EARETTE HEARING AID SEARS MODEL 8053

EARETTE HEARING AID SEARS MODEL 8053 is an FDA 510(k)-cleared medical device (K810389) manufactured by Oticon Corp.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 3, 1981. Regulation: 8.