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

Measurement of quality of life using the SSQi15 questionnaire

Quality of life will be assessed using questionnaires SSQi15. The SSQ-15 (Speech, Spatial, and Qualities of Hearing Scale, 15-item version) is a questionnaire that evaluates real-life hearing situations related to speech understanding, spatial hearing, and perceived qualities of hearing.

Time frame: After one month (Month 1) and at the end of follow-up (Month 3 and Month 4)

Measurement of quality of life using the COSI questionnaire

The Client Oriented Scale of Improvement (COSI) is a clinical tool developed by the National Acoustic Laboratories to assess hearing aid outcomes. Patients identify up to five specific listening situations they wish to improve. After a period of use, they rate the perceived improvement and their final ability to hear in each situation.

Time frame: After one month of using (Month 1) and at the end of the follow up (Month 3 and Month 4)

Treatment preference (Likert)

The subject will be asked to indicate their preference between not using a hearing aid and using a hearing aid on a scale from 0 to 10.

Time frame: After one month (Month 1) and at the end of the patient's follow-up (Month 3 and Month 4)

Reduction of the time required to attain adaptation to the hearing aid (remote interplay path)

The advantage of the remote interplay path is assessed through: 2.a.1. If necessary for the patient, number of adjustments requested and/or number of positive responses to requests from the application to adjust the setting compared with the standard mode, 2.a.2. The number of adjustments requested in the remote interplay path during the first month is higher than the last month, 2.a.3. Comparison of the time interval between the last setting remote requested and the standard last visit, 2.a.4. Subjects in remote interplay path have an equal or better average wearing time than subject in standard interplay path, 2.a.5. During the last month, subjects in remote interplay path don't use their previous setting and don't request a new one, 2.a.6. During the last month, subjects in remote interplay path don't change significantly the global broadcast level of their hearing aid.

Time frame: After one month (Month 1) and at the end of follow-up (Month 3 and Month 4)

Remote interplay path empowers the subject to take control of and better manage their hearing loss.

Subject empowerment is assessed by the PAM-13 questionnaire.

Time frame: After one month (Month 1) and at the end of follow-up (Month 3 and Month 4)

Acceptability assessed by wearing time (data logging)

Acceptability assessed by wearing time (data logging).

Time frame: After one month (Month 1) and at the end of follow-up (Month 3 and Month 4)

Usability (Ergonomic questionnaire)

Usability assessed via the ergonomics questionnaire. The ergonomic questionnaire is specially custom to evaluate the medical device (clear information, typeface, visual presentation, design, use and use of each feature).

Time frame: After one month of use (M1) and at the end of the follow up (M3 and M4).

Safety of the device : reporting adverse events, serious adverse events and device deficiencies.

Safety of the device : number of adverse events, serious adverse events and device deficiencies (in the context of CE marking)

Time frame: This endpoint is measured at each subject visit in the study (visit 2 (Day 15), visit 3 (Month 1), visit 4 (Day 45), visit 5 (Month 2) and visit 6 (Month 4)).