Device Dossier

Hearing aid, air-conduction, receiver-in-canal

Device Dossier for Hearing aid, air-conduction, receiver-in-canal (Hearing aid, air-conduction, receiver-in-canal, Class IIa, sponsor TLC Diagnostics).…

Intended purpose

Abattery-powered acoustic device intended to compensate for impaired hearing by transmiting amplifed sound waves to the eardrumthrough air. It consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) inthe ear canal [receiver-in-canal (RIC)]. The microphone receives sound waves and converts them into electrical signals which arencreased by the amplifer and sent as sound waves, by the speaker, to the eardrum. The device is used for mild to profound hearing Loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors

TGA Public Summary