PFO

12 FDA 510(k) clearances · Product code

FDA profile

Official device name

Active Implantable Bone Conduction Hearing System

Device class

Class II (moderate risk)

Regulation

21 CFR 874.3340

Medical specialty

Ear, Nose, Throat

Flags

Implant

FDA 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.

Adverse events (MAUDE)

2021: 237 · 2022: 306 · 2023: 473 · 2024: 712 · 2025: 1,008 · 2026: 604
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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