# US 5,626,629 A · Programming of a speech processor for an implantable cochlear stimulator

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- Number: US 5,626,629 A
- Document ID: US5626629A
- Status: Granted
- Kind: A
- Application number: 08/456,141
- Filed: 1995-05-31
- Granted: 1997-05-06
- Earliest claimed: 1995-05-31
- Assignees: Advanced Bionics AG
- Inventors: Michael A. Faltys; James H. Wolfe; Kitti McMeel; Chris J. Hetlinger
- Web page: https://patentgrep.com/patent/US5626629A

## CPC

- H04R 25/70: {Adaptation of deaf aid to hearing loss, e.g. initial electronic fitting}
- A61N 1/36038: {Cochlear stimulation}
- A61N 1/36039: {fitting procedures}
- H04R 25/505: {using digital signal processing}
- Y02A 90/10: Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
- 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)
- 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)
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

A method and apparatus for fitting an auditory stimulation system involve, in one embodiment, coupling a programmer unit to an implanted unit implanted in the patient; prompting and/or assisting the operator to make and enter an objective or other measurement; receiving the objective measurements into the programmer unit; and determining an estimated threshold stimulation current for an electrode channel of the implanted unit as a function of the objective measurement. In another embodiment, the method and apparatus involve coupling a programmer unit to an implanted unit implanted in the patient; stimulating the patient with a speech signal; and displaying, in real time, a graphical representation of the speech signal using the programmer unit.

## Claims

### Claim 1

A method of fitting an auditory stimulation system, the stimulation system including an implanted unit and a programmer unit; the implanted unit having means for generating a stimulating current and at least one electrode channel associated therewith through which said stimulating current is applied to a patient, said at least one electrode channel having a gain associated therewith and means for adjusting the gain within limits so that the magnitude of the stimulating current may be adjusted; and the programmer unit having coupling means for coupling it to the implanted unit, storage means for storing information, prompting means for prompting entry of specified information, and entry means for entering information into the storage means, the method comprising:
coupling the programmer unit to the implanted unit implanted in the patient;
detecting whether demographic information of the patient is stored in a patient database stored in the storage means of the programmer unit, and if not prompting an operator of the programmer unit to enter demographic information of the patient for storage in the patient data base;
prompting the operator to enter a fitting session for the patient;
entering the fitting session into the storage means of the programmer unit, whereby a record is made within the storage means that the patient was fitted during the entered fitting session;
prompting the operator to enter an objective measurement;
receiving the objective measurement into the programmer unit; and
determining an initial threshold stimulation current for the at least one electrode channel of the implanted unit as a function of the objective measurement.

### Claim 2 (depends on 1)

The method of claim 1 wherein said prompting includes prompting said operator to enter a stapedius reflex measurement of the patient, said receiving includes receiving the stapedius reflex measurement into the programmer unit, and said determining includes determining the initial threshold stimulation current as a function, at least in part, of the stapedius reflex measurement.

### Claim 3 (depends on 1)

The method of claim 1 wherein said prompting includes prompting said operator to enter an electrically elicited auditory brainstem response (EABR) measurement of the patient, said receiving includes receiving the EABR measurement into the programmer unit, and said determining includes determining the initial threshold stimulation current as a function, at least in part, of the EABR measurement.

### Claim 4 (depends on 1)

The method of claim 1 further including assisting the operator in making the objective measurement by prompting the operator through the prompting means of specific types of objective measurements the operator may make.

### Claim 5 (depends on 1)

The method of claim 1 wherein said determining includes determining a most comfortable stimulation current for the at least one electrode channel as a function of said objective measurement.

### Claim 6 (depends on 1)

The method of claim 1 further including:
stimulating said patient through said implanted unit using said initial threshold stimulation current on said at least once electrode channel;
receiving subjective feedback from said patient regarding said stimulating using the initial threshold stimulation current; and
adjusting said initial threshold stimulation current for said at least one electrode channel in response to the subjective feedback received from said patient, and generating an adjusted threshold stimulation current in response thereto.

### Claim 7 (depends on 6)

The method of claim 6 further including:
determining an initial most comfortable stimulation current for said electrode channel as a function of said objective measurement;
stimulating the patient through the implanted unit using the initial most comfortable stimulation current on the at least one electrode channel;
receiving subjective feedback from the patient regarding said stimulating using the initial most comfortable stimulation current; and
adjusting the initial most comfortable stimulation current for the electrode channel in response to the subjective feedback from the patient, and generating an adjusted most comfortable stimulation current in response thereto.

### Claim 8 (depends on 7)

The method of claim 7 wherein the stimulation system further includes display means for displaying the specified information, the method further including:
mapping a lower stimulation level determined by an estimated input dynamic range to said adjusted threshold stimulation current, said estimated input dynamic range defining a range of sound amplitudes that cause stimulation currents to be appplied through the at least one electrode channel to stimulate the patient;
mapping a zero decibel (0 dB) reference level to said adjusted initial most comfortable stimulation current, said 0 dB reference level defining a maximum stimulation current that may be applied to stimulate the patient through the at least one electrode channel;
stimulating said patient through said at least one electrode channel with a speech stimulation current that varies as a function of a speech signal; and
displaying a graphical representation using said programmer unit, said graphical representation including a comparative display of said speech signal, said estimated input dynamic range, and said 0 dB reference level.

### Claim 9 (depends on 8)

The method of claim 8 including:
receiving speech signal subjective feedback from the patient relative to the stimulating performed using the speech stimulation current corresponding to the speech signal;
adjusting said estimated input dynamic range in response to the speech signal subjective feedback, and generating an adjusted input dynamic range in response thereto; and
adjusting the gain of said at least one electrode channel in response to the speech signal subjective feedback, and generating an adjusted gain in response thereto.

### Claim 10 (depends on 8)

The method of claim 8 including:
receiving speech perception performance data from the patient relative to the stimulating performed using the speech stimulation current corresponding to the speech signal;
adjusting said estimated input dynamic range in response to the speech perception performance data received from said patient, and generating an adjusted input dynamic range in response thereto; and
adjusting the gain of said at least one electrode channel in response to speech perception performance data received from said patient, and generating an adjusted gain in response thereto.

### Claim 11 (depends on 1)

The method of claim 1 including storing said objective measurement in the storage means of said programmer unit.

### Claim 12

A method of fitting an auditory stimulation system, the stimulation system including an implanted unit and a programmer unit; the implanted unit having means for generating a stimulating current and a plurality of electrode channels through which a respective stimulating current may be applied to a patient, each of said plurality of electrode channels having a gain associated therewith and means for adjusting the gain so that the magnitude of the stimulating current applied through the channel may be adjusted within limits; and the programmer unit having coupling means for coupling it to the implanted unit, storage means for storing information, a patient data base stored in the storage means, prompting means for prompting entry of specified information, display means for displaying specified information, and entry means for entering information into the storage means, the method comprising:
coupling the programmer unit to the implanted unit;
detecting whether demographic information of the patient is stored in the patient database, and if not prompting an operator of the programmer unit to enter demographic information of the patient for storage in the patient data base;
prompting the operator to enter a fitting session for the patient;
entering the fitting session into the storage means of the programmer unit, whereby a record is made within the storage means that the patient was fitted during the entered fitting session;
stimulating the patient with a stimulating current through at least one of the plurality of electrode channels, the stimulating current being a function of a speech signal;
displaying, in real time, a graphical representation of the speech signal using the programmer unit;
adjusting the gain of the respective electrode channel through which the stimulating current is being applied, while viewing the graphical representation of the speech signal, thereby providing an adjusted stimulating current, until the patient perceives the adjusted stimulating current is at a most comfortable stimulation level, thereby providing a most comfortable stimulating current.

### Claim 13 (depends on 12)

The method of claim 12 including:
mapping a lower sound stimulation level determined by an estimated input dynamic range to said adjusted stimulation current, said estimated input dynamic range defining a range of sound amplitudes that cause stimulation currents to be appplied through the at least one electrode channel to stimulate the patient;
mapping a zero decibel (0 dB) reference level to the most comfortable stimulating current, said 0 dB reference level defining a maximum stimulating current that may be comfortably applied to stimulate the patient through a respective one of said plurality of electrode channels; and
displaying the estimated input dynamic range and the zero decibel reference level along with the graphical representation of the speech signal, using the programmer unit.

### Claim 14 (depends on 13)

The method of claim 13 including:
prompting an operator to enter an objective measurement;
receiving the objective measurement into said programmer unit;
storing the objective measurement in said storage means;
determining an estimated threshold stimulation current for at least one of the plurality of electrode channels of said implanted unit as a function of the objective measurement; and
determining an estimated comfortable stimulation current for said electrode channel as a function of the objective measurement.

### Claim 15 (depends on 14)

The method of claim 14 including:
stimulating said patient through said implanted unit using said estimated threshold stimulation current on said at least one of said plurality of electrode channels;
receiving subjective feedback from said patient regarding said stimulating using the estimated threshold stimulation current;
adjusting said estimated threshold stimulation current for said at least one electrode channel in response to the subjective feedback received from said patient;
stimulating said patient through said implanted unit using said estimated comfortable stimulation current on said at least one of said plurality of electrode channels;
receiving subjective feedback from said patient regarding said stimulating using the estimated comfortable stimulation current; and
adjusting said estimated comfortable stimulation current for said at least one electrode channel in response to the subjective feedback received from said patient.

### Claim 16

A method of fitting an auditory stimulation system, the stimulation system including an implanted unit and a programmer unit; the implanted unit having means for generating a stimulating current and at least one electrode channel through which a respective stimulating current may be applied to a patient, said at least one electrode channel having a gain associated therewith and means for adjusting the gain within limits so that the magnitude of the stimulating current applied through the channel may be adjusted; and the programmer unit having coupling means for coupling it to the implanted unit, storage means for storing information, a patient data base stored in the storage means, prompting means for prompting entry of specified information, entry means for entering information into the storage means, and display means for displaying specified information, the method comprising:
coupling the programmer unit to the implanted unit implanted in the patient;
detecting whether demographic information of the patient is stored in the patient database;
in the event the demographic information is not detected as being in the patient database, prompting an operator of the programmer unit through the prompting means to enter the demographic information and receiving the demographic information into the storage means of the programmer unit;
prompting the operator to enter a fitting session;
entering the fitting session into the storage means of the programmer unit, whereby a record is made within the storage means that the patient was fitted during the entered fitting session;
prompting the operator to enter an objective measurement;
receiving the objective measurement into the programmer unit;
storing the objective measurement in the storage means;
determining an estimated threshold stimulation current for the at least one electrode channel of the implanted unit as a function of the objective measurement, where said estimated threshold stimulation current represents a stimulation current of sufficient magnitude intended to be perceived by the patient;
determining an estimated comfortable stimulation current for the at least one electrode channel as a function of the objective measurement, where said estimated comfortable stimulation current represents a stimulation current of a maximum magnitude that is intended to be comfortably perceived by the patient;
stimulating the patient using the estimated threshold stimulation current on the at least one electrode channel;
receiving subjective feedback from said patient relative to whether the stimulating using the estimated threshold stimulation current on the at least one electrode channel is perceived;
adjusting the estimated threshold stimulation current using the means for adjusting the gain of the at least one electrode channel in response to the subjective feedback received from the patient, thereby providing an adjusted threshold stimulation current;
stimulating the patient using the estimated comfortable stimulation current on the at least one electrode channel;
receiving subjective feedback from said patient relative to whether the stimulating using the estimated comfortable stimulation current on the at least one electrode channel is comfortably perceived;
adjusting the estimated comfortable stimulation current for the at least one electrode channel in response to the subjective feedback received from the patient, thereby providing an adjusted comfortable stimulation current;
mapping an estimated input dynamic range to the adjusted threshold stimulation current, said estimated input dynamic range defining a range of sound amplitudes that cause stimulation currents to be appplied through the at least one electrode channel to stimulate the patient;
mapping a zero decibel (0 dB) reference level to the adjusted comfortable stimulation current, said 0 dB reference level defining a maximum stimulation current that may be comfortably applied to stimulate the patient through the at least one electrode channel, the input dynamic range being measured relative to the 0 dB reference level;
stimulating the patient through the at least one electrode channel with a variable stimulation current that varies as a function of a speech signal;
displaying a graphical representation of the speech signal, along with the estimated input dynamic range and the 0 dB reference level, using the display means of the programmer unit;
receiving subjective feedback from the patient relative to the stimulating using the variable stimulation current;
adjusting the estimated input dynamic range in response to the subjective feedback received from the patient relative to the stimulating with the variable stimulation current that varies as a function of the speech signal, and generating an adjusted input dynamic range in response thereto; and
adjusting the gain of the at least one electrode channel in response to the subjective feedback received from the patient relative to the stimulating with the variable stimulation current that varies as a function of the speech signal, and generating an adjusted gain in response thereto.

### Claim 17

An apparatus for fitting a patient with an implantable cochlear stimulator (ICS), the ICS including means for generating stimulation currents and at least one electrode channel having an electrode channel gain associated therewith through which stimulation currents may be applied to the patient, the fitting apparatus comprising:
a programmer unit (14) comprising:
a data entry device (18);
means for coupling the programmer unit with the ICS, whereby data may be transferred between the programmer unit and the ICS;
memory means for storing a patient data base, said patient data base including demographic information, as well as stimulation parameters, for a plurality of patients, each of whom uses an ICS;
means for prompting entry of demographic information using the data entry device if the demographic information is not detected in the data base;
means for prompting entry of an objective measurement using the data entry device for the patient who is to be fitted using the programmer unit;
means for receiving the objective measurement into the memory circuit of the programmer unit;
means for determining an estimated threshold stimulation current for the at least one electrode channel of the ICS as a function of the objective measurement;
means for determining an estimated comfortable stimulation current for said at least one electrode channel as a function of said objective measurement;
means for adjusting the estimated threshold stimulation current and the estimated comfortable stimulation current to produce an adjusted threshold stimulation current and an adjusted comfortable stimulation current to be used by the ICS of the patient;
means for storing the adjusted threshold stimulation current and the adjusted comfortable stimulation current in the patient data base stored in the memory means of the programmer unit; and
means for transferring the adjusted threshold stimulation current and the adjusted comfortable stimulation current to the ICS of the patient, whereby the adjusted threshold stimulation current and the adjusted comfortable stimulation current may thereafter be used by the ICS.

### Claim 18 (depends on 17)

The apparatus of claim 17 wherein the coupling means includes:
a clinician's programmer (22) comprising:
a first serial interface coupled to the programmer unit (14);
a second serial interface including means for interfacing the clinician's programmer to the ICS;
protocol converter means for converting a first data protocol used by the first serial interface to a second data protocol used by the second serial interface as data is transferred between the programmer unit and the ICS.

### Claim 19 (depends on 17)

The apparatus of claim 17 wherein said coupling means further comprises an equalizer board (28) coupled to the programmer unit (14) through the clinician's programmer (22).

### Claim 20 (depends on 19)

The apparatus of claim 19 wherein said equalizer board includes:
at least one potentiometer connected thereto for adjusting the electrode channel gain on the at least one electrode channel of said ICS.

### Claim 21 (depends on 20)

The apparatus of claim 20 wherein said equalizer board includes:
at least one potentiometer connected thereto for adjusting an input dynamic range of the ICS, said input dynamic range defining a range of stimulation currents that may be generated at levels between the adjusted threshold stimulation level and the adjusted comfortable stimulation level.

### Claim 22 (depends on 21)

The apparatus of claim 21 wherein said equalizer board includes:
a first potentiometer connected thereto for adjusting electrode channel gain on at least one electrode channel of said implantable cochlear stimulator; and
a second potentiometer connected thereto for adjusting the input dynamic range of said ICS.

### Claim 23 (depends on 22)

The apparatus of claim 22 wherein said first potentiometer and said second potentiometer are slider-type potentiometers.

### Claim 24

An apparatus for fitting a patient with an implantable cochlear stimulator (ICS), the ICS including means for generating stimulation currents and at least one electrode channel having an electrode channel gain associated therewith through which stimulation currents may be applied to the patient, the fitting apparatus comprising:
a programmer unit comprising:
a display device;
means for coupling the programmer unit with the ICS, whereby data may be transferred between the programmer unit and the ICS;
memory means for storing a patient data base, said patient data base including demographic information, as well as stimulation parameters, for a plurality of patients, each of whom uses an ICS;
means for prompting entry of demographic information if the demographic information is not detected in the data base;
means for generating a speech signal;
means for determining an estimated threshold stimulation current for the at least one electrode channel of the ICS that defines a lower limit of stimulation currents that can be perceived by the patient;
means for determining an estimated comfortable stimulation current for the at least one electrode channel that defines an upper limit of stimulation currents that can be comfortably perceived by the patient;
means for causing the (ICS) to stimulate the patient with a variable stimulation current derived from the speech signal, said variable stimulation current having a magnitude that lies within a range between the estimated threshold stimulation current and the estimated comfortable stimulation current;
means for displaying, in real time, a graphical representation of the speech signal using the display device of the programmer unit; and
means for adjusting the estimated threshold stimulation current and the estimated comfortable stimulation current to produce an adjusted threshold stimulation current and an adjusted comfortable stimulation current that may be used to set new upper and lower limits for the variable stimulation current that are fitted to what the patient comfortably perceives.

### Claim 25 (depends on 24)

The apparatus of claim 24 wherein said programmer unit further comprises:
means for mapping an estimated input dynamic range to the adjusted threshold stimulation current, said estimated input dynamic range defining a range of sound amplitudes that cause stimulation currents to be applied to the patient between the adjusted threshold stimulation level and the adjusted comfortable stimulation level;
means for mapping a zero decibel (0 dB) reference level to the adjusted comfortable stimulation current, the 0 dB reference level defining a maximum stimulation current that may be applied to comfortably stimulate the patient through the at least one electrode channel, the input dynamic range being measured relative to the 0 dB reference level; and
means for displaying the estimated input dynamic range and the 0 dB reference level, along with said graphical representation of the speech signal.

### Claim 26 (depends on 25)

The apparatus of claim 25 wherein said coupling means includes a clinician's programmer comprising:
a first serial interface coupled to the programmer unit;
a second serial interface including means for interfacing the clinician's programmer to the ICS;
protocol converter means for converting a first data protocol used by the first serial interface to a second protocol used by the second serial interface as data is transferred between the programmer unit and the ICS.

### Claim 27 (depends on 26)

The apparatus of claim 26 wherein said coupling means further comprises an equalizer board coupled to the programmer unit through the clinician's programmer.

### Claim 28 (depends on 27)

The apparatus of claim 27 wherein said equalizer board includes:
at least one potentiometer connected thereto for adjusting the electrode channel gain on at least one electrode channel of said ICS.

### Claim 29 (depends on 27)

The apparatus of claim 27 wherein said equalizer board includes:
at least one potentiometer connected thereto for adjusting an input dynamic range of the ICS, said input dynamic range defining a range of stimulation currents that may be generated at levels between the adjusted threshold stimulation level and the adjusted comfortable stimulation level.

### Claim 30 (depends on 27)

The apparatus of claim 27 wherein said equalizer board includes:
at least one potentiometer connected thereto for adjusting the electrode channel gain on at least one electrode channel of said ICS; and
at least another potentiometer connected thereto for adjusting an input dynamic range of the ICS, said input dynamic range defining a range of stimulation currents that may be generated at levels between the adjusted threshold stimulation level and the adjusted comfortable stimulation level.

### Claim 31

An apparatus for fitting a patient with an implantable cochlear stimulator (ICS), the ICS including means for generating stimulation currents and at least one electrode channel having an electrode channel gain associated therewith through which stimulation currents may be applied to the patient, the fitting apparatus comprising:
a programmer unit comprising:
a clinician's programmer connected to the programmer unit including means for coupling the programmer unit with the ICS, whereby data may be transferred between the programmer unit and the ICS, the clinician's programmer including:
a first serial interface coupled to the programmer unit,
a second serial interface including means for interfacing the clinician's programmer to the implantable cochlear stimulator, and
data protocol converter means for converting a first data protocol used by the first serial interface to a second data protocol used by the second serial interface;
storage means for storing data within the programmer unit;
means for prompting entry of data associated with an objective measurement into the storage means of the programmer unit;
means for determining an estimated threshold stimulation current and an estimated comfortable stimulation current as a function of the objective measurement data, the estimated threshold stimulation current defining a lower limit for stimulation current applied to the patient through the at least one electrode channel of the ICS, and the estimated comfortable stimulation current defining an upper limit for the stimulation current applied to the patient; and
means for adjusting the estimated threshold stimulation current and the estimated comfortable stimulation current in order to maintain the stimulation currents applied through the at least one electrode channel within a range of stimulation currents that are comfortably perceived by the patient.

### Claim 32

An apparatus for fitting a patient with an implantable cochlear stimulator (ICS), the ICS including means for generating stimulation currents and at least one electrode channel having an electrode channel gain associated therewith through which stimulation currents may be applied to the patient, the fitting apparatus comprising:
a programmer unit comprising:
a clinician's programmer connected to the programmer unit including means for coupling the programmer unit with the ICS, whereby data may be transferred between the programmer unit and the ICS, the clinician's programmer including:
a first serial interface coupled to the programmer unit,
a second serial interface including means for interfacing the clinician's programmer to the implantable cochlear stimulator, and
data protocol converter means for converting a first data protocol used by the first serial interface to a second data protocol used by the second serial interface,
means for generating a speech signal;
means for determining a threshold stimulation current and a comfortable stimulation current that may be applied to the patient through the at least one electrode channel of the ICS;
means for causing the implantable cochlear stimulator to stimulate the patient with a stimulation current derived from the speech signal, said stimulation current being greater than the threshold stimulation current and less than the comfortable stimulation current, whereby the threshold stimulation current defines a lower limit for the stimulation current and the comfortable stimulation current defines an upper limit for the stimulation current;
means for displaying, in real time, a graphical representation of the stimulation current derived from the speech signal as compared to the threshold stimulation current and the comfortable stimulation current; and
means for adjusting the threshold stimulation current and the comfortable stimulation current for the at least one electrode channel of the ICS in order to maintain the stimulation current within a range of stimulation currents that is comfortably perceived by the patient.