adjust the digital processing stage to normalize the frequency response of the combined analog and digital processing stage. <Aspect 56> 56. A cochlear implant system as described in embodiment 55, wherein the frequency response of the combined analog processing stage and the digital processing stage is normalized to make the ratio of the digitally processed signal to the corresponding received stimulation signal approximately constant across multiple frequencies or frequency ranges. <Aspect 57> 1. A method of compensating for middle ear sensor variations, comprising: receiving a stimulation signal via a middle-ear sensor; generating an input signal based on the stimulation signal using the middle ear sensor; applying an analog filter to the generated input signal to generate an analog filtered signal; applying a digital filter to the generated analog filtered signal to generate a digital filtered signal; measuring a frequency response of the digitally filtered signal and / or the analog filtered signal with respect to the input signal; and adjusting the digital filter to normalize the frequency response of the digitally filtered signal with respect to the stimulus signal. <Aspect 58> the stimulus signal comprises a broad-spectrum stimulus signal; The method of claim 57, wherein measuring the frequency response of the digitally filtered signal and / or the analog filtered signal with respect to the input signal includes performing a transform of the spread spectrum signal to determine its frequency components, and determining the frequency response based on the determined frequency components. <Aspect 59> The method of claim 57, further comprising applying a plurality of stimulation signals having known frequency content to the middle ear sensor, wherein the measuring of the frequency response of the digitally filtered signal with respect to the stimulation signals is performed for each of the plurality of stimulation signals. <Aspect 60> 60. The method of claim 59, wherein applying the plurality of stimulation signals includes applying stimulation signals having frequencies in the range of 100 Hz to 10 kHz. <Aspect 61> The method of claim 59, wherein measuring the frequency response of the digitally filtered signal with respect to the received stimulus signal includes determining a ratio of a magnitude of the digitally filtered signal to a magnitude of the stimulus signal for a plurality of frequencies or frequency ranges. <Aspect 62> The method of embodiment 61, wherein adjusting the digital filter to normalize the frequency response with respect to the received stimulus signal includes adjusting the digital filter so that the determined ratio is approximately equal for each of the multiple frequencies or frequency ranges. <Aspect 63> 58. The method of embodiment 57, wherein applying an analog filter to the generated input signal includes applying a plurality of analog filters and / or analog amplifiers. <Aspect 64> 64. The method of embodiment 63, further comprising adjusting the analog filter to normalize the frequency response of the digitally filtered signal with respect to the stimulus signal. <Aspect 65> 1. A system comprising: A cochlear electrode; a stimulator in electrical communication with the cochlear electrode; a middle ear sensor configured to receive a stimulation signal and generate an input signal based on the received stimulation signal; a signal processor in communication with the stimulator and the middle ear sensor, the signal processor having an analog processing stage and a digital processing stage and programmed with a transfer function; receiving the input signal from the middle ear sensor; inputting the received input signal into the analog processing stage to generate an analog processed signal; inputting the analog processed signal into the digital processing stage to generate a digital processed signal, the digital processed signal corresponding to a stimulus signal that has been normalized to reduce variation in frequency response of the middle ear sensor; outputting a stimulation signal to the stimulator based on the digitally processed signal and the transfer function. <Aspect 66> 1. A cochlear implant system comprising: A cochlear electrode; a stimulator in electrical communication with the cochlear electrode; a signal processor in communication with the stimulator, the signal processor programmed with a transfer function and configured to receive one or more input signals and output a stimulation signal to the stimulator based on the received one or more input signals and the transfer function; an implantable battery and / or communication module in communication with the signal processor, the implantable battery and / or communication module including an implanted short-range communication device for communicating via a first wireless communication protocol and an implanted wireless communication device for communicating via a second wireless communication protocol, the second wireless communication protocol having a longer range of wireless communication than the first wireless communication protocol; an external device having an external short-range communication device configured to wirelessly communicate with the implanted short-range communication device via the first wireless communication protocol, and an external wireless communication device configured to wirelessly communicate with the implanted wireless communication device via the second wireless communication protocol; wherein communication between the external wireless communication device and the implanted wireless communication device via the second wireless communication protocol is enabled by first establishing communication between the implanted near-field communication device and the external near-field communication device via the first wireless communication protocol. <Aspect 67> 67. The cochlear implant system of claim 66, wherein the external device comprises a charger. <Aspect 68> 68. The cochlear implant system of claim 67, wherein the implanted near-field wireless communication device includes an implanted coil and the external near-field wireless communication device includes an external coil. <Aspect 69> A cochlear implant system as described in embodiment 68, wherein the external device is configured to charge a power source within the implantable battery and / or communication module via the implanted coil and the external coil. <Aspect 70> 67. The cochlear implant system of embodiment 66, wherein the second wireless communication protocol comprises Bluetooth communication. <Aspect 71> 67. The cochlear implant system of embodiment 66, further comprising a second external wireless communication device configured to wirelessly communicate with the implanted wireless communication device. <Aspect 72> A cochlear implant system as described in aspect 71, wherein the external wireless communication device is configured to enable wireless communication between the second external wireless communication device and the implantable battery and / or communication module. <Aspect 73> A cochlear implant system as described in aspect 66, wherein the external wireless communication device is configured to communicate control signals and / or streaming audio to the implantable battery and / or communications module. <Aspect 74> A cochlear implant system as described in aspect 66, wherein once communication between the external wireless communication device and the implanted wireless communication device via the second wireless communication protocol is enabled for the first time, each subsequent connection between the external wireless communication device and the implanted wireless communication device can be enabled without establishing communication between the implanted near-field communication device and the external near-field communication device via the first wireless communication protocol. <Aspect 75> The cochlear implant system of embodiment 66, wherein the external wireless communication device is a laptop, PC, smartphone, tablet, or watch. <Aspect 76> The cochlear implant system of aspect 75, wherein the external wireless communication device is configured to control one or more attributes of the cochlear implant system via the second wireless communication protocol after communication between the external wireless communication device and the implanted wireless communication device is enabled. <Aspect 77> A cochlear implant system as described in aspect 76, wherein the external wireless communication device is configured to adjust the transfer function of the signal processor via the second wireless communication protocol. <Aspect 78> A cochlear implant system as described in aspect 77, wherein the external wireless communication device comprises a microphone configured to collect environmental auditory data representing a surrounding environment, and the external wireless communication device is configured to adjust the transfer function of the signal processor based on the collected environmental auditory data. <Aspect 79> A cochlear implant system as described in aspect 78, wherein the external wireless communication device is configured to identify background noise in the collected environmental auditory data and update the transfer function to reduce the contribution of the identified background noise in the stimulation signal. <Aspect 80> 80. The cochlear implant system of claim 79, wherein updating the transfer function to reduce the contribution of the identified background noise includes attenuating frequencies outside a typical human speech range. <Aspect 81> 81. The cochlear implant system of embodiment 80, wherein attenuating frequencies outside of a typical human speech range includes attenuating signals having frequencies below about 200 Hz. <Aspect 82> 80. The cochlear implant system of claim 79, wherein updating the transfer function to reduce the contribution of the identified background noise includes emphasizing signals having frequency components between approximately 200 Hz and 20 kHz. <Aspect 83> 83. The cochlear implant system of claim 82, wherein updating the transfer function to reduce the contribution of the identified background noise includes emphasizing signals having frequency components between approximately 300 Hz and 8 kHz. <Aspect 84> The cochlear implant system of embodiment 76, wherein the external wireless communication device is configured to receive the location data and implement one or more predetermined settings based on the received location data. <Aspect 85> The cochlear implant system of embodiment 84, wherein the external wireless communication device includes a smartphone and the location data comprises GPS data. <Aspect 86> The cochlear implant system of embodiment 84, wherein the external wireless communication device includes an Internet-enabled device and receiving the location data includes recognizing one or more available wireless Internet networks. <Aspect 87> the external wireless communication device is configured to provide an input signal to the implanted wireless communication device via the second wireless communication protocol; 77. The cochlear implant system of claim 76, wherein the signal processor is configured to output a stimulation signal to the stimulator based on the input signal provided from the external wireless communication device. <Aspect 88> A cochlear implant system as described in aspect 87, wherein the input signal provided by the external wireless communication device is based on audio generated by the external wireless communication device. <Aspect 89> The cochlear implant system of embodiment 88, wherein the sound generated by the external wireless communication device comprises at least one of a sound from a telephone, an automatically read out text message, an alarm, and a media sound. <Aspect 90> 1. A method for pairing an external device to an implanted cochlear implant system, comprising: establishing communication between the implanted cochlear implant system and the external device via a short-range wireless communication protocol; pairing the external device with the implanted cochlear implant system; and establishing wireless communication between the implanted cochlear implant system and the external device via a wireless communication protocol, the wireless communication protocol having a longer communication range than the short-range communication protocol. <Aspect 91> The method of aspect 90, wherein the wireless communication protocol comprises Bluetooth. <Aspect 92> 91. The method of aspect 90, further comprising receiving, at the external device, an instruction to pair the external device with the implanted cochlear implant system. <Aspect 93> 93. The method of claim 92, further comprising, after receiving an instruction to pair the external device with the implanted cochlear implant system, outputting, via the external device, an instruction to position the external device to enable near-field wireless communication between the implanted cochlear implant system and the external device via the near-field communication protocol. <Aspect 94> The method of embodiment 90, wherein the external device comprises a charger. <Aspect 95> The method of claim 94, wherein the charger includes an external coil, the implanted cochlear implant system includes an implantable coil, and the near-field wireless communication protocol comprises communication between the external coil and the implantable coil. <Aspect 96> 96. The method of claim 95, wherein the charger is configured to provide power to the implanted cochlear implant system by transferring electrical energy from the external coil to the internal coil. <Aspect 97> detecting, via the external device, the presence of a second external device capable of communicating with the implanted cochlear implant system via the wireless communication protocol; receiving, via the external device, a selection of the second external device; The method of aspect 90, further comprising: in response to the received selection, pairing the second external device with the implanted cochlear implant system such that the second external device communicates with the implanted cochlear implant system via the wireless communication protocol. <Aspect 98> The method of embodiment 97, further comprising receiving control signals and / or receiving streaming audio at the implanted cochlear implant system from the external device and / or the second external device via the wireless communication protocol. <Aspect 99> The method of embodiment 98, further comprising determining environmental auditory data representative of an ambient environment via the second external device, and receiving, at the implanted cochlear implant system, a control signal from the second external device based on the determined environmental auditory data. <Aspect 100> The method of aspect 98, wherein the method includes receiving streaming audio, the streaming audio comprising at least one of audio from a telephone, an auto-read text message, an alarm, and a media audio. <Aspect 101> 1. A method for pairing an external device to an implanted cochlear implant system, comprising: pairing the implanted cochlear implant system with a first external device by establishing communication between the implanted cochlear implant system and the first external device via a near field communication protocol; and pairing the second external device with the implanted cochlear implant system by establishing wireless communication between the implanted cochlear implant system and the second external device via a wireless communication protocol using the established communication between the cochlear implant system and a first external device after the first external device has been paired with the implanted cochlear implant system, the wireless communication protocol having a longer communication range than the near-field communication protocol. <Aspect 102> 1. A system comprising: 1. A fully implantable cochlear implant, comprising: A cochlear electrode; a stimulator in electrical communication with the cochlear electrode; an input source configured to receive a stimulus and generate an input signal representative of the received stimulus; a signal processor in communication with the stimulator and the input source, the signal processor programmed with a transfer function and configured to receive one or more input signals from the input source and to output a stimulation signal to the stimulator based on the received one or more signals and the transfer function; an implantable battery and / or communication module configured to communicate with and power the signal processor; an external hub including a speaker and a wireless communication interface, the external hub configured to communicate wirelessly with the implantable battery and / or communication module, the external hub configured to output a predetermined acoustic signal via the speaker and communicate information regarding the predetermined acoustic signal to the implantable battery and / or communication module via the wireless communication interface. <Aspect 103> in response to the external hub outputting a predetermined audio signal via the speaker, the input source receives a stimulus resulting from the predetermined acoustic signal and generates the input signal in response thereto; the signal processor receives the input signal from the input source and communicates information representative of the received input signal to the implantable battery and / or communication module; The implantable battery and / or communication module comprises: receiving information from the external hub regarding an audio signal output from the speaker of the external hub; The system of aspect 102, wherein the system is configured to analyze the information regarding the output predetermined acoustic signal received from the external hub and the information representing the received input signal received from the signal processor to determine a relationship between the predetermined acoustic signal output from the speaker of the external hub and the resulting input signal generated via the input source. <Aspect 104> The system of aspect 103, wherein the implantable battery and / or communication module is configured to update the transfer function of the signal processor in response to the determined relationship. <Aspect 105> the external hub is configured to output a plurality of predetermined acoustic signals; For each of the outputted predetermined acoustic signals, the implantable battery and / or communications module: receiving information from the external hub regarding the acoustic signal output from the speaker of the external hub; The system of aspect 103, wherein the system is configured to analyze information regarding the output predetermined acoustic signal received from the external hub and information representing the received input signal received from the signal processor to determine the relationship between the predetermined acoustic signal output from the speaker of the external hub and the resulting input signal generated via the input source. <Aspect 106> The system of embodiment 105, wherein each of the plurality of predetermined acoustic signals comprises a plurality of frequencies and / or intensities. <Aspect 107> The system of embodiment 106, wherein each of the plurality of predetermined acoustic signals has substantially the same intensity. <Aspect 108> The system of aspect 102, wherein the speaker of the external hub comprises an in-ear speaker. <Aspect 109> the input source includes a middle ear sensor, and the implantable battery and / or communication module is receiving information from the signal processor representative of an input signal output from the middle ear sensor in response to a received stimulus; The system of aspect 108, further configured to detect the wearer's acoustic reflex based on the information received from the signal processor. <Aspect 110> The system of embodiment 109, wherein the external hub is configured to provide an acoustic signal through the in-ear speaker at a first intensity and to increase the intensity over time. <Aspect 111> The implantable battery and / or communication module comprises: detecting the acoustic reflex of the wearer in response to increasing an intensity of the acoustic signal; determining the intensity of the acoustic signal from the external hub that elicits the acoustic reflex; and The system of embodiment 110, further configured to: update a transfer function of the signal processor based on the determined strength. <Aspect 112> the external hub is configured to output a predetermined acoustic signal at the first intensity for each of a plurality of frequencies and to increase the intensity over time; For each of the outputted predetermined acoustic signals, the implantable battery and / or communications module: detecting the acoustic reflex of the wearer in response to increasing an intensity of the acoustic signal; determining the intensity of the acoustic signal from the external hub that elicits the acoustic reflex; and The system of embodiment 111, further configured to: update a transfer function of the signal processor based on the determined strength. <Aspect 113> further comprising the external device in communication with the external hub; The system of aspect 112, wherein the external device includes a user interface and provides the user interface for communicating with the external hub. <Aspect 114> 1. A method of calibrating an implanted cochlear implant system, comprising: receiving a first input signal via a first implanted signal processor, the first input signal representing a predetermined acoustic signal; providing a stimulation signal from a signal processor to a stimulator based on the first input signal and a transfer function; outputting an electrical signal via the stimulation device to the wearer's cochlear tissue, the electrical signal being based on the stimulation signal; receiving a measurement signal via an implanted middle ear sensor; and detecting an acoustic reflex of the wearer based on the received measurement signals. <Aspect 115> outputting a predetermined acoustic signal at a first intensity, the first input signal being representative of the predetermined acoustic signal at the first intensity; The method of embodiment 114, further comprising increasing the intensity of the predetermined acoustic signal over time. <Aspect 116> The method comprises: detecting the acoustic reflex of the wearer in response to increasing an intensity of the predetermined acoustic signal; The method of embodiment 115, further comprising determining the intensity of the predetermined acoustic signal that elicits the acoustic reflex. <Aspect 117> The method of embodiment 116, further comprising updating the transfer function based on the intensity of the predetermined acoustic signal that elicits the acoustic reflex. <Aspect 118> receiving, via the first implanted signal processor, a plurality of first input signals, each of the plurality of first input signals representing a corresponding plurality of predetermined acoustic signals, each of the plurality of predetermined acoustic signals comprising a corresponding one of a plurality of frequencies; increasing the intensity of each of the plurality of predetermined acoustic signals over time; detecting the acoustic reflex of the wearer in response to increasing an intensity of each of the plurality of predetermined acoustic signals; The method of embodiment 115, further comprising determining the intensity that elicits the acoustic reflex for each of the plurality of predetermined acoustic signals. <Aspect 119> The method of embodiment 118, further comprising updating the transfer function based on the intensity of each of the predetermined acoustic signals that elicit the stapedius reflex. <Aspect 120> The method of embodiment 118, wherein each of the multiple input signals representing the multiple predetermined acoustic signals is provided at a different time. <Aspect 121> The method of embodiment 114, wherein the first input signal is received by a first implanted signal processor located on a first side of the wearer and the measurement signal is received by a second implanted signal processor located on a second side of the wearer. <Aspect 122> The method of embodiment 114, wherein the first input signal and the measurement signal are received by the first implanted signal processor. <Aspect 123> The method of embodiment 114, wherein the first input signal is provided through an external speaker. <Aspect 124> The method of embodiment 123, wherein the external speaker comprises an in-ear speaker. <Aspect 125> The method of embodiment 114, wherein the first input signal is provided from an external device via a wireless communication link. <Aspect 126> The method of aspect 125, wherein the external device comprises at least one of a laptop, a PC, a smartphone, a tablet, and a smartwatch. <Aspect 127> 1. A calibration system for a cochlear implant, comprising: 1. A fully implantable cochlear implant, comprising: A cochlear electrode; a stimulator in electrical communication with the cochlear electrode; an input source comprising a middle-ear sensor configured to receive a stimulus and to generate an input signal representative of the received stimulus; a signal processor in communication with the stimulator and the input source, the signal processor programmed with a transfer function and configured to receive one or more input signals from the input source and to output a stimulation signal to the stimulator based on the received one or more input signals and the transfer function; an implantable battery and / or communication module configured to communicate with and provide power to the signal processor; and an external device including a wireless communication interface, the external device comprising: wirelessly communicating with the implantable battery and / or communication module; outputting a predetermined acoustic signal, the predetermined acoustic signal having a first intensity; increasing the intensity of the predetermined acoustic signal over time; and communicating information about the predetermined acoustic signal to the implantable battery and / or communication module via the wireless communication interface; The implantable battery and / or communication module comprises: receiving information from the signal processor representative of an input signal output from the middle ear sensor; detecting an acoustic reflex of the wearer based on the received information from the signal processor; and and determining the intensity of the predetermined acoustic signal from the external device corresponding to the detected acoustic reflex. <Aspect 128> A calibration system as described in aspect 127, wherein the implantable battery and / or communication module is further configured to update a transfer function of the signal processor based on the determined strength of the specified acoustic signal corresponding to the detected stapedius reflex. <Aspect 129> The external device is outputting a plurality of predetermined acoustic signals, each of the plurality of predetermined acoustic signals having a corresponding one of a plurality of frequencies; increasing the intensity of each of the plurality of predetermined acoustic signals; The implantable battery and / or communication module comprises: receiving from the signal processor information representative of a plurality of input signals output from the middle-ear sensor in response to a plurality of receive stimuli, the plurality of receive stimuli corresponding to the plurality of predetermined acoustic signals; detecting the acoustic reflex of the wearer in response to increasing intensities of the plurality of predetermined acoustic signals; determining, for each of the plurality of frequencies, the intensity of the predetermined acoustic signal that triggers the acoustic reflex; The calibration system of aspect 128, further configured to: update a transfer function of the signal processor based on the determined intensities of the plurality of predetermined acoustic signals that trigger the stapedius reflex. <Aspect 130> A calibration system as described in embodiment 129, wherein each of the multiple predetermined acoustic signals is provided at a different time. <Aspect 131> A calibration system as described in aspect 127, further comprising a speaker in communication with the external device, wherein the predetermined acoustic signal is provided by the speaker in communication with the external device. <Aspect 132> the predetermined acoustic signal is provided to the implantable battery and / or communication module via a wireless communication interface; A calibration system as described in aspect 127, wherein the signal processor receives the input signal from the implantable battery and / or communication module, and the input signal is based on the predetermined acoustic signal provided to the implantable battery and / or communication module from the external device. <Aspect 133> A calibration system as described in aspect 127, wherein the external device is configured to connect to the Internet and provide communication between a clinician and the implantable battery and / or communication module via the Internet and the external device. <Aspect 134> A calibration system as described in aspect 127, wherein the external device comprises a user interface. <Aspect 135> A calibration system as described in aspect 134, wherein the implantable battery and / or communication module is configured to receive an input via a user interface of the external device indicating whether the wearer is able to detect the predetermined acoustic signal. <Aspect 136> the external device is configured to output a predetermined acoustic signal to a middle-ear sensor on a first side of the wearer; the implantable battery and / or communication module is configured to detect the acoustic reflex of the wearer at a second side of the wearer; A calibration system as described in aspect 127, wherein the first side is either the left or right side of the wearer, and the second side is the other of the left or right side of the wearer. <Aspect 137> 1. A cochlear implant system comprising: A first subsystem, a first cochlear electrode; a first stimulator in communication with the first cochlear electrode; a first input source configured to receive a first stimulus signal and generate a first input signal based on the received first stimulus signal; a first signal processor in communication with the first stimulator and the first input source, the first signal processor programmed with a first transfer function; receiving the first input signal from the first input source; a first subsystem configured to output a first stimulation signal to the first stimulator based on the first input signal and the first transfer function; a second subsystem, a second cochlear electrode; a second stimulator in communication with the second cochlear electrode; a second input source configured to receive a second stimulus signal and generate a second input signal based on the received second stimulus signal; a second signal processor in communication with the second stimulator and the second input source, the second signal processor programmed with a second transfer function; receiving the second input signal from the second input source; a second subsystem configured to output a second stimulation signal to the second stimulator based on the second input signal and the second transfer function; and an implantable battery and / or communications module configured to communicate with the first signal processor and the second signal processor and to provide power to the first signal processor and the second signal processor. <Aspect 138> 138. The cochlear implant system of embodiment 137, wherein the first subsystem is implanted adjacent to a left ear of the patient and the second subsystem is implanted adjacent to a right ear of the patient. <Aspect 139> the first stimulator and the first signal processor are contained in a first housing; the first cochlear electrode extends from the first housing; the second stimulator and the second signal processor are contained in a second housing; The cochlear implant system of embodiment 138, wherein the second cochlear electrode extends from the second housing. <Aspect 140> The first housing and the second housing each have an exterior surface, the exterior surfaces comprising: A first side; a second side opposite the first side; and 140. The cochlear implant system of claim 139, further comprising a return electrode extending from the first side to the second side. <Aspect 141> A cochlear implant system as described in aspect 137, wherein the implantable battery and / or communication module is configured to adjust the first transfer function associated with the first signal processor and to adjust the second transfer function associated with the second signal processor. <Aspect 142> the implantable battery and / or communication module in communication with the first signal processor via a first lead; the implantable battery and / or communication module is in communication with the second signal processor via a second lead, the second lead being different from the first lead; the implantable battery and / or communication module is configured to adjust the first transfer function via communication with the first signal processor via the first lead; A cochlear implant system as described in aspect 141, wherein the implantable battery and / or communication module is configured to adjust the second transfer function via communication with the second signal processor via the second lead. <Aspect 143> A cochlear implant system as described in embodiment 141, wherein the implantable battery and / or communication module communicates with both the first signal processor and the second signal processor via a branched lead. <Aspect 144> A cochlear implant system as described in embodiment 143, wherein the implantable battery and / or communication module transmits the same signal to each of the first signal processor and the second signal processor via the branched lead. <Aspect 145> A cochlear implant system as described in aspect 144, wherein the implantable battery and / or communication module is configured to communicate addressed output signals to the first signal processor and the second signal processor via the branched lead, the addressed output signals comprising address information designating at least one of the first signal processor and the second signal processor. <Aspect 146> A cochlear implant system as described in embodiment 145, wherein the first signal processor is not affected by an addressed output signal comprising address information that specifies the second signal processor and not the first signal processor. <Aspect 147> A cochlear implant system as described in aspect 141, wherein the implantable battery and / or communication module is configured to receive commands to adjust the first transfer function and the second transfer function from an external device via a wireless communication interface. <Aspect 148> The cochlear implant system of embodiment 147, wherein the external device comprises a smartphone, tablet, charger, or programmer. <Aspect 149> The cochlear implant system of embodiment 147, wherein the wireless communication interface comprises Bluetooth communication or a short-range wireless communication network. <Aspect 150> The implantable battery and / or communication module comprises: adjusting the first transfer function based on the received command and the first transfer function; and adjusting the second transfer function based on the received command and the second transfer function, so that 148. The cochlear implant system of claim 147, wherein adjusting the first transfer function is independent of adjusting the second transfer function. <Aspect 151> the received command includes a command to change a volume associated with the cochlear implant system; In response to the received command, the implantable battery and / or communications module: determining an existing first transfer function associated with the first signal processor; determining an updated first transfer function based on the determined existing first transfer function and the received command, the updated first transfer function reflecting a change in perceived volume relative to the existing first transfer function defined in the received command; determining an existing second transfer function associated with the second signal processor; The cochlear implant system of embodiment 150, wherein the cochlear implant system is configured to: determine an updated second transfer function based on the determined existing second transfer function and the received command, the updated second transfer function reflecting a change in perceived volume relative to the existing second transfer function defined in the received command. <Aspect 152> the first input source comprises a microphone or a middle-ear sensor; The cochlear implant system of embodiment 137, wherein the second input source comprises a microphone or a middle-ear sensor. <Aspect 153> 1. A method for adjusting operation of a stereo cochlear implant system, comprising: receiving a command to adjust operation of the stereo cochlear implant system; determining a first existing transfer function associated with a first cochlear subsystem, the existing first transfer function defining a relationship between a received stimulation signal and a first output stimulation signal; determining a first updated transfer function reflecting an adjusted operation associated with the received command, the first updated transfer function being based on the first existing transfer function and the received command; updating operation of a first cochlear implant subsystem to replace the first existing transfer function with the first updated transfer function; determining a second existing transfer function associated with a second cochlear subsystem, the existing second transfer function defining a relationship between a received stimulation signal and a second output stimulation signal; determining a second updated transfer function reflecting an adjusted operation associated with the received command, the second updated transfer function being based on the second existing transfer function and the received command; and updating operation of a second cochlear implant subsystem to replace the second existing transfer function with the second updated transfer function. <Aspect 154> The updating operation of the first cochlear implant subsystem to replace the first existing transfer function with the first updated transfer function comprises: outputting signals specifying the first cochlear implant subsystem and the first updated transfer function to both the first cochlear implant subsystem and the second cochlear implant subsystem; 154. The method of embodiment 153, comprising updating a transfer function associated with only the first cochlear implant subsystem and not the second cochlear implant subsystem. <Aspect 155> The method of embodiment 154, wherein outputting the signal to both the first cochlear implant subsystem and the second cochlear implant subsystem includes outputting the signal via a bifurcated lead that communicates with both the first cochlear implant subsystem and the second cochlear implant subsystem. <Aspect 156> The method of embodiment 153, wherein the received command to adjust operation of the stereo cochlear implant system comprises a command to adjust a volume of the stereo cochlear implant system.

Claims

1. 1. A cochlear implant system comprising: A first implantable subsystem, comprising: a first cochlear electrode; a first stimulator in communication with the first cochlear electrode; a first input source configured to receive a first acoustic stimulus signal corresponding to a detected sound and to generate a first input signal based on the received first acoustic stimulus signal; a first signal processor in communication with the first stimulator and the first input source, the first signal processor programmed with a first transfer function; receiving the first input signal from the first input source; and outputting a first stimulation signal to the first stimulator based on the first input signal and the first transfer function; a first implantable subsystem, the first stimulator configured to supply an electrical signal to the first cochlear electrode in response to the first stimulation signal received from the first signal processor; a second implantable subsystem, a second cochlear electrode; a second stimulator in communication with the second cochlear electrode; a second input source configured to receive a second acoustic stimulus signal corresponding to the detected sound and to generate a second input signal based on the received second acoustic stimulus signal; a second signal processor in communication with the second stimulator and the second input source, the second signal processor programmed with a second transfer function; receiving the second input signal from the second input source; and outputting a second stimulation signal to the second stimulator based on the second input signal and the second transfer function; a second implantable subsystem, the second stimulator configured to supply an electrical signal to the second cochlear electrode in response to the second stimulation signal received from the second signal processor; an implantable module configured to communicate with the first signal processor and the second signal processor and to provide power to the first signal processor and the second signal processor.

2. 2. The cochlear implant system of claim 1, wherein the first implantable subsystem is implanted adjacent to a patient's left ear and the second implantable subsystem is implanted adjacent to the patient's right ear.

3. the first stimulator and the first signal processor are contained in a first housing; the first cochlear electrode extends from the first housing; the second stimulator and the second signal processor are contained in a second housing; The cochlear implant system of claim 2 , wherein the second cochlear electrode extends from the second housing.

4. The first housing and the second housing each have an exterior surface, the exterior surfaces comprising: A first side; a second side opposite the first side; and 4. The cochlear implant system of claim 3, further comprising a return electrode extending from the first side to the second side.

5. 2. The cochlear implant system of claim 1, wherein the implantable module is configured to adjust the first transfer function associated with the first signal processor and to adjust the second transfer function associated with the second signal processor.

6. the implantable module communicating with the first signal processor via a first lead; the implantable module is in communication with the second signal processor via a second lead, the second lead being different from the first lead; the implantable module is configured to adjust the first transfer function via communication with the first signal processor via the first lead; 6. The cochlear implant system of claim 5, wherein the implantable module is configured to adjust the second transfer function via communication with the second signal processor via the second lead.

7. 6. The cochlear implant system of claim 5, wherein the implantable module communicates with both the first signal processor and the second signal processor via a bifurcated lead.

8. 8. The cochlear implant system of claim 7, wherein the implantable module transmits the same signal to each of the first signal processor and the second signal processor via the bifurcated lead.

9. 9. The cochlear implant system of claim 8, wherein the implantable module is configured to communicate addressed output signals to the first and second signal processors via the branched leads, the addressed output signals comprising address information designating at least one of the first and second signal processors.

10. 10. The cochlear implant system of claim 9, wherein the first signal processor is not affected by an output signal addressed with address information that designates the second signal processor and not the first signal processor.

11. 6. The cochlear implant system of claim 5, wherein the implantable module is configured to receive commands to adjust the first and second transfer functions from an external device via a wireless communication interface.

12. 12. The cochlear implant system of claim 11, wherein the external device comprises a smartphone, a tablet, a charger, or a programmer.

13. 12. The cochlear implant system of claim 11, wherein the wireless communication interface comprises a Bluetooth communication or a short-range wireless communication network.

14. The implantable module comprises: adjusting the first transfer function based on the received command and the first transfer function; and adjusting the second transfer function based on the received command and the second transfer function, such that:

12. The cochlear implant system of claim 11, wherein adjusting the first transfer function is independent from adjusting the second transfer function.

15. the received command includes a command to change a volume associated with the cochlear implant system; In response to the received command, the implantable module: determining an existing first transfer function associated with the first signal processor; determining an updated first transfer function based on the determined existing first transfer function and the received command, the updated first transfer function reflecting a change in perceived volume relative to the existing first transfer function defined in the received command; determining an existing second transfer function associated with the second signal processor; and determining an updated second transfer function based on the determined existing second transfer function and the received command, the updated second transfer function reflecting a change in perceived volume relative to the existing second transfer function defined in the received command.

16. the first input source comprises a microphone or a middle-ear sensor; The cochlear implant system of claim 1 , wherein the second input source comprises a microphone or a middle-ear sensor.

17. 10. A method for adjusting the operation of a cochlear implant system according to claim 1, comprising: receiving a command to adjust operation of the cochlear implant system; determining a first pre-existing transfer function associated with the first implantable subsystem, the first pre-existing transfer function defining a relationship between a received acoustic stimulus signal corresponding to a detected sound and a first output stimulus signal; determining a first updated transfer function reflecting an adjusted operation associated with the received command, the first updated transfer function being based on the first existing transfer function and the received command; updating operation of the first implantable subsystem to replace the first existing transfer function with the first updated transfer function; determining a second pre-existing transfer function associated with the second implantable subsystem, the second pre-existing transfer function defining a relationship between a received acoustic stimulus signal corresponding to a detected sound and a second output stimulus signal; determining a second updated transfer function reflecting an adjusted operation associated with the received command, the second updated transfer function being based on the second existing transfer function and the received command; updating operation of the second implantable subsystem to replace the second existing transfer function with the second updated transfer function.

18. updating the operation of the first implantable subsystem to replace the first existing transfer function with the first updated transfer function, outputting signals specifying the first implantable subsystem and the first updated transfer function to both the first implantable subsystem and the second implantable subsystem; and updating a transfer function associated with only the first implantable subsystem and not the second implantable subsystem.

19. 20. The method of claim 18, wherein outputting the signal to both the first implantable subsystem and the second implantable subsystem comprises outputting the signal via a bifurcated lead that communicates with both the first implantable subsystem and the second implantable subsystem.

20. 18. The method of claim 17, wherein the received command to adjust operation of the cochlear implant system comprises a command to adjust a volume of the cochlear implant system.

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