MIRACLE-EAR MODEL PBM PROGRAMMABLE HEARING AID

MIRACLE-EAR MODEL PBM PROGRAMMABLE HEARING AID is an FDA 510(k)-cleared medical device (K950691) 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 March 30, 1995. Regulation: 8.