ABRA MODEL LINE LOW DRAIN CUST IN-THE-EAR HEAR AID

ABRA MODEL LINE LOW DRAIN CUST IN-THE-EAR HEAR AID is an FDA 510(k)-cleared medical device (K910311) manufactured by Ototech, Ltd.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 17, 1991. Regulation: 8.