New hearing aid aims to boost sound for millions
NCT ID NCT07252492
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
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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 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Sep 2027
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: 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.
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The places running it
4 sites. 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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Clinique Rive-Gauche
RECRUITINGToulouse, France, 31000, France
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Clinique de l'Oreille
NOT_YET_RECRUITINGParis, France, 75000, France
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Hôpital Edouard Herriot
NOT_YET_RECRUITINGLyon, France, 69000, France
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Hôpital Lariboisière (APHP)
NOT_YET_RECRUITINGParis, France, 75000, France
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Other studies related to the condition(s) this trial covers.
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- Do future health workers know enough about hearing loss?
- Brain scans reveal secrets of hearing in noise for implant users
- AI could slash wait times for hearing and tinnitus care
- Hearing aids may be key to slowing dementia – new study tests easy access