Sophono Bone Conduction Systems (S) Configuration and (M) Configuration

Sophono Bone Conduction Systems (S) Configuration and (M) Configuration is an FDA 510(k)-cleared medical device (K153391) manufactured by Sophono, 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 15, 2016. Regulation: 8.