Implantable cochlea system with integrated component and lead characterization

Abstract

A cochlear implant system may include a signal processor programmed with a transfer function and configured to receive an input signal and output a stimulation signal based on the received input signal and the transfer function. The system may include an implantable battery and / or a communication module in communication with the signal processor. The implantable battery and / or communication module may be configured to interface with the signal processor and update the transfer function of the signal processor. The implantable battery and / or communication module may communicate with one or more external devices and may facilitate calibration and normalization of the system. Digital and / or analog filtering may be used to compensate for non-uniformities of system behavior across a frequency range. A single implantable battery and / or communication module may provide power and data to multiple signal processors implanted as components of separate subsystems.

Description

[0001] This application is a divisional application of the patent application with an application date of February 21, 2020, an application number of 2020800230204, and an invention title of "Implantable Cochlear Systems with Integrated Components and Lead Characterization". Background Art

[0002] Cochlear implants are electronic devices that can be at least partially surgically implanted into the cochlea - the hearing organ of the inner ear - to improve a patient's hearing. Cochlear implants can include components worn externally by the patient and components implanted internally within the patient's body.

[0003] The external components can include a microphone, a processor, and a transmitter. The cochlear implant can detect sound via an ear-level microphone, which conveys these sounds to a wearable processor. Some processors can be worn behind the patient's ear. The electrical signals from the processor can be sent to a transmission coil worn externally behind the ear and located above the implant. The transmission coil can send signals to an implant receiver located beneath the patient's scalp.

[0004] The internal components can include a receiver and one or more electrodes. Some cochlear implants can include additional processing circuitry between the internal components. The receiver can direct the signals to one or more electrodes implanted within the cochlea. Then, in response to these signals, they can be transmitted along the auditory nerve to the cerebral cortex, where the response is interpreted as sound.

[0005] Some cochlear implants can be fully implanted and can include a microphone-like mechanism for measuring sound, signal processing electronics, and means for directing signals to one or more electrodes implanted within the cochlea. Fully implantable cochlear implants generally do not include a transmission coil or a receiver coil.

[0006] The internal components of such cochlear implant systems typically require power to operate. Accordingly, a power source is generally included along with the other internal components. However, the performance of such power sources typically degrades over time, and the power source may need to be replaced. Additionally, processing circuitry technology continues to advance rapidly. Improvements in processing technology over time may render the processing technology in the implantable processing circuitry obsolete. Thus, it is sometimes advantageous to replace / upgrade the processing circuitry.

[0007] However, this replacement procedure can be difficult. The location of the implantable internal components is not optimal for surgical procedures and often does not fully heal after multiple incisions. Additionally, replacing some components such as the signal processor may require removing components such as electrical leads and reintroducing the components into the patient's cochlear tissue, which can be tissue-damaging and can negatively impact the efficacy of cochlear stimulation.

[0008] In addition, there are different challenges associated with transmitting electrical signals through a patient's body. For example, safety standards may limit the amount of current that can safely flow through a patient's body (especially DC current). Additionally, a patient's body can act as an undesired signal path between different components within the body (e.g., by contacting the housing or "can" of each component). This can result in a reduction in signal strength and / or undesired communication or interference between components. In some cases, the electrical signal may even stimulate an undesired area of the patient's cochlear tissue, thereby interfering with the efficacy of the cochlear implant. SUMMARY OF THE INVENTION

[0009] Some aspects of the present disclosure generally relate to cochlear implant systems. Such systems can include a cochlear electrode, a stimulator in electrical communication with the cochlear electrode, an input source, and a signal processor. The signal processor can 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.

[0010] In some instances, the signal processor and an implantable battery and / or communication module can be electrically coupled by a plurality of conductors, e.g., to transfer data and / or deliver power between components. In some such embodiments, the signal processor and / or the implantable battery and / or communication module can 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 can be configured to measure one or more electrical parameters of the first conductor, the second conductor, and / or the first and second conductors. In some embodiments, applying the test signal can include: continuously applying a plurality of signals, where each signal of the plurality of signals has a different frequency; and determining an impedance that varies with frequency between the first conductor and the second conductor. Additionally or alternatively, in some instances, measuring the one or more electrical parameters includes determining whether the second conductor is intact.

[0011] In some embodiments, the signal processor and an implantable battery and / or communication module can be coupled by a first lead having a first conductor, a second conductor, a third conductor, and a fourth conductor. In some such instances, the implantable battery and / or communication module can 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 can transmit the power signal, the inverted power signal, the data signal, and the inverted data signal to the signal processor through the first conductor, the second conductor, the third conductor, and the fourth conductor of the first lead, respectively. The power signal and the data signal can be provided at similar or different clock rates.

[0012] The implantable battery and / or communication module can 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 instances, performing one or more characterization processes includes determining the impedance versus frequency relationship between two conductors. Additionally or alternatively, in some instances, performing one or more characterization processes includes measuring the current sent through a test conductor, measuring the voltage across the test conductor while sending the current, and determining the impedance of the test conductor.

[0013] Some aspects of the present disclosure generally relate to cochlear implant systems. Such systems can include a cochlear electrode, a stimulator in electrical communication with the cochlear electrode, an input source, and a signal processor. The signal processor can 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 the transfer function of the signal processor.

[0014] In some instances, the signal processor and the stimulator can be integrated into a single hermetically sealed housing, where the cochlear electrode extends from the single hermetically sealed housing. In some instances, the single hermetically sealed hose includes a return electrode coupled to its outer surface. In some such instances, 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 includes a conductive material and includes a pin receptacle that includes a non-conductive material, such as a biocompatible polymer. In some such embodiments, the non-conductive material of the pin receptacle provides electrical isolation between the return electrode and the conductive housing.

[0016] Some aspects of the present disclosure generally relate to cochlear implant systems. Such systems can include a cochlear electrode, a stimulator in electrical communication with the cochlear electrode, an input source, and a signal processor. The signal processor can 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 the transfer function of the signal processor.

[0017] In some instances, the signal processor includes an analog processing stage and a digital processing stage. In some such instances, the signal processor is configured to receive an input signal from an input source and input the received input signal into the analog processing stage to generate an analog-processed signal. The signal processor may input the analog-processed signal into the digital processing stage to generate a digital-processed signal. In some instances, the signal processor is configured such that the digital-processed signal corresponds to a normalized stimulation signal in which gain variability is reduced across a certain frequency range and the frequency response variability of the middle ear sensor is compensated for.

[0018] In some embodiments, the analog processing stage and / or the digital processing stage may be adjusted to normalize the frequency response of the combined analog and digital processing stages. In some instances, normalizing the frequency response causes the ratio of the digital-processed signal to the corresponding received stimulation signal to be substantially constant across multiple frequencies or frequency ranges.

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

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

[0021] Some aspects of the present disclosure generally relate to cochlear implant systems. Such systems 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 the transfer function of the signal processor.

[0022] In some embodiments, the implant system includes a near-field 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 instances, the near-field communication device and the wireless communication device are included in the implantable battery and / or communication module.

[0023] In some embodiments, the system includes an external device having an external near-field communication device configured to wirelessly communicate with an implantable near-field communication device via the first wireless communication protocol. The external device may include an external wireless communication device configured to wirelessly communicate with an implantable wireless communication device via the second wireless communication protocol.

[0024] Communication between the external wireless communication device and the implantable wireless communication device via the second wireless communication protocol can be achieved by first establishing communication between the implantable near-field communication device and the external near-field communication device via the first wireless communication protocol. In one exemplary embodiment, Bluetooth wireless communication between the implantable system and the external device can be established by implementing Bluetooth communication via near-field communication.

[0025] In some embodiments, an external device that wirelessly communicates with the implantable system via the second wireless communication protocol can enable wireless communication between the implantable system and a second external device via the second wireless communication protocol. For example, in one instance, an external device using Bluetooth pairing can be used to enable Bluetooth communication with another external device.

[0026] In some instances, the external device can provide audio and / or data to the implantable system via the second wireless communication protocol. In some embodiments, one or more external devices can interface with the implantable system by providing input signals such as streaming audio data, wake-up alerts, etc. for stimulating the cochlear tissue of the wearer. Additionally or alternatively, in some instances, the external device can be used to interface with the implantable 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 position sensor, an ambient sound sensor, etc. In some such instances, the external device may communicate with the implantable battery and / or communication module and may be configured to cause the implantable battery and / or communication module to update the signal processor transfer function in response to information determined based on the one or more sensors. Causing the implantable battery and / or communication module to update the transfer function may include providing sensor data to the implantable battery and / or communication module, where the implantable battery and / or communication module updates the transfer function based on the received data, or the external device determines that the transfer function should be updated based on data received from the sensors. Updating the transfer function may include adjusting one or more settings (e.g., gain settings, filter settings, etc.) or may include implementing a predetermined transfer function. In one example, the external device includes a GPS sensor, and the external device and / or the implantable battery and / or communication module are configured to update the transfer function to a predetermined transfer function associated with a specific location based on detecting a predetermined location.

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

[0029] Some aspects of the present disclosure generally relate to cochlear implant systems. Such systems 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 the transfer function of the signal processor.

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

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

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

[0033] Some aspects of the present disclosure generally relate to cochlear implant systems. In some instances, a cochlear implant system may include a first subsystem having a first cochlear electrode, a first stimulator, a first input source, and a first signal processor. The first input source may be configured to receive a first stimulus signal to generate a first input signal. The first signal processor may be configured to receive the first signal from the first input source and output a first stimulus 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 similar to the first subsystem, including a second cochlear electrode, a second stimulator, a second input source, and a second signal processor. The second input source may be configured to receive a second stimulus signal to produce a second input signal. The second signal processor may be configured to receive the second signal from the second input source and output a second stimulus 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, a wearer may have a first subsystem implanted near the first ear and a second subsystem implanted near the second ear.

[0035] The system may include an implantable battery and / or communication module that communicates with both the first signal processor and the second signal processor. The implantable battery and / or communication module may be configured to provide power to both the first signal processor and the second signal processor. Additionally or alternatively, the implantable battery and / or communication module may be configured to transmit data to and / or receive data from each of the first signal processor and the second signal processor. In various embodiments, the implantable battery and / or communication module may communicate with each signal processor of the first signal processor and the second signal processor via separate leads or via split leads.

[0036] In some instances, the implantable battery and / or communication module may be configured to update the transfer function associated with each of the first signal processor and the second signal processor. In instances having separate leads connecting the implantable battery and / or communication module to the respective signal processors, the implantable battery and / or communication module may transmit a signal to each respective signal processor to update the transfer function associated with each respective signal processor. In some instances, such as in instances where both the first signal processor and the second signal processor communicate with the implantable battery and / or communication module via split leads, the implantable battery and / or communication module may transmit an addressed signal to the two signal processors. The addressed signal may include information addressing one of the signal processors as the desired recipient of the signal. Each signal processor may be configured to respond only to the signal addressed to it.

[0037] In some instances, the implantable battery and / or communication module may receive commands, such as a command to adjust the volume of the system. In some such instances, the implantable battery and / or communication module may be configured to update each signal processor transfer function based on the existing transfer function of each respective signal processor, as each subsystem may operate differently and independently of one another. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 A schematic illustration of a fully implantable cochlear implant system is shown.

[0039] Figure 2 An embodiment of a fully implantable cochlear implant is shown.

[0040] Figure 3A and 3B is an exemplary illustration showing communication with the signal processor.

[0041] Figure 4 and 5 illustrates an embodiment of an exemplary middle ear sensor for use in conjunction with a patient's anatomical features.

[0042] Figure 6 Shows a diagram of an exemplary detachable connector.

[0043] Figure 7 Shows an exemplary cochlear implant system for a patient with an underdeveloped body, such as a child.

[0044] Figure 8 Is a process flow diagram that illustrates an exemplary process for implanting a cochlear implant system into a patient and / or updating a cochlear implant system.

[0045] Figure 9 Is a schematic diagram that illustrates an exemplary implantable system that includes an acoustic stimulator.

[0046] Figure 10A Is an advanced electrical schematic diagram that shows the communication between an implantable battery and / or communication module and a signal processor.

[0047] Figure 10B Shows an exemplary schematic diagram that illustrates a cochlear electrode having multiple contact electrodes and fixedly or detachably connected to an electrical stimulator.

[0048] Figure 11A Shows an advanced schematic diagram that illustrates an exemplary communication configuration between an implantable battery and / or communication module, a signal processor, and a stimulator in an exemplary cochlear implant system.

[0049] Figure 11B Is a schematic diagram that illustrates 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.

[0050] Figure 12A Is an alternative advanced schematic diagram that illustrates an exemplary communication configuration between an implantable battery and / or communication module, a signal processor, and a stimulator.

[0051] Figure 12B Is an alternative schematic diagram that illustrates an exemplary electrical communication between an implantable battery and / or communication module and a signal processor in a cochlear implant system, similar to that shown in Figure 12A as shown in.

[0052] Figure 12C Is another alternative schematic diagram that illustrates an exemplary electrical communication between an implantable battery and / or communication module and a signal processor in a cochlear implant system, similar to that shown in Figure 12ASimilar to that shown in

[0053] Figure 12D is a high-level schematic diagram that shows exemplary electrical communication between an implantable battery and / or communication module and a signal processor in a cochlear implant system, similar to that shown in Figure 12A Similar to that shown in

[0054] Figure 13A shows an exemplary schematic illustration of a processor and a stimulator combined into a single housing.

[0055] Figure 13B shows Figure 13A a simplified cross-sectional view of the processor / stimulator taken along line B-B as shown in

[0056] Figure 14A is a schematic diagram that shows an exemplary signal processing configuration for accommodating variability in the sensor frequency response.

[0057] Figure 14B shows exemplary gain and frequency response curves of signals at various stages in the processing configuration.

[0058] Figure 15 is a process flow diagram that shows an exemplary process for establishing a preferred transfer function for a patient.

[0059] Figure 16 is a process flow diagram that shows an exemplary process for establishing a preferred transfer function for a patient.

[0060] Figure 17 is a process flow diagram that shows an exemplary method for testing the efficacy of one or more sounds using one or more transfer functions on a preprocessed signal.

[0061] Figure 18 is a schematic representation of an exemplary database of preprocessed sound signals.

[0062] Figure 19 is a schematic diagram that shows possible communication between various system components according to some embodiments of a fully implantable system.

[0063] Figure 20 is a schematic diagram that shows establishing a secure wireless connection between components in an implantable system.

[0064] Figure 21 shows a process flow diagram that shows an exemplary method for pairing a charger with an implantable system.

[0065] Figure 22A process flow diagram is shown, which shows an exemplary method for pairing another device with an implantable system using a paired charger.

[0066] Figure 23 A chart showing various parameters that can be adjusted by each of various external devices.

[0067] Figure 24 An example configuration of an interface device configured to assist system calibration is shown.

[0068] Figure 25 A process flow diagram which shows an example process for calibrating an implantable system.

[0069] Figure 26 An example embodiment is shown where a cochlear implant system includes components implanted on both sides of a wearer (e.g., both their right ear and their left ear). Detailed Description

[0070] Figure 1 A schematic illustration of a fully implantable cochlear implant system is shown. Figure 1 The system includes a middle ear sensor 110 that communicates 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 a signal from the middle ear sensor 110 and generate an output signal based on the signal. For example, the signal processor 120 can be programmed with instructions to output a certain 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 the input signal from the middle ear sensor 110 and the output signal. Although not necessarily explicitly based on a function, the relationship between the input (e.g., from the middle ear sensor 110) to the signal processor 120 and the output of the signal processor 120 is referred to as the transfer function of the signal processor 120.

[0071] Figure 1The system further includes a cochlear electrode 116 implanted in the cochlear tissue of a patient. The cochlear electrode 116 is in electrical communication with an electrical stimulator 130, which may 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 instances, the cochlear electrode 116 is fixedly attached to the electrical stimulator 130. In other instances, the cochlear electrode 116 is removably attached to the electrical stimulator 130. As shown, the electrical stimulator 130 communicates with the 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.

[0072] In various embodiments, the cochlear electrode 116 may include any number of contact electrodes that make electrical contact with different components of the cochlear tissue. In such embodiments, the electrical stimulator 130 may be configured to provide an electrical signal 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 may assist the patient in differentiating between different input signals.

[0073] During exemplary operation, the middle ear sensor 110 detects an audio signal, for example, using characteristics of the patient's ear anatomy as described elsewhere herein and in U.S. Patent Publication No. 2013 / 0018216, which is hereby incorporated by reference in its entirety. The signal processor 120 may receive such a signal from the middle ear sensor 110 and generate an output to the electrical stimulator 130 based on the transfer function of the signal processor 120. The electrical stimulator 130 may then stimulate one or more contact electrodes of the cochlear electrode 116 based on the received signal from the signal processor 120.

[0074] Reference Figure 2 , an embodiment of a fully implantable cochlear implant is shown. The device in this embodiment includes a processor 220 (e.g., a signal processor), a sensor 210, a first lead 270 connecting the sensor 210 to the processor 220, and a combined lead 280 attached to the processor 220, where the combined lead 280 contains both a ground electrode 217 and a cochlear electrode 216. The illustrated processor 220 includes a housing 202, a coil 208, a first female jack 271 and a second female jack 281 for inserting the leads 270 and 280, respectively.

[0075] In some embodiments, coil 208 may receive power and / or data from an external device, e.g., including a transmission coil (not shown). Some such examples are described in U.S. Patent Publication No. 2013 / 0018216, which is incorporated by reference. In other examples, processor 220 is configured to receive power and / or data from other sources, such as Figure 1 the implantable battery and / or communication module shown to receive power and / or data. Such battery and / or communication module may be implanted, for example, in the pectoral muscle region of a patient to provide sufficient space for a larger device (e.g., a relatively large battery) to extend operation (e.g., longer battery life). Additionally, in the case where the battery needs to be ultimately replaced, several replacement procedures may be performed in the pectoral muscle region of the patient without the potential vascularization issues that may occur near the cochlear implant location. For example, in some cases, repeated procedures (e.g., battery replacement) near the cochlear implant can reduce the ability of the skin in the region to heal after the procedure. Placing a replaceable component such as a battery in the pectoral muscle region can facilitate a replacement procedure with reduced risk of such problems.

[0076] Figure 3A and 3B are exemplary diagrams showing communication with a signal processor. For example, referring to Figure 3A and 3B , a processor 320 including a housing 302, a coil 308, and a universal lead 380 is shown. The lead 380 is removable and may be attached to the processor 320 by inserting a male connector 382 of the universal lead 380 into any available female jack, shown here as 371 or 381. Figure 3A Processor 320 with the universal lead 380 removed is shown. Figure 3B Processor 320 with the universal lead 380 attached is shown. The male connector 382 is changeable and serves as a seal to prevent or minimize fluid transfer into the processor 320.

[0077] Figure 4 and 5 show embodiments of exemplary middle ear sensors for use in conjunction with the anatomical features of a patient. Referring to Figure 4, showing an embodiment of a sensor 410 of a fully implantable cochlear implant. Here, the sensor 410 touches the malleus 422. The sensor may include a cantilever 432 within a sensor housing 434. The sensor 410 may communicate with a processor 420 via at least two wires 436 and 438, which two wires may form a first lead (e.g., 270). The two wires may be made of a biocompatible material, but need not be the same biocompatible material. Examples of such biocompatible materials may include tungsten, platinum, palladium, etc. In various embodiments, one wire, two wires, or either wire of the wires 436 and 438 is coated with a coating and / or disposed within a housing, as described in U.S. Patent Publication No. 2013 / 0018216, which is incorporated by reference.

[0078] The shown cantilever 432 includes at least two ends, with at least one end operatively contacting one or more bones of the tympanic membrane or the ossicular chain. The cantilever 432 may be a laminate of at least two layers of material. The materials used may be piezoelectric. An example of such a cantilever 432 is a piezoelectric bimorph well known in the art (see, for example, U.S. Patent 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 more than two layers of piezoelectric material. In yet another embodiment, the cantilever is made of more than two layers of piezoelectric material and non-piezoelectric material.

[0079] 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, for example, the sensor 410 may be similar to the sensor described in U.S. Patent No. 7,524,278 to Madsen et al. or an available sensor such as the sensor 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. Patent No. 5,540,095.

[0080] Reference Figure 5 , showing an embodiment of a sensor 510 of a fully implantable cochlear implant. Also shown is a portion of the anatomy of a subject, which, if the subject is anatomically normal, includes 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. Here, the sensor 510 touches the incus 524. The sensor 510 in this embodiment may be as described for Figure 4described by the embodiment of the sensor 410 shown. Further, although not shown in the drawings, the sensor 510 may be operatively in contact with the tympanic membrane or the stapes or any combination of the tympanic membrane, malleus 522, incus 524, or stapes 526.

[0081] Figure 4 and 5 Exemplary middle ear sensors for use with the systems described herein are shown. However, other middle ear sensors may be used, such as sensors using microphones or other sensors capable of receiving an input corresponding to a detected sound and outputting a corresponding signal to a signal processor. Additionally or alternatively, the system may include other sensors configured to output a signal representative of a sound received at or near the user's ear, such as a microphone or other acoustic pickup located in the user's outer ear or implanted under the user's skin. Such devices may act as an input source to, for example, a signal processor such that the signal processor receives an input signal from the input source and generates and outputs one or more stimulation signals based on the received input signal and a signal processor transfer function.

[0082] Returning to Figure 1 , the signal processor 120 is shown 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 may receive input signals from the middle ear sensor 110 and / or other input sources and output signals to the electrical stimulator 130 for stimulating the cochlear electrodes 116. The signal processor 120 may receive data (e.g., processing data for establishing or updating the 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 may communicate with such components through inputs such as shown in FIG. 3.

[0083] In some embodiments, the implantable battery and / or communication module 140 may communicate with external components such as the programmer 100 and / or the battery charger 102. When the battery charger 102 is brought close to the implantable battery and / or communication module 140 in the patient's pectoral muscle region, the battery charger may wirelessly charge the battery in the implantable battery and / or communication module 140. This charging may be accomplished using, for example, inductive charging. The programmer 100 may be configured to wirelessly communicate with the implantable battery and / or communication module 140 through any suitable wireless communication technology such as Bluetooth, Wi-Fi. In some instances, the programmer 100 may be used to update the system firmware and / or software. In an exemplary operation, the programmer 100 may be used to transfer 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 may be separate devices or may be integrated into a single device.

[0084] In Figure 1 the illustrated example, the signal processor 120 is connected to the middle ear sensor 110 via a lead 170. In some embodiments, the lead 170 may provide communication between the signal processor 120 and the middle ear sensor 110. In some embodiments, the lead 170 may include a plurality of isolated conductors that provide a plurality of communication channels between the middle ear sensor 110 and the signal processor 120. The lead 170 may include a coating such as an electrical insulation sheath for minimizing any conduction of electrical signals to the patient's body.

[0085] In various embodiments, one or more communication leads are detachable such that communication between the two components can be disconnected to electrically and / or mechanically separate such components. For example, in some embodiments, the lead 170 includes a detachable connector 171. The detachable connector 171 may facilitate decoupling of the signal processor 120 and the middle ear sensor 110. Figure 6 An illustration of an exemplary detachable connector is shown. In the illustrated example, the detachable connector 671 includes a male connector 672 and a female connector 673. In the illustrated example, the male connector 672 includes a plurality of isolated electrical contact regions 682, and the female connector 673 includes a corresponding plurality of electrical contact regions 683. When the male connector 672 is inserted into the female connector 673, the contact regions 682 make electrical contact with the contact regions 683. Each pair of corresponding contact regions 682, 683 may provide a separate communication channel between the components connected by the detachable connector 671. In the illustrated example, there may be four communication channels, but it should be understood that any number of communication channels is possible. Additionally, although shown as separate circumferentially extending contact regions 683, other configurations are possible.

[0086] In some embodiments, the male 672 and female 673 connectors are respectively attached to the ends of leads 692, 693. Such leads may extend from components of an implantable cochlear system. For example, referring to Figure 1 , in some embodiments, the lead 170 may include a first lead extending from the middle ear sensor 110 having one of a male (e.g., 672) or female (e.g., 673) connector and a second lead extending from the signal processor 120 having the other of the male or female connector. The first lead and the second lead may be connected at the detachable connector 171 to facilitate communication between the middle ear sensor 110 and the signal processor 120.

[0087] In other instances, components of the detachable connector 171 may be integrated into one of the middle ear sensor 110 and the signal processor 120 (e.g., as shown in FIG. 3). For example, in an exemplary embodiment, the signal processor 120 may include a female connector (e.g., 673) integrated into the housing of the signal processor 120. The lead 170 may extend completely from the middle ear sensor 110 and terminate at a corresponding male connector (e.g., 672) for insertion into the female connector of the signal processor 120. In still other embodiments, the lead (e.g., 170) may include connectors located at each end, the connectors being configured to detachably connect to connectors in each of the components integrated into the communicating components. For example, the lead 170 may include two male connectors, two female connectors, or one male connector and one female connector for detachably connecting to corresponding connectors integrated into the middle ear sensor 110 and the signal processor 120. Thus, the lead 170 may include two or more detachable connectors.

[0088] A similar communication configuration may be established for the detachable connector 181 of the lead 180 that facilitates communication between the signal processor 120 and the stimulator 130 and the detachable connector 191 of the lead 190 that facilitates communication between the signal processor 120 and the implantable battery and / or communication module 140. The leads (170, 180, 190) may include paired leads having corresponding connectors extending from each piece of communication equipment, or the connectors may be built into any one or more of the communication components.

[0089] In such configurations, each of the electrical stimulator 130, the signal processor 120, the middle ear sensor 110, and the battery and / or communication module may each be enclosed in a housing, such as an airtight housing including biocompatible materials. Such components may include feedthroughs that provide communication with the internal components enclosed in the housing. The feedthroughs may provide electrical communication with the components through leads extending from the housing and / or connectors integrated into the components.

[0090] In as Figure 1In the module configuration shown, such as the module configuration, each component can be accessed separately from other components (e.g., for upgrading, repairing, replacing, etc.). For example, as the signal processor 120 is technologically improved (e.g., improved in terms of size, processing speed, power consumption, etc.), the signal processor 120 implanted as a component of the system can be removed and replaced independently of other components. In an exemplary procedure, the implantable signal processor 120 can be disconnected from the electrical stimulator 130 by cutting the detachable connector 181, disconnected from the middle ear sensor 110 by cutting the detachable connector 171, and disconnected from the implantable battery and / or communication module 140 by cutting the detachable connector 191. Thus, the signal processor 120 can be removed from the patient's body, while other components such as the electrical stimulator 130, the cochlear electrode 116, the middle ear sensor 110, and the battery and / or communication module can remain in place in the patient's body.

[0091] After removing the old signal processor, 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 respectively through the detachable connectors 181, 171, and 191. Thus, the signal processor (e.g., 120) can be replaced, repaired, upgraded, or any combination thereof without affecting other system components. This can reduce the risks, complexity, duration, and recovery time, etc. of this procedure. Specifically, the cochlear electrode 116 can remain in place in the patient's cochlea, while other system components can be adjusted, thereby reducing the trauma to the patient's cochlear tissue.

[0092] When replacing the signal processor 120 as described above, this modularity of system components can be particularly advantageous. Processor technology is constantly improving and may continue to improve significantly in the future, making the signal processor 120 a likely candidate for significant upgrading and / or replacement during the patient's life. Additionally, in embodiments such as the Figure 1 embodiment shown, the signal processor 120 communicates with many system components. For example, as shown in the figure, 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. Disconnecting such components from the signal processor 120 detachably (e.g., through the detachable connectors 181, 171, and 191) enables the replacement of the signal processor 120 without disturbing any other components. Thus, in the case of upgrading the available signal processor 120 and / or the failure of the signal processor 120, the signal processor 120 can be disconnected from and removed from other system components.

[0093] Although there are many advantages to having a replaceable signal processor 120, modularity of other system components also has advantages, for example, for upgrading any system component. Similarly, if a system component (e.g., middle ear sensor 110) fails, the component can be disconnected from the rest of the system (e.g., via detachable connector 171) and replaced without disturbing the rest of the system components. In another example, even the rechargeable battery included in the implantable battery and / or communication module 140 may eventually wear out and need to be replaced. The implantable battery and / or communication module 140 can be replaced or accessed (e.g., for battery replacement) without disturbing other system components. Further, as discussed elsewhere herein, when implanting the implantable battery and / or communication module 140 in the pectoral muscle region of a patient, as in the example shown, this procedure can keep the patient's pin site out of contact, thus eliminating unnecessary frequent entry under the skin.

[0094] Although the various components are described herein as detachable, in various embodiments, one or more components configured to communicate with each other can be integrated into a single housing. For example, in some embodiments, the signal processor 120 can be formed integrally 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 can be integrally formed as a single unit in a housing coupled to the cochlear electrode. The cochlear electrode and the signal processor / stimulator can be implanted during an initial procedure and operate as a single unit.

[0095] In some embodiments, although the integrated signal processor / stimulator / cochlear electrode assembly is not removed from the patient due to potential damage to the cochlear tissue in which the cochlear electrode is implanted, system upgrades are still possible. For example, in some embodiments, a modular signal processor can be implanted along the integrated signal processor / stimulator assembly and communicate with it. In some such instances, the integrated signal processor can include a built-in bypass to allow a later-implanted signal processor to interface directly with the stimulator. Additionally or alternatively, the modular signal processor can communicate with the integrated signal processor, which can be programmed with a unit transfer function. Thus, in some such embodiments, signals from the modular signal processor can pass through the integrated signal processor essentially unchanged, such that the modular signal processor effectively controls the operation of the integrated stimulator. Thus, in various embodiments, there are hardware and / or software solutions for a signal processor that is integrally attached and may be difficult or dangerous to remove.

[0096] As Figure 1Another advantage of the modular cochlear implant system shown is the ability to implant different system components into the patient at different times. For example, infants and children are generally not suitable for a fully implantable system such as Figure 1 shown. Instead, such patients are typically candidates for wearing a conventional cochlear implant system. For example, Figure 7 illustrates an exemplary cochlear implant system for a patient with an incompletely developed body, such as a child. The system includes a cochlear electrode 716 implanted into the cochlear tissue of the patient. Figure 7 The cochlear electrode 716 of Figure 7 may include many of the properties of the cochlear electrodes described herein. The cochlear electrode 716 may be in electrical communication with an electrical stimulator 730, which may be configured to stimulate portions of the cochlear electrode 716 in response to an input signal as described elsewhere herein. The electrical stimulator 730 may receive the input signal from a signal processor 720.

[0097] In some cases, components such as middle ear sensors are not compatible with patients with an incompletely developed body. For example, the various dimensions within the anatomy of a growing patient, such as the spacing between anatomies or the positions on the anatomy (e.g., device attachment points), may change as the patient grows, which may render middle ear sensors that are extremely sensitive to movement ineffective. Similarly, undeveloped patients may not be able to support an implantable battery and / or communication module. Accordingly, the signal processor 720 may communicate with a communication device for communicating with components external to the patient. Such communication components may include, for example, a coil 708 shown connected to the signal processor 720 by a lead 770. The coil 708 may be used to receive data and / or power from a device external to the user. For example, a microphone or other audio sensing device (not shown) may communicate with an external coil 709, which is configured to transmit data to the coil 708 implanted within the patient. Similarly, a power source (e.g., a battery) may be coupled to the external coil 709 and may be configured to provide power to the implantable components through the implantable coil 708. Additionally, data to be processed (e.g., an update to the transfer function of the signal processor 720) may also be transmitted from the external coil 709 to the implantable coil 708. Although generally discussed using the coil 708, it should be understood that other communication technologies, such as various forms of wireless communication, may be used to perform communication between external components and implantable components (e.g., the signal processor 720). As shown, in Figure 7 the embodiment of Figure 7 , the signal processor 720 is coupled to the coil 708 by a lead 770 and a detachable connector 771. Accordingly, the coil 708 may be detached from the signal processor 720 and removed without damaging the signal processor 720.

[0098] When the patient is fully developed to the point where, for example, 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, once the patient has developed, the cochlear implant system (e.g., Figure 7 the cochlear implant system) can be updated to a fully implantable cochlear implant system (e.g., Figure 1 the fully implantable cochlear implant system). In some instances, once the patient reaches the age of 18 or another predetermined age, the patient is considered to be fully developed. Additional or alternative criteria can be used, such as when various anatomical sizes or determined developmental states are reached.

[0099] Figure 8 is a process flow diagram that shows an exemplary process for implanting an implantable cochlear implant system into a patient and / or updating an implantable cochlear implant system. Cochlear electrodes can be implanted to communicate with the patient's cochlear tissue, and a stimulator can be implanted to communicate with the cochlear electrodes (step 850). A signal processor can be implanted into the patient (step 852). As described elsewhere herein, the signal processor can be connected to the stimulator through a detachable connector (step 854). In instances where the signal processor is integrally formed with one or more components such as the stimulator and cochlear electrodes, steps 850, 852, and 854 can be combined into a single step that includes implanting the cochlear electrodes, stimulator, and signal processor components.

[0100] If, when implementing the Figure 8 process, it can be determined whether the patient is considered fully 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 the signal processor through a detachable connector (step 860), and the cochlear implant can be operated in conjunction with external components such as a microphone and an external power supply and coil (step 862).

[0101] However, if the patient has already been fully developed or has become fully developed (step 856), then additional components can be implanted into the patient. For example, the method can include implanting a middle ear sensor (step 864) and connecting the middle ear sensor to the signal processor through a detachable connector (step 866). Additionally, the method can include implanting a battery and / or communication module (step 868) and connecting the battery and / or communication module to the signal processor through a detachable connector (step 870). If the patient is wearing such as with respect to Figure 7If the portions of the external device described in steps 858 - 862 become fully developed later, the method may include removing each previously implanted component. For example, during the procedure of implanting the middle ear sensor, the coil implanted in step 858 may be disconnected and removed (step 864).

[0102] Figure 8 The process can be embodied in a method of fitting an implantable hearing system to a patient. This method may include implanting a first system (e.g., Figure 7 a system) into the patient at a first age. This may include, for example, performing Figure 8 steps 850 - 562. The method may further include, when the patient reaches a second age, removing some components (e.g., the coil) of the first system and implanting the yet - to - be - implanted components of a second system (e.g., Figure 1 a system), for example, by Figure 8 steps 864 - 870, where the second age is greater than the first age.

[0103] For example, transitioning from Figure 8 a system to Figure 7 a system through Figure 1 a process can have several advantages. From the perspective of patient preference, some patients may prefer a fully implanted system that does not require wearable external components. Additionally, compared to external devices such as coils, an implantable battery and / or communication module that communicates with the signal processor through lead 190 (and detachable connector 191) can relay power and / or data to the signal processor more efficiently.

[0104] This modular system offers significant advantages over previously implantable or partially implantable cochlear implant systems. Generally, previous systems included several components incorporated into a single housing implanted in the patient. For example, the functions of the signal processor, the electrical stimulator, and the sensor could be enclosed in a single complex component. If any such aspect of the component fails, which becomes more likely as complexity increases, the entire module must be replaced. In contrast, in a modular system such as Figure 1 shown, a single component can be replaced while leaving other components in place. Additionally, communication such as through lead 190 in such systems that includes, for example, coil - to - coil power and / or data communication through the patient's skin is generally less efficient than internal connections. A modular system such as Figure 1 and 7 shown also allows for a smooth transition from a partially implantable system for a patient who has not fully developed to a fully implantable system when the patient has fully developed.

[0105] Although typically described herein as using an electrical stimulator to stimulate a patient's cochlear tissue via cochlear electrodes, in some instances, the system may additionally or alternatively include an acoustic stimulator. The acoustic stimulator may include, for example, a transducer (e.g., a piezoelectric transducer) configured to provide mechanical stimulation to the ear structure of the patient. In an exemplary embodiment, the acoustic stimulator may be configured to stimulate one or more portions of the ossicular chain of the patient via amplified vibrations. The acoustic stimulator may include any suitable acoustic stimulator, such as those present in the ESTEEM™ implant (Envoy Medical Corporation, St. Paul, Minnesota) or as described in U.S. Patent Nos. 4,729,366, 4,850,962, and 7,524,278 and U.S. Patent Publication No. 20100042183, each of which is incorporated herein by reference in its entirety.

[0106] Figure 9 is a schematic diagram that shows an exemplary implantable system that includes an acoustic stimulator. The acoustic stimulator may be implanted near the ossicular chain of the patient and may communicate with a signal processor via leads 194 and a detachable connector 195. The signal processor may behave as described elsewhere herein and may be configured to cause acoustic stimulation of the ossicular chain via the acoustic stimulator in response to an input signal from a middle ear sensor according to the transfer function of the signal processor.

[0107] Figure 9 The acoustic stimulator of may be used similarly to the electrical stimulator described elsewhere herein. For example, the acoustic stimulator may be mechanically coupled to the ossicular chain of the patient when implanted and may be coupled to the signal processor via leads 194 and a detachable connector 195. Similar to the systems described elsewhere herein with respect to electrical stimulators, if the signal processor needs to be replaced or repaired, the signal processor may be disconnected from the acoustic stimulator (via the detachable connector 195) such that the signal processor may be removed without disturbing the acoustic stimulator.

[0108] Generally, a system incorporating an acoustic sensor as shown in Figure 9 may operate in the same manner as the systems described elsewhere herein that employ an electrical stimulator and cochlear electrodes with only electrical stimulation instead of acoustic stimulation. The same modular benefits, including system maintenance and upgrades, and the ability to be converted to a fully implantable system when the patient becomes fully developed, may be similarly achieved using an acoustic stimulation system. For example, the process shown in Figure 8 may be performed in the acoustic stimulation system simply by replacing the acoustic stimulator with an electrical stimulator and cochlear electrodes.

[0109] Some systems can include hybrid systems that include both an electrical stimulator and an acoustic stimulator that communicate with a signal processor. In some such instances, the signal processor can be configured to perform electrical stimulation and / or acoustic stimulation according to the transfer function of the signal processor. In some instances, the type of stimulation used can 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 can specify the type of stimulation. In some cases, frequencies below a threshold frequency can be represented using one of electrical stimulation and acoustic stimulation, while frequencies above the threshold frequency can be represented using the other of electrical stimulation and acoustic stimulation. This threshold frequency can be adjusted based on the patient's hearing profile. Using a limited frequency range can reduce the number of frequency bins and, thus, the number of contact electrodes on the cochlear electrode. In other instances, rather than a single threshold frequency defining which frequencies are electrically and acoustically stimulated, both electrical stimulation and acoustic stimulation can be performed on a variety of frequencies. In some such instances, the relative amount of electrical stimulation and acoustic stimulation can be frequency-dependent. As described elsewhere herein, the signal processor transfer function can be updated to meet the patient's needs, including electrical and acoustic stimulation profiles.

[0110] Further reference Figure 1 and 9 , in some instances, the system can include a cut-off controller 104 that can be configured to wirelessly prevent the electrical stimulator 130 from stimulating the patient's cochlear tissue and / or prevent the acoustic stimulator 150 from stimulating the patient's ossicular chain. For example, if the system malfunctions or a loud input sound that is uncomfortable results in an undesired stimulation level, the user can use the cut-off controller 104 to interrupt the stimulation from the stimulator 130. The cut-off controller 104 can be embodied in a variety of ways. For example, in some embodiments, the cut-off controller 104 can be integrated into other external components such as the programmer 100. In some such instances, the programmer 100 includes a user interface through which the user can select an emergency shutdown feature for interrupting the stimulation. Additionally or alternatively, the cut-off controller 104 can be embodied as a separate component. The separate component can be used in situations where the patient may not have immediate access to the programmer 100. For example, the cut-off controller 104 can be implemented as a wearable component that the patient can wear all or most of the time, such as a ring, bracelet, necklace, etc.

[0111] The cut-off controller 104 can communicate with the system to stop stimulation in a variety of ways. In some instances, the cut-off controller 104 includes a magnet that can be detected by a sensor (such as a Hall-Effect sensor) implanted in the patient, such as a processor and / or an implantable battery and / or a communication module 140. In some such embodiments, when the magnet is brought close enough to the sensor, the system can stop stimulating the cochlear tissue or the ossicular chain.

[0112] After using the cut-off controller 104 to disable stimulation, stimulation can be re-enabled in one or more of a variety of ways. For example, in some embodiments, stimulation is re-enabled after a predetermined amount of time after stimulation is disabled. In other instances, the cut-off controller 104 can be used to re-enable stimulation. In some such instances, the patient brings the cut-off controller 104 within a first distance of the sensor (e.g., a magnetic sensor) to disable stimulation and then removes the cut-off controller 104. Subsequently, once the patient brings the cut-off controller 104 within a second distance of the sensor, stimulation can be re-enabled. In various embodiments, the first distance can be less than, equal to, or greater than the second distance. In still other embodiments, another device such as a separate on controller (not shown) or the programmer 100 can be used to re-enable stimulation. Any combination of this re-enabling of stimulation can be used, such as alternatively using the programmer 100 or the cut-off controller 104 to enable stimulation or combining a minimum "off" time before any other method can be used to re-enable stimulation.

[0113] In some embodiments, instead of completely disabling stimulation, other actions can be taken, such as reducing the magnitude of the stimulation. For example, in some embodiments, a cut-off sensor can be used to reduce the output signal by a predetermined amount (e.g., an absolute amount, a percentage, etc.). In other instances, the cut-off sensor may affect the transfer function of the signal processor to reduce the magnitude of the stimulation in a customized manner, such as according to the frequency of the input signal or other parameters (e.g., from a middle ear sensor).

[0114] Return reference Figure 1 , as described elsewhere herein, an implantable battery and / or communication module can be used to provide power and / or data (e.g., processing instructions) to other system components via the lead 190. There are different challenges in transmitting electrical signals through the patient's body. For example, safety standards may limit the amount of current that can safely flow through the patient's body (especially DC current). Additionally, the patient's body may act as an unwanted signal path from component to component (e.g., by contacting the housing or "can" of each component). Various systems and methods can be employed to improve the communication capabilities between system components.

[0115] Figure 10Ais a high-level electrical schematic diagram that shows the 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 the 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 leads (190) represented by a lead transfer function. The lead transfer function can include, for example, parasitic resistances and capacitances between the leads connecting the implantable battery and / or communication module and the signal processor and the patient's body and / or between two or more conductors that make up the leads (e.g., 191). Signals transmitted from the circuitry in the implantable battery and / or communication module to the circuitry in the signal processor can include power and / or data (e.g., processing data regarding the transfer function of the signal processor) provided for operating and / or stimulating system components (e.g., middle ear sensors, signal processors, electrical and / or acoustic stimulators, and / or cochlear electrodes).

[0116] As discussed elsewhere herein, the patient's body provides a circuit path between system components, such as the "can" of the implantable battery and / or communication module and the "can" of the signal processor. This path is represented in Figure 10A by the flow path through R 身体 . Thus, the patient's body may provide an unwanted signal path that can negatively affect communication between components. To address this issue, in some embodiments, the operating circuitry in each component can be substantially isolated from the component "can" and thus from the patient's body. For example, as shown, a resistor R 罐 is positioned between the circuitry and the "can" of both the implantable battery and / or communication module and the signal processor.

[0117] Although shown as R 罐 in each of the implantable battery and / or communication module and the signal processor, it should be understood that the actual values of the resistances between the circuitry and the respective "cans" of the different elements may not be equal. Additionally, R 罐 need not consist only of a resistor, but can include other components, such as one or more capacitors, inductors, etc. That is, R 罐 can represent an isolation circuit that includes any type of component that serves to increase the impedance between the circuitry within a component and the "can" of the component. Thus, R 罐 can represent the impedance between the operating circuitry of a component and the respective "can" and the patient's tissue. Isolating the circuitry from the "can" and the patient's body serves to similarly isolate the circuitry from the "cans" of other components, thereby allowing each component to operate with respect to a substantially isolated component ground. This can eliminate unwanted communication and interference between system components and / or between system components and the patient's body.

[0118] For example, as described elsewhere herein, in some instances, an electrical stimulator may provide electrical stimulation to one or more contact electrodes on a cochlear electrode implanted in a patient's cochlear tissue. Figure 10B An exemplary schematic diagram is shown that depicts a cochlear electrode having a plurality of contact electrodes and fixedly or removably coupled to an electrical stimulator. As shown, the cochlear electrode 1000 has four contact electrodes 1002, 1004, 1006, and 1008, but it should be understood that any number of contact electrodes is possible. As described elsewhere herein, the electrical stimulator may provide an electrical signal to one or more such contact electrodes in response to an output from a signal processor according to a signal processor transfer function and a received input signal.

[0119] Because each of the contact electrodes 1002 - 1008 is in contact with the patient's cochlear tissue, each contact electrode is separated from the "can" of the electrical stimulator (and the "cans" of other system components) by an impedance of the patient tissue shown as R 身体 . Thus, if the circuitry within various system components has an insufficiently high impedance to the component "can" (e.g., R 罐 ), the electrical signal may stimulate an undesired region of the patient's cochlear tissue. For example, stimulation intended for a particular contact electrode (e.g., 1002) may result in undesired stimulation of other contact electrodes (e.g., 1004, 1006, 1008), thereby reducing the overall efficacy of the system. Due to the patient's body, incorporating an impedance minimizing conductive path between the component circuitry and the corresponding "can" (e.g., to the contact electrodes of the cochlear electrode) via R 罐 can thus improve the ability to apply electrical stimulation to only the desired portions of the patient's body.

[0120] It should be understood that the term R 身体 is used herein to generally represent the resistance and / or impedance of the patient tissue between various components and does not refer to a specific value. Additionally, each depiction or R 身体 in the figures does not necessarily represent the same resistance and / or impedance as other depictions.

[0121] Figure 11A A high - level schematic diagram is shown that depicts an exemplary communication configuration between an implantable battery and / or communication module, a signal processor, and a stimulator. In Figure 11AIn an example, the implantable battery and / or communication module 1110 communicates bi - directionally with the signal processor 1120. For example, the implantable battery and / or communication module 1110 can transmit power and / or data signal 1150 to the signal processor 1120. In some examples, the power and data signal 1150 can be included in a single signal generated in the implantable battery and / or communication module 1110 and can be transmitted to the signal processor 1120. Such a signal can include, for example, a digital signal transmitted at a specific clock rate, which in some embodiments can be adjusted, for example, by the implantable battery and / or communication module 1110.

[0122] In some embodiments, the signal processor 1120 can transmit information, such as feedback information and / or a request for more power, etc., to the implantable battery and / or communication module 1110 (e.g., 1151). In response, the implantable battery and / or communication module 1110 can adjust its output to the signal processor 1120 (e.g., magnitude, duty cycle, clock rate, etc.) to accommodate the received feedback (e.g., to provide more power, etc.). Thus, in some such examples, the implantable battery and / or communication module 1110 can transmit power and data (e.g., 1150) to the signal processor 1120, and the signal processor 1120 can transmit various data back to the implantable battery and / or communication module 1110 (e.g., 1151).

[0123] In some embodiments, similar communication can be implemented between the signal processor 1120 and the stimulator 1130, where the signal processor 1120 provides power and data to the stimulator 1130 (e.g., 1160) and in turn receives data from the stimulator 1130 (e.g., 1161). For example, the signal processor 1120 can be configured to output signals (e.g., power and / or data) to the stimulator 1130 (e.g., based on received input from a middle - ear sensor or other device) through a similar communication protocol as implemented between the implantable battery and / or communication module 1110 and the signal processor 1120. Similarly, in some embodiments, the stimulator can be configured to provide a feedback signal to the signal processor, such as indicating the performed stimulation process. Additionally or alternatively, the stimulator can provide diagnostic information, such as electrode impedance and neural response telemetry or other biomarker signals.

[0124] Figure 11B is a schematic diagram that shows 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 the signal processor 1120 through a lead (e.g., 190). As regarding Figure 11AAs described, in some instances, signal generator 1112 is configured to generate both data and power signals (e.g., 1150) for communication with signal processor 1120. In some embodiments, signal generator 1112 generates digital signals for communication with signal processor 1120. The digital signals from signal generator 1112 can be transmitted to signal processor 1120 at a particular clock rate. In some instances, the signals are generated at approximately 30 kHz. In various instances, the data and power frequencies can range from approximately 100 Hz to approximately 10 MHz and can be adjusted, for example, by a user in some instances.

[0125] In the illustrated embodiment, implantable battery and / or communication module 1110 includes a controller that communicates with signal generator 1112. In some instances, the controller is capable of adjusting communication parameters such as the clock rate of signal generator 1112. In an exemplary embodiment, the controller and / or signal generator 1112 can communicate with, for example, an external programmer of a patient (e.g., Figure 1 as shown). The controller and / or signal generator 1112 can be configured to transmit data to signal processor 1120 (e.g., 1151), such as updated firmware, transfer functions of signal processor 1120, etc.

[0126] As shown, signal generator 1112 outputs the generated signals to amplifier 1190 and inverter amplifier 1192. In some instances, both amplifiers are unity-gain amplifiers. In some instances that include digital signals, inverter amplifier 1192 can include a digital NOT gate. The outputs from amplifier 1190 and inverter amplifier 1192 are generally opposite to each other and are directed towards signal processor 1120. In some embodiments, the relative nature of the signal outputs from amplifiers 1190 and 1192 to signal processor 1120 results in charge-neutral communication between implantable battery and / or communication module 1110 and signal processor 1120 such that no net charge flows through the wearer.

[0127] In Figure 11BIn the illustrated example, the receiving circuitry in signal processor 1120 includes a rectifier circuit 1122 that receives signals (e.g., 1150) from amplifier 1190 and inverter amplifier 1192. Since the output of one of amplifiers 1190 and 1192 will be high, rectifier circuit 1122 can be configured to receive differential signals from amplifiers 1190 and 1192 and thereby generate a substantially DC power output 1123. In various embodiments, the DC power 1123 can be used to power various components, such as signal processor 1120 itself, middle ear sensors, electrical and / or acoustic stimulators, etc. For example, rectifier circuit 1122 can include any known suitable circuitry components for rectifying one or more input signals, such as a diode rectifier circuit or a transistor circuit.

[0128] As described elsewhere herein, implantable battery and / or communication module 1110 can transmit data to signal processor 1120. In some embodiments, controller and / or signal generator 1112 is configured to encode data for transmission via output amplifiers 1190 and 1192. Signal processor 1120 can include a signal extraction module 1124 that is configured to extract a data signal 1125 from signals (e.g., 1150) transmitted to signal processor 1120 to produce a signal for use by signal processor 1120. In some instances, signal extraction module 1124 is capable of decoding signals encoded by implantable battery and / or communication module 1110. Additionally or alternatively, signal extraction module 1124 can extract signals 1125 produced by lead transfer functions. In various instances, the extracted signals 1125 can include, for example, an updated transfer function for signal processor 1120, a desired stimulation command, or other signals that affect the operation of signal processor 1120.

[0129] In the illustrated example, signal processor 1120 includes a controller 1126 capable of monitoring DC power 1123 and signals 1125 received from an implantable battery and / or communication module 1110. Controller 1126 may be configured to analyze the received DC power 1123 and signals 1125 and determine whether the power and / or signals are sufficient. For example, controller 1126 may determine that the DC power received by signal processor 1120 for stimulating cochlear electrodes is insufficient, or that data from implantable battery and / or communication module 1110 is not being transmitted at a desired rate, based on the transfer function of signal processor 1120. Thus, in some instances, controller 1126 of signal processor 1120 may communicate with controller 1114 of implantable battery and / or communication module 1110 and provide feedback regarding the received communication. Based on the received feedback from controller 1126 of signal processor 1120, controller 1114 of implantable battery and / or communication module 1110 may adjust various properties of the signals output by implantable battery and / or communication module 1110. For example, the controller of implantable battery and / or communication module 1110 may adjust the clock rate of the communication from signal generator 1112 to signal processor 1120.

[0130] In some systems, the transfer efficiency between implantable battery and / or communication module 1110 and signal processor 1120 depends on the transfer clock rate. Thus, in some instances, implantable battery and / or communication module 1110 starts by transmitting at an optimized clock rate until a change in clock rate is requested by signal processor 1120, for example to enhance data transfer (e.g., rate, resolution, etc.). In other cases, if more power is needed (e.g., controller of signal processor 1120 determines that DC power is insufficient), the clock frequency may be adjusted to increase transfer efficiency and thus increase the magnitude of the signals received at signal processor 1120. It should be understood that in addition to or instead of adjusting the clock rate, adjusting the amount of power transferred to signal processor 1120 may include adjusting the magnitude of the signals output from signal generator 1112. In some embodiments, for example with respect to Figure 11A -B, power and data may be transferred from implantable battery and / or communication module 1110 to signal processor 1120 at a rate of approximately 30 kHz and may be adjusted as needed and / or as required, for example, by signal processor 1120.

[0131] Figure 12A is an alternative high-level diagram that shows an exemplary communication configuration between an implantable battery and / or communication module, a signal processor, and a stimulator. In Figure 12AIn an example, 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 further communicates bidirectionally to provide additional signals (e.g., 1251) together with the signal processor 1220. In Figure 12A In an example, the implantable battery and / or communication module 1210 may provide a power signal (e.g., 1250) to the signal processor 1220 via a communication link and additionally perform bidirectional data communication (1251) with the signal processor 1220 via a second communication link. In some such examples, the power (1250) and data (1251) signals may each comprise digital signals. However, in some embodiments, the power and data signals are transmitted at different clock rates. In some examples, the clock rate of the data signal is at least one magnitude greater than the clock rate of the power signal. For example, in an exemplary embodiment, the power signal is transmitted at a clock rate of approximately 30 kHz, while the data communication occurs at a clock rate of approximately 1 MHz. Similar to Figure 11A the embodiments described, in some examples, the clock rate may be adjustable, e.g., by the implantable battery and / or communication module 1210.

[0132] As regarding Figure 11A As described, in some embodiments, the signal processor 1220 may transmit information, such as feedback information and / or a request for more power, etc. (e.g., data signal 1251), to the implantable battery and / or communication module 1210). In response, the implantable battery and / or communication module 1210 may adjust the power and / or data output to the signal processor 1220 (e.g., magnitude, duty cycle, clock rate, etc.) to accommodate the received feedback (e.g., to provide more power, etc.).

[0133] In some embodiments, similar communication may be implemented between the signal processor 1220 and the stimulator 1230, where the signal processor 1220 provides power and data to the stimulator 1230 and in turn receives data 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 received input from a middle ear sensor or other device). This communication may be implemented via a similar communication protocol as implemented between the implantable battery and / or communication module 1210 and the signal processor 1220. In some examples, the power signal provided to the stimulator 1230 (e.g., 1260) is the same signal (e.g., 1250) received by the signal processor 1220 from the implantable battery and / or communication module 1210. Additionally, in some embodiments, the stimulator 1230 may be configured to provide a feedback signal, such as indicating the performed stimulation process, to the signal processor 1220 (e.g., 1261).

[0134] Figure 12B is an alternative schematic diagram that shows 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 Figure 12A In Figure 12B the illustrated embodiment, 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 signals to the signal processor 1220b via leads (e.g., 190). In some embodiments, the power signal generator 1211 and the signal generator 1212 each generate digital signals for communicating with the signal processor 1220b. In some such embodiments, the digital signal from the power signal generator 1211 (e.g., 1250) may be transmitted to the signal processor 1220b at a power clock rate, while the digital signal from the signal generator 1212 (e.g., 1251b) may be transmitted to the signal processor 1220b at a data clock rate different from the power clock rate. For example, in some configurations, power and data can be transmitted most effectively and / or efficiently at different clock rates. In an exemplary embodiment, the power clock rate is approximately 30 kHz, while the data clock rate is approximately 1 MHz. Using different and separately transmitted power and data signals with different clock rates can improve the transfer efficiency of power and / or data from the implantable battery and / or communication module 1210b to the signal processor 1220b.

[0135] In the illustrated embodiment, the implantable battery and / or communication module 1210b includes a controller 1214 that communicates with the power signal generator 1211 and the signal generator 1212. In some instances, the controller 1214 is capable of adjusting communication parameters such as the clock rate or content 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 may communicate with, for example, an external programmer of the patient (e.g., Figure 1 as shown). The controller 1214 and / or the signal generator 1212 may be configured to transmit data to the signal processor 1220b, such as updated firmware, transfer functions of the signal processor 1220b, etc. Additionally or alternatively, the controller 1214 may be configured to transmit signals, such as audio or other signals streamed or otherwise received from one or more external devices as described elsewhere herein.

[0136] As shown and as in Figure 11BSimilar to the example shown, the power signal generator 1211 outputs the generated signal to the amplifier 1290 and the inverting amplifier 1292. In some examples, both amplifiers are unity-gain amplifiers. In some examples including digital signals, the inverting amplifier 1292 may include a digital NOT gate. The outputs from the amplifier 1290 and the inverting amplifier 1292 are generally opposite to each other and point to the signal processor 1220b. In the example shown, the receiving circuitry in the signal processor 1220b includes a rectifier circuit 1222 that receives signals from the amplifier 1290 and the inverting amplifier 1292. Since one of the outputs of the amplifiers 1290 and 1292 will be high, the rectifier circuit 1222 can be configured to receive the opposing signals from the amplifier 1290 and 1292 and thereby generate a substantially DC power output 1223.

[0137] In various embodiments, the DC power 1223 can be used to power various components, such as the signal processor 1220b itself, middle ear sensors, electrical and / or acoustic stimulators 1230, etc. For example, the rectifier circuit 1222 can include any known suitable circuitry components for rectifying one or more input signals, such as a diode rectifier circuit or a transistor circuit. In some embodiments, the signal from the power signal generator 1211 is generated at a clock rate that is optimal for power transmission through the leads (e.g., approximately 30 kHz). In Figure 12B the example shown, the rectifier circuit 1222 can be arranged in parallel with the power line that is configured to transmit the power signal to other components within the system, such as the stimulator 1230. For example, in some embodiments, the same power signal (e.g., 1250) generated by the power signal generator 1211 and output through the amplifier 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 amplifier 1290 and 1292, respectively. In alternative embodiments, the signal processor 1220b can similarly provide the signal from a separate power signal generator 1211 to the stimulator 1230 with a power signal (e.g., at approximately 30 kHz) in a similar manner as how power is provided to the signal processor 1220b from the implantable battery and / or communication module 1210b to Figure 12B the signal processor 1220b in

[0138] In Figure 12BIn an example, signal generator 1212 outputs a data signal (e.g., 1251b) to amplifier 1294 and inverter amplifier 1296. In some examples, both amplifiers are unity-gain amplifiers. In some examples that include digital signals, inverter amplifier 1296 may include a digital NOT gate. The outputs from amplifier 1294 and inverter amplifier 1296 are generally opposite to each other and are directed to signal processor 1220b.

[0139] As described elsewhere herein, in some embodiments, controller 1214 and / or signal generator 1212 are configured to encode data for transmission through output amplifiers 1294 and 1296. Signal processor 1220b may include a signal extraction module 1224 configured to extract data from signal 1225 transmitted to signal processor 1220b to generate signal 1225 for use by signal processor 1220b. In some examples, signal extraction module 1224 is capable of decoding signals encoded by implantable battery and / or communication module 1210b. Additionally or alternatively, signal extraction module 1224 may extract the resulting signal 1225 generated by the lead transfer function. In various examples, the extracted signal may include, for example, an updated transfer function of signal processor 1220b, a desired stimulation command, or other signals that affect the operation of signal processor 1220b.

[0140] In Figure 12B an example, signal extraction module 1224 includes a pair of tri-state buffers 1286 and 1288 that communicate with the signal output from signal generator 1212. Tri-state buffers 1286 and 1288 are shown as having an "enable" (ENB) signal provided by controller 1226 to control the operation of tri-state buffers 1286 and 1288 to extract signals from signal generator 1212. The signals from signal generator 1212 and buffered by tri-state buffers 1286 and 1288 are received by amplifier 1284, which may be configured to generate signal 1225 representative of the signal generated by signal generator 1212.

[0141] In some instances, the communication of the signal generated at signal generator 1212 can be transmitted to signal processor 1220b at a clock rate different from the clock rate of the signal generated by power signal generator 1211. For example, in some embodiments, the power signal from power signal generator 1211 is transmitted at approximately 30 kHz, which may be an efficient frequency for transmitting power. However, in some instances, the signal from signal generator 1212 is transmitted at a higher frequency than the signal from power signal generator 1211, e.g., at approximately 1 MHz. This high-frequency data transmission may be useful for faster data transfer compared to the data transfer available at lower frequencies (e.g., the frequency used to transmit the signal from power signal generator 1211). Thus, in some embodiments, power and data can be transmitted from implantable battery and / or communication module 1210b to signal processor 1220b at different frequencies via different communication channels.

[0142] Similar to Figure 11B the embodiment shown, in Figure 12B the illustrated example, signal processor 1220b includes a controller 1226 that communicates with implantable battery and / or communication module 1210b. In some such embodiments, the controller 1226 in signal processor 1220b is capable of monitoring the DC power 1223 and / or signal 1225 received from implantable battery and / or communication module 1210b. Controller 1126 can be configured to analyze the received DC power 1223 and signal 1225 and determine whether the power and / or signal is sufficient. For example, controller 1226 can determine that the DC power received by signal processor 1220b for stimulating the cochlear electrode is insufficient, or that the data from implantable battery and / or communication module 1210b is not being transmitted at the desired rate, based on the transfer function of signal processor 1220b. Thus, in some instances, the controller 1226 of signal processor 1220b can communicate with the controller 1214 of implantable battery and / or communication module 1210b and provide feedback regarding the received communication. Based on the received feedback from the controller 1226 of signal processor 1220b, the controller 1214 of implantable battery and / or communication module 1210b can adjust various properties of the signals output by power signal generator 1211 and / or signal generator 1212.

[0143] In Figure 12BIn the illustrated example, the bidirectional communication signal 1251b between the implantable battery and / or communication module 1210b and the signal processor 1220b includes signals from amplifiers 1294 and 1296 in one direction and communication from controller 1226 to controller 1214 in the other direction. It should be understood that a variety of communication protocols and techniques can be used to establish the bidirectional communication signal 1251b between the implantable battery and / or communication module 1210b and the signal processor 1220b.

[0144] For example, in some embodiments, the implantable battery and / or communication module 1210b need not include amplifiers 1294 and 1296 and instead transmits a signal to the signal processor 1220b rather than its inverted signal. In other examples, the signal processor includes amplifiers similar to 1294 and 1296 and outputs the signal and its inverted signal back to the implantable battery and / or communication module 1210b. Additionally or alternatively, in some embodiments, the signal generator 1212 can be integrated with the controller 1214 and / or the signal extraction module 1224 can be integrated with the controller 1226, where the controllers 1214 and 1226 can communicate bidirectionally through the signal generator 1212 and / or the signal extraction module 1224. Generally, the implantable battery and / or communication module 1210b and the signal processor 1220b can communicate bidirectionally for transmitting data signals separate from the power signal provided by the power signal generator 1211.

[0145] 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 communication module 1210b and the signal processor 1220b. This can allow separate data and power clock rates to improve power transfer efficiency as well as data transfer efficiency and / or rate. Additionally, in some examples, if the bidirectional communication (e.g., 1251b) between the implantable battery and / or communication module 1210b and the signal processor 1220b fails (e.g., due to component failure, connection failure, etc.), the data for communication from the implantable battery and / or communication 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 embodiments described with respect to Figure 11B both power and data can be transmitted through the same signal.

[0146] In some instances, the signal extraction module 1224 may be configured to receive data received from the power signal generator 1211, e.g., via an actuatable switch that may be actuated when a communication 1251b failure is detected. In other instances, the signal extraction module 1224 and / or the controller 1226 may generally monitor data from the power signal generator 1211 and identify when the signal received from the power signal generator 1211 contains a data signal encoded into the received power signal to determine when to consider causing the power signal to contain data.

[0147] Accordingly, in some embodiments, a configuration may be implemented Figure 12B to establish efficient two-way communication between the implantable battery and / or communication module 1210b and the signal processor 1220b. A failure of the two-way communication 1251b may be identified manually and / or automatically. Upon detection of a failure of the two-way communication 1251b, the controller 1214 may encode data into the power signal output from the power signal generator 1211, and the power and data may be combined into a single signal, as described with respect to Figure 11B above.

[0148] Figure 12C FIG. is another alternative schematic diagram that shows exemplary electrical communication between the implantable battery and / or communication module 1210c and the signal processor 1220c in a cochlear implant system, similar to that shown in Figure 12A FIG.. Similar to the embodiment of Figure 12B FIG., in the illustrated embodiment of Figure 12C FIG., the implantable battery and / or communication module 1210c includes a signal generator 1211 configured to output a signal to the signal processor 1220c via leads (e.g., 190). In some embodiments, the power signal generator 1211 generates a digital signal (e.g., 1250) for transmission to the signal processor 1220c, e.g., at a power clock rate. The power signal generator 1211 and corresponding amplifiers 1290, 1292, and rectifier circuit 1222 may operate similar to those described with respect to Figure 12B FIG. to extract DC power 1223 and, in some instances, output a power signal to additional system components such as the stimulator 1230.

[0149] In the illustrated embodiment, the implantable battery and / or communication module 1210c includes a signal generator 1213 capable of providing a data signal to the signal processor. In some embodiments, the signal generator 1213 generates a digital signal for transmission to the signal processor 1220c. In some such embodiments, the digital signal from the signal generator 1213 (e.g., 1251c) may be transmitted to the signal processor 1220b at a data clock rate different from the power clock rate. For example, as described elsewhere herein, in some configurations, power and data may be transmitted most effectively and / or efficiently at different clock rates. In an exemplary embodiment, the power clock rate is approximately 30 kHz, while the data clock rate is approximately 1 MHz. Utilizing different and separately transmitted power and data signals with different clock rates can improve the transfer efficiency of power and / or data from the implantable battery and / or communication module 1210c to the signal processor 1220c.

[0150] Figure 12C Embodiments include a controller 1215 in communication with the power signal generator 1211 and the signal generator 1213. In some instances, the controller 1215 is capable of adjusting communication parameters such as the clock rate or content of the signal generator 1213 and / or the power signal generator 1211. In an exemplary embodiment, the controller 1215 and / or the signal generator 1213 or the power signal generator 1211 may communicate with, for example, an external programmer of a patient (e.g., Figure 1 as shown). The controller 1215 and / or the signal generator 1213 may be configured to transmit data to the signal processor 1220c, such as updated firmware, transfer functions of the signal processor 1220c, etc.

[0151] Similar to the instance in Figure 12B , in the instance of Figure 12C , the signal generator 1213 outputs a data signal (e.g., 1251) to the amplifier 1295 and the inverting amplifier 1297. In some instances, both amplifiers are unity-gain amplifiers. In some instances, the amplifiers 1295, 1297 include tri-state buffers. In some instances including 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 opposite to each other and directed towards the signal processor 1220c.

[0152] 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 may include a signal extraction module 1234 configured to extract data from signals transmitted to the signal processor 1220c to generate signals for use by the signal processor 1220c. In some instances, the signal extraction module 1234 is capable of decoding signals encoded by the implantable battery and / or communication module 1210c. Additionally or alternatively, the signal extraction module 1234 may extract signals generated by the lead transfer function. In various instances, the extracted signals may include, for example, an updated transfer function of the signal processor 1220c, a desired stimulation command, or other signals that affect the operation of the signal processor 1220c.

[0153] In Figure 12C the instance of, similar to the signal extraction module 1224 of Figure 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 the operation of the tri-state buffers 1287 and 1289 to extract signals from the signal generator 1213. The signals from the signal generator 1213 and buffered by the tri-state buffers 1287 and 1289 are received by an amplifier 1285, which may be configured to generate a signal representative of the signal generated by the signal generator 1213.

[0154] As described elsewhere herein, in some instances, the communication of signals generated at the signal generator 1213 may be transmitted to the signal processor 1220c at a clock rate different from 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 instances, the signals from the signal generator 1213 are transmitted at a higher frequency than the signals from the power signal generator 1211, e.g., at approximately 1 MHz. This high-frequency data transmission may be useful for faster data transfer compared to the data transfer available at a lower frequency (e.g., the frequency used to transmit the signals from the power signal generator 1211). Thus, in some embodiments, power and data may be transmitted from the implantable battery and / or communication module 1210c to the signal processor 1220c at different frequencies via different communication channels.

[0155] In Figure 12CIn the illustrated example, signal processor 1220c includes signal generator 1217 and a controller 1227 that communicates with signal generator 1217. Similar to the operation of signal generator 1213 and amplifiers 1295 and 1299, the signal generator may be configured to generate output signals to buffers 1287 and 1289, which may be configured to output signals to an implantable battery and / or communication module 1210c.

[0156] In some such embodiments, controller 1227 in signal processor 1220c is capable of monitoring DC power 1223 and / or signals received from implantable battery and / or communication module 1210c. Controller 1126 may be configured to analyze the received DC power 1223 and signals and determine whether the power and / or signals are sufficient. For example, controller 1227 may determine that the DC power received by signal processor 1220c for stimulating cochlear electrodes is insufficient according to the transfer function of signal processor 1220c, or that data from implantable battery and / or communication module 1210c is not transmitted at a desired rate. Thus, in some instances, controller 1227 of signal processor 1220c causes signal generator 1217 to generate a communication signal for transmission to implantable battery and / or communication module 1210c. Such signals may be used to provide feedback regarding signals such as DC power 1223 received by signal processor 1220c.

[0157] In Figure 12C the example, amplifiers 1295 and 1297 are shown as including a three-state amplifier (e.g., a three-state buffer) that may be controlled by controller 1227. Similar to the configuration in signal processor 1220c, implantable battery and / or communication module 1210c includes a signal extraction module 1235, which is configured to extract data from signals transmitted from signal generator 1217 of signal processor 1220c to implantable battery and / or communication module 1210c. Signal extraction module 1235 includes amplifiers 1295 and 1297 (e.g., three-state buffers) that communicate with the signals output from signal generator 1217. Signals received from signal generator 1217 and received at amplifiers 1295 and 1297 are received by amplifier 1299, which may be configured to generate a signal representing the signal generated by signal generator 1217 to controller 1215 of implantable battery and / or communication module 1210. Thus, in some embodiments, controller 1227 of signal processor 1220c is configured to transmit data back to implantable battery and / or communication module 1210a via buffers 1287 and 1289.

[0158] As described with respect to other embodiments, based on received feedback from controller 1227 of signal processor 1220c, controller 1215 of implantable battery and / or communication module 1210c may adjust various properties of signals output by power signal generator 1211 and / or signal generator 1213.

[0159] Thus, in Figure 12C the illustrated example of, the two-way communication signal 1251 between implantable battery and / or communication module 1210c and signal processor 1220c includes communication between different signal extraction modules 1235 and 1234. As shown, both implantable battery and / or communication module 1210c and 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 through a three-state amplifier that includes an inverting amplifier (1297, 1289) for communicating across two-way communication 1251c for receipt by another signal extraction module (1234, 1235).

[0160] Thus, in some embodiments, two-way communication 1251c between implantable battery and / or communication module 1210c and signal processor 1220c may be enabled by each of the implantable battery and / or communication module and the signal processor, such that data is received and transmitted through a communication structure that is substantially the same as the other. In some such examples, implantable battery and / or communication module 1210c and signal processor 1220c include data extraction modules 1235 and 1234 that are respectively configured to both output signals from a signal generator (e.g., through signal generator 1213 or signal generator 1217) and receive and extract signals (e.g., through amplifier 1285 and amplifier 1299).

[0161] In Figure 12CIn an example, amplifiers 1295 and 1297 include three-state amplifiers that selectively (e.g., via "enable" control from controller 1215) output signals from signal generator 1213, and amplifier 1297 is shown as an inverting amplifier. As described above, in some examples, amplifiers 1295 and 1297 include three-state buffers. Similarly, in three-state buffers 1287 and 1289 that selectively (e.g., via "enable" control from controller 1227) output signals from signal generator 1217, buffer 1289 is shown as an inverting amplifier. As described elsewhere herein, transmitting a signal and its inverted signal (e.g., via 1295 and 1297) allows communication between the implantable battery and / or communication module 1210c and the signal processor 1220c without a net charge flow. Thus, two-way communication between the implantable battery and / or communication module 1210c and the signal processor 1220c can be performed without a net charge flow between components.

[0162] As described elsewhere herein, power from power generator 1211 and data from signal generator 1213 (and / or signal generator 1217) can be transmitted at different clock rates to optimize power and data transfer. In some examples, if data communication (e.g., via two-way 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, e.g., as described with respect to Figure 11B that is described.

[0163] Thus, in some embodiments, a configuration of Figure 12C can be implemented to establish efficient two-way communication between the implantable battery and / or communication module 1210 and the signal processor 1220. A failure of two-way communication 1251 can be identified manually and / or automatically. Upon detecting a failure of two-way communication 1251, controller 1215 can encode data into the power signal output from power signal generator 1211, and can combine power and data into a single signal, as described with respect to Figure 11B that is described.

[0164] As discussed elsewhere herein, there can be different safety standards regarding electrical communication within a patient's body. For example, safety standards may limit the amount of current that can safely flow through a patient's body (especially DC current). As shown in Figure 11B and 12B and 12C, each communication path in the illustrated communication paths between the implantable battery and / or communication module and the signal processor is coupled to an output capacitor. Capacitors located at the inputs and outputs of the implantable battery and / or communication module and the signal processor can substantially block the flow of DC current therebetween while allowing the transmission of AC signals.

[0165] As described elsewhere herein, in some embodiments, data transmitted between an implantable battery and / or communication module and a signal processor (e.g., from a signal generator) is encoded. In some such instances, the encoding may be performed according to a specific data encoding method such as an 8b / 10b encoding scheme to achieve DC balance in the transmitted signal. For example, in some embodiments, the data may be encoded such that the number of high and low bits at each clock signal transmitted between components meets certain criteria for preventing the buildup of unipolar charge on any of the capacitors of a capacitor. This encoding may minimize the total charge flowing between the implantable battery and / or communication module and the signal processor during communication.

[0166] Although described and shown as representing communication between an implantable battery and / or communication module and a signal processor, it should be understood that the communication configurations shown in FIGS. 10, 11A, 11B, 12A, 12B, and 12C may be implemented between any pair of devices that typically communicate with each other. For example, an isolation circuitry (e.g., R 罐 ) may be included in any component 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 corresponding can. Similarly, an exemplary capacitive AC coupled to a DC blocking capacitor and performing DC balance encoding as described elsewhere herein may be incorporated as a communication interface between any two communicating components.

[0167] As described above, data may be transmitted from the implantable battery and / or communication module to the signal processor for a variety of reasons. In some instances, the data is transmitted from an external component, such as Figure 1 the programmer shown, to the implantable battery and / or communication module. In an exemplary process, a programmer such as a clinician's computer may be used to communicate with the patient's fully implantable system through a communication configuration such as Figure 11B , 12B or as shown in 12C. For example, the programmer may communicate wirelessly with the patient's implantable battery and / or communication module (e.g., via Bluetooth or other suitable communication technology). Signals from the programmer may be sent from the implantable battery and / or communication module to the signal processor through a communication configuration such as Figure 11B , 12B or as shown in 12C.

[0168] During such procedures, a clinician may communicate with the signal processor and, in some cases, through the signal processor with other components. For example, the clinician may cause the signal processor to actuate an 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. Changing the stimulation parameters in real time may allow the clinician and the patient to determine the effectiveness of different stimulation techniques for an individual patient. Similarly, the clinician may communicate with the signal processor to update the transfer function. For example, the clinician may repeatedly update the transfer function signal processor when testing the efficacy of each signal processor for an individual patient. In some instances, combinations of stimulation parameters and signal processor transfer functions may be tested for customized system behavior for an individual patient.

[0169] In some embodiments, various internal properties of the system may be tested. For example, various impedance values such as sensor impedance or stimulator impedance may be tested as described in U.S. Patent Publication No. 2015 / 0256945, assigned to the assignee of the present application and entitled "TRANSDUCER IMPEDANCE MEASUREMENT FOR HEARING AID", the relevant portions of which are incorporated herein by reference.

[0170] Additionally or alternatively, various characteristics of individual leads may be analyzed. Figure 12D is a high-level schematic diagram that shows exemplary electrical communication between an implantable battery and / or communication module and a signal processor in a cochlear implant system, similar to that shown in Figure 12A . In Figure 12D simplified example, conductors 1201, 1202, 1203, and 1204 extend between the implantable battery and / or communication module 1210d and the signal processor 1220d. In some instances, 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 Figure 12D example, the implantable battery and / or communication module 1210d includes a controller 1205, and the signal processor 1220d includes a controller 1206. Other internal components of the implantable battery and / or communication module 1210d and the signal processor 1220d are not shown, but various configurations are possible, as shown in Figure 11B , 12B or 12C.

[0171] 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 properties of such conductors. During an exemplary test process, a controller (e.g., 1205) can drive a signal (e.g., a sine wave or a wave of other shape) across a conductor (e.g., 1201) and measure the current sent and the voltage across which the current is sent. Based on 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 ground a second conductor (e.g., 1202) while driving a test signal across the test conductor (e.g., 1201) to measure one or more electrical parameters (e.g., capacitance, impedance, etc.) between the two conductors.

[0172] 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 instances, the controller can be configured to perform such tests using any two of the conductors 1201, 1202, 1203, 1204 to test a baseline value (e.g., when the system is in a known operating condition) or an expected value (e.g., compared to an established baseline). In different embodiments, the controller in the implantable battery and / or communication module 1210d (controller 1205) and / or the controller in the signal processor 1220d (controller 1206) can perform grounding one or more conductors and / or applying a test signal to one or more conductors.

[0173] In some embodiments, such test procedures may be automatically performed, for example, according to a programmed schedule. Additionally or alternatively, such test procedures may be manually initiated, for example, by the wearer or a clinician via an external device, such as a programmer (e.g., 100) or a charger (e.g., 102). The results of such procedures may be stored in an internal memory for later access and analysis, and / or may be output to an external device for viewing. In some instances, results and / or warnings may be automatically output to an external device if one or more results deviate sufficiently from a baseline value. In various instances, a sufficient change relative to the baseline for triggering an output may be based on a percentage change relative to the baseline (e.g., a deviation greater than 1%, greater than 5%, greater than 10%, etc. relative to the baseline). Additionally or alternatively, a sufficient change includes changing a certain number of standard deviations from the baseline (e.g., greater than one standard deviation, two standard deviations, etc.). In various embodiments, the amount of change triggering the output of results and / or warnings may be adjustable. Additionally or alternatively, this amount may vary between different measurement results.

[0174] In some embodiments, one or more actions may be performed in response to the results of this analysis. For example, in the exemplary embodiment described Figure 12B above, if the test reveals an unexpected impedance on one of the signal conductors, such as an open circuit (e.g., from amplifier 1294 or inverting amplifier 1296), then controller 1214 may be configured to change the operation of the system. For example, controller 1214 may be configured to adjust the output from power generator 1211 to provide both a power signal and a data signal by power generator 1211, as described for the configuration in Figure 11B . In some instances, controller 1214 may be configured to transmit a signal to an external device, thereby signaling a change in operation and / or alerting the wearer and / or clinician that one or more conductors may be damaged or otherwise inoperable.

[0175] Although shown as separate components connected by leads (e.g., lead 180) in several embodiments (e.g., Figure 1 , 9 , 11A, 12A), in some instances, a processor (e.g., 120) and a stimulator (e.g., 130) may be integrated into a single component, e.g., within a hermetically sealed housing. Figure 13A An exemplary schematic illustration of a processor and a stimulator combined into a single housing is shown. In Figure 13AIn an example, 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 communication module) via lead 1390. The processor / stimulator 1320 may include receptacles 1322, 1324 for receiving leads 1370, 1390, respectively.

[0176] The processor / stimulator 1320 may be configured to receive an input signal from the sensor, process the received input signal according to a transfer function, and output a stimulation signal via electrode 1326. Electrode 1326 may include one or more contact electrodes (e.g., 1328) that contact the cochlear tissue of the wearer to provide electrical stimulation thereto, such as described with respect to Figure 10B that described.

[0177] The processor / stimulator 1320 of FIG. 13 includes a return electrode 1330 for providing a return path (e.g., 1332) for the stimulation signal emitted from electrode 1326. The return electrode 1330 may be electrically coupled to a ground portion of the circuitry within the processor / stimulator 1320 to complete a circuit including the circuitry within the processor / stimulator 1320, electrode 1326, the cochlear tissue of the wearer, and ground. In some examples, the return electrode 1330 includes a conductive material that is in electrical communication with the circuitry 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.

[0178] In some embodiments, the return electrode 1330 and the housing of the processor / stimulator 1320 include a conductive material. For example, in some examples, the housing includes titanium, while the return electrode 1330 includes platinum or a platinum alloy. The receptacle 1324 may generally include a non-conductive biocompatible material such as a biocompatible polymer. The non-conductive receptacle 1324 may provide isolation between the return electrode 1330 and the conductive housing of the processor / stimulator 1320.

[0179] Although shown in Figure 13A to be located within the power receptacle 1324 of the processor / stimulator 1320, generally the return electrode 1330 may be located anywhere on the outer 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 electrode 1326. In some examples, the return electrode may be located on the proximal end of electrode 1326 itself. In some embodiments having multiple return electrodes (e.g., the return electrode 1330 and a return electrode on the proximal end of electrode 1326), a switch may be used to select which return electrode to use. Additionally or alternatively, multiple return electrodes may be used simultaneously.

[0180] Figure 13B shows Figure 13A a simplified cross-sectional view of the processor / stimulator taken along line B-B as shown in Figure 13B FIG. As shown, 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 contacting the tissue of the wearer, such as platinum. In the illustrated example, the return electrode 1330 is wrapped around both sides of the housing of the processor / stimulator 1320 such that the return electrode 1330 is coupled to the outer surface of the housing on the first side 1319 and the second side 1321.

[0181] This can facilitate implantation on either side of the wearer's anatomy because in some cases only one side of the processor / stimulator electrically contacts the conductive tissue of the wearer while the other side contacts, for example, the wearer's skull and does not readily 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 providing a sufficient return path through the return electrode 1330.

[0182] In various instances, the return electrode 1330 can extend around the peripheral edge of the processor / stimulator 1320 as shown in Figure 13B FIG. In other instances, the return electrode 1330 can include segments located on either side of the housing and can be connected to each other inside the housing rather than by wrapping. Additionally, although shown as embedded in the housing of the processor / stimulator 1320, in some instances the return electrode 1330 can project outwardly from the housing. The return electrode 1330 can generally be of any shape and size among a variety of shapes and sizes while including electrical contact segments on opposite sides of the housing to enable usability on either side of the wearer's anatomy. In other embodiments, for custom right or left implementations, the return electrode can be located on only one side of the housing.

[0183] As described elsewhere herein, in various embodiments, a processor generally receives an input signal, processes the signal, and generates a stimulation signal that can be applied by an integrated stimulator (e.g., by a processor / stimulator such as in Figure 13A and 13B ) or a separate stimulator in communication with the processor (e.g., Figure 1 and 9 as described). In some such embodiments, the input signal received by the signal processor is generated by an implantable sensor such as a middle ear sensor (e.g., as described in Figure 4 and 5 ).

[0184] However, such sensors typically measure or otherwise receive some stimulus that is converted into an output read and processed by a signal processor. For example, some middle ear sensors may produce different output signals for a given stimulus based on various factors such as the variability of the wearer's inner ear anatomy and movement. Thus, when designing a system, the output of a sensor for a given input may be unpredictable, especially across a certain frequency range.

[0185] Figure 14A is a schematic diagram that shows an exemplary signal processing configuration for normalizing a stimulus signal and accommodating variability in the sensor frequency response. Figure 14B Shows exemplary gain and frequency response curves for the signals at various stages in the processing configuration. As regarding Figure 14B The "gain" associated with a particular frequency as used is the relationship (e.g., ratio) between the magnitude of the input stimulus received by the sensor and processor and the magnitude of the resulting signal at various stages of processing. In the example shown, the processor / stimulator 1400 receives an input signal 1405 from the sensor.

[0186] As Figure 14B shown, the gain is very non-uniform across the frequency distribution shown in the figure. For example, according to the example shown, a stimulus signal received at 1 kHz at the sensor will result in a much larger magnitude of signal 1405 compared to the same magnitude of stimulus signal received at 10 kHz at the sensor. This difference in frequency response can make signal processing difficult. Additionally, this frequency response typically varies from person to person, or over the life of the wearer, due to physical movement or anatomical changes of the sensor.

[0187] The input signal 1405 undergoes analog processing 1410 to produce an analog-processed signal 1415. As Figure 14B shown, the analog processing step 1410 improves the consistency of the gain across the frequency range because the analog-processed signal 1415 provides a flatter frequency response curve compared to the input signal 1405. In some embodiments, the analog processing may include one or more filters and / or amplifiers that are typically configured to flatten the frequency response curve, as Figure 14B shown. In some instances, the analog processing components 1410 within the processor / stimulator 1400 may be substantially the same across various implantable systems to provide a first-order correction of the frequency response. In other instances, the analog processing configuration 1410 may be customized for the wearer, e.g., based on known anatomical features, measurements, analysis, etc.

[0188] The analog-processed signal 1415 undergoes a digital processing step 1420 to produce a digital-processed signal 1425. As Figure 14BAs shown, the analog processing step 1420 further improves the consistency of the gain across the frequency range because the digitally processed signal 1425 provides a flatter frequency response curve compared to the analog processed signal 1415. In some embodiments, the digital processing 1420 can be configured to substantially flatten the frequency response to correct for the remaining frequency response inconsistencies in the analog processed signal 1415. For example, in some embodiments, after the digital processing 1420, a given magnitude of a stimulation signal at a first frequency and a second frequency will result in a digitally processed signal 1425 having the same magnitude at the first frequency and the second frequency. Thus, the digitally processed signal 1425 corresponds to a normalized stimulation signal, thereby reducing or eliminating variability that occurs with different wearer anatomies and wearer motion and / or that varies over time. Having a normalized frequency response across a large frequency range can simplify the assessment of the efficacy of the implantable system, the programming of the signal processor transfer function, the assessment of system operation, etc. In some instances, a flat frequency response can enable the system to present electrical stimulation to the wearer at an appropriate intensity level, e.g., relative to the received external acoustic stimulation, independent of the frequency content of the external acoustic stimulation.

[0189] In some embodiments, the digital processing 1420 can be customized after system implantation via a calibration process. In an exemplary calibration process, a clinician or other user can provide, for example, a series of stimulation signals to be "picked up" by the sensor at multiple frequencies and having similar magnitudes, and the sensor generates an input signal 1405 for each received signal. The clinician or other user can then sample the resulting analog processed signals 1415 and / or the initial digitally processed signals 1425 at multiple frequencies to determine the remaining non-uniformity of the gain across the frequency sweep. The digital processing 1420 can be established or updated to compensate for the non-uniformity in order to establish a substantially flat frequency response curve for the digitally processed signal 1425. In some instances, multiple signals having different frequencies are provided in sequence and the magnitude response (e.g., gain) at each frequency is determined. After determining this magnitude response, the digital processing stage 1420 can be updated based on the response-versus-frequency relationship to flatten the frequency response curve.

[0190] In an alternative process, a white noise signal to be "picked up" by the sensor can be provided. A transformation of the signal (e.g., a Fast Fourier Transform or FFT) can be performed to extract the frequency content of the signal. The extracted frequency content can be used to determine the magnitude response at each frequency, and the digital processing 1420 can be updated to flatten the frequency response similar to that described above.

[0191] In Figure 14AIn the illustrated example, the digitally processed signal 1425 (e.g., having a uniform gain across a frequency range relative to the input signal received from the sensor) is processed according to the signal processor transfer function 1430 to generate a stimulation signal 1435. The stimulation signal 1435 may be received by a stimulator 1440, which may apply an electrical signal 1445 to electrodes as described elsewhere herein.

[0192] In some examples, the digital processing step 1420 for providing a uniform frequency response may be incorporated into the transfer function 1430, where both digitally processing the analog processed signal 1415 to flatten the frequency response and generating a stimulation signal (e.g., 1435) according to the programmed transfer function are performed. Additionally or alternatively, as described elsewhere herein, in some examples, the stimulator 1440 may be located external to the processor rather than being combined as a single processor / stimulator assembly 1400.

[0193] As described elsewhere herein, while many examples show the middle ear sensor communicating with the implantable signal processor, in various embodiments, one or more additional or alternative input sources may be included. For example, in some embodiments, a microphone may be implanted under the user's skin and may be positioned to communicate with the signal processor (e.g., via a detachable connector such as 171). The signal processor may receive an input signal from the implanted microphone and provide a signal to the stimulator based on the received input signal and the signal processor transfer function.

[0194] Additionally or alternatively, one or more system components may be configured to receive a broadcast signal for conversion into a stimulation signal. Figure 15 is a schematic system diagram showing an implantable system configured to receive a broadcast signal from a broadcast device. As Figure 15 shown in the example, a broadcast source 1550 broadcasts a signal via a communication link 1560. The communication link 1560 may include communication via various communication protocols such as Wi-Fi, Bluetooth, or other known data transmission protocols. The broadcast source 1550 may include any of a variety of components, such as a media source (e.g., a television, radio, etc.), a communication device (e.g., a phone, smartphone, etc.), a pickup coil, or other broadcast system (e.g., in a live performance), or any other source of an audio signal that may be transmitted to the implantable system or an external component of the implantable system (e.g., a system programmer, etc.).

[0195] An implantable system that includes a programmer 1500, an implantable battery and / or communication module 1510, a signal processor 1520, and a stimulator 1530 can generally receive data from a broadcast source 1550 via a communication link 1560. In various embodiments, any number of components in the implantable system can include a receiving device, such as a pickup coil, configured to receive a broadcast signal for eventual conversion into a stimulation signal.

[0196] For example, in some embodiments, the programmer 1500 can include a pickup coil repeater configured to receive a broadcast pickup coil signal from the broadcast source 1550. The programmer can be configured to then transmit a signal representative of the received broadcast signal, for example, to the implantable battery and / or communication module 1510 and / or the signal processor 1520 via Bluetooth communication. If communication is received from the programmer 1500 by the implantable battery and / or communication module 1510, the implantable battery and / or communication module 1510 can transmit a signal to the signal processor, for example, Figure 11A 、 11B 、any one of 12A or 12C.

[0197] In some such embodiments, the signal processor 1520 can be configured to receive this signal from the implantable battery and / or communication module 1510 and output a stimulation signal to the stimulator 1530 based on the received signal and a signal processor transfer function. In other instances, the signal processor 1520 can include a pickup coil repeater or other device capable of receiving a broadcast signal from the broadcast source 1550. In some such embodiments, the signal processor 1520 processes the received signal according to the signal processor transfer function and outputs a stimulation signal to the stimulator 1530.

[0198] In some embodiments, the signal processor 1520 can communicate with a combination of multiple input sources, such as an implantable microphone, a middle ear sensor, and the broadcast source 1550 (e.g., via the implantable battery and / or communication module 1510). In some such instances, the signal processor can be programmed with multiple transfer function programs, each according to a corresponding 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 its corresponding input source.

[0199] In some instances, a signal processor 1520 that receives multiple input signals from corresponding multiple input sources effectively combines the signals when generating a stimulation signal for a stimulator 1530. That is, in some embodiments, the input sources are combined to form a stimulation signal from the signal processor 1520. In some such instances, a user may be able to mix the various received input signals in any desired manner. For example, the user may choose to blend various different input streams, such as inputs from a middle ear sensor or other implantable devices, signals received from an external device (e.g., a pick-up coil repeater, a Bluetooth connection such as a smart phone), etc. In an exemplary configuration, the user may choose to blend two input sources equally such that the stimulation signal is based on 50% of a first input source and 50% of a second input source.

[0200] Additionally or alternatively, the user may choose to effectively "mute" one or more input sources such that the signal processor 1520 outputs a stimulation signal based on the input signals received from the non-muted sources. Similarly, the user may be able to select a single source for processing the received input signals. For example, in some embodiments, the user may choose to process the signals received from a broadcast source 1550 and convert them into a stimulation signal while ignoring the signals received from, for example, a middle ear sensor.

[0201] In some instances, direct communication with the signal processor can be used to test the efficacy of a given signal processor transfer function and associated stimulation (e.g., acoustic or electrical) parameters. For example, a programmer can be used to disable the input signals from a middle ear sensor or other input source and provide a customized signal to the signal processor to simulate the signals from the input source. The signal processor processes the received signal according to its transfer function and actuates the electrical stimulator and / or acoustic stimulator accordingly. The processor can be used to test multiple customized "sounds" to determine the efficacy of the signal processor transfer function for each "sound" for a given patient.

[0202] Figure 16 is a process flow diagram that shows an exemplary process for establishing an optimal transfer function for a patient. The method may include connecting an external programmer to an implantable battery and / or communication module (step 1650). The connection may include, for example, establishing a wireless connection (e.g., Bluetooth communication) between the external programmer and the implantable battery and / or communication module. The external programmer may include any of a variety of components capable of providing programming instructions to the implantable battery and / or communication module, such as a computer, a smart phone, a tablet computer, etc.

[0203] Once communication is established, if no signal processor transfer function is active (step 1652), a signal processor transfer function can be established (step 1654). If the transfer function is already active, or after the transfer function is established (step 1654), a programmer can be used to input one or more simulated "sounds" to the signal processor. This "sound" can be received and processed by the signal processor as if it were received from an input source such as a middle ear sensor. The "sound" can be, for example, a signal generated by a computer, which is designed to simulate various input signals, such as a certain frequency range, voice sounds, or other distinguishable sound characteristics.

[0204] The process can further include testing the efficacy of the signal processor transfer function (step 1658). This can include, for example, determining how well the patient responds to each sound of a given signal processor transfer function. In some instances, this can include rating the transfer function under tests of each sound in the "sound", and determining an overall rating of the transfer function based on the scores associated with one or more "sounds".

[0205] After testing the efficacy of the signal processor transfer function, if not all desired transfer functions have been tested (step 1660), the signal transfer function can be updated (step 1654). One or more simulated "sounds" can be input to the signal processor (step 1656) and processed according to the updated transfer function, and the efficacy of the updated transfer function can be tested (step 1658). Once all desired transfer functions have been tested (step 1660), a user's signal processor transfer function can be created or selected and implemented for the patient (step 1662). In some instances, the best transfer function among the tested transfer functions is selected based on user preference, highest score, or other metrics. In other instances, the composite results from the tested transfer functions can be combined to create a customized transfer function for the patient.

[0206] In other instances, instead of continuously updating the signal processor transfer function, preprocessing of the simulated "sounds" can be performed outside the signal processor, for example, on-site with a clinician or audiologist. For example, in an exemplary process, processing software can be used to preprocess one or more simulated sounds to establish simulated stimulus signals that will be generated by specific input signals processed by a specific transfer function. In some instances, such signals can be transmitted to, for example, a signal processor for directly applying the stimulus signals to the wearer.

[0207] For example, communication with the stimulator can be performed directly by various system components such as a programmer. In other instances, this communication can be performed via an implantable battery and / or communication module and signal processor. For example, in an exemplary embodiment, the preprocessed signal can be transmitted via wireless (e.g., Bluetooth) communication to the implantable battery and / or communication module. The implantable battery and / or communication module can transmit the preprocessed signal to a signal processor that can be configured with a unit transfer function. Thus, the signal processor only transmits the preprocessed signal to the stimulator for performing stimulation.

[0208] Figure 17 is a process flow diagram that illustrates an exemplary method of testing the efficacy of one or more sounds using one or more transfer functions on a preprocessed signal. In Figure 17 the method, a sound can be loaded (step 1750) into, for example, an application or processing software capable of processing the received sound. In some instances, the sound can be an analog sound, such as a computer-generated signal representing a desired sound. In other instances, the sound can comprise a recorded actual sound such as a human voice or other stimuli. The loaded sound can be preprocessed according to the transfer function to generate a stimulation signal (step 1752). For example, the preprocessing can be performed on a stand-alone workstation, a system programmer, etc.

[0209] Figure 17 the method further includes the step of applying the stimulation signal from the preprocessed sound to a stimulator of an implantable system (step 1754). As described elsewhere herein, this transmission 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, the user's programmer, etc.) or via a signal processor.

[0210] After applying the stimulation signal (step 1754), the method can further comprise the step of testing the efficacy of the stimulation signal (step 1756). This can include, for example, testing the user's understanding of the original sound from the received stimulation signal, receiving a rating score from the user, or any other suitable means of quantifying the efficacy of the stimulation signal. Since the stimulation signal applied in step 1754 is based on the sound and the transfer function used for preprocessing, testing the efficacy of the stimulation signal is analogous to testing the efficacy of the transfer function for a given sound.

[0211] After testing the efficacy of the stimulation signal, it can be determined whether all simulated transfer functions have been tested for a given sound (step 1758). If not, the method can include the steps of: establishing or updating the simulated transfer function (step 1760), and repeating the step of preprocessing the sound to establish the stimulation signal (step 1752), applying the stimulation signal (step 1754) and testing the efficacy of the stimulation signal all according to the updated transfer function (step 1756). Thus, a given sound can be processed according to multiple transfer functions, and multiple corresponding stimulation signals can be tested relative to a given user. If all simulated transfer functions have been tested at step 1758, the process can include establishing a preferred processing of the sound (step 1762).

[0212] In some instances, the process can be performed in real time Figure 17 . For example, in some embodiments, a device communicating with a stimulator in an implantable 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 a sound signal before transmitting it to the user's system. In some such instances, after establishing a preferred processing technique (e.g., a simulated transfer function) for a given sound (e.g., in step 1762), the user's signal processor transfer function can be updated to reflect the preferred transfer function for the given user.

[0213] Additionally or alternatively, the process can be repeated Figure 17 for multiple different sounds. In some embodiments, multiple sounds can be preprocessed according to multiple different simulated transfer functions, and the resulting generated stimulation signals can be stored in a database. A test device such as a workstation, programmer, etc. can be used to perform Figure 17 the method while using the database of stimulation signals to test the efficacy of various transfer functions for various sounds relative to the user.

[0214] In some instances, this database can be used to fit a particular implantable system to a patient. For example, the stimulation signals generated by preprocessing multiple sounds can be transmitted to an implantable stimulator of the user having an implantable stimulator and cochlear electrodes to test the efficacy of the transfer functions simulated in the preprocessing. In various instances, multiple generated stimulation signals associated with a given sound can be applied to the stimulator until a preferred simulated transfer function is established. In other instances, generated stimulation signals representing multiple sounds can be established for each of the multiple transfer functions such that each transfer function for the user can be tested for multiple sounds before testing another transfer function.

[0215] Figure 18 is a schematic representation of an exemplary database of preprocessed sound signals. As shown, the database is represented as a table having n rows corresponding to different sounds (Sound 1, Sound 2, …, Sound n) and m columns corresponding to different simulated transfer functions (Simulated Transfer Function 1, Simulated Transfer Function 2, …, Simulated Transfer Function m). As shown, at the intersection of each row (i) and each column (j), preprocessing Sound i with Simulated Transfer Function j produces a stimulus signal (i,j). In some embodiments, a table of stimulus signals generated from preprocessed sounds as shown Figure 18 may be stored in a database of preprocessed sound signals of a device fitted to a user.

[0216] As described elsewhere herein, during respective fitting procedures, a sound (e.g., Sound 1) may be selected from the database and multiple different stimulus signals (e.g., stimulus signals (1,1), (1,2), …, (1,m)) may be delivered to an implantable stimulator. This stimulus signal typically corresponds to the result of preprocessing Sound (e.g., Sound 1) according to various simulated transfer functions (1-m). As regarding Figure 17 described, a preferred stimulus signal (and thus a preferred corresponding simulated transfer function) may be established for a given sound (e.g., Sound 1). A similar process may be repeated for each sound in the database. In various instances, one or more signal processor transfer functions may be delivered to a signal processor based on the determined preferred simulated transfer function. For example, in some instances, the simulated transfer function preferred for most sounds may be implemented as the signal processor transfer function. In other embodiments, the signal processor includes multiple transfer functions and different transfer functions may be applied to different detected sounds according to the preferred transfer function for each sound.

[0217] In other exemplary fitting procedures, multiple stimulus signals (e.g., stimulus signals (1,1), (2,1), …, (n,1)) corresponding to a single simulated transfer function (e.g., Simulated Transfer Function 1) may be applied to the stimulator. This stimulus signal corresponds to multiple sounds preprocessed according to a single simulated transfer function. This may be used to test the efficacy of the selected transfer function. The process may be repeated for multiple simulated transfer functions (e.g., 2-m) to determine the best transfer function across various sounds (e.g., Sound 1-n).

[0218] Generally, the preprocessed sound signal passes through as shown Figure 18The data set of the stimulation signals generated by the various transfer functions shown can be used to accelerate the testing of such transfer functions for a particular user. Preprocessing this sound allows the processing to be done, for example, in a laboratory or at a workstation before any fitting process, and allows the efficient application of stimulation signals corresponding to different transfer functions to the user's stimulator without updating the signal processor. Additionally, this preprocessing can allow the efficacy of more advanced or computationally demanding processing techniques to be tested, even if the implantable signal processor has not yet effectively implemented such processing techniques (e.g., due to various hardware limitations). Testing the efficacy of such processing techniques can drive the evolution of processing methods and hardware capabilities, for example, in an effort to adopt more complex processing techniques in the future.

[0219] Various features and functions of implantable systems have been described herein. As described, in various embodiments, system operation can be adjusted based on communication from components located outside the body while the system remains implanted. In some embodiments, the system can include any number of external components capable of interfacing with the system in a variety of ways.

[0220] Figure 19 is a schematic diagram that shows possible communications between various system components according to some embodiments of a fully implantable system. In the illustrated embodiment, the implantable components of the system (outlined in dashed lines) include an implantable battery and / or communication module 1910, a signal processor 1920, and a stimulator 1930. Such implantable components can operate according to various examples described herein to effectively stimulate a user in response to received input signals (e.g., by electrical and / or acoustic stimulation).

[0221] Figure 19 The schematic illustration of includes a plurality of external devices capable of wirelessly interfacing with one or more of the implantable components, for example, via a communication link 1925. Such devices can include a programmer 1900, a charger 1902, a smart phone / tablet computer 1904, a smart watch or other wearable technology 1906, and a key fob 1908. In some instances, such components can communicate with one or more implantable components by means of one or more communication protocols such as Bluetooth, Zigbee, or other suitable protocols via the wireless communication link 1925. In various embodiments, different external devices are capable of performing one or more functions associated with system operation. In some such embodiments, each external device is capable of performing the same functions as other devices. In other instances, some external devices are capable of performing more functions than other devices.

[0222] For example, the programmer 1900 can wirelessly interface with one or more implantable components to control various operating parameters of the implantable system. For example, in some embodiments, the programmer 1900 can be configured to adjust a signal processor transfer function or select an operating profile (e.g., associated with a particular signal processor transfer function based on a particular user, environment, etc.). In some instances, the programmer 1900 can be used to establish a user profile, such as a preferred signal processor transfer function, as described elsewhere herein. The programmer 1900 can additionally or alternatively be used to turn the system on or off, adjust the volume of the system, receive input data, and stream the input data to the system (e.g., the implantable battery and / or communication module 1910). In some embodiments, the programmer 1900 includes a display for presenting various information to the user. For example, the display can be used to indicate the mode of operation (e.g., the loaded user profile), the remaining power level, etc. In some such embodiments, the display can serve as a user interface through which the user can adjust one or more parameters, such as volume, profile, input source, input mix, etc.

[0223] 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 in the implantable battery and / or communication module 1910. In some instances, 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.

[0224] In some embodiments, various external devices, such as a smart phone or a tablet computer 1904, can include an application ("app") that can be used to interface with the implantable system. For example, in some embodiments, the user can communicate with the system via the smart phone or the tablet computer 1904 (e.g., via link 1925) to use a predetermined app to adjust certain operating factors of the system to 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 instances, the smart phone / tablet computer 1904 can be used to stream input signals to the implantable system, such as media or communication being played on the smart phone / tablet computer 1904.

[0225] In some systems, a smart watch or other wearable technology 1906 can interact with the system in a manner similar to the smart phone / tablet computer 1904. For example, the smart watch or other wearable technology 1906 can include an app similar to that operable on the smart phone / tablet computer for controlling various aspects of the implantable system, such as volume control, on / off control, etc.

[0226] In some embodiments, the key fob 1908 may be used to perform basic functions regarding the implantable system. For example, in some embodiments, the key fob 1908 may be used to load / implement a specific operation profile associated with the key fob 1908. Additionally or alternatively, the key fob 1908 may act similar to Figure 1 the cut-off controller 104 and may be used to quickly disable the system and / or mute the system. As described elsewhere herein, in some instances, the same device (e.g., the key fob 1908) used to disable the system and / or mute the system may be used to enable the system and / or unmute the system.

[0227] Figure 19 The schematic diagram of Figure 15 further includes a broadcast source 1950 configured to broadcast a signal 1960 that can be received by one or more external devices and / or one or more implantable system components. Similar to

[0228] the broadcast source 1550 in

[0229] , the broadcast source 1950 may be configured to transmit a signal that can become a stimulation signal for application by the stimulator 1930. The broadcast signal 1960 may include, for example, a pick-up coil signal, a Bluetooth signal, etc. In various embodiments, one or more external devices such as the programmer 1900, the charger 1902, the smart phone / tablet computer 1904, the smart watch / wearable device 1906, and / or the key fob 1908 may include components (e.g., a pick-up coil repeater) capable of receiving the broadcast signal 1960. The external device may be further configured to transmit a signal representing the received broadcast signal 1960 to one or more implantable components to apply stimulation to the patient based on the broadcast signal 1960.

[0230] In some embodiments, one or more implantable system components include a near-field communication component configured to facilitate communication between the system and an external device only when in very close proximity to the near-field communication component. In some such instances, once near-field communication is established, a pairing for wireless communication at a greater distance (e.g., Bluetooth) can be established. For example, in an exemplary embodiment, both a charger and an implantable battery and / or communication module can each include a near-field communication component for establishing secure near-field communication and then pairing with each other for additional wireless communication.

[0231] Figure 20 is a schematic diagram that shows the establishment of a secure wireless connection between various components in an implantable system. In the illustrated example, the charger 2010 is configured to communicate with an implantable battery and / or communication module 2020. The charger 2010 includes a wireless communication component 2016, such as a Bluetooth link, that can facilitate communication between the charger 2010 and other devices. The charger 2010 further includes a near-field communication component 2012, such as a coil, and a processor / memory component 2014 that can receive signals from and transmit signals to the near-field communication component 2012 and / or the wireless communication component 2016.

[0232] The implantable battery and / or communication module 2020 includes a wireless communication component 2026, such as a Bluetooth link, that can facilitate communication between the charger 2010 and other devices. The implantable battery and / or communication module 2020 further includes a near-field communication component 2022, such as a coil, and a processor / memory component 2024 that can receive signals from and transmit signals to the near-field communication component 2022 and / or the wireless communication component 2026.

[0233] In some embodiments, the near-field communication components 2012 and 2022 include coils capable of establishing near-field wireless communication therebetween. In some embodiments, the coils can also be used to transfer power between a power source 2018 of the charger 2010 and a power source 2028 of the implantable battery and / or communication module 2020, e.g., to charge the power source 2028 in the implantable system for continued use. In various embodiments, the power source 2018 and / or the power source 2028 can include one or more batteries, capacitors (e.g., supercapacitors), and / or other electrical energy storage devices capable of storing electrical energy and providing electrical energy to other components. In some embodiments, the power source 2018 in 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 inserted into a standard wall outlet.

[0234] In some instances, an implantable battery and / or communication module 2020 may not be able to communicate with an external component via a wireless communication component 2026 until this communication is first enabled. In such embodiments, this communication is achieved by performing near-field communication through a near-field communication component 2022 to ensure that the device does not accidentally or undesirably pair with the implantable battery and / or communication module 2020.

[0235] In Figure 20 an exemplary embodiment of, the numbers in the boxes illustrate an exemplary sequential process for establishing wireless communication between a charger 2010 and an implantable battery and / or communication module 2020. In the illustrated embodiment, the charger 2010 first establishes contact with the implantable battery and / or communication module 2020 through near-field communication components 2012, 2022. In various embodiments, this near-field communication operates only at very short distances, such as within two inches. This prevents other devices from accidentally or undesirably establishing near-field communication with the implantable battery and / or communication module 2020. During this step, the user may position the charger 2010 close to the pectoral muscle region where the implantable battery and / or communication module 2020 is implanted to achieve this communication. In some instances, after the charger 2010 is paired with the implantable battery and / or communication module 2020 through near-field communication 2012, 2022, such devices may then communicate via wireless communication 2016, 2026.

[0236] In some embodiments, an external device 2030 (e.g., a smart phone or other audio / media source) may include a wireless communication component 2036 and a processor / memory 2034 capable of facilitating communication with the implantable battery and / or communication module 2020 (e.g., via a wireless communication component 2026), but may not include a near-field communication component for pairing the external device 2030. Thus, in some instances, a paired charger 2010 may be configured to effect subsequent pairing of the implantable battery and / or communication module 2020 with the external device 2030.

[0237] The circled reference numerals illustrate the sequence of an exemplary pairing of the external device 2030 with the implantable battery and / or communication module 2020. The charger 2010 may communicate with the external device 2030 via wireless communication components 2016, 2036, e.g., to determine that the user desires to pair the external device 2030 with the implantable battery and / or communication module 2020. The charger 2010 may then communicate with the implantable battery and / or communication module 2020 (e.g., via wireless communication components 2016, 2026) to pair the implantable battery and / or communication module 2020 with the external device 2030 to effect subsequent wireless communication between the implantable battery and / or communication module 2020 and the external device 2030 (e.g., via wireless communication components 2026, 2036).

[0238] In some instances, once the device is paired with the implantable battery and / or communication module 2020, the device can be used to subsequently pair additional devices with the implantable battery and / or communication module, as described above with respect to the charger 2010. In other embodiments, only some devices include the ability to pair additional devices with the implantable battery and / or communication module, such as only the charger 2010. In still other instances, each device must be paired with the implantable battery and / or communication module via a near-field communication process (e.g., via the in-field communication component 2022) before wireless (e.g., Bluetooth) communication over a greater distance can be established.

[0239] Additionally or alternatively, once an external device is paired with the implantable battery and / or communication module 2020, the external device (e.g., the external device 2030) can be used to perform additional functions. In some embodiments, the additional functions can include adjusting the transfer function of the signal processor. In some instances, the external device includes one or more sensors or otherwise communicates with one or more sensors and can be configured to update the transfer function of the signal processor based on one or more signals detected by the one or more sensors. In some such instances, one or more such sensors can include a microphone, a position sensor (e.g., GPS, position based on one or more available wireless networks, etc.), a clock, or other sensors known to those of ordinary skill in the art. In some embodiments, the external device (e.g., 2030) that includes such one or more sensors or communicates with such one or more sensors includes a smart phone, a tablet computer, or a computer.

[0240] In embodiments where the external device includes a microphone or communicates with a microphone, the external device can be configured to reprogram the signal processor based on information collected from the microphone representing the acoustic environment. For example, the external device can be configured to identify background noise (e.g., low-end noise) and update the signal processor transfer function accordingly. In some such instances, the external device 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, the user can initiate the process of identifying background noise to adjust the operation of the signal processor via the external device, e.g., via a user interface (e.g., a smart phone or tablet computer touch screen).

[0241] In embodiments where the external device includes a position sensor and / or a clock or communicates with a position sensor and / or a clock, the external device may reprogram the signal processor based on the detected position and / or time. For example, in an exemplary embodiment, when the external device is located in a known noisy place (such as a mall or a stadium), the external device may be configured to detect the position and automatically reprogram the signal processor to reduce background noise (e.g., a specific frequency or frequency range) and / or reduce the overall gain associated with the transfer function. Similarly, in some instances, when located in a place where the wearer may wish to specifically identify speech (such as a movie theater), the external device may be configured to reprogram the signal processor to emphasize the frequencies associated with speech.

[0242] In some instances, the transfer function may be updated to reduce the contribution of the identified background noise. In some embodiments, reducing the contribution of the identified background noise includes emphasizing signals having a frequency content between approximately 200 Hz and 20 kHz. In some embodiments, updating the transfer function to reduce the contribution of the identified background noise includes emphasizing signals having a frequency content between approximately 300 Hz and 8 kHz. Emphasizing signals within such frequency ranges may help to emphasize human speech or other similar signals within a noisy environment.

[0243] Additionally or alternatively, the external device may be configured to reprogram the signal processor based on the determined time of day. For example, when the wearer generally does not want to be disturbed (such as at night), the external device may be configured to reduce the volume of all or most sounds. In some instances, the wearer may additionally or alternatively temporarily reprogram the signal processor via the external device to adjust the transfer function of the signal processor (e.g., to reduce the volume) for a predetermined amount of time (such as 15 minutes, 1 hour, or 1 day).

[0244] In some instances, reprogramming the signal processor includes adjusting the transfer function to achieve a relative change (e.g., reducing the volume). In some cases, reprogramming the signal processor includes implementing a predefined transfer function in response to received data, such as position data indicating that the wearer is in a specific location. In some such instances, multiple pre-programmed transfer functions are stored in a memory and may be implemented based on data obtained by one or more sensors of the external device.

[0245] In some embodiments, the external device may be configured to provide an input signal based on audio generated by the external device. For example, the external device may be a smart phone and may provide an input signal to the wearer's implantable battery and / or communication module, the input signal including audio from a phone call, text-to-speech audio (e.g., reading aloud a text message or article), and / or media audio (e.g., video, music, games, etc.). The implantable battery and / or communication module may be configured to relay the input signal to a signal processor for the signal processor to convert it into a corresponding stimulation signal.

[0246] Figure 21 A process flow diagram is shown that illustrates an exemplary method for pairing a charger with an implantable system. The method includes turning on the charger (step 2100) and initiating a pairing process through the charger (step 2102). The charger may instruct the user to place and hold a communication coil associated with the charger over the implant (step 2104). When within the range of coil communication, the charger communicates with the implant (step 2106), e.g., through the implantable battery and / or communication module. The charger may determine whether the pairing with the implant is successful (step 2108) and display to the user whether the pairing is successful (step 2110) or unsuccessful (step 2112).

[0247] Figure 22 A process flow diagram is shown that illustrates an exemplary method for pairing another device with an implantable system using a paired charger. The method includes selecting an option for pairing a device with the implant on the charger (step 2200), thereby turning on the desired device and placing it in pairing mode (step 2202). The implant determines the pairable devices and transmits a list of available devices to the charger (step 2204), and the charger displays the list of available devices to the customer (step 2206). The user may select from the list of displayed devices to initiate pairing (step 2208). The charger and / or the selected device may determine whether the pairing is successful (step 2210). If the pairing is successful, a "pairing successful" message may be displayed through the charger and / or the newly paired device (step 2212). If the pairing is unsuccessful, a "pairing unsuccessful" message may be displayed on the charger (step 2214). For example, in some embodiments, after attempting to initiate a pairing between the implant (e.g., through the implantable battery and / or communication module of the system) and another device (e.g., step 2208), if the charger does not receive an indication confirming the pairing from the implant or the selected device after a predetermined amount of time, the charger may determine that the pairing is unsuccessful, output a "pairing unsuccessful" message (step 2214), and stop attempting to establish the pairing.

[0248] In various instances, it may be through the charger, such as throughFigure 22 The methods shown and devices for pairing with an implant (e.g., for communicating with an implantable battery and / or communication module) can include a remote control, a smart device running an application for interfacing with the implant, a key fob, an audio streaming device, or other consumer electronics capable of wireless communication (e.g., Bluetooth).

[0249] Return reference Figure 20 , in various embodiments, once a device (e.g., charger 2010, external device 2030, etc.) has been paired with an implantable battery and / or communication 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) such that pairing does not need to be performed again in the future. In some embodiments, one or more devices can be unpair ed from the communication with the implantable battery and / or communication module 2020. For example, if the user no longer uses the device (e.g., discards, returns, gifts, etc.), the device can be used to disconnect from the implantable battery and / or communication module 2020. Additionally or alternatively, if the device does not establish wireless communication with the implantable battery and / or communication module 2020 within a certain amount of time since the last connection, the device can be automatically unpair ed. For example, in an exemplary embodiment, if a device that transmits a Bluetooth audio stream to the implantable system via the implantable battery and / or communication module is disconnected from the implantable battery and / or communication module for more than 5 minutes, the device is unpair ed from the implantable battery and / or communication module and must be re-pair ed for future use.

[0250] As described, in various embodiments, different external devices can interface with the implantable components to adjust the operation of the system in various ways. In some embodiments, not all components are capable of performing the same functions as other components. Figure 23 is a chart showing various parameters that can be adjusted by each of various external devices according to some exemplary systems. In Figure 23 's example, an entry in the chart containing an "X" indicates a component configured to perform the corresponding function. For example, in the illustrated embodiment, only the charger is capable of performing an initial wireless pairing with the implantable system, as described with respect to Figure 20 and 21 . In some such instances, the remaining devices that can be programmed for wireless communication with the implantable system are paired through the charger, as described with respect to Figure 22 . Other instances where different components include different functions, such as those represented by the example of Figure 23 , are possible, where components other than or in addition to the charger can initiate a wireless pairing with the implantable system.

[0251] Typically, the modularity of such systems allows system modifications to be performed with minimal disruption to the implantable system components, such as repairing, replacing, upgrading the system components, and / or transitioning from a partially implantable system to a fully implantable system. For example, when implanting and / or replacing other system components, the cochlear implant electrodes and the electrical stimulator and / or acoustic stimulator can remain in place, thereby reducing the risk of additional procedures damaging the patient's cochlear tissue. Additionally, communication techniques such as those described herein can be used to assist in customizing and / or optimizing the signal processor transfer function for a particular patient, as well as enabling the system to meet safety standards, provide sufficient power and data transfer rates between system components, and operate at high efficiency. It should be understood that while the present disclosure has been generally described with respect to implantable hearing systems, the communication techniques described can be used in 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), etc.

[0252] In some embodiments, the system can communicate with an external device to assist in the assembly and / or calibration of the implantable system. Figure 24 An example configuration of an interfacing device configured to assist in system calibration is shown. As shown, an external device 2400 (e.g., a laptop computer, PC, smart phone, tablet computer, smart watch, etc.) communicates with an assembly hub 2402. The assembly hub 2402 includes a speaker 2404 or otherwise communicates with a speaker that can output sound based on commands from the assembly hub 2402.

[0253] In the example shown, the assembly 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 instances, the assembly hub 2402 includes a near-field communication component 2408 (e.g., a communication coil) or otherwise capable of interfacing with the near-field communication component to enable Bluetooth communication between the assembly hub 2402 and the implantable system as described elsewhere herein (e.g., via the implantable battery and / or communication module 2440). Additionally or alternatively, another device (e.g., a charger) can be used to enable wireless (e.g., Bluetooth) communication between the assembly hub 2402 and the implantable battery and / or communication module 2440.

[0254] Figure 24The system shown includes an implantable modular cochlear implant system, the modular cochlear implant system including an implantable battery and / or communication module 2440, a signal processor 2420, a sensor 2410, a stimulator 2430, and cochlear electrodes 2416. Such components may be configured and arranged similar to the various embodiments described herein and may be configured to provide electrical signals from the stimulator 2430 through the cochlear electrodes 2416 based on signals received at the signal processor from the sensor 2410.

[0255] During an exemplary calibration process, the fitting hub 2402 may be configured to output sound through the speaker 2404 and also transmit information about the sound (e.g., intensity, frequency content, etc.) to the implantable battery and / or communication module 2440 of the implantable system. The implantable system, e.g., through the signal processor 2420, may be configured to compare the output of the sensor 2410 (received at the signal processor 2420) with the actual sound emitted from the speaker 2404. This data may be repeated for multiple sounds from the output of the speaker (e.g., various frequencies and / or magnitudes) and used to determine the relationship between the sound picked up by the sensor 2410 and the output from the sensor 2410 to the signal processor 2420. Based on this information, the transfer function of the signal processor 2420 may be calibrated such that the stimulation signal sent to the stimulator 2430 based on the output from the sensor 2410 accurately represents the sound from the environment. Additionally or alternatively, the information may be used to identify how effectively the sensor responds to various external acoustic stimuli, such as different frequencies, intensities, etc. This information may be determined specifically for the wearer, as the sensor response may depend on various factors specific to the wearer and / or the positioning of the sensor.

[0256] In some embodiments, the fitting hub 2402 may be configured to output one or more sounds including a single frequency and / or a single intensity. For example, each sound may have a signal frequency component at a certain intensity, such as various tones. Additionally or alternatively, 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 of ordinary skill in the art.

[0257] Although described as occurring in an implantable system (e.g., signal processor 2420), the calibration process can be similarly performed by the fitting hub 2402. For example, the speaker 2404 can output sound based on instructions from the fitting hub 2402. The sensor 2410 can output a signal based on the sensor's response to the sound emitted from the speaker 2404, and the signal processor 2420 can receive the signal from the sensor 2410 and output a stimulation signal to the stimulator 2430 based on the received signal and the signal processor transfer function.

[0258] In various instances, the implantable battery and / or communication module 2440 can be configured to receive any combination of signals from the sensor 2410, stimulation signals from the signal processor 2420, or signals representative of one or both of such signals. The implantable battery and / or communication module 2440 can then transmit 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. The comparison of the sound output from the speaker 2404 with the corresponding resulting signals in the implantable system can be performed by processing in the fitting hub 2402. Similar to that discussed above, this comparison can be used to determine the relationship between the sound picked up by 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 such that the stimulation signal sent to the stimulator 2430 based on the output from the sensor 2410 accurately represents the sound from the environment. Additionally or alternatively, the information can be used to identify how effectively the sensor responds to various external acoustic stimuli, such as different frequencies, intensities, etc. This information can be determined specifically for the wearer, as the sensor response may depend on various factors specific to the wearer and / or the positioning of the sensor.

[0259] As described, in various instances, the external device 2400 can be used in conjunction with the fitting hub 2402. For example, in some instances, the external device 2400 can provide processing and control capabilities for the processes described herein, and the fitting hub 2402 can act as an interface between the external device 2400 and the implantable system (e.g., by providing the speaker 2404, wireless communication interface 2406, near - field communication component 2408, etc.).

[0260] In some embodiments, the features and / or functions of the fitting hub 2402 as described herein may be performed by an external device, such as a laptop computer, PC, smart phone, tablet computer, etc., incorporating the various capabilities described with respect to the fitting hub. For example, the external device may include a speaker capable of outputting a desired sound in response to a command from the external device, and a wireless communication interface for communicating, for example, with the implantable system via an implantable battery and / or communication module 2440.

[0261] In some instances, 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, the features and / or functions of the fitting hub 2402 may be performed by the application. For example, in some instances, the fitting hub may receive instructions to perform functions via an application running on the external device 2400. In some such embodiments, the wearer and / or the physician may provide input via the application, for example, during the various procedures described herein. In some embodiments, the wearer may receive sound from the fitting hub 2402 and provide input via the application indicating whether the sound was heard or not heard, whether the sound was too loud or too quiet, whether the sound was distinguishable or indistinguishable from a previous sound, and / or other input. In some instances, the implant system (e.g., via the fitting hub 2402 or the implantable battery and / or communication module 2440) may be configured to update the signal processor transfer function in response to such received input.

[0262] In some embodiments, the fitting hub 2402 and / or the external device 2400 may be configured to communicate with a remote facility, such as a physician, e.g., an audiologist. In some such embodiments, the fitting hub 2402 and / or the external device 2400 include a remote communication device 2407 configured to communicate with such remote facility, e.g., via the Internet. The remote communication device 2407 may transmit various information associated with the fitting hub 2402, the external device 2400, and the cochlear implant to another device, such as a device used by an audiologist. Additionally or alternatively, the remote communication device 2407 may be configured to receive input from such another device, such as input related to the features and / or functions performed by the fitting hub, the external device, and / or the 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 predetermined sounds and / or perform one or more fitting functions. Additionally or alternatively, the audiologist may receive information such as how often the wearer uses and / or updates the features of the cochlear implant system.

[0263] In an example implementation, a physician may receive diagnostic information regarding any tests or other procedures performed by the external device 2400, the fitting hub 2402, and / or the cochlear implant system via the telecommunication device 2407. In some such instances, the physician may receive information regarding how often a test or other procedure is performed, the results of any performed tests or procedures, data regarding how often various devices (e.g., the fitting hub 2402) are used, and / or any feedback regarding the use or availability of the cochlear implant.

[0264] In some instances, the physician may initiate or perform various tests or other procedures via the telecommunication device 2407 by another device. In some embodiments, the features and / or functions of the fitting hub 2402 as described herein may be performed or initiated by the physician using another device via the telecommunication device 2407. In various instances, the physician may perform various features such as providing one or more sounds via a speaker (e.g., 2404), performing a stapedial reflex test, or the like as described herein. In response to the one or more sounds provided from the speaker, the physician may receive one or more signals representative of the output of the sensor 2410 and / or the signal processor 2420. The comparison of the one or more sounds provided from the speaker with the corresponding resulting signals in the implant system may be performed by another device and / or by the physician who receives this information via another device.

[0265] In some embodiments, the telecommunication device 2407 may communicate with another device (e.g., at the remote facility of the physician) via a wireless connection (such as Bluetooth, Wi-Fi, NFC, cellular network, Internet access, etc.). Although the telecommunication device 2407 is depicted as communicating via the external device 2400, the telecommunication device 2407 may alternatively or additionally communicate via the fitting hub 2402 or different components of the system. In various embodiments, this telecommunication device may be integrated into the external device 2400 and / or the fitting hub 2402. In some embodiments, the telecommunication device 2407 and the wireless communication interface 2406 may be integrated together to facilitate communication with the remote facility and the implant system. Alternatively, the telecommunication device 2407 and the wireless communication interface 2406 may be separate or partially separate components.

[0266] Figure 25 is a process flow diagram that illustrates an example process for calibrating an implant system. In some instances, one or more sensors (e.g., a sensor contacting the incus, such as Figure 5The sensor shown (540) can detect a physiological phenomenon called the stapedius reflex, in which the muscles of the middle ear contract in response to various stimuli, such as loud sounds or the anticipation of loud sounds. In some instances, an implantable signal processor in communication with this sensor can identify the occurrence of the stapedius reflex based on characteristic outputs, e.g., by pre-programmed signal recognition or through a learning process in which the stapedius reflex is triggered and the response from the sensor is measured and learned.

[0267] Figure 25 The calibration process includes applying an electrical stimulus of a predetermined intensity (step 2500) and measuring the physiological response through the middle ear sensor (step 2510). The measured physiological response can be used to detect whether the stapedius reflex has occurred (step 2520). If the stapedius reflex is not detected, the intensity of the electrical stimulus is increased (step 2530), and a new intensity of electrical stimulus is applied (step 2500) and the physiological response is measured (step 2510). This process can be repeated until the stapedius reflex is detected at step 2520.

[0268] Once the stapedius reflex is detected, the intensity that caused the stapedius reflex can be mapped to a predetermined sound pressure level (step 2540). For example, in some instances, the lowest electrical intensity determined to have caused the detected stapedius reflex can be mapped to an input sound pressure of 100 dB. The method can include calibrating the stimulus intensity that varies with the sound pressure level based on the mapping of the intensity that caused the stapedius reflex to the predetermined sound pressure level (step 2550).

[0269] Figure 25 The calibration process 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 implantable system, such as a programmer, a charger, an external device, an assembly hub, etc. This process can be performed during initial assembly and / or calibration after the system has been in use for some time.

[0270] Utilizing a fully implantable system and initiating the process via wireless communication (e.g., by a programmer, an assembly hub, an external device, etc.) greatly simplifies the process of triggering and / or detecting the stapedius reflex. For example, using cochlear electrodes (e.g., 2416) to cause the stapedius reflex and using an implantable middle ear sensor to sense the reflex eliminates the need for cumbersome diagnostic devices such as tympanometry equipment used to analyze the stapedius reflex.

[0271] In some instances, the systems and processes described with respect to Figure 25 can be used in the calibration steps discussed with respect to Figure 24 For example, in an illustrative example, Figure 24The assembly hub 2402 can cause the speaker 2404 to produce a sound with a sound pressure level of 100 dB while also transmitting details of the sound (e.g., intensity, frequency, etc.) to the implantable battery and / or communication module 2440 (e.g., via Bluetooth communication). The output of the sensor 2410 in response to the 100 dB sound can be identified and associated with the lowest electrical stimulation intensity that causes the detected stapedial reflex. This process can be repeated for multiple frequencies to associate various external acoustic stimuli (e.g., from the speaker 2404) with specific electrical stimulations.

[0272] Several embodiments discussed herein generally relate to cochlear implant systems. As discussed herein, a cochlear implant system can include cochlear electrodes implanted into the cochlear tissue of a wearer, as well as various other components such as an electrical stimulator, a signal processor, and a middle ear sensor. In some embodiments, the cochlear implant system includes components implanted on one or both sides of the wearer. For example, the system can include components implanted on the left side of the wearer (e.g., for their left ear), their right side (e.g., for their right ear), or both.

[0273] Figure 26 An example embodiment is shown in which the cochlear implant system includes components implanted on both sides of the wearer (e.g., into both their right ear and their left ear). As shown, Figure 26 the cochlear implant system includes a first subsystem and a second subsystem. The first subsystem includes a first cochlear electrode 2616a, a first electrical stimulator 2630a, a first middle ear sensor 2610a, and a first signal processor 2620a. The second subsystem includes a second cochlear electrode 2616b, a second electrical stimulator 2630b, a second middle ear sensor 2610b, and a second signal processor 2620b. The first subsystem and the second subsystem 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, where the first cochlear electrode 2616a extends from the first housing. Additionally or alternatively, the second electrical stimulator 2630b and the second signal processor 2620b can be housed in a second housing, where the second cochlear electrode 2616b extends from the second housing.

[0274] Figure 26 the cochlear implant system includes an implantable battery and / or communication module 2640. In some embodiments, the cochlear implant system can include multiple implantable batteries and / or communication modules, but Figure 26 not shown in the figure. The implantable battery and / or communication module 2640 can 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.

[0275] In some such embodiments, the implantable battery and / or communication module 2640 may communicate with the first signal processor 2620a via a first lead 2670a and with the second signal processor 2620b via a second lead 2670b. In some such embodiments, as Figure 26 shown, the first lead 2670a may be different from the second lead 2670b.

[0276] Additionally or alternatively, the implantable battery and / or communication module 2640 may communicate with both the first signal processor 2620a and the second signal processor 2620b via a bifurcated lead 2675. In some such instances, the implantable battery and / or communication module 2640 may be configured to simultaneously send output signals to each of the first signal processor 2620a and the second signal processor 2620b via the bifurcated 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 may be configured to transmit addressed output signals to the first signal processor 2620a and the second signal processor 2620b via the bifurcated lead 2675, wherein the addressed output signals include address information specifying at least one of the first signal processor 2620a and the second signal processor 2620b. In some such embodiments, the first signal processor 2620a and the second signal processor 2620b may be configured to detect the address information and respond only to signals addressed to a particular signal processor. For example, in some instances, the first signal processor 2620a may be unaffected by an addressed output signal including address information specifying the second signal processor 2620b rather than the first signal processor 2620a. Similarly, the second signal processor 2620b may be unaffected by an addressed output signal including address information specifying the first signal processor 2620a rather than the second signal processor 2620b. Alternatively, the battery and / or communication module 2640 may transmit the same signal or different signals to the first signal processor 2620a and the second signal processor 2620b without the bifurcated lead 2675, such as in embodiments having two separate outputs from the battery and / or communication module 2640.

[0277] As discussed herein, an implantable battery and / or communication module can be configured to communicate with a signal processor to adjust a transfer function associated therewith. In some instances, the implantable battery and / or communication module 2640 can be configured to, for example, adjust a first transfer function of the first signal processor 2620a, a second transfer function of the second signal processor 2620b, or a combination of both in response to a received command. In such embodiments, the implantable battery and / or communication module 2640 can be configured to receive commands from an external device via a wireless communication interface (such as Bluetooth, Wi-Fi, NFC, etc.).

[0278] In some embodiments, a cochlear implant system can receive commands for changing the volume associated with the cochlear implant system. In some embodiments, the volume associated with the cochlear implant system can be a total volume or a volume for a specific frequency and / or pitch range (such as reducing background noise, emphasizing speech, increasing the volume from one source relative to another, etc.). In some instances, 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 for changing the volume.

[0279] However, in some instances, the wearer may have different amounts or types of hearing loss on one side compared to the other. In such instances, increasing the volume of the first transfer function by the same amount as the second transfer function may not be relevant to the patient perceiving the same relative volume change on both sides. Thus, the first transfer function and the second transfer function can be updated such that the patient perceives similar output changes via the first electrical stimulator 2630a and the second electrical stimulator 2630b in response to a given stimulus.

[0280] In response to a command for changing the volume, the implantable battery and / or communication module 2640 can 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 can be configured to determine an existing second transfer function associated with the second signal processor 2620b and determine an updated second transfer function based on the determined existing second transfer function and the received command. In such embodiments, the updated first transfer function and the updated second transfer function can reflect the perceived change in volume as specified in the received command. However, although generated by the same received command, the changes to the first transfer function and the second transfer function need not be the same.

[0281] For example, in some embodiments, in response to a command to change volume, an implantable battery and / or communication module may be configured to separately change the volume associated with a first transfer function and the volume associated with a second transfer function. In some such embodiments, an adjustment to the first transfer function may reflect the same or a different adjustment as the adjustment to the second transfer function. In an example embodiment, in response to receiving a command to change volume, an implantable battery and / or communication module may be configured to adjust the volume of the first transfer function to be greater than or less than the second transfer function such that the wearer perceives more or less change in the stimulation output by the first stimulator 2630a compared to the second stimulator 2630b.

[0282] Transfer functions associated with separate signal processors may be updated differently in response to a common command (e.g., "increase volume") to accommodate different hearing profiles associated with each subsystem. For example, in an example embodiment, different transfer functions may be programmed for a first subsystem and a second subsystem based on, for example, the hearing profiles of the wearer in the left and right ears, the operation of middle ear sensors in each of the first and second subsystems (which may behave differently based on, for example, the anatomy of the wearer), etc. A command for "increase volume" may result in different adjustments to different transfer functions. For example, in one or more frequency ranges, the first transfer function may increase the gain by 10% while the second transfer function may increase the gain by 20%. Each change may be determined, for example, based on a prescribed response to a given command based on an existing transfer function.

[0283] In some embodiments, a system including two different subsystems as Figure 26 shown may be used to perform the various functions described herein, such as detecting the stapedius reflex of a wearer. In an example embodiment, acoustic stimulation may be provided to a first ear of a wearer, such as through an in-ear speaker (e.g., communicating with an assembly hub). The acoustic stimulation may be detected by a first middle ear sensor 2610, which may provide an input signal to a first signal processor 2620a programmed with a first transfer function and output a corresponding stimulation signal to a first stimulator 2630a. The first stimulator 2630a may provide electrical stimulation to the cochlear tissue of the wearer based on the stimulation signal.

[0284] The implantable battery and / or communication module 2640 can receive information representing data received from the second middle ear sensor 2610b from the second signal processor 2620b. Generally, the stapedius reflex occurs in the inner ears on both sides of a person, even when a stimulus is applied to only a single ear. Thus, the implantable battery and / or communication module 2640 can be configured to detect a stapedius reflex triggered in the wearer's body in response to a detected stimulus through the first middle ear sensor 2610a, based on the information received from the second signal processor 2620b.

[0285] In some embodiments, this phenomenon can be utilized to perform the various stapedius reflex procedures described herein. For example, the fitting hub can provide an increasing intensity of stimulus to the wearer's first ear until the implantable battery and / or communication module detects a stapedius reflex in the wearer's other ear. Similar to that described elsewhere herein, the intensity of the sound that triggers the stapedius reflex can be used to calibrate the transfer function of the signal processor associated with the sensor used in the first ear. This process can be repeated for multiple frequencies and for the other ear.

[0286] Various non-limiting embodiments have been described. These and other embodiments are within the scope of the embodiments recited below.

Claims

1. A cochlear implant system, comprising: a cochlear electrode; a stimulator that is 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; and a signal processor that communicates with the stimulator and the middle ear sensor, the signal processor having an analog processing stage and a digital processing stage, and programmed with a transfer function and configured to: receive the input signal from the middle ear sensor; input the received input signal into the analog processing stage and process the received input signal through the analog processing stage to generate an analog-processed signal; input the analog-processed signal into the digital processing stage and process the received analog-processed signal through the digital processing stage to generate a digitally processed signal, the digitally processed signal corresponding to a normalized stimulation signal with reduced gain variability across a certain frequency range and compensating for variability in the frequency response of the middle ear sensor; and output a stimulation signal to the stimulator based on the digitally processed signal and the transfer function.

2. The cochlear implant system according to claim 1, wherein processing the received input signal through the analog processing stage includes flattening the frequency response curve of the received input signal.

3. The cochlear implant system according to claim 2, wherein the analog processing stage includes one or more filters and / or amplifiers.

4. The cochlear implant system according to claim 1, wherein the stimulator and the signal processor are integrated into a single hermetically sealed housing, and wherein the cochlear electrode extends from the single hermetically sealed housing.

5. The cochlear implant system according to claim 4, wherein the single hermetically sealed housing includes an outer surface having a first side, a second side generally opposite the first side, and a return electrode coupled to the outer surface on both the first side and the second side.

6. The cochlear implant system according to claim 1, wherein the signal processor is configured to apply the transfer function to the generated digitally processed signal to generate the stimulation signal.

7. The cochlear implant system according to claim 1, wherein the digital processing stage can be adjusted to calibrate the signal processor with respect to the middle ear sensor.

8. The cochlear implant system according to claim 7, further comprising an external device that communicates with the signal processor, and wherein the external device is configured to receive the digitally processed signal generated by the signal processor and adjust the digital processing stage to change the frequency response of the digital processing stage.

9. The cochlear implant system according to claim 8, further comprising an implantable battery and / or communication module that communicates with the signal processor and is configured to communicate wirelessly with the external device to facilitate communication between the external device and the signal processor.

10. The cochlear implant system according to claim 1, wherein the signal processor is configured to: receive a broad-spectrum input signal corresponding to a broad-spectrum stimulation signal including a plurality of frequencies received at the middle ear sensor; and determine the frequency responses of the analog processing stage and the digital processing stage.

11. The cochlear implant system according to claim 10, wherein the signal processor is configured to adjust the digital processing stage to normalize the frequency response of the combined analog and digital processing stages based on the fast Fourier transform of the broad-spectrum stimulation signal and / or the broad-spectrum input signal.

12. The cochlear implant system according to claim 1, wherein the signal processor is configured to receive a plurality of input signals and determine the frequency responses of the analog processing stage and the digital processing stage, each input signal representing a stimulation signal having a unique frequency content.

13. The cochlear implant system according to claim 12, wherein the signal processor is further configured to adjust the digital processing stage to normalize the frequency response of the combined analog and digital processing stages.

14. The cochlear implant system according to claim 13, wherein normalizing the frequency response of the combined analog processing stage and the digital processing stage causes the ratio of the digitally processed signal to the received corresponding stimulation signal to be substantially constant across multiple frequencies or frequency ranges.

15. A method of compensating for variability of a middle ear sensor, comprising: receiving a stimulation signal through the middle ear sensor; using the middle ear sensor to generate an input signal based on the stimulation signal; applying an analog filter to the generated input signal to generate an analog-filtered signal; applying a digital filter to the generated analog-filtered signal to generate a digitally filtered signal; measuring the frequency response of the digitally filtered signal and / or the analog-filtered signal relative to the input signal; and adjusting the digital filter to normalize the frequency response of the digitally filtered signal relative to the stimulation signal.

16. The method according to claim 15, wherein: the stimulation signal includes a broad-spectrum stimulation signal; and measuring the frequency response of the digitally filtered signal and / or the analog-filtered signal relative to the input signal includes performing a transform on the broad-spectrum signal to determine the frequency content of the broad-spectrum signal and determining the frequency response based on the determined frequency content.

17. The method according to claim 15, further comprising applying a plurality of stimulation signals having known frequency content to the middle ear sensor, and wherein measuring the frequency response of the digitally filtered signal relative to the stimulation signal is performed for each of the plurality of stimulation signals.

18. The method according to claim 17, wherein applying the plurality of stimulation signals includes applying stimulation signals having a frequency range between 100 Hz and 10 kHz.

19. The method according to claim 17, wherein measuring the frequency response of the digitally filtered signal relative to the received stimulus signal comprises determining, for a plurality of frequencies or frequency ranges, the ratio of the magnitude of the digitally filtered signal to the magnitude of the stimulus signal.

20. The method according to claim 19, wherein adjusting the digital filter to normalize the frequency response relative to the received stimulus signal comprises adjusting the digital filter such that the determined ratio is substantially equal for each of the plurality of frequencies or frequency ranges.

21. The method according to claim 15, wherein applying an analog filter to the generated input signal comprises applying a plurality of analog filters and / or analog amplifiers.

22. The method according to claim 21, further comprising adjusting the analog filter to normalize the frequency response of the digitally filtered signal relative to the stimulus signal.

23. A system comprising: a cochlear electrode; a stimulator in electrical communication with the cochlear electrode; a middle ear sensor configured to receive a stimulus signal and generate an input signal based on the received stimulus signal; and a signal processor in communication with the stimulator and the middle ear sensor, the signal processor having an analog processing stage and a digital processing stage and programmed with a transfer function, and configured to: receive the input signal from the middle ear sensor; input the received input signal into the analog processing stage to generate an analog processed signal; input the analog processed signal into the digital processing stage to generate a digitally processed signal, the digitally processed signal corresponding to a normalized stimulus signal for reducing variability in the frequency response of the middle ear sensor; and output a stimulus signal to the stimulator based on the digitally processed signal and the transfer function.

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