U.S. patent application number 09/733497 was filed with the patent office on 2001-08-16 for implantable hearing assistance system with calibration and auditory response testing.
Invention is credited to Kennedy, Joel A..
Application Number | 20010014818 09/733497 |
Document ID | / |
Family ID | 25187988 |
Filed Date | 2001-08-16 |
United States Patent
Application |
20010014818 |
Kind Code |
A1 |
Kennedy, Joel A. |
August 16, 2001 |
Implantable hearing assistance system with calibration and auditory
response testing
Abstract
A hearing assistance system includes electric response
audiometry (ERA) functions for diagnostic, self-calibration,
frequency-response parameter adjustment, feedback self-testing, and
automatic gain control (AGC) purposes. The invention includes
partial middle ear implantable (P-MEI), total middle ear
implantable (T-MEI), cochlear implant, or other hearing assistance
systems. Auditory response signals are obtained by auditory
brain-stem response (ABR), cortical ERA, and electrocochleography.
A mechanical vibration or electrical stimulus is introduced
directly in the middle or inner ear, either in response to an input
signal corresponding to sound, or in response to an independent
calibration signal. Auditory response signals are obtained by
surface electroencephalography (EEG) or by an implanted
electrocochleographic sensor. Calibration stimuli have constant or
adjustable amplitudes, frequencies, and repetition frequencies.
Wide-band clicks, pure audio tones, and other calibration stimuli
are included. The diagnostic and calibration capabilities are
particularly useful to assess efficacy during implantation of
components into a patient under general anesthesia.
Inventors: |
Kennedy, Joel A.; (Arden
Hills, MN) |
Correspondence
Address: |
Steven J. Keough
Fredrikson & Byron, P.A.
1100 International centre
900 Second Avenue South
Minneapolis
MN
55402
US
|
Family ID: |
25187988 |
Appl. No.: |
09/733497 |
Filed: |
December 8, 2000 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09733497 |
Dec 8, 2000 |
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09455848 |
Dec 7, 1999 |
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09455848 |
Dec 7, 1999 |
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08804016 |
Feb 21, 1997 |
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5999856 |
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Current U.S.
Class: |
607/57 |
Current CPC
Class: |
A61N 1/36039
20170801 |
Class at
Publication: |
607/57 |
International
Class: |
A61N 001/36 |
Claims
What is claimed is:
1. A method of testing an auditory response in a living organism,
the method comprising: introducing a stimulus directly in a middle
or inner ear; and obtaining an electrical auditory response signal
in response to the stimulus.
2. The method of claim 1, wherein the stimulus is a mechanical
vibration.
3. The method of claim 2, wherein the mechanical vibration is
provided by an output stimulator comprising an electromechanical
transducer disposed within the middle ear.
4. The method of claim 3, wherein the electromechanical transducer
is mechanically coupled to a stapes bone.
5. The method of claim 1, wherein the stimulus is electrical.
6. The method of claim 5, wherein the stimulus is provided by an
output stimulator comprising a cochlear implant disposed within the
inner ear.
7. The method of claim 1, wherein the auditory response signal is
obtained by electroencephalography (EEG) techniques.
8. The method of claim 1, wherein the auditory response signal is
obtained by electrocochleographic techniques.
9. The method of claim 1, wherein the auditory response signal is
obtained by cortical electric response audiometry techniques.
10. The method of claim 1, wherein the auditory response signal is
obtained by auditory brain stem response techniques.
11. A method of testing an auditory response in a living organism,
the method comprising: applying sound to an ear; transducing the
sound into an electrical input signal; processing the electrical
input signal to provide a resulting electrical output signal;
introducing an output stimulus directly in the middle ear or inner
ear in response to the output signal; and obtaining an electrical
auditory response signal in response to the output stimulus.
12. The method of claim 11, wherein the step of transducing the
sound includes sensing a mechanical vibration in the middle
ear.
13. The method of claim 11, wherein the step of transducing the
sound includes sensing sound waves.
14. A method of using an at least partially implantable hearing
assistance device, the method comprising the steps of: positioning
an output stimulator in a middle or inner ear; providing a stimulus
to the middle or inner ear via the output stimulator; and measuring
an auditory response to the stimulus.
15. The method of step 14, further comprising the step of
repositioning the output stimulator if insufficient auditory
response is measured.
16. The method of step 14, further comprising the step of adjusting
characteristics of an electrical signal provided to the output
stimulator based upon the measured auditory response.
17. The method of step 14, further comprising the step of adjusting
a signal processing parameter based upon the measured auditory
response.
18. The method of step 14, wherein the step of providing a stimulus
to the middle or inner ear via the output stimulator is in response
to sound transduced by an input transducer, and further comprising
the step of adjusting characteristics of an electrical signal
provided to the output stimulator in response to the transduced
sounds.
19. A method of using an at least partially implantable hearing
assistance device, the method comprising the steps of: (a)
providing a calibration stimulus to the middle or inner ear via an
output stimulator; (b) detecting a feedback signal; and (c)
changing a characteristic of the calibration stimulus based upon
the detected feedback signal.
20. The method of claim 19, wherein the step of changing a
characteristic of the calibration stimulus comprises the step of
increasing the amplitude of the calibration stimulus if the
detected feedback signal does not meet a threshold.
21. The method of claim 19, further comprising the steps of: (d)
adjusting a signal processing parameter if the detected feedback
signal meets a threshold.
22. The method of claim 21, wherein steps (a)-(d) are repeated
using calibration stimuli of different frequencies.
23. The method of claim 19, wherein the feedback signal is detected
at an input transducer.
24. The method of claim 19, wherein the feedback signal is detected
at a response sensor.
25. An apparatus, comprising: an input transducer for converting a
sound vibration into an electrical input signal; an output
stimulator, proportioned for disposition within a middle ear region
or an inner ear region an ear and providing an output stimulus
thereto in response to an electrical output signal; a response
sensor for measuring an auditory response signal; and an
electronics unit that receives the input signal and provides the
output signal to the output stimulator.
26. The apparatus of claim 25, wherein the response sensor includes
an external electroencephalography (EEG) device and an external
electrode.
27. The apparatus of claim 25, wherein the response sensor includes
an implantable electrode that is electrically coupled to the
electronics unit.
28. The apparatus of claim 27, wherein the response sensor is
proportioned for disposition near and coupling to a cochlea or
auditory nerve in the inner ear.
29. The apparatus of claim 25, wherein the auditory response signal
results from the output stimulus.
30. The apparatus of claim 25, wherein a signal processing
parameter is adjustable based upon the auditory response
signal.
31. The apparatus of claim 25, wherein the electronics unit
provides an automatic gain control (AGC) function based upon the
auditory response signal.
32. An apparatus, comprising: an input transducer for converting a
sound vibration into an electrical input signal; an output
stimulator, proportioned for disposition within a middle ear region
or an inner ear region an ear and providing an output stimulus
thereto in response to an electrical output signal; an electronics
unit that receives the input signal and provides the output signal
to the output stimulator; and a calibration module, which is
carried by the electronics unit, for providing a calibration output
signal to the output stimulator.
33. The apparatus of claim 32, wherein the output stimulator
provides a calibration stimulus in response to the calibration
output signal received from the electronics unit.
34. The apparatus of claim 33, wherein the input transducer
provides a feedback signal, resulting from the calibration
stimulus, to the electronics unit.
35. The apparatus of claim 34, wherein a signal processing
parameter is adjusted based upon the feedback signal.
36. The apparatus of claim 33, further comprising a response sensor
for measuring an auditory response signal resulting from the
calibration stimulus.
37. The apparatus of claim 36, wherein the response sensor is
electrically coupled to the electronics unit for providing the
auditory response signal thereto.
38. The apparatus of claim 37, further comprising a calibration
module that adjusts characteristics of the calibration output
signal based upon the auditory response signal.
39. The apparatus of claim 37, wherein a signal processing
parameter is adjustable based upon the auditory response
signal.
40. An apparatus, comprising: a transducer positioned in
transducing relation with a cochlea; and a calibration module for
sending a calibration output signal to the transducer.
41. The apparatus of claim 40, wherein the calibration module
includes calibration circuitry.
42. The apparatus of claim 40, further comprising a signal
processing unit in communication with the calibration module,
wherein the calibration module includes a set of instructions
executable on the signal processing unit.
43. The apparatus of claim 42, wherein the signal processing unit
includes a microprocessor.
44. The apparatus of claim 40, further comprising a mechanism for
receiving a feedback signal.
45. The apparatus of claim 40, wherein the transducer is
mechanically coupled to the cochlea.
Description
THE FIELD OF THE INVENTION
[0001] This invention relates generally to an at least partially
implantable hearing assistance system, and more particularly to the
calibration or adjustment of such a hearing assistance system, and
also to testing a patient's auditory response.
BACKGROUND
[0002] Some types of partial middle ear implantable (P-MEI), total
middle ear implantable (T-MEI), cochlear implant, or other hearing
assistance systems utilize components disposed within the middle
ear or inner ear regions. Such components might include an input
transducer for receiving sound vibrations or an output stimulator
for providing mechanical or electrical output stimuli corresponding
to the received sound vibrations.
[0003] An example of such a device is disclosed in U.S. Pat. No.
4,729,366, issued to D. W. Schaefer on Mar. 8, 1988. In the '366
patent, a mechanical-to-electrical piezoelectric input transducer
is associated with the malleus, transducing mechanical energy into
an electrical signal, which is amplified and further processed by
an electronics unit. A resulting electrical signal is provided to
an electrical-to-mechanical piezoelectric output transducer that
generates a mechanical vibration coupled to an element of the
ossicular chain or to the oval window or round window for assisting
hearing. In the '366 patent, the ossicular chain is interrupted by
removal of the incus. Removal of the incus prevents the mechanical
vibrations delivered by the piezoelectric output transducer from
mechanically feeding back to the piezoelectric input
transducer.
[0004] Introducing components into the middle or inner ear regions
typically involves intricate surgical procedures for positioning or
affixing the components for communication or coupling to the
desired auditory elements. The proper positioning and affixation
for obtaining the best input signal and providing the best output
stimuli is a difficult task. The patient is typically under general
anesthesia, and is thus unable to provide the implanting physician
with any information regarding how well sound is being perceived.
Thus, the implanting surgeon faces a difficult task that may yield
uneven results in the proper positioning and affixation of
components in the middle or inner ear regions in order to obtain
proper sound perception.
[0005] Other complicating factors are also present. There may be a
large variations between patients in the sound perception
characteristics of their auditory systems. Moreover, there may be
variations between hearing assistance systems, such as in their
component characteristics, for example, the characteristics of the
input transducer and output stimulator may well vary to some
degree. There is a need in the art for hearing assistance systems
to provide diagnostic or calibration information to the physician,
such as during the surgical implantation procedure, in order to
ascertain efficacy and adjust therapy accordingly. There is a
further need in the art for self-calibration of such hearing
assistance systems to increase their ease of use.
SUMMARY
[0006] The present invention provides a method of testing an
auditory response in a living organism. A stimulus is introduced
directly into the middle or inner ear. An electrical auditory
response signal is obtained in response to the stimulus.
[0007] Another such method includes applying sound to an ear. The
sound is transduced into an electrical input signal. The electrical
input signal is processed to provide a resulting electrical output
signal. An output stimulus is introduced directly in the middle ear
or inner ear in response to the electrical output signal. An
electrical auditory response signal is obtained in response to the
output stimulus.
[0008] In one embodiment, the invention provides a method of
assisting hearing using an at least partially implantable hearing
assistance device. An output stimulator is positioned in a middle
or inner ear for providing a stimulus thereto. An auditory response
to the stimulus is measured. The output stimulator is repositioned
if the measured auditory response does not exceed a threshold
value.
[0009] In another calibration method, an output stimulator is
positioned in a middle or inner ear for providing a calibration
stimulus thereto. An auditory response to the calibration stimulus
is measured. Characteristics of an electrical signal, provided to
the output stimulator in response to transduced sounds, are
adjusted.
[0010] In another calibration method, an input transducer is
positioned in the middle ear. An output stimulator is positioned in
the middle or inner ear. Sound is provided to and received by the
input transducer. An output stimulus is provided by the output
stimulator in response to the sound received by the input
transducer. An auditory response signal to the output stimulus is
measured. At least one signal processing parameter is adjusted
based upon the measured auditory response signal.
[0011] In another method of using an at least partially implantable
hearing assistance device, such as for calibration, a calibration
stimulus is provided to the middle or inner ear via an output
stimulator. A feedback signal is detected, such as at an input
transducer. A characteristic of the calibration stimulus is
changed, based upon the detected feedback signal. In one
embodiment, for example, the amplitude of the calibration stimulus
is increased if the detected feedback signal does not meet a
threshold value. In another embodiment, a signal processing
parameter is adjusted if the detected feedback signal does meet the
threshold. In a further embodiment the above-described calibration
is repeated over a range of frequencies to obtain a calibrated
frequency response.
[0012] The system also provides an apparatus, which may be used for
assisting hearing or testing an auditory response. An input
transducer converts a sound wave or mechanical vibration into an
electrical input signal. An output stimulator is proportioned for
disposition within a middle or inner ear region of an ear. The
output stimulator receives an output electrical signal from an
implantable electronics unit in response to the input electrical
signal. In one embodiment, the electronics unit includes a
calibration module that provides an output calibration signal to
the output stimulator.
[0013] In another embodiment, the system comprises an input
transducer for converting a sound wave or mechanical vibration into
an electrical input signal. An output stimulator is proportioned
for disposition within the middle ear region or an inner ear region
of an ear. The output stimulator receives an output electrical
signal from an implantable electronics unit in response to the
input electrical signal. A response sensor is also included for
providing an auditory response signal. In one embodiment, the
response sensor includes an external EEG device and a surface
electrode. In another embodiment, the response sensor includes an
implantable electrode for providing the auditory response signal to
the electronics unit.
[0014] Thus, the present invention provides a hearing assistance
system for testing an auditory response. The system provides
diagnostic or calibration information to the physician, which is
particularly useful during implantation of middle or inner ear
components; a patient under general anesthesia is unable to
independently provide the physician with any information regarding
the adequacy of sound perception. The invention also provides for
feedback detection and self-calibration to increase its ease of
use.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] In the drawings, like numerals describe substantially
similar components throughout the several views.
[0016] FIG. 1 illustrates a frontal section of an anatomically
normal human ear in which the invention operates.
[0017] FIG. 2 is a generalized schematic illustration of a frontal
view of a person with cutaway views of each ear, including one
embodiment of the invention partially disposed in one ear.
[0018] FIG. 3 further illustrates the embodiment of FIG. 2,
including a triggering signal provided to an EEG signal
processor.
[0019] FIG. 4 is a generalized schematic illustration of a frontal
view of a person with cutaway views of each ear, including an
embodiment of the invention comprising a cochlear implant output
stimulator.
[0020] FIG. 5 is a generalized schematic illustration of a frontal
view of a person with cutaway views of each ear, including an
embodiment of the invention comprising an implanted sensor for
receiving an electrical auditory response signal.
[0021] FIG. 6 is a flow chart illustrating one embodiment of a
self-calibration function provided by the invention, such as by the
embodiment of FIG. 5.
[0022] FIG. 7 is a flow chart illustrating another embodiment of a
frequency-response self-calibration function provided by the
invention, such as by the embodiment of FIG. 5.
[0023] FIG. 8 is a flow chart illustrating one embodiment of a
feedback self-test function provided by the invention, such as by
the embodiment of FIG. 5.
[0024] FIG. 9 is a generalized schematic illustration of a frontal
view of a person with cutaway views of each ear, including an
embodiment of the invention which receives sound externally and
provides a resulting auditory response signal.
DETAILED DESCRIPTION
[0025] The present invention provides a hearing assistance system
having built-in diagnostic and calibration capability. The hearing
assistance system is capable of use as or with a middle ear
implantable hearing system such as a partial middle ear implantable
(P-MEI), total middle ear implantable (T-MEI), cochlear implant, or
other hearing system. A P-MEI or T-MEI hearing system assists the
human auditory system in converting acoustic energy contained
within sound waves into electrochemical signals delivered to the
brain and interpreted as sound. FIG. 1 illustrates generally a
human auditory system. Sound waves are directed into an external
auditory canal 20 by an outer ear (pinna) 25. The frequency
characteristics of the sound waves are slightly modified by the
resonant characteristics of the external auditory canal 20. These
sound waves impinge upon the tympanic membrane (eardrum) 30,
interposed at the terminus of the external auditory canal 20,
between it and the tympanic cavity (middle ear) 35. Variations in
the sound waves produce tympanic vibrations. The mechanical energy
of the tympanic vibrations is communicated to the inner ear,
comprising cochlea 60, vestibule 61, and semicircular canals 62, by
a sequence of articulating bones located in the middle ear 35. This
sequence of articulating bones is referred to generally as an
ossicular chain 37. Thus, the tympanic membrane 30 and ossicular
chain 37 transform acoustic energy in the external auditory canal
20 to mechanical energy at the cochlea 60.
[0026] The ossicular chain 37 includes three primary components: a
malleus 40, an incus 45, and a stapes 50. The malleus 40 includes
manubrium and head portions. The manubrium of the malleus 40
attaches to the tympanic membrane 30. The head of the malleus 40
articulates with one end of the incus 45. The incus 45 normally
couples mechanical energy from the vibrating malleus 40 to the
stapes 50. The stapes 50 includes a capitulum portion, comprising a
head and a neck, connected to a footplate portion by means of a
support crus comprising two crura. The footplate portion of stapes
50 is disposed in and against a membrane-covered opening on the
cochlea 60. This membrane-covered opening between the cochlea 60
and middle ear 35 is referred to as the oval window 55. Oval window
55 is considered part of cochlea 60 in this patent application. The
incus 45 articulates the capitulum of the stapes 50 to complete the
mechanical transmission path.
[0027] Normally, prior to implantation of the invention, tympanic
vibrations are mechanically conducted through the malleus 40, incus
45, and stapes 50, to the oval window 55. Vibrations at the oval
window 55 are conducted into the fluid-filled cochlea 60. These
mechanical vibrations generate fluidic motion, thereby transmitting
hydraulic energy within the cochlea 60. Pressures generated in the
cochlea 60 by fluidic motion are accommodated by a second
membrane-covered opening on the cochlea 60. This second
membrane-covered opening between the cochlea 60 and middle ear 35
is referred to as the round window 65. Round window 65 is
considered part of cochlea 60 in this patent application. Receptor
cells in the cochlea 60 translate the fluidic motion into neural
impulses which are transmitted to the brain and perceived as sound.
However, various disorders of the tympanic membrane 30, ossicular
chain 37, and/or cochlea 60 can disrupt or impair normal
hearing.
[0028] Hearing loss due to damage in the cochlea 60 is referred to
as sensorineural hearing loss. Hearing loss due to an inability to
conduct mechanical vibrations through the middle ear 35 is referred
to as conductive hearing loss. Some patients have an ossicular
chain 37 lacking sufficient resiliency to transmit mechanical
vibrations between the tympanic membrane 30 and the oval window 55.
As a result, fluidic motion in the cochlea 60 is attenuated. Thus,
receptor cells in the cochlea 60 do not receive adequate mechanical
stimulation. Damaged elements of ossicular chain 37 may also
interrupt transmission of mechanical vibrations between the
tympanic membrane 30 and the oval window 55.
[0029] Various techniques have been developed to remedy hearing
loss resulting from conductive or sensorineural hearing disorder.
For example, tympanoplasty is used to surgically reconstruct the
tympanic membrane 30 and establish ossicular continuity from the
tympanic membrane 30 to the oval window 55. Various passive
mechanical prostheses and implantation techniques have been
developed in connection with reconstructive surgery of the middle
ear 35 for patients with damaged elements of ossicular chain 37.
Two basic forms of prosthesis are available: total ossicular
replacement prostheses (TORP), which is connected between the
tympanic membrane 30 and the oval window 55; and partial ossicular
replacement prostheses (PORP), which is positioned between the
tympanic membrane 30 and the stapes 50.
[0030] Various types of hearing aids have been developed to
compensate for hearing disorders. A conventional "air conduction"
hearing aid is sometimes used to overcome hearing loss due to
sensorineural cochlear damage or mild conductive impediments to the
ossicular chain 37. Conventional hearing aids utilize a microphone,
which transduces sound into an electrical signal. Amplification
circuitry amplifies the electrical signal. A speaker transduces the
amplified electrical signal into acoustic energy transmitted to the
tympanic membrane 30. However, some of the transmitted acoustic
energy is typically detected by the microphone, resulting in an
unwanted feedback signal which degrades sound quality. For example,
the unwanted feedback signal may limit the volume, i.e. signal
amplitude, of the sound that can be transmitted to the tympanic
membrane 30. Conventional hearing aids also often suffer from a
significant amount of signal distortion.
[0031] Implantable hearing systems have also been developed,
utilizing various approaches to compensate for hearing disorders.
For example, cochlear implant techniques are used to implement an
inner ear hearing system. Cochlear implants electrically stimulate
auditory nerve fibers within the cochlea 60. A typical cochlear
implant system includes an external microphone, an external signal
processor, and an external transmitter, as well as an implanted
receiver and an implanted single channel or multichannel probe. A
single channel probe has one electrode. A multichannel probe has an
array of several electrodes. In the more advanced multichannel
cochlear implant, a signal processor converts speech signals
transduced by the microphone into a series of sequential electrical
pulses corresponding to different frequency bands within a speech
frequency spectrum. Electrical pulses corresponding to low
frequency sounds are delivered to electrodes that are more apical
in the cochlea 60. Electrical pulses corresponding to high
frequency sounds are delivered to electrodes that are more basal in
the cochlea 60. The nerve fibers stimulated by the electrodes of
the cochlear implant probe transmit neural impulses to the brain,
where these neural impulses are interpreted as sound.
[0032] Other inner ear hearing systems have been developed to aid
patients not having an intact tympanic membrane 30, upon which "air
conduction" hearing aids depend. For example, temporal bone
conduction hearing systems produce mechanical vibrations that are
coupled to the cochlea 60 via a temporal bone in the skull. In such
temporal bone conduction hearing systems, a vibrating element can
be implemented percutaneously or subcutaneously.
[0033] A particularly interesting class of hearing systems includes
those which are configured for disposition principally within the
middle ear 35 space. In middle ear implantable (MEI) hearing
assistance systems, an electrical-to-mechanical output transducer
couples mechanical vibrations to the ossicular chain 37, which is
optionally interrupted to allow this coupling of the mechanical
vibrations to the ossicular chain 37. Both electromagnetic and
piezoelectric output transducers have been used to effect the
mechanical vibrations upon the ossicular chain 37.
[0034] One example of a partial middle ear implantable (P-MEI)
hearing system having an electromagnetic output transducer
comprises: an external microphone transducing sound into electrical
signals; external amplification and modulation circuitry; and an
external radio frequency (RF) transmitter for transdermal RF
communication of an electrical signal. An implanted receiver
detects and rectifies the transmitted signal, driving an implanted
coil in constant current mode. A resulting magnetic field from the
implanted drive coil vibrates an implanted magnet that is
permanently affixed only to the incus 45. Such electromagnetic
output transducers have relatively high power consumption requiring
larger batteries, which limits their usefulness in total middle ear
implantable (T-MEI) hearing systems.
[0035] A piezoelectric output transducer is also capable of
effecting mechanical vibrations to the ossicular chain 37. An
example of such a device is disclosed in U.S. Pat. No. 4,729,366,
issued to D. W. Schaefer on Mar. 8, 1988. In the '366 patent, a
mechanical-to-electrical piezoelectric input transducer is
associated with the malleus 40, transducing mechanical energy into
an electrical signal, which is amplified and further processed by
an electronics unit. A resulting electrical signal is provided to
an electrical-to-mechanical piezoelectric output transducer that
generates a mechanical vibration coupled to an element of the
ossicular chain 37 or to the oval window 55 or round window 65. In
the '366 patent, the ossicular chain 37 is interrupted by removal
of the incus 45. Removal of the incus 45 prevents the mechanical
vibrations delivered by the piezoelectric output transducer from
mechanically feeding back to the piezoelectric input
transducer.
[0036] As discussed above, the implanting surgeon faces a difficult
task in the proper positioning and affixation of components within
the middle ear 35 or inner ear regions in P-MEI, T-MEI, cochlear
implant, or other hearing assistance systems in order to obtain
proper sound perception. The present invention includes a hearing
assistance system having built-in diagnostic and calibration
capability that is particularly useful during the surgical
implantation procedure, in order to ascertain efficacy and adjust
therapy accordingly. As will be described below, the present
invention includes self-calibration, frequency response
self-calibration, feedback self-test, and automatic gain control
(AGC) embodiments of the hearing assistance systems in order to
increase its effectiveness and ease of use.
[0037] FIG. 2 is a generalized schematic illustration of one
embodiment of the present invention. FIG. 2 illustrates a frontal
view of a person with cutaway views of the anatomical features of
each of a right ear 200 and a left ear 205. Input transducer 210
and output stimulator 215 are introduced into the middle ear 35 or
inner ear regions of right ear 200 or left ear 205. In one
embodiment, input transducer 210 is an electromechanical transducer
for receiving mechanical sound vibrations in the middle ear 35
region. In another embodiment, input transducer 210 is a microphone
for receiving sound waves in the middle ear 35 region. Input
transducer 210 provides a resulting electrical input signal through
subcutaneous input lead 236 to electronics unit 225. Electronics
unit 225 provides through subcutaneous output lead 237 an
electrical output signal to output stimulator 215. In one
embodiment, output stimulator 215 is an electromechanical output
transducer, for producing mechanical vibrations that are coupled to
stapes 50 or other suitable auditory element in order to assist
hearing. Such an electromechanical output transducer may include
piezoelectric, electromagnetic, or other suitable output transducer
elements. In one embodiment, incus 45 is removed from right ear 200
to prevent unwanted mechanical feedback of mechanical vibrations
from output stimulator 215 to input transducer 210.
[0038] Electronics unit 225 may be locally implanted in the mastoid
portion of the patient's temporal bone, or remotely implanted in
the patient's pectoral region or elsewhere. Electronics unit 225
includes power source 230, signal processing unit (SPU) 235, and
calibration module 240. SPU 235 performs amplification and other
signal processing of the input signal received through input lead
236 and provides the resulting output signal through output lead
237 to output stimulator 215. As discussed below, calibration
module 240, which may be incorporated into SPU 235 and may also be
triggered externally, provides electrical calibration output
signals through output lead 237 to output stimulator 215; the
calibration output signals are typically independent of, i.e. not
in response to, the input signals received through input lead 236.
Output stimulator 215 provides an output stimulus, such as a
mechanical vibration, in response to the output signal received
through output lead 237. Output stimulator 215 also provides a
calibration stimulus, such as a mechanical vibration, in response
to the calibration output signals received through output lead
237.
[0039] In the above-described embodiment, electrical brain waves
are received by a response sensor, which includes
electroencephalography (EEG) device 300. An auditory response
signal, i.e. the portion of the received brain waves resulting from
auditory neural pathway's response to the calibration stimuli, is
extracted through electric response audiometry (ERA), such as
through auditory brain-stem response (ABR), cortical electric
response, electrocochleography, or other known audiometric
techniques. In this embodiment, EEG device 300 is electrically
coupled through external leads 305A-C to external surface
electrodes 310A-C. Electrodes 310A-C typically comprise a ground
electrode and two signal electrodes that are suitably placed for
reception of the brain waves. For example, one of electrodes 310A-C
is placed on the scalp vertex or the forehead, and each of the
other two of electrodes 310A-C are placed on opposing mastoid
prominences or earlobes. EEG device 300 typically includes a
differential amplifier for amplification of the received brain
waves. EEG device 300 may also include filtering circuits and a
display monitor for observation of the brain waves and other
electrical signals. In this embodiment, EEG device 300 provides a
resulting EEG output signal through EEG output node 315 to EEG
signal processor 330.
[0040] EEG signal processor 330 includes filtering, averaging, and
correlation functions to extract the auditory response signal from
the brain waves received at EEG output node 315. EEG signal
processor 330 provides the resulting auditory response signal,
either on its own display monitor, or through auditory response
signal output node 320 for display on any monitor in EEG device
300. EEG signal processor 330 may also provide other diagnostic
information, such as an indicator of the maximum amplitude of the
auditory response signal. As described below, extraction of the
auditory response signal may include both unsynchronized mode and
synchronized mode embodiments.
[0041] In an unsynchronized mode, the calibration output signal
provided by calibration module 240 to output stimulator 215
produces repeated calibration stimuli. Each calibration stimulus is
in a known timing relationship to previous and subsequent
calibration stimuli. For example, the calibration output signals
provided by calibration module 240 typically produce repeated
calibration stimuli separated by a known fixed time interval, such
as 10 milliseconds, which is longer than a response time of the
auditory neural pathway for most patients. In one embodiment, EEG
signal processor 330 uses a measuring window, of similar duration
as the time interval between calibration stimuli, to perform its
averaging and correlation functions. An average auditory response
signal is obtained by measuring the auditory response signals to
multiple calibration stimuli.
[0042] FIG. 3 is a generalized schematic illustration of one
embodiment of a synchronized mode of extracting the auditory
response signal. In FIG. 3, calibration module 240 provides a
trigger signal through signal path 325 to EEG signal processor 330.
Signal path 325 may be an electrically coupled signal, a
telemetered signal, or any other suitable means of communicating
timing information about the calibration stimuli to EEG signal
processor 330. In one embodiment, EEG signal processor 330 uses a
measuring window, of similar duration as the time interval between
calibration stimuli, to perform its averaging and correlation
functions. An average auditory response signal is obtained by
measuring the auditory response signals to multiple calibration
stimuli. Alternatively, if electrical access to output lead 237 is
available, the calibration output signal can be monitored on output
lead 237 to provide timing information to EEG signal processor
330.
[0043] Calibration module 240 may be incorporated into SPU 235,
either as hardware circuitry or as a set of instructions executed
by a microprocessor therein. Calibration module 240 is typically
capable of providing different calibration output signals to output
stimulator 215 resulting in different calibration stimuli. For
example, the calibration output signals and corresponding
calibration stimuli may comprise a series of wide-band audio
frequency clicks at a known, controllable repetition frequency. In
another example, the wide-band audio click includes superimposed
high-pass noise, i.e. noise above an adjustable cutoff frequency.
Adjusting the cutoff frequency thereby varies the frequency content
of the calibration stimuli, from which different average auditory
response signals are obtained in response thereto. Yet another
embodiment provides an audio frequency substantially pure tone
burst. The frequency of the pure tone burst is adjusted between
several discrete frequencies in the audio frequency range, such as
at 500 Hz, 1 kHz, 2 kHz, 4 kHz and 8 kHz for obtaining
corresponding average auditory response signals at each such
discrete frequency.
[0044] The diagnostic and calibration capabilities of the present
invention are particularly useful during surgical implantation of
hearing assistance system components into a patient under general
anesthesia. In particular, the present invention allows the
physician to ascertain efficacy and adjust therapy accordingly.
[0045] For example, in implanting output stimulator 215 in the
middle 35 or inner ear regions, the physician can place calibration
module 240 in an unsynchronized mode delivering repeated constant
amplitude calibration stimuli. EEG device 300 and EEG signal
processor 330 provide the resulting average auditory response
signal and other diagnostic information. The physician can position
and affix output stimulator 215 in such a manner that maximizes the
average auditory response signal that is obtained.
[0046] After the output stimulator has been positioned and affixed,
the calibration stimuli are discontinued and audio frequency
signals are applied, such as by an earphone placed in the external
auditory canal 20. The physician can then position and affix input
transducer 210 and adjust the signal processing parameters in SPU
235, such as amplification gain and filter rolloff frequencies, to
obtain the desired auditory response signal.
[0047] The present invention also offers advantages subsequent to
the positioning and affixing of input transducer 210 and output
stimulator 215. Signal processing parameters in SPU 235 can be
adjusted based upon the average auditory response signal and other
diagnostic information provided by EEG device 300 and EEG signal
processor 330 resulting from the output stimuli or calibration
stimuli.
[0048] FIG. 4 is a generalized schematic illustration of another
embodiment of the invention including a frontal view of a person in
which it is used. FIG. 4 includes some of the features of the
invention described with respect to FIG. 2, but the output
stimulator 215 comprises a single channel or multiple channel
cochlear implant rather than an electromechanical output
transducer. In this embodiment, the output stimuli are typically
electrical stimuli rather than mechanical vibrations. The cochlear
implant output stimulator 215 is typically disposed in cochlea 60
by insertion either through the oval window 55, round window 65, or
elsewhere, or is disposed elsewhere in the inner ear region. In
this embodiment, signal processing unit 235 includes cochlear
implant processing capability, and output lead 237 includes an
appropriate configuration of conductors corresponding to the
particular type (i.e., single channel or multiple channel) of
cochlear implant output stimulator 215.
[0049] FIG. 5 is a generalized schematic illustration of another
embodiment of the invention including a frontal view of the person
in which it is used. Unlike the embodiment illustrated in FIG. 2,
in the embodiment of FIG. 5 the auditory response signal to output
or calibration stimuli is received by an implanted portion of the
invention rather than by an external response sensor that includes
surface electrodes 310A-C, external leads 305A-C, and external EEG
device 300. In one such embodiment, electronics unit 225 receives
an electrocochleographic or other auditory response signal through
response lead 400 from implantable response sensor 405 or other
mechanism for receiving a feedback signal such as the auditory
response signal. The auditory response signal received through
response lead 400 results either from calibration stimuli
introduced into the middle ear 35 or inner ear regions, or from
output stimuli provided in the middle ear 35 or inner ear in
response to sound waves or mechanical vibrations received from
input transducer 210 and processed by electronics unit 225.
[0050] In one embodiment, response sensor 405 includes at least one
electrode placed on the bone of the promontory or in contact with
cochlea 60 or the auditory nerve such that response sensor 405 is
in close proximity with the cochlear sites that generate electric
potentials in response to internal cochlear pressures resulting
from sound. The technique of obtaining an auditory response signal
from response sensor 405, which is located as described above, is
referred to as electrocochleography. Electrocochleography typically
provides a good prediction of the patient's audiometric threshold,
but only measures the most peripheral portion of the patient's
auditory system.
[0051] FIG. 6 is a flow chart illustrating one embodiment of a
self-calibration function provided by the invention, such as by the
embodiment of FIG. 5. At step 600, the amplitude of the calibration
output signal is initialized to a value at the lower end of a range
of possible amplitude values. At step 605, a calibration stimulus
is delivered, such as by output stimulator 215, in response to the
calibration output signal provided by electronics unit 225. At step
610, an auditory response signal is monitored. In one embodiment,
the auditory response signal is provided by response sensor 405 in
response to the calibration stimulus. At step 615, if the amplitude
of the auditory response signal exceeds a programmably adjustable
threshold value, at least one signal processing parameter, such as
amplification gain in SPU 235, is adjusted accordingly at step 620.
At step 615, if the amplitude of the auditory response signal does
not exceed the programmably adjustable threshold value, and if the
amplitude of the calibration output signal is not yet at its
maximum value at step 625, the amplitude of the calibration output
signal is increased at step 630. A calibration stimulus is then
delivered at step 605 in response to the higher amplitude
calibration output signal in order to further test for an adequate
auditory response signal.
[0052] FIG. 7 is a flow chart illustrating another embodiment of a
frequency-response self-calibration function provided by the
system. The frequency response self-calibration function is similar
to the embodiment described with respect to FIG. 6, except that it
is performed over a range of frequencies, such as over the audio
range of frequencies. At step 700, the frequency of the calibration
output signal is initialized to a frequency at or near one end of
the audio range of frequencies, such as, for example, 500 Hz. The
self-calibration is performed at that frequency according to the
method described with respect to FIG. 6. At step 620, signal
processing parameters are adjusted, such as based upon the
calibration output signal amplitude for the particular frequency of
calibration output signal. If, at step 705, the frequency of the
calibration output signal has not yet reached a value at the
opposite end of the audio frequency range, such as a maximum
calibration output signal frequency of approximately 10 kilohertz,
the frequency of the calibration output signal is incremented at
step 710. The self-calibration is then repeated at step 600 using
the new frequency of calibration output signal. When at step 705
the frequency of the calibration output signal has reached its
maximum value, the self-calibration of FIG. 7 is exited at step
715. In this way, signal processing parameters are adjusted to
obtain a self-calibrated frequency response.
[0053] FIG. 8 is a flow chart illustrating another embodiment of a
feedback self test function provided by the invention, such as by
the embodiment of FIG. 5. It is possible for mechanical vibrations
provided by output stimulator 215 to generate an undesirable
mechanical positive feedback signal which vibrates input transducer
210. Such mechanical feedback can result from any mechanical or
acoustic coupling in the middle ear. In particular, if incus 45 is
not removed, it may provide a mechanical feedback path for
vibrations from output stimulator 215 to input transducer 210. FIG.
8 illustrates one embodiment of a feedback-self test for detecting
the presence of mechanical feedback, and adjusting signal
processing parameters accordingly.
[0054] At step 600, the amplitude of the calibration output signal
is initialized to a value at the lower end of a range of possible
amplitude values. At step 605, a calibration stimulus is delivered,
such as by output stimulator 215 in response to the calibration
output signal provided by electronics unit 225. At step 800, an
input signal is monitored, such as by input transducer 210 or other
mechanism for detecting a feedback signal, for mechanical feedback
resulting from the calibration stimulus provided by output
stimulator 215. At step 805, if the amplitude of the input signal
exceeds a programmably adjustable threshold value, signal
processing parameters, such as amplification gain in SPU 235, are
adjusted at step 620 to reduce the effect of the feedback. At step
805, if the amplitude of the input signal does not exceed the
programmably adjustable threshold value, and if the amplitude of
the calibration output signal is not at its maximum value at step
625, the amplitude of the calibration output signal is increased at
step 630. A calibration stimulus is then delivered at step 605 in
response to the higher amplitude calibration output signal to
further test for the presence of mechanical feedback.
[0055] In another embodiment, the system of FIG. 5 provides a
feedback signal or an automatic gain control (AGC) function using
electrocochleography. Electronics unit 225 either periodically or
continuously monitors the amplitude of the auditory response signal
received through response lead 400 from response sensor 405.
Electronics unit 225 adjusts signal processing parameters, such as
amplification gain in SPU 235, based upon the amplitude of the
received auditory response signal. In one embodiment, for example,
the amplification gain is adjusted in SPU 235 such that the
response signal obtained from response sensor 405 is maintained at
an approximately constant amplitude.
[0056] FIG. 9 is a generalized schematic illustration of another
embodiment of the present invention. FIG. 9 illustrates that though
the system has been described with particular emphasis on its
calibration and diagnostic capabilities, it is intended to include
any use of electrical response audiometry (EAR) techniques in
conjunction with any at least partially implantable hearing
assistance system. In FIG. 9, sounds are provided, such as through
external earphone 900 placed in the external auditory canal 20. The
sounds are converted to mechanical vibrations by tympanic membrane
30. Either the sounds or the associated mechanical vibrations are
sensed by input transducer 210, which is disposed in the external
auditory canal 20 or middle ear 35 region to produce a resulting
electrical input signal. The resulting electrical input signal is
provided through input lead 236 to electronics unit 225, and
processed by electronics unit 225 to provide a resulting electrical
output signal. The output signal is provided through output lead
237 to output stimulator 215 to provide an electrical or mechanical
output stimulus to the middle ear 35 or inner ear regions. Brain
waves are monitored and an auditory response signal is extracted
from a response sensor, such as by EEG device 300 and EEG signal
processor 330, or by an implanted response sensor 405 as
illustrated in FIG. 5.
[0057] Thus, the present invention provides a hearing assistance
system having built-in diagnostic and calibration capability that
is particularly useful during the surgical implantation procedure,
in order to ascertain efficacy and adjust therapy accordingly. The
system also includes self-calibration, frequency-response
self-calibration, feedback self-test, and automatic gain control
(AGC) embodiments in order to increase its ease of use.
[0058] It is to be understood that the above description is
intended to be illustrative, and not restrictive. Many other
embodiments will be apparent to those of skill in the art upon
reviewing the above description. For example, though the invention
is described with respect to disposition of components within one
ear, the invention is intended to include any embodiment in which
components in either or both ears. More particularly, input
transducer 210 could be disposed in right ear 200 and output
stimulator 215 could be disposed in left ear 205, or vice-versa. In
embodiments having an implanted response sensor 405, the response
sensor 405 is typically disposed in the same ear as the output
stimulator 215. The scope of the invention should, therefore, be
determined with reference to the appended claims, along with the
full scope of equivalents to which such claims are entitled.
* * * * *