MAICO BTE MODEL RD-111 AND ITE MODEL RD-312 HEARING AID

MAICO BTE MODEL RD-111 AND ITE MODEL RD-312 HEARING AID is an FDA 510(k)-cleared medical device (K933291) manufactured by Maico Hearing Instruments, 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 22, 1993. Regulation: 8.