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Hearing aid showdown: lexie B3 pro vs. competitor in new study

NCT ID NCT06878300

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 aimed to compare two over-the-counter hearing aids—the Lexie B3 Pro and a competitor—in adults with mild to moderate hearing loss. Participants would have tested each device and reported their experiences. However, the trial was withdrawn before any participants were enrolled, so no data was collected.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Over-the-counter hearing aid (Lexie B3 Pro)
What this could lead to
If successful, this could show that the Lexie B3 Pro hearing aid is as good as other over-the-counter options for improving hearing and user satisfaction.
What could go wrong
The trial was withdrawn before enrolling anyone, so no results are available. It is unclear if the devices will actually help in real-world use.

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.

Started

Jul 2025

Finished

Aug 2025

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 105 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * The participant must be 18 years or older. * The outer ear must be free from excessive cerumen, outer or middle ear disease. * 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 present with Type A or As or Ad tympanogram as measured by tympanometry. * Must be in possession of a smartphone compatible with the Lexie App (Android OS 8) Exclusion Criteria: * Younger than 18 years * Severe or greater hearing loss * 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 an Android smartphone, compatible with the Lexie App (minimum Android OS 8)

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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 Self perceived hearing loss

More trials for these conditions

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