BEHIND-THE-EAR HEARING AID MODEL 48 AGCI

BEHIND-THE-EAR HEARING AID MODEL 48 AGCI is an FDA 510(k)-cleared medical device (K892338) 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 August 2, 1989. Regulation: 8.