Device Dossier

Audiometric measuring instrument

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

Intended purpose

An electroacoustic device intended to be used during the diagnosis of hearing loss (audiometer function), for the verification of amplification (real-ear-measurement) and for hearing instrument analysis (functions as the hearing aid analyser to check its proper function when this is being fitted to the patient). It typically consists of a test box and a control unit with electronics that connect to a computer that runs application software to provide the results and graphics, which may be stored in an appropriate database. 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