Study of the Audiocap Connected Hearing Aid to Improve Hearing in Adults with Hearing Loss

What this Trial Is About

Researchers are evaluating the performance, clinical benefits, and safety of the Audiocap connected hearing rehabilitation device for adults with hearing loss. The study aims to determine if using the Audiocap hearing aid for one month improves hearing ability more than a placebo hearing aid that delivers no hearing assistance. Participants are first-time hearing aid users, adults eligible for hearing aid fitting, and French-speaking. Participants will use either the Audiocap connected hearing aid in standard mode without remote adjustment or a placebo version with a flat frequency response equivalent to not wearing a hearing aid. The study has a first period lasting one month where participants use one of these devices in a standard care setting. The study evaluates outcomes after this month of use. During the study, participants will undergo assessments including audiological gain measurements, quality of life questionnaires SSQi15 and COSI, treatment preference surveys, and data logging of device use. Safety monitoring includes reporting any adverse events throughout several visits up to four months. The study also examines usability and participant control over hearing loss management with remote features. Follow-up visits occur up to four months after starting the device use.

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