Cochlear Osia System
FDA 510(k) K240155 · Cochlear Americas
510(k) numberK240155
Submission
- Device name
- Cochlear Osia System
- Applicant
- Cochlear Americas
Lone Tree, CO, US - Received
- January 19, 2024
- Decision date
- April 18, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PFO – Active Implantable Bone Conduction Hearing System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3340
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
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.
Other 510(k)s with product code PFO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260902 | Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear Osia® 3…PFO · Traditional | Cochlear Americas | 07/10/2026SE |
| K240614 | Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHSPFO · Traditional | Oticon Medical AB | 07/10/2024SE |
| K231204 | Cochlear Osia® System; Cochlear Osia® OSI300 Implant; Cochlear Magnet Cassette…PFO · Traditional | Cochlear | 08/18/2023SE |
| K220922 | Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor…PFO · Traditional | Cochlear Americas | 07/27/2022SE |
| K201983 | BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)PFO · Traditional | Med-El Elektromedizinische Geraete GmbH | 10/09/2020SE |
| K200504 | BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 RemotePFO · Traditional | Med-El Elektromedizinische Geraete GmbH | 07/29/2020SE |
| K191921 | Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software…PFO · Traditional | Cochlear Americas | 11/15/2019SE |
| K191457 | BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit…PFO · Traditional | Med-El Elektromedizinische Geraete GmbH | 09/18/2019SE |
| K190589 | Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test…PFO · Traditional | Cochlear Americas | 07/03/2019SE |
| K183373 | BonebridgePFO · Traditional | Med-El Elektromedizinische Geraete GmbH | 03/07/2019SE |
More from Med-El Elektromedizinische Geraete GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K260902 | Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear Osia® 3…PFO · Traditional | 07/10/2026SE |
| K231604 | Instrument CaseKCT · Special | 08/24/2023SE |
| K220922 | Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor…PFO · Traditional | 07/27/2022SE |
| K212136 | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart AppLXB · Traditional | 09/29/2021SE |
| K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha…LXB · Traditional | 02/23/2021SE |
| K191921 | Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software…PFO · Traditional | 11/15/2019SE |
| K190589 | Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test…PFO · Traditional | 07/03/2019SE |
| K182116 | BA310 Abutment, BIA310 Implant/AbutmentMAH · Traditional | 12/19/2018SE |
| K171088 | Cochlear Baha SoundArcLXB · Special | 06/07/2017SE |
| K161123 | Baha 5 Power Sound ProcessorLXB · Special | 05/20/2016SE |
Questions and answers
When was Cochlear Osia System cleared by the FDA?
Cochlear Osia System (K240155) received a 510(k) decision of Substantially Equivalent on April 18, 2024, 90 days after the submission was received.
What is the product code of K240155?
The FDA product code is PFO – Active Implantable Bone Conduction Hearing System, a Class II (moderate risk) device regulated under 21 CFR 874.3340.