INTERNATIONAL MODEL SC SEMICANAL IN THE EAR HEAR A

INTERNATIONAL MODEL SC SEMICANAL IN THE EAR HEAR A is an FDA 510(k)-cleared medical device (K853171) manufactured by Int'L Hearing Aids, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 30, 1985. Regulation: 8.