Active Implantable Bone Conduction Hearing System
The Active Implantable Bone Conduction Hearing System is a prescription device comprising an implanted transducer, electronic components, and an external audio processor, intended to compensate for conductive or mixed hearing loss by transmitting amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone. It is an FDA Class 2 device regulated under 21 CFR 874.3340, requiring 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The product code is PFO, falling under the Ear, Nose, and Throat (EN) medical specialty. The device is flagged as an implant given its surgically placed transducer component.
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Basic Information
- Product Code
- PFO
- Device Class
- FDA class 2
- Regulation Number
- 874.3340
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K240614 | Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS | Jul 10, 2024 | Substantially Equivalent | Oticon Medical AB |
| K240155 | Cochlear Osia System | Apr 18, 2024 | Substantially Equivalent | Cochlear Americas |
| K231204 | 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 | Aug 18, 2023 | Substantially Equivalent | Cochlear |
| K220922 | Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit | Jul 27, 2022 | Substantially Equivalent | Cochlear Americas |
| K201983 | BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) | Oct 09, 2020 | Substantially Equivalent | Med-El Elektromedizinische Geraete GmbH |
| K200504 | BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote | Jul 29, 2020 | Substantially Equivalent | Med-El Elektromedizinische Geraete GmbH |
| K191921 | Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments | Nov 15, 2019 | Substantially Equivalent | Cochlear Americas |
| K191457 | BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) | Sep 18, 2019 | Substantially Equivalent | Med-El Elektromedizinische Geraete GmbH |
| K190589 | Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments | Jul 03, 2019 | Substantially Equivalent | Cochlear Americas |
| K183373 | Bonebridge | Mar 07, 2019 | Substantially Equivalent | Med-El Elektromedizinische Geraete GmbH |
| DEN170009 | Bonebridge | Jul 20, 2018 | Unknown | Med-El Elektromedizinische Geraete GmbH |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.