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Cochlear

Also registered as COCHLEAR LIMITED

Country not established FDA

Devices
1,511
Registrations
FDA
FDA recalls
0

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.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

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FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Cochlear Ltd Macquarie University New South Wales · AU FEI 3009092818