Device typeAudiometric/hearing aid tester: An electroacoustic device intended to be used for both the evaluation of hearing loss (audiometer function) and the evaluation of hearing aids while worn for optimal amplification [real-ear measurement (REM)]; some types may in addition be used to test hearing aid function when being fitted to the patient. It typically consists of a test box and a control unit that connect to an off-the-shelf computer that runs application software to provide results and graphics (which may be stored in a database). It may be used as an audiometer or real-ear-measurement instrument without the test box.
FDA categoryCalibrator, Hearing Aid / Earphone And Analysis Systems
Device IDB161AXIOM0
MRI safetyLabeling does not contain MRI Safety Information