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New study tests if Over-the-Counter hearing aids work as well as prescription ones

NCT ID NCT06942325

Symptom relief Sponsor: HearX SA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to see if a self-fitting over-the-counter (OTC) hearing aid works as well as a professionally fitted prescription device for adults with mild-moderate hearing loss. The research involves three phases: validating a hearing test, checking user experience, and a randomized trial comparing the two types of hearing aids. The goal is to improve access and affordability of hearing aids without sacrificing effectiveness.

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

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.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

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

18 to 110 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * Participant must be 18 years or older. * The outer ear must be free from excessive cerumen, outer or middle ear disease (determined through otoscopic examination of the ear) * The participant must have bilateral self-perceived mild-moderate hearing loss. * Baseline pure tone evaluations should fall within a 4-frequency PTA (0.5, 1.0, 2.0, 4.0 kHz) of 65 dB HL or less. * The participant must have an adequate level of English proficiency as measured objectively using an English proficiency test (EF SET). * The participant must have Type A or As or Ad tympanogram as measured by tympanometry. * Must be in possession of a smartphone compatible with the Lexie App (minimum iOS 13 or Android OS 10), preferably within equal distributio Exclusion Criteria: * Younger than 18 years * Presents with severe or greater hearing loss in either ear * Presents with an outer or middle ear abnormality Have any of the following as per FDA (21 CFR 801.420) reg-flag conditions as contraindications to OTC hearing aid use : (i) Visible congenital or traumatic deformity of the ear preventing insertion of the receiver wire and dome into the ear. (ii) History of sudden active drainage (i.e. blood or pus) from the ear within the previous 6 months. (iii) Painful or uncomfortable feeling in your ear (iv) Visible evidence of significant cerumen accumulation or a foreign body in the ear canal. (v) History of sudden or rapidly progressive hearing loss within the previous 6 months. (vi) Acute or chronic dizziness. (vii) Unilateral hearing loss. (viii) Fluctuating hearing loss (ix) Unilateral tinnitus * Low English proficiency - \<51% of EF-SET * No access or in possession of a smartphone, compatible with the Lexie App (minimum iOS 13 or Android OS 10)

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Conditions

The condition(s) this trial relates to.

hearing loss disorder sensorineural hearing loss disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hearing impairment Hearing loss

More trials for these conditions

Other studies related to the condition(s) this trial covers.