Clinical Trial

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

Study acronym: AUDIOCAP-2
Recruiting
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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).
Trial Details
NCT Number NCT07252492
Lead Sponsor Archean Technologies
Conditions Hearing Loss, Adult-Onset, Hearing Aid
Enrollment 100 participants
Start Date 2025-09-10
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2025-11-26