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RECRUITING
NCT07252492
NA

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

Sponsor: 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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-09-10

Completion Date

2027-09

Last Updated

2025-11-26

Healthy Volunteers

No

Interventions

DEVICE

Audiocap connected hearing aid

The hearing aids will be used in a standard mode, that is, without the possibility of remote adjustment (remote interplay path).

DEVICE

Placebo

Audiocap connected hearing aid with a 'NONE' setting (flat frequency response for the patient (equivalent to not wearing hearing aid) in a standard interplay path.

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