Cochlear Americas Inc.
FDA Regulatory Profile
Cochlear Americas Inc. appears in FDA public data with 3 recalls, 21 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0792-2020, Class II) was initiated on December 18, 2018. Its most recent 510(k) clearance was granted on July 10, 2026.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 21
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0792-2020 | Class II | Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.) | December 18, 2018 |
| Z-2155-2015 | Class II | Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone | June 5, 2015 |
| Z-1699-2014 | Class II | Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness | April 9, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260902 | Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear Osia® 3 Charger;Coc | July 10, 2026 |
| K240155 | Cochlear Osia System | April 18, 2024 |
| K231604 | Instrument Case | August 24, 2023 |
| K220922 | Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia | July 27, 2022 |
| K212136 | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App | September 29, 2021 |
| K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App | February 23, 2021 |
| K191921 | Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia Smart | November 15, 2019 |
| K190589 | Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia | July 3, 2019 |
| K182116 | BA310 Abutment, BIA310 Implant/Abutment | December 19, 2018 |
| K171088 | Cochlear Baha SoundArc | June 7, 2017 |
| K161123 | Baha 5 Power Sound Processor | May 20, 2016 |
| K153245 | Baha 5 Super Power Sound Processor | March 2, 2016 |
| K150751 | Cordelle II Sound Processor | July 22, 2015 |
| K150555 | BA400 14mm Abutment | July 15, 2015 |
| K142907 | Baha 5 Sound Processor | March 25, 2015 |
| K131240 | COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT | November 7, 2013 |
| K132278 | COCHLEAR BAHA 4 SOUND PROCESSOR | September 26, 2013 |
| K121317 | COCHLEAR BAHA IMPLANT SYSTEM | October 12, 2012 |
| K110996 | BAHA 3 POWER SOUND PROCESSOR | May 10, 2011 |
| K100360 | BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT | July 13, 2010 |