Cochlear Americas
Lone Tree, CO, US
COCHLEAR AMERICAS appears in FDA device records in Lone Tree, CO. FDA records list 21 510(k) clearances between and , 501 PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 21 510(k) clearances for Cochlear Americas between 2008 and 2026. The busiest year on record is 2015, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 2 |
| 2015 | 3 |
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 2 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260902 | Cochlear™ Osia® 3(I) Sound Processor;Cochlear™ Osia® 3 Sound Processor;Cochlear™ Osia® 3 Charger;Cochlear™ Osia® 3 Aqua+;Cochlear™ Osia® Fitting Software 3;Cochlear™ Osia® Smart App;Cochlear™ Osia® System | PFO | Substantially Equivalent | |
| K240155 | Cochlear Osia System | PFO | Substantially Equivalent | |
| K231604 | Instrument Case | KCT | Substantially Equivalent | |
| K220922 | Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit | PFO | Substantially Equivalent | |
| K212136 | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App | LXB | Substantially Equivalent | |
| K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App | LXB | Substantially Equivalent | |
| K191921 | Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments | PFO | Substantially Equivalent | |
| K190589 | Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments | PFO | Substantially Equivalent | |
| K182116 | BA310 Abutment, BIA310 Implant/Abutment | MAH | Substantially Equivalent | |
| K171088 | Cochlear Baha SoundArc | LXB | Substantially Equivalent | |
| K161123 | Baha 5 Power Sound Processor | LXB | Substantially Equivalent | |
| K153245 | Baha 5 Super Power Sound Processor | LXB | Substantially Equivalent | |
| K150751 | Cordelle II Sound Processor | LXB | Substantially Equivalent | |
| K150555 | BA400 14mm Abutment | MAH | Substantially Equivalent | |
| K142907 | Baha 5 Sound Processor | LXB | Substantially Equivalent | |
| K131240 | COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT | LXB | Substantially Equivalent | |
| K132278 | COCHLEAR BAHA 4 SOUND PROCESSOR | LXB | Substantially Equivalent | |
| K121317 | COCHLEAR BAHA IMPLANT SYSTEM | MAH | Substantially Equivalent | |
| K110996 | BAHA 3 POWER SOUND PROCESSOR | LXB | Substantially Equivalent | |
| K100360 | BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT | LXB | Substantially Equivalent | |
| K081606 | BAHA INTENSO | LXB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005900820 | 3005900820 | COCHLEAR AMERICAS | 10350 Park Meadows Drive, Lone Tree, CO 80124 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- PFOActive Implantable Bone Conduction Hearing System
- PGQCochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
- MJGDevice, Percutaneous, Biopsy
- LRJDisinfectant, Medical Devices
- OSMHearing Aid, Air-Conduction With Wireless Technology, Prescription
- LXBHearing Aid, Bone Conduction
- MAHHearing Aid, Bone Conduction, Implanted
- MHEImplant, Auditory Brainstem
- MCMImplant, Cochlear
- LRCInstrument, Ent Manual Surgical
- OUGMedical Device Data System
- GEYMotor, Surgical Instrument, Ac-Powered
- FZEProsthesis, Nose, Internal
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0792-2020 | Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.) | Product was packaged with the Incorrect tamper proof battery door. | Class II | Terminated | |
| Z-2155-2015 | 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 of the implant well and appropriate positions for tie down holes | Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed. | Class II | Terminated | |
| Z-1699-2014 | 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. | Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potentially leave residual metal on the patient's skin. | Class II | Terminated | |
| Z-0003-2012 | 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 restore a level of auditory sensation via the electrical stimulation of the auditory nerve. | Cochlear implant may shut down and cease to function. | Terminated | ||
| Z-0119-2010 | Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited. | Cochlear implant device component was mis-labeled. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain