Australia TGA ARTG recordHearing aid, air-conduction, receiver-in-canal
Australia TGA ARTG Registered Device · Tacktronics Hearing · Austar Hearing Science & Technology (Xiamen) Co Ltd · Class IIa · Started December 18, 2017
Good Name: Tacktronics Hearing - Hearing aid, air-conduction, receiver-in-canal
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- December 18, 2017
- Effective Date
- December 18, 2017
- Country
- China
- Address
- RM201 No2 Gaoqi South 12th Road Huli District, Xiamen Fujian, 361006
A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]; this separation reduces acoustic feedback. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier 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.
Access comprehensive regulatory information for Hearing aid, air-conduction, receiver-in-canal in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Tacktronics Hearing, manufactured by Austar Hearing Science & Technology (Xiamen) Co Ltd in China. The device registration started on December 18, 2017.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.