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).
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.
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
Subject not able to give consent
Parallel
Audiocap connected hearing aid
DeviceThe hearing aids will be used in a standard mode, that is, without the possibility of remote adjustment (remote interplay path).
Placebo
DeviceAudiocap connected hearing aid with a 'NONE' setting (flat frequency response for the patient (equivalent to not wearing hearing aid) in a standard interplay path.
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.
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: 1. Mean tonal gain of 10 dB (mean 500 / 1000 / 2000 / 4000 Hz). 2. Minimum vocal prosthetic gain of 7 dB (dissyllabic words). 3. Improvement in speech in noise of at least 2 dB SNR (FrMatrix test). Clarification: The primary endpoint measures the audiological gain in decibels (dB) through standard audiometric tests. Three non-cumulative possibilities (i.e., at least one of the three improvements) are defined: depending on the patient's hearing loss, the improvement is not expressed in the same way.
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.
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.
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.
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.
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