OTICON BTE HEARING AID (BEHIND-THE-EAR), MODEL E44

OTICON BTE HEARING AID (BEHIND-THE-EAR), MODEL E44 is an FDA 510(k)-cleared medical device (K901292) 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 April 9, 1990. Regulation: 8.