INTERNATIONAL MODEL SC CUSTOM IN THE EAR HEARG AID

INTERNATIONAL MODEL SC CUSTOM IN THE EAR HEARG AID is an FDA 510(k)-cleared medical device (K853170) 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 October 3, 1985. Regulation: 8.