BEHIND-THE-EAR HEARING INSTRUMENT, H56

BEHIND-THE-EAR HEARING INSTRUMENT, H56 is an FDA 510(k)-cleared medical device (K790700) 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 April 30, 1979. Regulation: 8.