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DigiCare 2002 Tinnitus and Amplification Study: Design and Prospectus

Table of Contents

  1. TA2002 Research Study Design
  2. TA2002 Study Objectives/Outcome Measures
  3. TA2002 Supervision & Compilation
  4. TA2002 FAQ Sheet mailed to prospective participants prior to scheduling first visit
  5. TA2002 Patient Prospectus Summary mailed to prospective participants prior to scheduling first visit
  6. Forms utilized in TA2002
  7. Supporting documents:
  • Post-Study I: "Tinnitus Management in the Dispensing Practice" (1993)
  • From Study I: "Tinnitus & Amplification" (1989)
  • Letters of commendation by other professionals
  • From Study II: "Inferential Correlates Derived From a Tinnitus & Hearing Impairment Survey Among Hearing Health Professionals" (1994)
  • Video Otoscopy Observation & Referral: The FDA Red Flags (2002)
  • Video Otoscopy Observations in Hearing Health Practice Utilizing Miracell Botanical Solution (2002)
  • Nutritional/Ototoxicity Documents for Patients
  • Self-Management Technique for Stress-related Tinnitus
  • The Sircletm Method of Treating Occupational Overuse Syndrome (OOS)-Foundation Document (1993)
  • Self-Help Resources: Membership Benefits in the American Tinnitus Association
  • A Literature Review: References and Bibliography for TA2002 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:

  1. Otoscopy (Red Flag assessment)
  2. Health History Review:
    • Questionnaire #1 review
    • Tinnitus Oral Interview Form
    • Confidential Hearing Research Questionnaire
  3. Middle ear assessment: Weber, screening tympanometry, etc. to rule out conductive involvement.
  4. Pure-tone tests (air & bone), Masking, where indicated
  5. Speech audiometry (SRT, UCL, MCL, discrim), Masking, where indicated
  6. Soundfield/real ear on their current hearing aids (if needed)
  7. The next session is primarily for more definitive video otoscopy, tinnitus assessment and hearing aid evaluation:
  8. High-definition video otoscopic view
  9. Miracell recommendation, if indicated (missing keratin, tympanosclerosis, fungus, non-Red Flag issues)
  10. Review of medications, nutrition supplements for ototoxicity, etc.
  11. Nutrition/health review
  12. Review of doctor reports, etc., if available
  13. Review of tinnitus: causes, management strategies
  14. Tinnitus assessment (pitch/mode/intensity matching)
  15. Residual inhibition screening (none, partial, complete)
  16. Discussion of amplification strategies & demonstration
  17. 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:

  1. Doctor reports and lab tests
  2. Correspondence with other professionals
  3. Observations of other ear anomalies (if known), such as:
  • Diplacusis
  • Hyperacusis
  • oHypoacusis
  • Cochlear stroke
  • Meniere'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.
  • Dvonne Wells, Accounting and business manager
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