
Phonic Ear, Inc.
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GROUP AUDITORY TRAINER,FM RECEIVER is an FDA 510(k)-cleared medical device (K912356) 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 August 14, 1991. Regulation: 8.

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