Cochlear
Country not established FDA
- Devices
- 1,511
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Cochlear makes
The company manufactures components and systems for cochlear implants and auditory brainstem implants, including internal coils, external reusable magnets, sound processors, batteries, peripheral connectors, earhooks, and cable assemblies. These devices are designed for individuals with severe to profound hearing loss or specific auditory nerve disorders. The portfolio also includes research platforms for experimental use.
The portfolio includes Class II and Class III devices, regulated under the FDA’s Unique Device Identifier (UDI) system. Products are listed in the FDA’s UDI database, ensuring traceability and compliance with U.S. medical device regulations. The company is headquartered in the United States.
Catalogue
Search and filter all 1,511 devicesShowing 1-50 of 1,511
FDA establishments
- Cochlear Ltd Macquarie University New South Wales · AU FEI 3009092818
Frequently asked questions
How many devices does Cochlear have in the registry?
The registry currently lists 1511 devices for Cochlear. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cochlear's devices?
Among its 50 most recently registered devices, Cochlear has devices listed in EUDAMED (18 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Cochlear's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Cochlear's devices are Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Cochlear in the registry?
The most recently registered devices listed for Cochlear include Cochlear® Osia® Fitting Software 3 v 3.0, Cochlear® Osia® 3(I) Sound Processor base unit P2053391, Cochlear® Osia® 3 Sound Processor base unit P2053390 and Cochlear® Osia® 3(I) Sound Processor P1982310.
Which FDA establishments are linked to Cochlear?
1 FDA establishment is linked to Cochlear in the registry; they are listed on the company page.