BEHIND-THE-EAR HEARING AID MODEL 46 PP PC

BEHIND-THE-EAR HEARING AID MODEL 46 PP PC is an FDA 510(k)-cleared medical device (K892337) manufactured by Qualitone. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 9, 1989. Regulation: 8.