NCT07252492

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Archean Technologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hearing Loss, Adult-Onset
• Hearing Aid

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-10
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2025-11-26
• Last updated: 2025-11-26

Locations

4 sites across 1 country: France