INTERNATIONAL MODEL XL BEHIND-THE-EAR

INTERNATIONAL MODEL XL BEHIND-THE-EAR is an FDA 510(k)-cleared medical device (K873799) 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 19, 1987. Regulation: 8.