Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments
FDA 510(k) K191921 · Cochlear Americas
Submission
- Device name
- Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments
- Applicant
- Cochlear Americas
Centennial, CO, US - Received
- July 18, 2019
- Decision date
- November 15, 2019
- 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 |
| K240155 | Cochlear Osia SystemPFO · Traditional | Cochlear Americas | 04/18/2024SE |
| 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 |
| 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 |
| K240155 | Cochlear Osia SystemPFO · Traditional | 04/18/2024SE |
| 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 |
| 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 OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments cleared by the FDA?
Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments (K191921) received a 510(k) decision of Substantially Equivalent on November 15, 2019, 120 days after the submission was received.
What is the product code of K191921?
The FDA product code is PFO – Active Implantable Bone Conduction Hearing System, a Class II (moderate risk) device regulated under 21 CFR 874.3340.