DeviceClearance

Product code PFO— Ear, Nose, Throat

Bonebridge

Classification name
Active Implantable Bone Conduction Hearing System
Device class
Class 2
Regulation
21 CFR 874.3340
Advisory panel
Ear, Nose, Throat
Total cleared
12
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PFO under 21 CFR 874.3340, via openFDA

Market context for product code PFO

FDA has cleared 12 devices under product code PFO between 2018 and 2026, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PFO

Adverse events under product code PFO

product code PFO
Injury
2,752
Total
2,752

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code PFO

Data sourced from openFDA. This site is unofficial and independent of the FDA.