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New hearing aid aims to boost sound for millions

NCT ID NCT07252492

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 tests a new hearing aid, Audiocap, in 100 adults with mild-to-moderate hearing loss who have never used a hearing aid before. The goal is to see if it improves hearing better than a placebo device after one month of use. Participants will undergo standard hearing tests and complete a quality-of-life questionnaire.

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.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Sep 2027

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 years and older

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: 1. Subjects presenting one or more of the following criteria: a.Subject with mild to moderate hearing loss (20dB to 50dB average at 500, 1000, 2000, and 4000 Hz) in the better ear according to WHO standards, / b. Subject with a speech reception threshold (SRT) in quiet exceeding 30dB, corresponding to the minimum speech level required to achieve 50% recognition in silence (HAS eligibility criteria for hearing aid reimbursement), / c. Subject with significant degradation of speech intelligibility in noise, defined as a speech-to-noise ratio (SNR) deviation greater than 3dB compared to normative reference values (HAS eligibility criteria for hearing aid reimbursement), / d.Subject with high-frequency hearing loss greater than 30dB from 2000 Hz onwards, associated with a speech reception threshold exceeding 30dB in quiet and/or a significantly degraded speech intelligibility in noise (HAS eligibility criteria for hearing aid reimbursement). 2. Subjects eligible for first hearing aid. 3. Subjects over 18 years of age. French-speaking subjects. 5\. Subjects affiliated with a social security scheme. 6. Subjects who are not subject to another medical option, without external pathology and excluding implants. 7\. Subjects who have signed an informed consent. 8. Subjects available for the study. Exclusion Criteria: 1. Subject deprived of his/her liberty by a judicial or administrative decision 2. Subject with severe psychiatric disorder 3. Subject admitted to a health or social care establishment 4. Subject not able to give consent 5. Adults under guardianship or trusteeship. 6. Subjects with disabling tinnitus that are not suitable for adaptation (THI\>56). 7. Subjects eligible for a cochlear implant. 8. Subjects not able to participate in the study according to the investigator. 9. Subjects with acute and chronic suppurative otitis media, congenital ear atresia, or any type of ear discharge. 10. Subjects with congenital atresia of external ear or deformity of any part of the ear canal. 11. Subjects with deafness that is unstable and with a degree of hearing loss often fluctuating. 12. Subjects with persistent headaches, dizziness, earaches, or other symptoms that are not suitable for adaptation. 13. Subjects with sudden onset of hearing loss within the past 3 months, rapid progressive deafness, unilateral hearing loss or other acute ear disease. 14. Subjects with effusion (secretions/ discharge) in the ear and/or frequent purulence (pus). 15. Subjects with central deafness (central nervous system) or non-organic deafness. 16. Subjects with acute otitis extrema and tympanitis. 17. Subjects who are allergic to materials of the device.

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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.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Clinique Rive-Gauche

    RECRUITING

    Toulouse, France, 31000, France

  • Clinique de l'Oreille

    NOT_YET_RECRUITING

    Paris, France, 75000, France

  • Hôpital Edouard Herriot

    NOT_YET_RECRUITING

    Lyon, France, 69000, France

  • Hôpital Lariboisière (APHP)

    NOT_YET_RECRUITING

    Paris, France, 75000, France

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