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Active Implantable Bone Conduction Hearing System

FDA product code PFO · 11 cleared devices

Class 2 Ear, Nose, Throat
Regulation
21 CFR 874.3340
Review panel
EN
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2019-03-07 – 2026-07-10

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.

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