Device Dossier

Integrity V500 - Audiometer, auditory evoked response

Device Dossier for Integrity V500 - Audiometer, auditory evoked response (Audiometer, auditory evoked response, Class IIa, sponsor Sonic Equipment). ARTG…

Intended purpose

The V500 System is intended to aid in detecting hearing loss and lesions in the auditory pathway. It is intended for trained professionals for diagnostic Evoked Potential (EP)/Auditory Brainstem Response (ABR) audiometer system used for the purpose of hearing level threshold estimation and/or side of lesion testing. With Otoacoustic Emission (OAE) capabilities, the unit is capable of evaluating cochlear outer hair cell function.

TGA Public Summary