MIRACLE EAR MODEL SM IN-THE-EAR HEARING AID

MIRACLE EAR MODEL SM IN-THE-EAR HEARING AID is an FDA 510(k)-cleared medical device (K900237) manufactured by Miracle-Ear, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 21, 1990. Regulation: 8.