Device Dossier
Audiometer, auditory evoked response
Device Dossier for Audiometer, auditory evoked response (Audiometer, auditory evoked response, Class IIa, sponsor Sonova). ARTG record, intended purpose,…
- GMDN category: Audiometer, auditory evoked response
Intended purpose
A 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.