SONOTONE BEHIND THE EAR MODEL ST 47I

SONOTONE BEHIND THE EAR MODEL ST 47I is an FDA 510(k)-cleared medical device (K914898) manufactured by Sonotone Hearing Instruments. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on January 8, 1992. Regulation: 8.