Evaluation of Performances, Clinical Benefits and Safety of the 'Audiocap' Connected Hearing Reha… (NCT07252492) | Clinical Trial Compass
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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
France100 participantsStarted 2025-09-10
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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).
✓. Subjects eligible for first hearing aid.
✓. Subjects over 18 years of age. French-speaking subjects.
Exclusion criteria
✕. Subject deprived of his/her liberty by a judicial or administrative decision
✕. Subject with severe psychiatric disorder
✕. Subject admitted to a health or social care establishment
What they're measuring
1
The effectiveness of the Audiocap connected hearing aid will be measured by the improvement of at least one of the following three audiological gain criteria.
Timeframe: After one month of hearing aid use (Month 1)