Device Dossier

Audiometric measuring instrument

Device Dossier for Audiometric measuring instrument (Audiometric measuring instrument, Class IIa, sponsor WS AUDIOLOGY). ARTG record, intended purpose,…

Intended purpose

Electroacoustic device used to diagnose hearing loss, verify amplification and for hearing instrument analysis. It consists of a test box and a control unit with electronics that connect to a computer which runs application software. The control unit can also be connected to other manufacturers test boxes or run as an audiometer and real-ear-measurement instrument without the test box.

TGA Public Summary