MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT

MODEL ALPHA BEHIND-THE-EAR HEARING INSTRUMENT is an FDA 510(k)-cleared medical device (K962228) manufactured by Ototech Intl., Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 27, 1996. Regulation: 8.