Device Dossier

Hearing aid, in-the-ear

Device Dossier for Hearing aid, in-the-ear (Hearing aid, in-the-ear, Class IIa, sponsor GN Hearing). ARTG record, intended purpose, GMDN category —…

Intended purpose

A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a miniature microphone, amplifier, and speaker (receiver) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. The device is used for mild to severe hearing loss;

TGA Public Summary