INTERNATIONAL MODEL SC CANAL IN THE EAR HEARING AI

INTERNATIONAL MODEL SC CANAL IN THE EAR HEARING AI is an FDA 510(k)-cleared medical device (K853172) 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 16, 1985. Regulation: 8.