Audio-Smart - Otoacoustic emission system, battery-powered - ARTG 435150
Access comprehensive regulatory information for Audio-Smart - Otoacoustic emission system, battery-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 435150 and sponsored by AIMedical International Pty Ltd, manufactured by Neurosoft LLC in Russia. The device registration started on January 18, 2024.
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.
๏ท Hearing screening, including newborns (configurations 1-4). ๏ท Detection of hearing loss degree (configurations 1, 3, 4). ๏ท Detection of electrophysiological threshold of hearing (with ABR using Jewett V marker) (configurations 1, 4). ๏ท Middle ear and Eustachian tube disorders (configurations 3, 4, 5). The Audio-SMART system can be used in healthcare and hearing diagnostic centers, maternity centers, ambulatory-care and neurosurgery clinics, testing laboratories of research institutes. The Audio-SMART system is to be used by trained personnel only, such as audiologists, ear-nose-throat (ENT) doctors, pediatricians, and other hearing health care professionals and audiologically trained technicians. The system should not be used without the necessary knowledge and training to understand its use and how results should be interpreted. The Audio-SMART system can be used to diagnose hearing disorders in patients of all ages. When performing the Eustachian tube function (ETF) test, patient should understand the instructions and perform the maneuvers to obtain reliable results.