Device Dossier

Otoacoustic emission system, battery-powered

Device Dossier for Otoacoustic emission system, battery-powered (Otoacoustic emission system, battery-powered, Class IIa, sponsor Hear Clear Acoustics).…

Intended purpose

The Otoacoustic Emissions (OAE) screener is a device testing the cochlear functionality which relates to the amplification activity by the outer hair cells. When the cochlea is stimulated by sound, including Transient-evoked (TEOAE) and Distortion-product (DPOAE), the outer hair cells vibrate producing an almost imperceptible sound which goes back to the middle-ear. This subtle sound is measured by a probe inserted into the ear canal.

TGA Public Summary