Device Dossier

Audiometer, auditory evoked response

Device Dossier for Audiometer, auditory evoked response (Audiometer, auditory evoked response, Class IIa, sponsor Sonic Equipment). ARTG record, intended…

Intended purpose

The Otodynamics audiometers screen for both Otoscustic Emissions and Auditory Brainstem Response. The devices have two presentations, A hand held device and a binaural device that connects to a PC. They are intended to be used to screen for hearing disorders, clinical investigations and monitoring of the functional status of the peripheral auditory function by objective/non-invasive means.

TGA Public Summary