Active Implantable Bone Conduction Hearing System — FDA 510(k) Devices
An Active Implantable Bone Conduction Hearing System Is A Prescription Device Consisting Of An Implanted Transducer, Implanted Electronics Components, And An Audio Processor. The Active Implantable Bone Conduction Hearing System Is Intended To Compensate For Conductive Or Mixed Hearing Losses By Conveying Amplified Acoustic Signals To The Cochlea Via Mechanical Vibrations On The Skull Bone.
List of Active Implantable Bone Conduction Hearing System devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Active Implantable Bone Conduction Hearing System devices (product code PFO). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Ear, Nose, Throat FDA review panel. Browse all Ear, Nose, Throat devices →