Coupler-Based Hearing-Aid Fitting Approach for Experienced Users

Study Overview
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Brief Summary
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The overall aim of the study is to compare the verification accuracy and hearing-aid outcomes between the traditional, fitting approach where the patient is present during the visit and a coupler-based fitting approach where the patient is not present and mailed their hearing aids. If the coupler-based fitting protocol tested in this study as effective as the traditional fitting protocol, then patients receiving replacement hearing aids may circumvent a face-to-face visit.

Detailed Description
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This study will incorporate a verification technique that simulates the patient's actual ear during probe microphone verification measurements, called real-ear to coupler difference (RECD). Because the patient's ear is not used during the RECD measurement, but rather simulated, the patient would not need to be present during the RECD verification. This RECD hearing aid verification can occur in the clinic after which the hearing aids will be mailed to the patient. This study will compare the fitting accuracy and outcomes between the two approaches.

Official Title
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Efficacy of a Coupler-Based Hearing-Aid Fitting Approach for Experienced Users

Conditions
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Hearing Loss

Intervention / Treatment
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* Behavioral: standard hearing aid fitting
* Behavioral: coupler-based fitting
* Behavioral: coupler-based fitting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: no more than a moderate sensorineural hearing loss (defined as < 60 dB HL pure-tone average at 500, 1000, and 2000 Hz AU) experienced BTE hearing-aid users who are obtaining replacement VA-issued BTE hearing aids coupled to a custom earmold that is simply an upgrade in model with the same style earmold ability to read and write in English as determined by reading a few sentences from the consent document aloud so that self-report measures can be completed Exclusion Criteria: outer or middle ear pathology as determined by otoscopy, immittance, and/or audiometric testing (e.g., conductive or mixed losses) lack of phone or non-use of the phone as the participants will be required to conduct a telephone interview after they obtain their replacement hearing aids unwilling or unable to be mailed hearing aids co-morbid condition that would preclude their participation as determined by a chart review

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care group<br>Standard of Care group will receive the standard, face-to-face hearing aid fitting and verification approach | Behavioral: standard hearing aid fitting<br>* standard hearing aid, face-to-face fitting<br>|
| Experimental: Average RECD group<br>This group will have their hearing aid fitting via the coupler using average RECD values during the fitting | Behavioral: coupler-based fitting<br>* coupler-based fitting using average RECDs<br>|
| Experimental: Measured RECD group<br>This group will have their hearing aid fitting via the coupler using measured RECD values during the fitting | Behavioral: coupler-based fitting<br>* coupler-based fitting using measured RECDs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in Situ Real-ear Aided Response (REAR) | Deviation from prescriptive target (re: in situ REAR) from both ears of each participant for each group. This measure reflects the accuracy of the hearing aid fittings from 250 Hz through 3000 Hz (the average bandwidth of audibility). | at the visit where in-situ real ear measurements are made (immediate post-fitting) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Client-Oriented Scale of Improvement (COSI) | The listener nominates up to five listening goals. After hearing-aid use, the listener assesses two outcomes for each goal. One outcome is the degree of change relative to the patient's unaided experience. Responses are recorded on a 5 unit categorical scale from 'worse' to 'much better'. The second outcome is the final satisfactory 'aided' ability for each goal as measured on a 5 unit categorical scale from hardy ever (10%) to almost always (95%). Higher scores reflect better outcomes for nominated goals. We calculated the percent of better and much better responses over the nominated goals and the average satisfactory aided ability over the nominated goals. | 1 month post-fitting | 
| Device Oriented Subjective Outcome (DOSO) Scale | The questionnaire is comprised of 28 items making up the following six subscales related to listening performance with hearing aids: (1) speech cues, (2) listening effort, (3) pleasantness, (4) quietness, (5) convenience, and (6) use. Responses from 'not at all' (1 point) to tremendously (7 points) are recorded for each item and are averaged across all items to obtain a total scale score. Higher scores reflect higher outcomes. The minimum and maximum total scores can range from 1-7 and for the three groups were: standard of care group (3.8-6.8), Average RECD group (3.3-6.7), and measured RCD group (3.8-6.5). | 1 month post-fitting | 
| Satisfaction With Amplification in Daily Life (SADL) | The SADL questionnaire has 15 items that examine self-reported hearing-aid satisfaction. The following four subscales are included: (1) positive effect, (2) negative features, (3) personal image, and (4) service and cost. Item 14 is omitted in populations who do not pay for hearing aids. Responses are on a 1 to 7 scale with higher numbers reflecting higher outcomes. The item responses are averaged to determine the total satisfaction score that can range from 1-7. The minimum and maximum total scores for the three groups were: standard of care group (5.1-7.0); average RECD group (4.2-6.9), and measured RECD group (4.9-7.0). | 1 month post-fitting | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hearing loss, hearing aids, outcome assessment