Cochlear Americas
United Statesfrom the FDA registration address FDA FEI 3005900820
Cochlear Americas is a medical device manufacturer, with 33 devices listed in FDA 510(k), FDA PMA and FDA GUDID (FDA Class II and III) and 5 FDA recalls as of 13 Nov 2026.
- Devices
- 33
- Registrations
- FDA
- FDA recalls
- 5
Registry facts
- Registries
- FDA 510(k) 21
- FDA PMA 6
- FDA GUDID 6
- Device classes
- FDA Class II 26
- FDA Class III 7
- FDA recalls
- Identifiers
- FDA FEI 3005900820
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Cochlear Americas makes
The company produces bone-conduction hearing implant systems, including implant and abutment components, sound processors, and wireless-fitting software for audiometric and hearing device applications. Their portfolio includes drill kits for surgical implantation, software tools for device customization and fitting, and standalone sound processor systems. Examples include the BAHA 6 Max Sound Processor, the Osia System, and audiometric software like CUSTOM SOUND PRO 7.0.
These devices are regulated under FDA classifications, with Class II and Class III authorizations required for bone-anchored implants and related software. They appear in FDA registries for 510(k), PMA, and UDI listings, reflecting compliance with U.S. medical device regulations. The company operates from its U.S. headquarters in Minneapolis, Minnesota.
Catalogue
Search and filter all 33 devicesCompany details
- FDA FEI number
- 3005900820
- Address
- 10350 Park Meadows Drive, Lone Tree, CO, 80124
FDA recalls
FDA recall records list 5 recalls initiated by Cochlear Americas, the earliest on 2009-09-30 and the most recent on 2018-12-18. By recorded status: 5 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, electrical or power and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2018
- 18 Dec 2018 Z-0792-2020 Class II Terminated Product was packaged with the Incorrect tamper proof battery door.
Full distribution text
- 18 Dec 2018 Z-0792-2020 Class II Terminated Product was packaged with the Incorrect tamper proof battery door.
2015
- 5 Jun 2015 Z-2155-2015 Class II Terminated Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed.
2014
- 9 Apr 2014 Z-1699-2014 Class II Terminated 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.
2011
- 16 Sep 2011 Z-0003-2012 Unclassified (pre-2012) Terminated Cochlear implant may shut down and cease to function.
2009
- 30 Sep 2009 Z-0119-2010 Unclassified (pre-2012) Terminated Cochlear implant device component was mis-labeled.
Full distribution text
- 30 Sep 2009 Z-0119-2010 Unclassified (pre-2012) Terminated Cochlear implant device component was mis-labeled.
Frequently asked questions
How many devices does Cochlear Americas have in the registry?
The registry currently lists 33 devices for Cochlear Americas. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cochlear Americas's devices?
Among its 33 most recently registered devices, Cochlear Americas has devices listed in FDA 510(k) (21 devices), FDA PMA (6 devices) and FDA GUDID (6 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Cochlear Americas's devices fall under?
Among its 33 most recently registered devices, the classes recorded for Cochlear Americas's devices are Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for Cochlear Americas?
FDA recall records list 5 recalls initiated by Cochlear Americas, the most recent initiated on 18 Dec 2018. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Cochlear Americas in the registry?
The most recently registered devices listed for Cochlear Americas include Cochlear™ Osia® 3(I) Sound Processor, Field Bone-Anchored Drill Kit 91053R, Rental Bone-Anchored Drill Kit FUZ180 and CUSTOM SOUND PRO 7.0 CD P2002452CD.