Device Dossier
Neuro-Audio - Audiometer, auditory evoked response
Device Dossier for Neuro-Audio - Audiometer, auditory evoked response (Audiometer, auditory evoked response, Class IIa, sponsor AIMedical). ARTG record,…
- GMDN category: Audiometer, auditory evoked response
Intended purpose
The Neuro-Audio system is intended for use in electrophysiological and audiologic evaluation of hearing and vestibular function as an aid in detecting hearing loss and diagnosing hearing and vestibular related disorders. It can be used for screening and diagnostic applications. It allows recording auditory brainstem response (ABR) and other auditory evoked potentials (AEP), otoacoustic emissions (OAE) and screening pure tone audiometry (PTA). Neuro-Audio bone conduction amplifier unit is intended to record bone conduction VEMPs. The target population for Neuro-Audio includes all ages.