# Active Implantable Bone Conduction Hearing System
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 11
- **Registered establishments:** 15
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PFO)
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