AUDIOTONE MODEL A-61 BEHIND-THE-EAR HEARING AID

AUDIOTONE MODEL A-61 BEHIND-THE-EAR HEARING AID is an FDA 510(k)-cleared medical device (K881652) manufactured by Audiotone, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 10, 1988. Regulation: 8.