GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)

GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM) is an FDA 510(k)-cleared medical device (K950730) manufactured by Phonic Ear, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 29, 1995. Regulation: 8.