PFO · Class II — Moderate Risk (510(k) clearance required) · Ear, Nose, Throat · 21 CFR 874.3340
Classification
FDA Product Code
PFO
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 874.3340
Review panel
EN
Medical specialty
Ear, Nose, Throat
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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.