INT'L MODEL XE BEHIND-THE-EAR HEARING AID

INT'L MODEL XE BEHIND-THE-EAR HEARING AID is an FDA 510(k)-cleared medical device (K853942) 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 December 17, 1985. Regulation: 8.