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Evaluation of Performances, Clinical Benefits and Safety of the 'Audiocap' Connected Hearing Rehabilitation Device for Improving Audibility in Hearing-impaired People in the Context of CE Marking - AUDIOCAP-2 | Clinical Trials | Clareo Health

RECRUITINGNA

Evaluation of Performances, Clinical Benefits and Safety of the 'Audiocap' Connected Hearing Rehabilitation Device for Improving Audibility in Hearing-impaired People in the Context of CE Marking - AUDIOCAP-2

Evaluation of Performances, Clinical Benefits and Safety of the 'Audiocap' Connected Hearing Rehabilitation Device for Improving Audibility in Hearing-impaired People in the Context of CE Marking

NCT07252492•Archean Technologies

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is the evaluation of performances, clinical benefits and safety of the 'Audiocap' connected hearing rehabilitation device for improving audibility in hearing-impaired people. The main question it aims to answer is to demonstrate, after one month's use of the Audiocap connected hearing aid, that the audiological gain for the patient is better than with a placebo hearing aid. Placebo hearing aid is a Audiocap connected hearing aid with a 'NONE' setting (flat frequency response for the patient (equivalent to not wearing hearing aid). Participants will be first-time hearing aid users, eligible for hearing aid fitting, and adults according to French legislation (18 years and older).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+7 more criteria

Locations (4)

Hôpital Edouard Herriot

Lyon, France, France

Clinique de l'Oreille

Paris, France, France

Hôpital Lariboisière (APHP)

Paris, France, France

Clinique Rive-Gauche

Toulouse, France, France

Key Dates

Start Date

September 10, 2025

Primary Completion Date

September 1, 2027

Completion Date

September 1, 2027

Last Updated

November 26, 2025

Enrollment

100

ESTIMATED participants

Conditions

Hearing Loss, Adult-OnsetHearing Aid

Interventions

Audiocap connected hearing aid

DEVICE

Placebo

DEVICE

Contacts

Sixtine Marié

CONTACT

+33 (0)6 23 83 22 81 smarie@archean.tech

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of Performances, Clinical Benefits and Safety of the 'Audiocap' Connected Hearing Rehabilitation Device for Improving Audibility in Hearing-impaired People in the Context of CE Marking - AUDIOCAP-2

Inclusion Criteria

Exclusion Criteria

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