MODEL H44-80 BEHIND THE EAR HEARING

MODEL H44-80 BEHIND THE EAR HEARING is an FDA 510(k)-cleared medical device (K791745) manufactured by Marcon Hearing Instruments, 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 29, 1979. Regulation: 8.