FDA Product Code PFO: Active Implantable Bone Conduction Hearing System
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.
Leading manufacturers include Cochlear Americas and Oticon Medical AB.
FDA 510(k) Cleared Active Implantable Bone Conduction Hearing System Devices (Product Code PFO)
About Product Code PFO - Regulatory Context
510(k) Submission Activity
11 total 510(k) submissions under product code PFO since 2018, with 10 receiving FDA clearance (average review time: 149 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under PFO have taken an average of 127 days to reach a decision - down from 152 days historically, suggesting improved FDA processing for this classification.
PFO devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →