AY8182 CUSTOM-SEMI CANAL-IN-THE-EAR HEARING AID

AY8182 CUSTOM-SEMI CANAL-IN-THE-EAR HEARING AID is an FDA 510(k)-cleared medical device (K864029) manufactured by Int'L Hearing Aids, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 12, 1986. Regulation: 8.