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U.S. Department of Health and Human Services

Medical Devices

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FDA-Approved Cochlear Implants

The Food and Drug Administration has approved several cochlear implants for sale in the US.

Many of the original implants approved by FDA are no longer implanted in patients because their technologies have been improved. These improved technologies often appear as Supplements to the original approved devices. Look at the Supplements and/or contact the implant manufacturers for the latest models and their features. Search for all FDA-approved cochlear implants in the nearby Search Cochlear Implants link.

FDA's Approval Process

To approve a cochlear implant or another device, FDA reviews information that gives details on the product, its description, what it is made of, how well it has worked in patients in a clinical trial, information on adverse effects, and other information to see whether it is safe and effective. If FDA concludes it is safe and effective, it approves the device for sale in the U.S. Later, when a company wants to change the device, it sends a Supplement to FDA for approval. Since their approvals, many cochlear implants have been changed by Supplements.

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Search For Approved Cochlear Implants

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