WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER

WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER is an FDA 510(k)-cleared medical device (K970974) manufactured by Williams Sound, LLC. 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 1, 1997. Regulation: 8.