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FDA, Cochlear Implant

Medical implants are devices or tissues that are placed inside or on the surface of the body. Many implants are prosthetics, intended to replace missing body parts. Other implants deliver medication, monitor body functions, or provide support to organs and tissues.

Cochlear implants are designed to help severely to profoundly deaf adults and children who get little or no benefit from hearing aids. Even individuals with severe or profound "nerve deafness" may be able to benefit from cochlear implants.

Some implants are made from skin, bone or other body tissues. Others are made from metal, plastic, ceramic or other materials.

Implants can be placed permanently or they can be removed once they are no longer needed. For example, stents or hip implants are intended to be permanent. But chemotherapy ports or screws to repair broken bones can be removed when they no longer needed.

The risks of medical implants include surgical risks during placement or removal, infection, and implant failure. Some people also have reactions to the materials used in implants.

All surgical procedures have risks. These include bruising at the surgical site, pain, swelling and redness. When your implant is inserted or removed, you should expect these types of complications.

Infections are common. Most come from skin contamination at the time of surgery. If you get an infection, you may need to have a drain inserted near the implant, take medication, or even have the implant removed.

Over time, your implant could move, break, or stop working properly. If this happens, you may require additional surgery to repair or replace the implant.

A cochlear implant is an implanted electronic hearing device, designed to produce useful hearing sensations to a person with severe to profound nerve deafness by electrically stimulating nerves inside the inner ear. Doctors implant cochlear implants into people with severe to profound hearing loss to produce useful hearing sensations.

These implants usually consist of 2 main components:

  • The externally worn microphone, sound processor and transmitter system.

  • The implanted receiver and electrode system, which contains the electronic circuits that receive signals from the external system and send electrical currents to the inner ear.

Currently made devices have a magnet that holds the external system in place next to the implanted internal system. The external system may be worn entirely behind the ear or its parts may be worn in a pocket, belt pouch, or harness.

FDA Regulation of Cochlear Implants

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. Cochlear implants are designated as Class III devices, meaning they receive the highest level of regulatory scrutiny. This is because they are surgically implanted near the brain, which increases health risk. Other risks, while minimal, include injury to the facial nerve, meningitis, perilymph fluid leak (fluid from the inner ear leaks through the hole created to place the implant), and dizziness or vertigo.

The Future of Cochlear Implants

Scientists continue to look for ways to improve cochlear implants and how they function once implanted. For example:

  • Companies are developing more sophisticated strategies that help to minimize background noise and increase the noise-to-sound ratio, helping the user to better focus and understand speech.

  • Hearing science researchers also are looking at the potential benefits of pairing a cochlear implant in one ear with either another cochlear implant or a hearing aid in the other ear.

“A cochlear implant won’t restore hearing the way that eyeglasses can fully restore vision,” Nandkumar says. “But companies are developing increasingly sophisticated processing strategies that can reduce background noise and increase the signal-to-noise ratio, in an effort to improve the quality of speech the wearer hears.”

Provision Consulting Group provides consulting service and solves customer problems accurately and quickly.

Our services allow manufacturers to spend more time developing their devices

rather than searching for distributors, negotiating contracts, and learning regulations.

If you have questions about FDA regulation of medical devices

or importing of medical devices to the United States,

please CONTACT US.

Office 1-909-493-3276



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