CompletedNot Applicable

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

United States278 participantsStarted 2021-04-26

Plain-language summary

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.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Hearing Aid Benefit as Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB)

Timeframe: Baseline, 3 months

Trial details

NCT IDNCT04739436

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-12

Results submitted2025-03-21

View on ClinicalTrials.gov More Hearing Loss trials