Are implants FDA-approved?

The Food and Drug Administration (FDA) regulates cochlear implant devices for both adults and children and approves them only after thorough clinical investigation. Be sure to ask your otolaryngologist for written information, including brochures provided by the implant manufacturers.

You need to be fully informed about the benefits and risks of cochlear implants, including how much is known about how safe, reliable, and effective a device is, how often you must come back to the clinic for checkups, and whether your insurance company pays for the procedure.

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