Pure Global

Behind-the-ear air-conduction hearing aid - ARTG 338717

Access comprehensive regulatory information for Behind-the-ear air-conduction hearing aid in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 338717 and sponsored by Hearnow Products Pty Ltd, manufactured by Austar Hearing Science & Technology (Xiamen) Co Ltd in China. The device registration started on July 01, 2020.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIa
ARTG 338717
Class IIa
Behind-the-ear air-conduction hearing aid
ARTG ID: 338717
Good Name: Hearnow Products Pty Ltd - Behind-the-ear air-conduction hearing aid
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

The Jaspa 3 BTE hearing aid is a battery-powered 12-band digital hearing aid, with 4 programs and 10 volume levels intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. The device consists of a microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). The device is used for mild to profound hearing loss.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
338717
Start Date
July 01, 2020
Effective Date
July 01, 2020
Manufacturer
Country
China
Address
Ground Floor and Third Floor Building B8 Biomedical Industrial Park No 2064, Wengjiao West Road Haicang District Xiamen City, Fujian Province, 361022