FDA.reportPublic FDA data

Product code PFO

Device name
Active Implantable Bone Conduction Hearing System
Medical specialty
Ear, Nose, Throat
Device class
2
Regulation number
874.3340
Review panel
EN
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
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.
Source
FDA openFDA device classification dataset