UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)

UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) is an FDA 510(k)-cleared medical device (K071462) manufactured by Siemens Hearing Instruments, 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 4, 2007. Regulation: 8.