FDA product code PFO: Active Implantable Bone Conduction Hearing System
PFO is the FDA product code for active implantable bone conduction hearing system. It is a Class II device, regulated under 21 CFR 874.3340 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 11 510(k) submissions under PFO, 5 in the last five years, from 4 different applicants. The average 510(k) review took 112 days (median 114); 111 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Active Implantable Bone Conduction Hearing System |
| Device class | Class II |
| Regulation | 21 CFR 874.3340 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PFO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 4 | 110 |
| 2020 | 2 | 116 |
| 2022 | 1 | 118 |
| 2023 | 1 | 113 |
| 2024 | 2 | 108 |
| 2026 | 1 | 114 |
Compare with all 510(k) review times · Search every PFO clearance
Top PFO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cochlear Americas | 5 | 2026-07-10 |
| Med-El Elektromedizinische Geraete GmbH | 4 | 2020-10-09 |
| Oticon Medical AB | 1 | 2024-07-10 |
| Cochlear | 1 | 2023-08-18 |
Most recent PFO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260902 | Cochlear Americas | Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear Osia® 3 Charger;Cochlear Osia® 3 Aqua+;Cochlear Osia® Fitting Software 3;Cochlear Osia® Smart App;Cochlear Osia® System | 2026-07-10 | 114 |
| K240614 | Oticon Medical AB | Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS | 2024-07-10 | 127 |
| K240155 | Cochlear Americas | Cochlear Osia System | 2024-04-18 | 90 |
| K231204 | Cochlear | Cochlear Osia® System; Cochlear Osia® OSI300 Implant; Cochlear Magnet Cassette; Cochlear Non-Magnetic Cassette; Cochlear Osia® 2(I) Sound Processor; Cochlear Osia® Fitting Software 2; Cochlear Osia® Smart App | 2023-08-18 | 113 |
| K220922 | Cochlear Americas | Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit | 2022-07-27 | 118 |
Recalls for PFO devices
openFDA lists no recalls for product code PFO.
Frequently asked questions
What is FDA product code PFO?
PFO is the FDA product code for active implantable bone conduction hearing system. It is a Class II device, regulated under 21 CFR 874.3340 and reviewed by the Ear, Nose and Throat panel.
What device class is PFO?
Class II, regulation 21 CFR 874.3340. Typical premarket route: 510(k).
How long does a 510(k) take for product code PFO?
Across 11 cleared submissions the average was 112 days from receipt to decision (median 114).
Which companies have the most PFO clearances?
Cochlear Americas (5); Med-El Elektromedizinische Geraete GmbH (4); Oticon Medical AB (1); Cochlear (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PFO
- Run a recall and safety report across every PFO manufacturer
- Watch product code PFO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Ear, Nose and Throat product codes · FDA product code lookup · 510(k) database search · 510(k) review times