IMPLANTABLE COCHLEAR SYSTEM WITH INTEGRATED COMPONENTS AND LEAD CHARACTERIZATION

1 . A system comprising:

a fully-implantable cochlear implant comprising:

a cochlear electrode;

a stimulator in electrical communication with the cochlear electrode;

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

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

an implantable battery and/or communication module in communication with the signal processor and 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.

2 . The system of claim 1 , wherein, in response to the external hub outputting a predetermined acoustic signal via the speaker:

the input source receives a stimulus resulting from the predetermined acoustic signal and generates the input signal in response thereto;

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

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

receive information from the external hub regarding an 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 input source.

3 . The system of claim 2 , wherein the implantable battery and/or communication module is configured to update the transfer function of the signal processor in response to the determined relationship.

4 . The system of claim 2 , wherein

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

for each of the output predetermined acoustic signals, the implantable battery and/or communication module is configured to:

receive information from the external hub regarding the acoustic signal output from the speaker of the external hub;

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 input source.

5 . The system of claim 4 , wherein the each of the plurality of predetermined acoustic signals comprises a plurality of frequencies and/or intensities.

6 . The system of claim 5 , wherein each of the plurality of predetermined acoustic signals comprise substantially the same intensity.

7 . The system of claim 1 , wherein the speaker of the external hub comprises an in-ear speaker.

8 . The system of claim 7 , wherein the input source comprises a middle ear sensor and wherein the implantable battery and/or communication module is configured to:

receive information from the signal processor representing an input signal output from the middle ear sensor in response to a received stimulus; and

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

9 . The system of claim 8 , wherein the external hub is configured to provide an acoustic signal via the in-ear speaker at a first intensity and increase the intensity over time.

10 . The system of claim 9 , wherein the implantable battery and/or communication module is configured to:

detect the stapedial reflex of the wearer in response to the increasing intensity of the acoustic signal;

determine the intensity of the acoustic signal from the external hub that causes the stapedial reflex; and

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

11 . The system of claim 10 , wherein

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

for each of the output predetermined acoustic signals, the implantable battery and/or communication module is configured to:

detect the stapedial reflex of the wearer in response to the increasing intensity of the acoustic signal;

determine the intensity of the acoustic signal from the external hub that causes the stapedial reflex; and

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

12 . The system of claim 11 , further comprising an external device in communication with the external hub; and

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

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

receiving a first input signal via a first implanted signal processor, the first input signal being representative of a predetermined acoustic signal;

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

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

receiving a measurement signal via an implanted middle ear sensor;

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

14 . The method of claim 13 , further comprising:

outputting a predetermined acoustic signal at a first intensity, wherein the first input signal is representative of the predetermined acoustic signal at the first intensity; and

increasing the intensity of the predetermined acoustic signal over time.

15 . The method of claim 14 , wherein the method further comprises the steps of:

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

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

16 . The method of claim 15 , further comprising updating the transfer function based on the intensity of the predetermined acoustic signal that causes the stapedial reflex.

17 . The method of claim 14 , further comprising:

receiving a plurality of first input signals via the first implanted signal processor, each of the plurality of first input signals being representative of a corresponding plurality of predetermined acoustic signals, and wherein each of the plurality of predetermined acoustic signals comprises a corresponding one of a plurality of frequencies;

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

detecting the stapedial reflex of the wearer in response to the increasing intensity for each of the plurality of predetermined acoustic signals; and

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

18 . The method of claim 17 , further comprising updating the transfer function based on the intensity of each of the predetermined acoustic signals that causes the stapedial reflex.

19 . The method of claim 17 , wherein each of the plurality of input signals representative of the plurality of predetermined acoustic signals is provided at a different time.

20 . The method of claim 13 , wherein the first input signal is received by the first implanted signal processor located on a first side of the wearer and the measurement signal is received by a second implanted signal processor located on a second side of the wearer.

21 . The method of claim 13 , wherein the first input signal and the measurement signal are received by the first implanted signal processor.

22 . The method of claim 13 , wherein the first input signal is provided via an external speaker.

23 . The method of claim 22 , wherein the external speaker comprises an in-ear speaker.

24 . The method of claim 13 , wherein the first input signal is provided via a wireless communication link from an external device.

25 . The method of claim 24 , wherein the external device comprises at least one of: a laptop, a PC, a smartphone, a tablet, and a smartwatch.

26 . A calibration system for a cochlear implant comprising:

a fully-implantable cochlear implant comprising:

a cochlear electrode;

a stimulator in electrical communication with the cochlear electrode;

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

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

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

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

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

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

increase the intensity of the predetermined acoustic signal increased over time; and

communicate information regarding the predetermined acoustic signal to the implantable battery and/or communication module via the wireless communication interface; and wherein

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

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

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

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

27 . The calibration system of claim 26 , wherein the implantable battery and/or communication module is further configured to update the signal processor transfer function based on the determined intensity of the predetermined acoustic signal corresponding to the detected stapedial reflex.

28 . The calibration system of claim 27 wherein:

the external device is configured to:

output a plurality of predetermined acoustic signals, each of the plurality of predetermined acoustic signals comprising a corresponding one of a plurality of frequencies; and

increase the intensity of each of the plurality of predetermined acoustic signals; and

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

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

detect the stapedial reflex of the wearer in response to the increasing intensity of the plurality of predetermined acoustic signals;

determine, for each of the plurality of frequencies, the intensity of the predetermined acoustic signal that triggers the stapedial reflex; and

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

29 . The calibration system of claim 28 , wherein each of the plurality of predetermined acoustic signals is provided at a different time.

30 . The calibration system of claim 26 , further comprising a speaker in communication with the external device; and wherein the predetermined acoustic signal is provided by the speaker in communication with the external device.

31 . The calibration system of claim 26 , wherein:

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

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

32 . The calibration system of claim 26 , wherein the external device is configured to connect to the internet and provide communication between a clinician and the implantable battery and/or communication module via the internet and the external device.

33 . The calibration system of claim 26 , wherein the external device comprises a user interface.

34 . The calibration system of claim 33 , wherein the implantable battery and/or communication module is configured to receive an input via the user interface of the external device indicating whether the wearer can detect the predetermined acoustic signal.

35 . The calibration system of claim 26 , wherein:

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

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

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