Could an app tune your hearing aids as well as an audiologist?
NCT ID NCT07738237
First seen Jul 31, 2026 · Last updated Aug 04, 2026 · Updated 2 times
Summary
This trial tests whether two self-assessment methods in a smartphone app can generate hearing aid settings that match those from a standard hearing test. Adults with perceived mild-to-moderate hearing loss will use the app to self-test their hearing and also undergo conventional audiometry. The study compares the prescribed gain from each method to see if the app-based approach is reliable and acceptable.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- OTC hearing aid self-fitting app (Rehear RH210) with two self-assessment methods
- What this could lead to
- If successful, this could make hearing aid fitting more accessible and convenient, allowing people to self-adjust their devices without needing a clinic visit.
- What could go wrong
- The trial is small (24 participants) and early-stage, so results may not apply to everyone. The self-assessment methods might not match the accuracy of professional audiometry.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 Criteria: \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Acoustic Laboratories
Macquarie Park, New South Wales, 2113, Australia
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