CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)

CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) is an FDA 510(k)-cleared medical device (K011366) 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 May 31, 2001. Regulation: 8.