MODEL 800, BEHIND-THE-EAR HEARING AID

MODEL 800, BEHIND-THE-EAR HEARING AID is an FDA 510(k)-cleared medical device (K911706) manufactured by Electone, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 16, 1991. Regulation: 8.