BEHIND-THE-EAR HEARING INSTRUMENT, H54

BEHIND-THE-EAR HEARING INSTRUMENT, H54 is an FDA 510(k)-cleared medical device (K790726) 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.