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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
Sponsor: Archean Technologies
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
Conditions
Interventions
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).
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