PFO — Active Implantable Bone Conduction Hearing System Class II
FDA product code PFO covers "Active Implantable Bone Conduction Hearing System", a Class II medical device regulated under 21 CFR 874.3340. Submissions are reviewed by the Ear, Nose, Throat panel. Devices under this code are implants. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PFO
- Device Class
- Class II
- Regulation Number
- 874.3340
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260902 | cochlear americas | Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear | July 10, 2026 |
| K240614 | oticon medical | Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS | July 10, 2024 |
| K240155 | cochlear americas | Cochlear Osia System | April 18, 2024 |
| K231204 | cochlear | Cochlear Osia® System; Cochlear Osia® OSI300 Implant; Cochlear Magnet Cassett | August 18, 2023 |
| K220922 | cochlear americas | Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Proc | July 27, 2022 |
| K201983 | med-el elektromedizinische geraete | BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm | October 9, 2020 |
| K200504 | med-el elektromedizinische geraete | BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote | July 29, 2020 |
| K191921 | cochlear americas | Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Soft | November 15, 2019 |
| K191457 | med-el elektromedizinische geraete | BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Si | September 18, 2019 |
| K190589 | cochlear americas | Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative | July 3, 2019 |
| K183373 | med-el elektromedizinische geraete | Bonebridge | March 7, 2019 |
| DEN170009 | med-el elektromedizinische geraete | Bonebridge | July 20, 2018 |