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

Who can take part

• 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
• Subjects affiliated with a social security scheme. 6. Subjects who are not subject to another medical option, without external pathology and excluding implants
• Subjects who have signed an informed consent. 8. Subjects available for the study

Who cannot take part

• Subjects eligible for a cochlear implant
• Subject with severe psychiatric disorder
• Subjects with sudden onset of hearing loss within the past 3 months, rapid progressive deafness, unilateral hearing loss or other acute ear disease
• Subjects who are allergic to materials of the device
• Subject deprived of his/her liberty by a judicial or administrative decision
• Subject admitted to a health or social care establishment
• Subject not able to give consent
• Adults under guardianship or trusteeship
• Subjects with disabling tinnitus that are not suitable for adaptation (THI>56)
• Subjects not able to participate in the study according to the investigator
• Subjects with acute and chronic suppurative otitis media, congenital ear atresia, or any type of ear discharge
• Subjects with congenital atresia of external ear or deformity of any part of the ear canal
• Subjects with deafness that is unstable and with a degree of hearing loss often fluctuating
• Subjects with persistent headaches, dizziness, earaches, or other symptoms that are not suitable for adaptation
• Subjects with effusion (secretions/ discharge) in the ear and/or frequent purulence (pus)
• Subjects with central deafness (central nervous system) or non-organic deafness
• Subjects with acute otitis extrema and tympanitis