AUDINA PREWIRES (FACEPLATE HEARING AID SERIES)

AUDINA PREWIRES (FACEPLATE HEARING AID SERIES) is an FDA 510(k)-cleared medical device (K942236) 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 June 16, 1994. Regulation: 8.