CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A

CUSTOM IN-THE-CANAL HEARING AID MODEL: I52A is an FDA 510(k)-cleared medical device (K890703) 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 16, 1989. Regulation: 8.