OE SERIES OF BEHIND-THE-EAR HEARING AIDS

OE SERIES OF BEHIND-THE-EAR HEARING AIDS is an FDA 510(k)-cleared medical device (K853381) manufactured by Emtech Laboratories. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 7, 1985. Regulation: 8.