Note: Certain requirements, including accessibility to a
participating office or clinic, must be met before one
may participate in this study. However, individuals
desiring more information about tinnitus and available
therapies are welcome to "contact us" about their
particular case.
DigiCare® Hearing Research & Rehabilitation
Tinnitus & Amplification 2002 Study
Table of Contents
I. TA2002 Research Study Design
II. TA2002 Study Objectives/Outcome Measures
III. TA2002 Supervision & Compilation
IV. TA2002 FAQ Sheet mailed to prospective participants
prior to scheduling first visit
V. TA2002 Patient Prospectus Summary mailed to
prospective participants prior to scheduling first visit
VI. Forms utilized in TA2002
VII. Supporting documents:
a. Post-Study I: “Tinnitus Management in the Dispensing
Practice” (1993)
b. From Study I: “Tinnitus & Amplification” (1989)
c. Letters of commendation by other professionals
d. From Study II: “Inferential Correlates Derived From a
Tinnitus & Hearing Impairment Survey Among Hearing
Health Professionals” (1994)
e. Video Otoscopy Observation & Referral: The FDA Red
Flags (2002)
f. Video Otoscopy Observations in Hearing Health
Practice Utilizing Miracell Botanical Solution (2002)
g. Nutritional/Ototoxicity Documents for Patients
h. Self-Management Technique for Stress-related Tinnitus
i. The Sircletm Method of Treating Occupational Overuse
Syndrome (OOS)-Foundation Document (1993)
j. Self-Help Resources: Membership Benefits in the
American Tinnitus Association
k. A Literature Review: References and Bibliography for
TA2002 Study
DigiCare® Hearing Research & Rehabilitation
Tinnitus & Amplification 2002 Study
Research Design Prospectus
Rationale for Study
Over the course of more than two decades of study about
subjective and objective tinnitus and their attendant
treatment modalities, the authors note more than 27,000
papers that have been published worldwide since the
formation of the American Tinnitus Association in 1977.
These papers braodly identify and describe hundreds of
types and several classifications of tinnitus, which
veritably fit into five main treatment groups or a
combination of these:
1) Nutrition and alternative medicine
2) Pharmacological therapies
3) Surgical intervention
4) Psychological/hypnosis/tinnitus retraining
therapy(TRT)*
5) Masking and amplification strategies
Of these, the most widely recognized is amplification
for the primary purpose of correcting hearing impairment
that has provided the greatest relief for the greatest
number of subjective (cochlear-based) tinnitus
sufferers. Yet, the door to this approach has most often
been opened only by chance by the patients themselves,
without benefit of referral from non-dispensing
professionals. Just as we have noted in other places
where auditory status and correction are typically
ignored before diagnoses and treatment are rendered for
cognitive pathologies (Alzheimer’s, attention deficit
dysfunction, et al), we maintain that professional lapse
of responsibility is just as vivid when patients
complain of tinnitus are given diagnoses or opinions
before first having received a complete assessment of
the tinnitus and auditory status. In this case, we feel
that tinnitus sufferers who present within a host of
practice settings should follow an accepted flowchart of
referral by the “gatekeeper” professional involved.
Instead, we note in the new Millennium that patients
routinely are told, when reporting their tinnitus, that,
“Nothing can be done about the ringing in your ears.
You’ll just have to learn to live with it.” No referral
for a hearing evaluation; no amplification trial; little
or no counseling relative to the known causes of the
many variants of tinnitus; and nor any information their
attendant treatments is shared. Finding a virtual vacuum
in allied professional practice models dealing with
tinnitus on an everyday basis has prompted us to
organize this study. It is our intention to publish a
recommended referral and practice model that may be
appropriate for the allied professions. So that, when a
patient enters virtually any healthcare practice with
complaint of tinnitus, with no readily evident etiology
or pathology, that some positive action will occur
rather than to be advised that “nothing can be done.”
TA2002 is a third stage study following two previous
studies, the first in 1982-89 with more than 2,000
hearing aid users; the second one in 1990-1991 involving
121 attendees (audiologists, hearing instrument
specialists and ear physicians) who participated in the
author’s 16-hour “Tinnitus & Amplification Workshop”.
Attached documents explain the premises and outcomes of
those studies.
The general purpose of TA2002, then, is to collect and
publish data and outcomes utilizing amplification and
other strategies that may be codified into practice
models for the allied professions.
*Note: As a side-note TRT has become more and more
widely accepted as the neurophysiological model for most
cochlear-based tinnitus. In this study, principles of
TRT are indirectly included, with the main focus to
determine protocols in fitting amplification in cases of
simultaneous hearing impairment and tinnitus. Hence,
TA2002 strives to develop a model that can be applied
under the current delivery system.
STUDY DESIGN
TA2002 is a private, free-standing, privately-sponsored
study without institutional or governmental agency
sponsorship. Since blind and double-blind designs are
inapplicable to the variants and idiosyncrasies of
tinnitus complaints in general, it is designed as an
anecdotal and imperical study, where each patient serves
as their own control (“before study”) compared to
subsequent experience (“after study”). There are no
placebos, pharmaceutical trials, or any potentially
harmful elements in the design or the administration of
study. While certain hearing aid circuits are
recommended for use in the study, it is the actual
electroacoustic parameters of said circuitry along with
specified coupler applications, which may be applied to
any brand or make of hearing instrument that comprises
the same characteristics. Pharmaceutical and nutrition
factors, because of their potential overlay status to
any tinnitus condition are merely incidental to the
study, and not intended to be a focus per se. Instead,
they must be notated as possible artifacts that can
affect outcomes of amplification strategies. The same
applies to stress levels and stress management
observations, and other physical conditions, such as
diabetes mellitus and renal disease, osteoarthritis and
osteoporosis, rheumatoid arthritis, hypercalcemia,
hypernatremia, hypokalemia, and matters of dehydration,
ototoxicity, and other otohealth conditions that may or
may not be under a doctor’s care.
Tinnitus maskers and tinnitus instruments were not
considered as part of this study for the following
reasons:
§The literature is already replete with such studies,
showing widely varying levels of effectiveness.
§ During the 1980s one of the investigators of TA2002
worked extensively in the design and testing of such
devices with the unhappy finding that only a very few of
these instruments are actually utilized by patients over
the long-term. Moreover, the return-for-credit rate is
historically astronomical industry-wide, making its
promotion highly impractical from a marketing and
business point-of-view. The purpose of this study is to
deal with known factors that can be mainstreamed to
benefit the largest number of tinnitus sufferers who
also wear amplification.
§ Some of the benefits of these devices, such as
residual inhibition, (environmental) masking, etc. will
be considered in the application of hearing aid
amplification in TA2002. This means that, ideally, the
hearing instrument bandwidth must cover the entire
spectrum of the tinnitus complaint, minimize
overamplification, and help redirect user’s auditory
attention to actually occurring acoustic stimuli rather
than artificially generated noise.
TA2002 is financed privately, and budgeted with an
advertising budget sufficient to attract the needed
participants. Participants are drawn from all over the
southern Colorado area, and from the areas of
participating DigiCare® Hearing Health Network members
who’ve met prerequisites to participate. Advertising
will consist almost solely upon several news release
advertisements in one or more local newspapers providing
a brief explanation of the study. Plus, additional
participants may come by referral from local physicians
and other allied professionals. Prospective
participants, upon calling our office for further
information, will be screened for possible candidacy in
a brief telephone interview. No appointments are made
unless they are a result of referral, in which case
candidacy may be assumed until assessment proves
otherwise. Before an appointment time is set, however,
participants are mailed a TA2002 Packet of material
consisting of:
§ Cover letter
§ TA2002 FAQ Sheet
§ TA2002 Study Participant Prospectus
§ Research Questionnaire #1
They are asked to read this material before coming in,
and are given another telephone screening call to assure
candidacy before setting of the first appointment.
Furthermore, it is to be made clear in all printed
material that although assessment, research, and
counseling services related to the study are free of
charge, that the purchase of any needed hearing aids are
the responsibility of the patient. However, costs of
hearing instrumentation have been significantly reduced
for participants, as well as flexibility in terms. Such
costs are customary in studies involving devices as part
of the protocols. However, it is understood that such
purchases are voluntary. If the patient is a current
hearing aid user and is realizing benefits for both
their tinnitus and hearing impairment, they may
participate with non-DigiCare instrumentation provided
necessary programming adjustments can be made. In
addition, in the event that patient is a current user of
hearing aids and has not realized any relief from their
hearing instruments, and does not wish to purchase
recommended amplification, they are ineligible for
participation in TA2002. However, they are still welcome
to benefit relative to consumer education material or
instruction provided them during the first visit.
Candidacy Criteria for TA2002:
1) Must be 18 years of age or older, and exhibit a
non-medically treatable hearing impairment that may
benefit from an appropriate amplification strategy with
accompanying tinnitus.
2) Must read and study educational material, indicate
willingness to participate in required follow-ups and
adjustment period
3) Must have been previously evaluated by a physician
for tinnitus complaint (if not, referral is made) and
unsuccessful in treatment
4) Exhibit no evidence of FDA Red Flag conditions, or if
they do, through their own free will, they may exercise
their rights for a medical waiver. However, even in
subsequent exercise of the waiver provision, prospective
participant may not be accepted for the study if it is
believed that in doing so will prevent any appreciable
degree of success in the study.
5) Demonstrate during their initial assessment that they
may benefit with wide-range amplification (within the
technology tier of their choice) in at least two of the
following tinnitus management benefits of amplification:
-Residual inhibition (partial or complete)
-Environmental masking
-Auditory reattention
-Stress reduction
6) Be willing to obtain or purchase recommended
amplification instrumentation in conformance with TA2002
objectives. Since the study is not brand-specific,
participants may purchase appropriate hearing
instrument(s) from the following classifications:
Advanced Analogue (with active/passive electronic
filters), Hybrid (digital-controlled analogue,
preferably WDRC) or Wide-Range DSP technology. In each
case, the spectral bandwidth must be sufficient to cover
the tinnitus. Coupler configuration (BTE, ITE, CC, MC,
et al) must also meet assessed needs of the patient. All
programmable technology must be built on open platform,
so as to be backwards compatible for future software
upgrades.
7) Must demonstrate willingness to recognize and report
changes based upon realistic expectations during the
study
Upon coming for their first appointment, participants
are given a pre-interview by Customer Care staff to
assure that they have read and brought with them the
necessary health information. They are also given a
reprint of “Tinnitus & Amplification” for further
reading, and a copy of a “Confidential Workshop Special
Event Price List”, so that they may review the various
levels of amplification technology offered in TA2002 and
their respective costs.
They then begin in the audiometric evaluation room,
where they receive the following battery of tests and
assessments, utilizing special forms designed
specifically for TA2002:
§ Otoscopy (Red Flag assessment)
§ Health History Review:
-Questionnaire #1 review
-Tinnitus Oral Interview Form
-Confidential Hearing Research Questionnaire
§ Middle ear assessment: Weber, screening tympanometry,
etc. to rule out conductive involvement.
§ Pure-tone tests (air & bone), Masking, where indicated
§ Speech audiometry (SRT, UCL, MCL, discrim), Masking,
where indicated
§ Soundfield/real ear on their current hearing aids (if
needed)
The next session is primarily for more definitive video
otoscopy, tinnitus assessment and hearing aid
evaluation:
§ High-definition video otoscopic view
§ Miracell recommendation, if indicated (missing
keratin, tympanosclerosis, fungus, non-Red Flag issues)
§ Review of medications, nutrition supplements for
ototoxicity, etc.
§ Nutrition/health review
§ Review of doctor reports, etc., if available
§ Review of tinnitus: causes, management strategies
§ Tinnitus assessment (pitch/mode/intensity matching)
§ Residual inhibition screening (none, partial,
complete)
§ Discussion of amplification strategies & demonstration
§ Plan Recommendation
Follow-up Schedule Plan:
§ The first visit requires about 3 hours on everyone’s
part, including the participant. This is to be sure all
bases are covered, and that all are in agreement as to
individual plan. Subsequent visits are as generally* as
follows:
§ (Approx. 2 weeks later) Fitting & delivery of hearing
instruments. This visit requires about 1 hour, and all
relevant rehabilitative/user instruction is provided the
participant. Video otoscopy given to ascertain
external/TM status since last visit. Real ear/soundfield
verification and appropriate adjustments are made.
Additional medical information placed in file, if
obtained.
§ (3-7 days later) First Follow-up Visit- consists of
ascertaining adaptation to amplification, needed
programming changes, earmold modification, and also
adjustments related to tinnitus activity. Relevant notes
placed in file.
§ (1 week later) Second Follow-up Visit- Activity Needs
Assessment (assistive devices, coping strategies, ADA
benefits), and also notations regarding amplification
progress.
§ (1 month later) Third Follow-up Visit- Oral interview
per the “Tinnitus & Amplification Follow-Up
Questionnaire”, make indicated adjustments. Decide
disposition of amplification: 1) satisfied with current
strategy, continue as before, 2) change model, circuit
to meet individual needs, expectations, 3) refund for
trial period, 4) counsel and continue.
§ (3 months later) Fourth Follow-Up Visit- Update
progress, document.
§ (6 months later) Final required study visit. Update
progress, document. Note changes that have occurred in
either treatment or outcomes. Compile all data for final
tally.
TA2002 Study Objectives/Outcome Measures
The primary objectives of TA2002 are as follows:
1) To compile and publish data and outcomes relative to
patient tinnitus management experience utilizing hearing
aid circuitry with specified electroacoustic
characteristics.
2) To analyze data in respect to minimizing use-gain
levels for optimized tinnitus management. Such data can
be presented in anecdotal, case (within-subject) study
form for individual cases, and in scattergram,
line-of-regression correlative form for the larger
population of subjects.
3) To draw inferential implications about other health
factors, including changes in TM compliance (with
non-pharmaceutical botanical solution remediation),
physician-ordered changes in medication, acupuncture,
chiropractic manipulation, biofeedback, Tinnitus
Retraining Therapy (TRT), etc. Some of this information,
while not a direct focus of the study, may be useful in
helping to delineate flow of patient referral in allied
practice model design.
4) To develop allied practice models of referral and
treatment in directing patients who present with
complaints of tinnitus. Specifically, will be emphasized
the need for assessment of auditory status before
diagnoses are rendered.
Hearing circuitry characteristics to be examined
There are several aspects of tinnitus and amplification
observed both in Study I and II, and elsewhere in the
literature, emphasizing specific capabilities that may
be desirable in fitting hearing aids whose secondary
objective is the management of tinnitus. Those
electroacoustic characteristics are:
1) Capable of generating only the minimum amount of
required use-gain to avoid further damage to cochlear
structures without over-amplifying in either the gain or
output domains. This is best achieved by the widest
bandwidth possible, with the ideal at or near the range
of normal human hearing (50Hz-16KHz).
2) That the real ear bandwidth of the instrument extend
high enough in frequency to “cover” the range of the
tinnitus
3) That the circuitry feature active rather passive
electronic filters of the circuit be active rather than
passive, whether analogue, hybrid, or DSP technology.
4) That the circuitry feature appropriate strategies for
controlling loudness growth. WDRC appears at this time
to be most appropriate strategy for most tinnitus
sufferers who wear hearing aids.
Discussion
Characteristic #1 deals with the fact that
over-amplification can not only aggravate tinnitus, but
also cause a rapid decline in residual hearing over
time. In our past research we’ve found that the more
acoustic information provided the ear (in the form of
wider range of frequencies and higher resolution) the
lower the actual use-gain required. Why this fact evades
many of the designers of today’s circuits is puzzling to
us. Also, the physical distance of the acoustic coupler
from the TM has been found to be critical so that the TM
becomes part of the “tranducer” resonating at the lowest
fundamental frequency possible, which is a key principle
in CIC acoustics. We’ve found this achieved best when
the distance between the two points is no greater than
3/8”. Hence, the wider the bandwidth, the less use-gain
required to achieve optimal audibility.
Characteristic #2 implies that if the patient’s tinnitus
is subjectively matched at 6KHz, the applied
amplification bandwidth must be at 7500Hz or higher. Our
objective here is to provide the widest bandwidth for
each participant within constraints of their personal
budget. Typically, most linear instruments cover only a
range of 200-4800Hz, so these have been essentially
eliminated for consideration. For the few whose budgets
can only handle the price range of linear technology, we
intend to substitute with a wider range, yet
inexpensive, Class D analogue with at least one active
filter. Advanced analogue with Class D (AGC-o, AGC-I,
etc.) generally cover a range of 100Hz-6800Hz, and in
some cases up to 8000Hz. Wide Dynamic Range Compression
(WDRC) circuits, such as EQ II & III, and K-Amp III,
have been found to generally top-out at around 9K-10KHz,
while DSP circuits, such as Paragon and Digi-K,
generally top-out at 12KHz and 16KHz, respectively under
certain real ear conditions.
Characteristic #3 Because many cochlear-based tinnitus
cases follow the “phantom hearing” (as in phantom limb)
or efferent neural involvement, subsequent changes
relative to loudness growth and auditory sensory
deprivation, as well as acoustic fatigue, can change the
hearing status of users over time. In other words, in
the course of a 90-120 period of use of a new
amplification strategy one’s sensitivity and utilization
of sound, especially at the central auditory processing
level, can change over time (see the Gatehouse-Killion
H.A.B.R.A.T. model for an example). Passive filters,
besides introducing earlier peak-clipping artifact,
simply do not allow the needed ranges of adjustment that
many patients will need during acclimatization. Active
filters, on the other hand, generally afford a much
larger range of post-fitting adjustability, and
eliminate most (if not all) of the distortion artifact.
Typically, manually and computer programmable
instruments utilize only active filters. Hybrid and DSP
utilize only active filters, with an even larger range,
depending on the logarithmic arrangement of the
software.
Characteristic #4- Attendant with nearly all
cochlear-based tinnitus or tinnitus related to
sensorineural hearing impairment, are abnormal loudness
growth distortions that require measured accommodation
to approach a more normal logarithm. Ideally, such
accommodation will be appropriately applied to at least
two-channels of compression, although a two-band, single
compression channel circuit (such as K-Amp III) seems to
cover the needs of many patients. Most effective for the
largest number of users appears to be WDRC circuits,
especially when spread over 3 or 4 bands and 2 WDRC
compression channels. Individual needs will dictate TK
(set for soft speech reception), use-gain (and its
distance from the both soft and loud speech settings),
and output (which must be set below a verifiable UCL).
AGC-o appears to work best in power cases that require
higher output levels (ideally, in cases where there is a
conductive component). AGC-I works well in cases of an
abnormally narrow dynamic range (both the complete
dynamic range of SRT to MCL, and especially in cases
where MCL and UCL are in close proximity). The AGC-o we
use provides compression ratios of 1:1 to 4:1 (which is
rarely used); AGC-I is generally 1.5:1 and 2:1. In some
cases, the AGC-I is manually activated with toggle
switch (BTE/ITE version) or may be environmentally
activated at various TK setting(s).
Below is an abbreviated illustration of some of the
electroacoustic characteristics and their anticipated
cost to the patient of amplification strategies
recommended for participants of TA2002:
HA Circuit Compression RE Bandwidth* El. Filters User
Cost**
Class D linear Peak-clipping 220-6000Hz Passive filters
only $595-995
Class D AdvancedAnalogue Power AGC-o 200-6500Hz Active
low-cut, passive high-cut, MPO $995-1148
Class D Advanced Analogue Power AGC-I 100-8000Hz Active
low, AGC, MPO $1198
WDRC-EQ II/III WDRC, two-channel 100-8000Hz Programmable
Hybrid $1095-1295
WDRC- K-amp III, two-band WDRC, one-channel of
compression 50-1000oHz (audible) Programmable Hybrid
$1095-1395
DSP 4-channel Paragon WDRC, two-channel compression
100-8000Hz Programmable DSP $1295-1595
DSP 4-channel Digi-K WDRC, two-channel 50-16KHz***
Programmable DSP $1695-1895
*Note: As measured at the TM, Modified Zwislocki, or
KEMAR
**Note: Instrument costs shown above include hearing
aids, earmolds, EARS rehab program, and specified
options and warranty. These prices were made possible
partly by special arrangement with the manufacturer via
applicable discounts and CWO/NET10 terms between center
and manufacturer.
Necessary changes to the recommended strategy may occur
during the study, and also as improved technological
features become available during the first twelve months
of the program. Individual fittings may be changed
without additional (upward tier adjustments excepted) to
help find the best strategy for each patient.
Configuration changes, such as from ITE to BTE, may be
made as indicated.
The four areas of subjectively perceived improvement as
a result of the amplification strategy used will fall
within the following categories:
1) Residual inhibition (RI)- Or the lessening of the
tinnitus intensity during wearing of the hearing
instrument(s) and/or, upon cessation of wearing said
instruments, a temporary reduction of tinnitus. During
the initial assessment, subjects will be given a
specified level of narrow or broadband noise for a
period of 15 seconds. As the noise is stopped, subjects
are to report any changes in tinnitus levels. If the
tinnitus stops completely, it is noted for what
duration, and if the tinnitus remains softer for the
duration of the visit. This condition is referred to as
“complete RI”. On the other hand, if there is no change
in the tinnitus following cessation of the noise
stimulus, the chart is marked “No RI”. Points between
are notated “Partial RI”. The significance of the
screening is to help determine 1) whether amplification
at given level will not make the tinnitus worse, or 2)
if appropriate amplification in a typical listening
environment may produce a positive inhibiting effect.
2) Environmental Masking (EM)- Most mild (<5dB above
threshold) tinnitus cases report hearing their tinnitus
only in quiet. With reduced hearing acuity, then, they
are left with a dilemma that makes their listening
environment generally softer than a normal hearing
individual. Therefore, by raising hearing thresholds
closer to the range of normality, and thereby increasing
the subjective sound environment itself, the subject may
realize some relief from their mild tinnitus. Moderate
levels of tinnitus (6-10dB) realize only partial benefit
from EM. The functional reading for EM is determined by
the level of masking noise required to provide residual
inhibition or to cover the tinnitus. If the level of
(EM) noise required is higher than 10dB under the user’s
MCL, they may not achieve a desirable level of
environmental masking.
3) Auditory Reattention (AR)- AR is defined as taking
one’s attention off of the tinnitus, and focusing it
instead on the more highly defined (amplified) signals
in the listening environment, particularly speech,
music, or warning signals. The neurophysiological model
for this mechanism follows some of the principles of
Tinnitus Retraining Therapy as described by Jastreboff
and Hazell (see attached reference list). In this case,
amplification accomplishes two objectives: 1) Improves
audibility of sound, and 2) Takes one’s attention off
the tinnitus noise and redirects it to meaningful
sounds. Patients most benefited by AR are usually the
more severe and severe-to-profound losses. For their
external sound environment has been so diminished that
all they have left is the internal generation of
artifact “sound” on which to direct their attention. AR
is also further enhanced when the patient experiences
round-the-clock soothing sounds of nature, such as ocean
swells, wind blowing through trees, or raindrops on a
roof. In other words, in addition to amplification, a
period for “habituation” may be needed during hours
where amplification is not being used. This can be
enhanced for most hearing aid users by playing constant
sounds as described above during quiet or sleeping
hours.
4) Stress Reduction (SR)- Stress is recognized as a
major cause or contributor to tinnitus, for both normal
hearing and hearing impaired tinnitus sufferers.
Uncorrected or inappropriately corrected hearing loss
also causes stress. By effectively fitting a
prescription-based amplification strategy the patient
may experience a significant reduction in stress levels.
In turn, reduced stress from better hearing ability
should help reduce at the least the intensity of
tinnitus. Related to this is physical stress caused by
disease, medication, sleep deprivation, nutritional
deficiency, dehydration, etc. These may also need to be
addressed to optimize stress reduction.
Follow-up reports will indicate long-term experience in
each of the above benefit areas. This information will
be useful in future tinnitus management strategies, as
well as in analysis of the current study population.
TA2002 Supervision & Compilation
To assure quality control of al protocols, data and
outcome interpretations, a supervisory hierarchy has
been established with the personnel listed below. Hence,
it is their duty to assure that all forms are filled
out, and procedures followed, so that uniformity may
exist from patient to patient. Supervision of data also
extends to those participants submitted by members of
the DigiCare Hearing Health Network. In some cases, case
files may be excluded if the information and conditions
of operation are not similar to those at the Colorado
City facility.
In addition to the information required by virtue of
forms explained above, other notes may be included,
which may prove helpful in a peripheral way. Some of the
other items we’d like to see accompanying each case file
are:
§ Doctor reports and lab tests
§ Correspondence with other professionals
§ Observations of other ear anomalies (if known), such
as:
o Diplacusis
oHyperacusis
oHypoacusis
oCochlear stroke
oMeniere’s syndrome
§ Comments by third parties related to the participant
§ Any changes in circuitry, earmolds, or hearing aid
options
§ Any other relevant material that may shed light on a
given case history
All data must be turned in to the office upon completion
of the program with each patient. At this point, a
tentative cut-off date is set for May 1, 2003. However,
because some patients were allowed on the program after
May 1, 2002, we may put latecomers in a separate group
or postpone final compilation.
Case numbers will be assigned to each participant after
successful completion of the first three-month visit.
However, it is important to stress confidentiality in
handling patient information, and to handle same as one
would their private business records. If the patient
comes under a public assistance program for
reimbursement, additional confidentiality procedures are
to be followed.
Assistance with each case study is available from the
staff listed below within their respective duties. Send
all materials att: Helen Horner. Faxed items may be sent
to (719)676-6882. Otherwise, normal collection method
will be through First Class Mail.
Supervisory & Supporting Personnel:
§ Max S. Chartrand, Ph.D., Health & Human
Services/research in communicative disorders, director
of research and education, registered hearing aid
provider. He is profoundly deaf and utilizes a cochlear
implant. He works as consultant and partner to DigiCare
Hearing Research & Rehabilitation in Colorado City,
Colorado, as Director of Research. Dr. Chartrand has
extensive industry experience, including hearing aid and
tinnitus instrument manufacturing, research &
development, and is the original inventor of the
widely-used Spectra Station sound enclosure. He also
worked for a major cochlear implant manufacturer for
several years, and headed their Network Audiology and
Cochlear Associates Program. During the 1990s he was
appointed to the Board of Hearing Aid Examiners of the
State of Texas and chair of the Complaints Committee.
Also, advised U.S. Food & Drug Administration Hearings
Panel on the FDA Hearing Aid Rule. He is a widely
recognized professional educator, and is well-published.
His demographic studies of the hearing impaired
population of the U.S. has been widely used by others in
research and in government assistance programs. He has
experience in private practice, various clinical
settings, and is a member of the International Hearing
Society and the American Academy of Audiology. He is
also owner of Aural Rehab Concepts, a 22-year old
private research and education enterprise. The reader is
also directed to the DigiCare Hearing Health Network
website (www.digicare.org) for more information on Dr.
Chartrand’s work.
§ Glenys A. Chartrand, AdDipOT, occupational
rehabilitation, Zone certified counselor, registered
hearing aid associate. Mrs. Chartrand has more than 30
years’ experience as an Occupational Therapist, 24 of
those years in Hospital-based OT. She worked at the
supervisory level during most of that, and was
instrumental in developing OT strategies in the adult
and geriatric population, including psychological and
stress-related illness. She served as the primary
therapist at Horowhenua Hospital for Acute Anxiety
Management under Dr. Barbara Simons, M.D. For six-years
thereafter she worked in private practice developing the
S.I.R.C.L.E. method (Stress Induced or Related
Conditions: Lifestyle Education). She also assisted
prominent rheumatologist Richard Wigley, M.D. in a 400
patient study on Outcomes of Treatment of Occupational
Overuse Syndrome, Palmerston North, New Zealand,
1996-1997. She earned her Advanced Diploma in
Occupational in Occupational Therapy in 1988. She has
also published and lectured widely in the U.S. on
auditory rehabilitation, and co-developed the EARS
program (Enhanced Auditory Rehabilitation Support) for
the DigiCare Hearing Health Network. She is co-owner and
lead partner of DigiCare® Hearing Research &
Rehabilitation based in Colorado City, Colorado.
§ David W. Chartrand, Technical Services Manager. David
has more than 2 years of college education in
electronics and advanced mathematics. He has worked as a
hearing aid repair and production technician for a
period of 6 years, and owned his own electronics
business in Texas for 4 years. His work with DigiCare
Hearing Research & Rehabilitation is to provide
technical and programming support, and to assist in
patient care under the EARS program. He has completed
the Distance Learning Course of IHS, and is preparing to
sit for the Board Certification exam of NBC-HIS. He is a
registered Hearing Aid Provider Associate in Colorado.
§ Helen Horner, Customer Care Manager, consumer
education and assistive device specialist. She has a
degree in Medical Systems Management, and provides
patient management skills in follow-up activities of
patients.
§ Lori Helgerson, Customer Care Assistant.
§ E. Dvonne Wells, Accounting and business manager |
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