# US 12,214,195 B2 · Implantable cochlear system with inner ear sensor

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- Number: US 12,214,195 B2
- Document ID: US12214195B2
- Status: Granted
- Kind: B2
- Application number: 18/502,762
- Filed: 2023-11-06
- Published: 2024-03-07
- Granted: 2025-02-04
- Earliest claimed: 2020-12-02
- Assignees: Envoy Medical Corporation
- Applicants: Envoy Medical Corporation
- Inventors: Paul R. Mazanec
- Web page: https://patentgrep.com/patent/US12214195B2

## CPC

- A61N 1/36038: {Cochlear stimulation}
- A61B 5/12: Audiometering
- A61B 5/6817: {Ear canal}
- A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)}
- A61N 1/0541: {Cochlear electrodes}
- A61N 1/37235: {Aspects of the external programmer}
- H04R 25/30: {Monitoring or testing of hearing aids, e.g. functioning, settings, battery power}
- H04R 25/556: {External connectors, e.g. plugs or modules (H04R25/607 takes precedence)}
- H04R 25/602: {of batteries}
- A61B 5/4851: {Prosthesis assessment or monitoring}
- A61N 1/025: {Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors}
- A61N 1/36039: {fitting procedures}
- H04R 2225/67: Implantable hearing aids or parts thereof not covered by H04R25/606
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- H04R: LOUDSPEAKERS, MICROPHONES, GRAMOPHONE PICK-UPS OR LIKE ACOUSTIC ELECTROMECHANICAL TRANSDUCERS; ELECTRIC HEARING AIDS; PUBLIC ADDRESS SYSTEMS (producing sounds with frequency not determined by supply frequency G10K)

## Abstract

Cochlear implant systems can include an inner ear sensor configured to receive a stimulus signal from the cochlear tissue of a wearer and generate an input signal based on the received stimulus signal. The inner ear sensor can be configured to detect pressure, for example, within a wearer's cochlear tissue and generate an input signal based on the detected pressure. The inner ear sensor can be integrated with a cochlear electrode implanted in the cochlear tissue. Systems can include a signal processor programmed with a transfer function and configured to receive an input signal and output a stimulation signal based on the received input signal and transfer function. Systems can include an implantable battery and/or communication module in communication with the signal processor. The implantable battery and/or communication module can be configured to interface with and update the transfer function of the signal processor.

## Claims

### Claim 1

A cochlear implant system comprising:
a cochlear electrode;
a stimulator in electrical communication with the cochlear electrode;
an inner ear sensor configured to receive a stimulus signal from surrounding cochlear tissue and/or fluid of a wearer and generate an input signal based on the received stimulus signal; and
a signal processor in communication with the stimulator and the inner ear sensor, the signal processor having an analog processing stage and a digital processing stage, the signal processor being programmed with a transfer function configured to:
receive the input signal from the inner ear sensor;
input the received input signal to the analog processing stage and process the received input signal via the analog processing stage to generate an analog processed signal, the analog processed signal having, compared to the input signal, reduced variability in gain relative to the received stimulus signal across a range of frequencies; and
input the analog processed signal to the digital processing stage and process the received analog processed signal via the digital processing stage to generate a digitally processed signal, the digitally processed signal having, compared to the analog processed signal, reduced variability in gain relative to the received stimulus signal across the range of frequencies such that the analog processing stage and the digital processing stage combine to compensate for variability in a frequency response of the inner ear sensor; and
output a stimulation signal to the stimulator based on the digitally processed signal and the transfer function; and wherein
the stimulator is configured to provide electrical signals to the cochlear electrode in response to the stimulation signal.

### Claim 2 (depends on 1)

The cochlear implant system of claim 1, wherein the inner ear sensor is included as a part of the cochlear electrode.

### Claim 3 (depends on 2)

The cochlear implant system of claim 2, wherein the inner ear sensor comprises a pressure sensor, and wherein the received stimulus signal comprises a measured pressure.

### Claim 4 (depends on 2)

The cochlear implant system of claim 2, further comprising a housing, the housing including the signal processor and stimulator;
wherein the cochlear electrode including the inner ear sensor extends from the housing.

### Claim 5 (depends on 1)

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

### Claim 6 (depends on 1)

The cochlear implant system of claim 1, wherein the digital processing stage is adjustable to calibrate the signal processor to the inner ear sensor.

### Claim 7 (depends on 1)

The cochlear implant system of claim 1, wherein the stimulus signal received at the inner ear sensor comprises a broad-spectrum stimulus signal, and wherein the signal processor is configured to:
receive a broad-spectrum input signal corresponding to the broad-spectrum stimulus signal, the broad-spectrum input signal comprising a plurality of frequencies;
determine the frequency response of the analog processing stage and the digital processing stage;
perform a Fast Fourier Transform of the broad-spectrum input signal; and
adjust the digital processing stage to normalize the frequency response of the combined analog processing stage and digital processing stage based on the Fast Fourier Transform of the broad-spectrum input signal.

### Claim 8 (depends on 1)

The cochlear implant system of claim 1,
wherein the inner ear sensor is configured to receive a plurality of stimulus signals from surrounding cochlear tissue and/or fluid of a wearer and generate a corresponding plurality of input signals based on the received plurality of stimulus signals, each of the plurality of stimulus signals having unique frequency content; and
wherein the signal processor is configured to receive the plurality of input signals and determine the frequency response of the analog processing stage and the digital processing stage.

### Claim 9 (depends on 8)

The cochlear implant system of claim 8, wherein the signal processor is configured to:
adjust the digital processing stage to normalize the frequency response of the combined analog processing stage and digital processing stage; and wherein
normalizing the frequency response of the combined analog processing stage and the digital processing stage results in a ratio of the digital processed signal to each of the plurality of received stimulus signal being approximately consistent across the plurality of received stimulus signals.

### Claim 10 (depends on 1)

The cochlear implant system of claim 1, further comprising:
an implantable battery and/or communication module in communication with the signal processor and being configured to provide electrical power to the signal processor; and
an external hub including a speaker and a wireless communication interface, the external hub being configured to communicate wirelessly with the implantable battery and/or communication module, the external hub being configured to output a predetermined acoustic signal via the speaker and communicate information regarding the predetermined acoustic signal to the implantable battery and/or communication module via the wireless communication interface.

### Claim 11 (depends on 10)

The cochlear implant system of claim 10, wherein, in response to the external hub outputting the predetermined acoustic signal via the speaker:
the inner ear sensor receives a stimulus resulting from the predetermined acoustic signal and generates the input signal in response thereto;
the signal processor receives the input signal from the inner ear sensor and communicates information representative of the received input signal to the implantable battery and/or communication module; and wherein the system is configured to:
receive information from the external hub regarding the acoustic signal output from the speaker of the external hub;
analyze the information received from the external hub regarding the output predetermined acoustic signal and the information received from the signal processor representative of the received input signal to determine a relationship between the predetermined acoustic signal output from the speaker of the external hub and the resulting input signal generated via the inner ear sensor.

### Claim 12 (depends on 11)

The cochlear implant system of claim 11, wherein the system is further configured to update the transfer function of the signal processor in response to the determined relationship.

### Claim 13 (depends on 11)

The cochlear implant system of claim 11, wherein
the predetermined acoustic signal comprises a first predetermined acoustic signal;
the external hub is configured to output a plurality of predetermined acoustic signals including the first predetermined acoustic signal; and
for each of the output predetermined acoustic signals, the system is configured to:
receive information from the external hub regarding the acoustic signal output from the speaker of the external hub;
analyze information received from the external hub regarding the output predetermined acoustic signal and information received from the signal processor representative of the received input signal to determine the relationship between the predetermined acoustic signal output from the speaker of the external hub and the resulting input signal generated via the inner ear sensor.

### Claim 14 (depends on 13)

The cochlear implant system of claim 13, wherein the each of the plurality of predetermined acoustic signals comprises a plurality of frequencies and each of the plurality of predetermined acoustic signals comprise substantially the same intensity.

### Claim 15 (depends on 13)

The cochlear implant system of claim 13, wherein the system is configured to:
receive information from the signal processor representing the input signal output from the inner ear sensor in response to the received stimulus; and
detect a stapedial reflex of a wearer based on the information received from the signal processor.

### Claim 16 (depends on 15)

The cochlear implant system of claim 15, wherein outputting the plurality of predetermined acoustic signals comprises providing the first predetermined acoustic signal via the in-ear speaker at a first intensity and increasing the intensity over time; and the system is configured to:
detect the stapedial reflex of the wearer in response to the increasing intensity of the predetermined acoustic signals;
determine the intensity of the predetermined acoustic signal from the external hub that causes the stapedial reflex; and
update the signal processor transfer function based on the determined intensity.

### Claim 17 (depends on 16)

The cochlear implant system of claim 16, wherein
outputting the plurality of predetermined acoustic signals comprises, for each of a plurality of frequencies, outputting one of the predetermined acoustic signals at the first intensity and increase the intensity over time; and
for each of the output predetermined acoustic signals, the system is configured to:
detect the stapedial reflex of the wearer in response to the increasing intensity of the predetermined acoustic signals;
determine the intensity of the predetermined acoustic signal from the external hub that causes the stapedial reflex; and
update the signal processor transfer function based on the determined intensity.

### Claim 18 (depends on 1)

The cochlear implant system of claim 1, comprising:
a first subsystem including:
the cochlear electrode, wherein the cochlear electrode comprises a first cochlear electrode;
the stimulator, wherein the stimulator comprises a first stimulator in communication with the first cochlear electrode;
the inner ear sensor, wherein the inner ear sensor comprises a first inner ear sensor configured to receive a first stimulus signal and generate a first input signal based on the received first stimulus signal; and
the signal processor, wherein the signal processor comprises a first signal processor in communication with the first stimulator and the first inner ear sensor, and wherein the transfer function comprises a first transfer function; and
a second subsystem including:
a second cochlear electrode;
a second stimulator in communication with the second cochlear electrode;
a second input source configured to receive a second stimulus signal and generate a second input signal based on the received second stimulus signal; and
a second signal processor in communication with the second stimulator and the second input source, the second signal processor programmed with a second transfer function and being configured to:
receive the second input signal from the second input source; and
output a second stimulation signal to the second stimulator based on the second input signal and the second transfer function; wherein
the second stimulator is configured to provide electrical signals to the second cochlear electrode in response to the second stimulation signal; and
an implantable battery and/or communication module in communication with the first signal processor and the second signal processor and configured to provide electrical power to the first signal processor and the second signal processor.

### Claim 19 (depends on 18)

The cochlear implant system of claim 18, further comprising a first housing and a second housing, and wherein
the first stimulator and the first signal processor are housed in the first housing;
the first cochlear electrode extends from the first housing;
the second stimulator and the second signal processor are housed in the second housing; and
the second cochlear electrode extends from the second housing.
