OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID

OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID is an FDA 510(k)-cleared medical device (K897023) manufactured by Audina Hearing Instrument. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 15, 1990. Regulation: 8.