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

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.

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TGA ARTG Official Data
Class IIa
Class IIa
Hearing aid, air-conduction, receiver-in-canal
Australia TGA ARTG Registered Device
Good Name: Tacktronics Hearing - Hearing aid, air-conduction, receiver-in-canal
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Intended Purpose

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.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
December 18, 2017
Effective Date
December 18, 2017
Manufacturer
Country
China
Address
RM201 No2 Gaoqi South 12th Road Huli District, Xiamen Fujian, 361006