BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL

BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL is an FDA 510(k)-cleared medical device (K901569) manufactured by Unitron Industries, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 17, 1990. Regulation: 8.