Clinical Evaluation of Hearing Aid OTC Self-Assessment Methods for Adults With Perceived Mild-to-… (NCT07738237) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Evaluation of Hearing Aid OTC Self-Assessment Methods for Adults With Perceived Mild-to-Moderate Hearing Loss
Australia24 participantsStarted 2026-08-15
Plain-language summary
The goal of this clinical trial is to compare two methods of self assessment of hearing with conventional audiometry in an OTC Hearing Aid for adults with perceived mild to moderate hearing loss. The main questions it aims to answer are:
1. To evaluate agreement between prescribed gain outputs generated from conventional audiometry and those generated from the self-assessment response method.
2. Determine whether either self-assessment response method provides acceptable estimated audibility.
3. Evaluate participant preference between the detection response method and the audibility-release response method.
Researchers will compare the two novel methods with conventional audiometry to determine levels of agreement.
Participants will self assess their hearing methods using two novel methods of hearing assessment as well as receive a conventional audiometric evaluation of hearing levels.
Who can participate
Age range
18 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:
* Age 18 years
* Self-perceived mild-to-moderate hearing difficulties/ hearing loss
* Competent smartphone use (able to complete self-fitting via the app)
* Able and willing to provide informed consent
* HHIA screening consistent with perceived hearing difficulty
* Willingness and ability to attend two in-person research appointments
* Ability to operate a SmartPhone
Exclusion Criteria:
* Conductive or mixed hearing loss
* Occluding cerumen
* Otologic disease/ active ear pathology
* Severe or profound hearing loss (PTA \>S0dBHL) (WHO, 2021)
* Presence of (red-flag) conditions relevant to OTC hearing aid use (per 21 CFR 801.421)
* Visible deformity of the ear (congenital or traumatic).
* Fluid, pus, or blood coming from the ear (e.g., active drainage).
* Sudden or rapidly progressive hearing loss within the recent past (often defined as within \~90 days).
* Any acute or chronic dizziness or vertigo associated with hearing issues.
* Pain or discomfort in or around the ear.
* Visible evidence of significant cerumen (ear wax) accumulation or foreign body in the ear canal.
* Unilateral hearing loss of sudden onset or large asymmetry between ears.
* Audiometric air-bone gap suggestive of possible conductive pathology (e.g., gap equal or more than 15 dB at key frequencies)
* Visible evidence of significant cerumen (ear wax) accumulation or foreign body in the ear canal.
* Unilateral hearing loss of sudden onset or large asymmetry between ears
Exclusion Criter…
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
1
Agreement of NAL-R prescribed gain outputs (dB) between the comparator conditions