AUDIOTONE MODEL A-95 BEHIND-THE-EAR HEARING AID

AUDIOTONE MODEL A-95 BEHIND-THE-EAR HEARING AID is an FDA 510(k)-cleared medical device (K914477) manufactured by Miracle-Ear, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 20, 1991. Regulation: 8.