TEOAE25

TEOAE25 is an FDA 510(k)-cleared medical device (K030016) manufactured by Interacoustics A/S, Assens. 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 March 27, 2003. Regulation: 8.