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

Exclusion Criteria

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