AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR

AUDINA 153 BEHIND THE EAR AND AUDINA 158 BEHIND THE EAR is an FDA 510(k)-cleared medical device (K964816) manufactured by Audina Hearing Instrument. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 16, 1997. Regulation: 8.