Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss

Study Overview
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Brief Summary
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This study aims to evaluate the benefit of bilateral hearing aid use compared to a unilateral hearing aid. Patients with mild to moderate bilateral hearing loss who are considering the purchase of a commercially available hearing aid will be considered for participation. Eligible participants will be randomized to one of the following treatment arms: (1) a bilateral hearing aid fitting group, and (2) a unilateral hearing aid fitting group.

Detailed Description
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Primary objectives: To compare the hearing-aid benefit of unilateral versus bilateral fittings of commercially-available hearing aids that incorporate a dome coupling (open or closed dome as required by degree of hearing loss, or custom coupling if clinically indicated), which represents the most popular style used for mild to moderate hearing loss. To compare other multi-dimensional outcomes including hearing-related quality of life, hearing aid satisfaction in patient-nominated goals, ecological hearing aid outcomes, and hearing aid use. Secondary objectives: To compare performance outcomes for unilateral versus bilateral hearing aid fittings To explore the differences in long-term patient reported outcomes for their final hearing aid configuration choice To explore patient experiences in each group (unilateral vs bilateral), and patient preference in regards to their choice of final hearing aid configuration. This study is being conducted at Duke and Vanderbilt Medical Centers, with Duke functioning as the main coordinating center. Study participants will pay out of pocket for the hearing aid(s), but will be able to extend the hearing aid fitting trial period from 60 days (standard of care) to 180 days (6 months). Participants will be given the opportunity to change their hearing aid configuration and/or return their hearing aid(s) for a refund after 3 months, and again at the end of the 6 month study period.

Official Title
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Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Hearing amplification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50+ years of age Ability to read and understand English Mild to moderate sensorineural hearing loss (defined by a pure-tone average at 500, 1000, and 2000 Hz of <55 dB HL in each ear, and the 3000 Hz and 4000 Hz threshold <80 in each ear), based on a hearing test obtained within the last 6 months by a licensed audiologist. Symmetrical hearing loss defined by <20 dB difference between the pure-tone average of 500, 1000, and 2000 Hz between ears) Interested in purchasing hearing aids, but is open minded about trying one or two hearing aids No prior hearing aid use longer than 3 months (as documented via self-report) Adequate literacy to complete questionnaires Willing to purchase study-specific hearing aid(s) Access to a smart phone and the internet Exclusion Criteria: Concerns for middle ear pathology (e.g., air bone gap of >15 dB at 2 consecutive octave frequencies in either ear) Concerns for retrocochlear pathology by audiologist (e.g unilateral tinnitus or ear fullness, referral to ENT/Auditory Brainstem Response testing to r/o acoustic neuroma) Severe tinnitus as the reason for seeking amplification Co-morbid condition that would interfere with study (e.g., dementia, blindness, neurologic pathology) History of fluctuating hearing loss

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Other: Bilateral hearing aid fitting group<br> | Device: Hearing amplification<br>* Bilateral vs. unilateral hearing aids for hearing loss<br>|
| Active Comparator: Unilateral hearing aid fitting group<br> | Device: Hearing amplification<br>* Bilateral vs. unilateral hearing aids for hearing loss<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hearing Aid Benefit | Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hearing Aid Benefit | Measured by Ecological Momentary Assessment (EMA) with in-situ Glasgow Hearing Aid Benefit Profile (GHABP) | 3 months, 6 months | 
| Change in Hearing Aid Benefit as measured by speech in noise performance | Bamford -Kowal-Bench speech in noise (BKB SIN) test | Baseline, 3 months | 
| Change in Hearing Aid Benefit as measured by Auditory Working Memory | Abbreviated Word Auditory Recognition and Recall Measure (WARRM) | Baseline, 3 months | 
| Change in Hearing Aid Satisfaction | Measured by Satisfaction with Amplification in Daily Life (SADL) survey completion | 3 months , 6 months | 
| Hours of Hearing Aid Use | Measured by automated data log extracted from hearing aid | 1 month | 
| Hours of Hearing Aid Use | Measured by automated data log extracted from hearing aid | 3 months | 
| Change in Hearing Related Quality Life | Measured by Hearing Handicap Inventory for Elderly (HHIE) survey completion | Baseline, 3 months, 6 months | 
| Change in complex ecological listening | Measured by Speech Spatial Qualities (SSQ) survey completion | Baseline, 3 months, 6 months | 
| Hearing aid expectations | Measured by Expected Consequences of Hearing Aid Ownership (ECHO) survey completion | Baseline | 
| Change in global hearing aid outcomes | Measured by International Outcome Inventory for Hearing aids (IOI_HA) survey completion | 3 months, 6 months | 
| Experience with hearing aid assignment | Measured by a self-reported questionnaire using a 10 point scale (1 = not at all and 10 is very highly likely/full recommendation) | 3 months | 
| Experience with hearing aid assignment | Measured by open ended questions and discussion during a participant focus group | 3 months | 
| Number of participants in each arm that chose 0 hearing aids as measured by patient preference | Measured by participant's final choice of 0, 1, or 2 hearing aids | 3 months | 
| Number of participants in each arm that chose 1 hearing aid as measured by patient preference | Measured by participant's final choice of 0, 1, or 2 hearing aids | 3 months | 
| Number of participants in each arm that chose 2 hearing aids as measured by patient preference | Measured by participant's final choice of 0, 1, or 2 hearing aids | 3 months | 
| Preference with hearing aid assignment | Measured by open ended questions and discussion during a participant focus group | 3 months | 
| Change in Hearing Aid Benefit | Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB) | Baseline, 3 months, 6 months |