Device Dossier

Celesta - Audiometer, auditory evoked response

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

Intended purpose

Celesta is a medical device designed to record the auditory evoked potentials and vestibular evoked myogenic potentials. It generates and delivers sound or vibratory stimuli of different types and intensities, records electrophysiological waveforms synchronized with the stimuli, and displays the stimulation-induced responses. The device helps the operator in assessing the patient’s auditory sensitivity and vestibular function for diagnostic purposes.

TGA Public Summary