HEARING AID (ALL-IN-THE-EAR)

HEARING AID (ALL-IN-THE-EAR) is an FDA 510(k)-cleared medical device (K953960) 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 September 11, 1995. Regulation: 8.