PFO

Active Implantable Bone Conduction Hearing System

Product code

PFO

Device name

Active Implantable Bone Conduction Hearing System

Device class

Class 2

21 CFR

21 CFR 874.3340

Medical specialty

Ear, Nose, Throat

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (last 3 years)

3

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

12 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-07-10.

2 summaries are archived here for direct download.