Company · US
Cochlear Americas
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (1 in 12 months)
5recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 10, 2026 | K260902 | Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear Osia® 3 Charger;Cochlear Osia® 3 Aqua+ Cochlear Americas | PFO |
| Apr 18, 2024 | K240155 | Cochlear Osia System Cochlear Americas | PFO |
| Aug 24, 2023 | K231604 | Instrument Case Cochlear Americas | KCT |
| Jul 27, 2022 | K220922 | Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear Americas | PFO |
| Sep 29, 2021 | K212136 | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App Cochlear Americas | LXB |
| Feb 23, 2021 | K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App Cochlear Americas | LXB |
| Nov 15, 2019 | K191921 | Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia S Cochlear Americas | PFO |
| Jul 3, 2019 | K190589 | Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, C Cochlear Americas | PFO |
| Dec 19, 2018 | K182116 | BA310 Abutment, BIA310 Implant/Abutment Cochlear Americas | MAH |
| Jun 7, 2017 | K171088 | Cochlear Baha SoundArc Cochlear Americas | LXB |
| May 20, 2016 | K161123 | Baha 5 Power Sound Processor Cochlear Americas | LXB |
| Mar 2, 2016 | K153245 | Baha 5 Super Power Sound Processor Cochlear Americas | LXB |
| Jul 22, 2015 | K150751 | Cordelle II Sound Processor Cochlear Americas | LXB |
| Jul 15, 2015 | K150555 | BA400 14mm Abutment Cochlear Americas | MAH |
| Mar 25, 2015 | K142907 | Baha 5 Sound Processor Cochlear Americas | LXB |
| Nov 7, 2013 | K131240 | COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT Cochlear Americas | LXB |
| Sep 26, 2013 | K132278 | COCHLEAR BAHA 4 SOUND PROCESSOR Cochlear Americas | LXB |
| Oct 12, 2012 | K121317 | COCHLEAR BAHA IMPLANT SYSTEM Cochlear Americas | MAH |
| May 10, 2011 | K110996 | BAHA 3 POWER SOUND PROCESSOR Cochlear Americas | LXB |
| Jul 13, 2010 | K100360 | BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT Cochlear Americas | LXB |
| Aug 28, 2008 | K081606 | BAHA INTENSO Cochlear Americas | LXB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2018 | Cochlear Americas Inc. Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.) Terminated |
LXB | K142907 |
| Jul 20, 2015 | Cochlear Americas Inc. Cochlear Nucleus Sterile Silicone Template
Product Usage:
The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth o Terminated |
MCM | None listed |
| Jun 2, 2014 | Cochlear Americas Inc. Cochlear Baha Soft tissue gauge 6mm.
Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system. Terminated |
LXB | K131240 |
| Oct 3, 2011 | Cochlear Americas Inc. Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia.
The cochlear implant is intended to rest Terminated |
MCM | None listed |
| Nov 2, 2009 | Cochlear Americas Inc. Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited. Terminated |
MCM | None listed |