Device Class Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)
Product Code Active Implantable Bone Conduction Hearing System (PFO) (1) Implantable Bone Conduction Hearing Aid (PFO) (1)