A cochlear implant is a small, complex electronic device that can help to provide a sense of sound. People who are profoundly deaf or severely hard-of-hearing can get help from them. The implant consists of two parts. One part sits on the outside of the body, behind the ear. A second part is surgically placed under the skin.

An implant does not restore normal hearing. It can help a person understand speech. Children and adults can benefit from them.

A cochlear implant is a small, complex electronic device that can help to provide a sense of sound to a person who is profoundly deaf or severely hard-of-hearing. The implant consists of an external portion that sits behind the ear and a second portion that is surgically placed under the skin (see figure).

An implant has the following parts:

• A microphone, which picks up sound from the environment.
• A speech processor, which selects and arranges sounds picked up by the microphone.
• A transmitter and receiver/stimulator, which receive signals from the speech processor and convert them into electric impulses.
• An electrode array, which is a group of electrodes that collects the impulses from the stimulator and sends them to different regions of the auditory nerve.

An implant does not restore normal hearing. Instead, it can give a deaf person a useful representation of sounds in the environment and help him or her to understand speech.

• Cochlear implants do not make hearing normal.
• Benefit of an implant depends, in part, on the
  • type of communication training (total communication, auditory-oral communication, cued speech, etc.) a student used before the implant
  • type of communication the student uses after the implant
• To get maximum benefit from a cochlear implant, a student will need individual training, such as
  • speech training
  • lip reading training
  • auditory training
• To progress with their classmates, students with cochlear implants may still need
  • special accommodation in the classroom
    • preferential seating
    • a note taker
    • a quiet environment, away from air handlers and other noisy equipment
    • a sign-language interpreter or cued speech interpreter
• Students need time to adjust and accommodate to their cochlear implants. The amount of time they need varies. During the accommodation period, students need language input from all sources they used before their implants.
• Educators should treat their students with cochlear implants as individuals, each having particular communication needs. Students don't get equal benefits from cochlear implants.
• Students with cochlear implants may find it harder to
  • digest new and difficult subject matter
  • interact in unfamiliar and complex social situations
• Educators should be aware that frequent changes to educational programs involving students with cochlear implants (program hopping) may impede learning.
• Educators can help their students in other ways to achieve full benefits from cochlear implants,
  • intervening early when there appears to be a problem
  • promoting family counseling
  • promoting specialized speech and language therapies
  • explaining to families that speech and language are not the same thing, and that education is based on language development
  • getting more information and support from local and national organizations of teachers of those with impaired hearing
• To assure that students with cochlear implants don't fall behind their classmates, educators should frequently evaluate them and their educational settings.
• Particularly for their younger students, educators need to assure that external cochlear implant components are securely attached or removed during active school events. The components are expensive and are easily lost or damaged.
• Students will often need extra batteries, either new or recharged, for their implants to work.
• Students with cochlear implants are usually not able to interpret complex auditory signals, such as those in music.

• About 2 to 3 out of every 1,000 children in the United States are born with a detectable level of hearing loss in one or both ears.
• More than 90 percent of deaf children are born to hearing parents.
• Approximately 15% of American adults (37.5 million) aged 18 and over report some trouble hearing.
• Among adults aged 20-69, the overall annual prevalence of hearing loss dropped slightly from 16 percent (28.0 million) in the 1999-2004 period to 14 percent (27.7 million) in the 2011–2012 period.
• Age is the strongest predictor of hearing loss among adults aged 20-69, with the greatest amount of hearing loss in the 60 to 69 age group.
• Men are almost twice as likely as women to have hearing loss among adults aged 20-69.
• Non-Hispanic white adults are more likely than adults in other racial/ethnic groups to have hearing loss; non-Hispanic black adults have the lowest prevalence of hearing loss among adults aged 20-69.
• About 18 percent of adults aged 20-69 have speech-frequency hearing loss in both ears from among those who report 5 or more years of exposure to very loud noise at work, as compared to 5.5 percent of adults with speech-frequency hearing loss in both ears who report no occupational noise exposure.
• One in eight people in the United States (13 percent, or 30 million) aged 12 years or older has hearing loss in both ears, based on standard hearing examinations.
• About 2 percent of adults aged 45 to 54 have disabling hearing loss. The rate increases to 8.5 percent for adults aged 55 to 64. Nearly 25 percent of those aged 65 to 74 and 50 percent of those who are 75 and older have disabling hearing loss.
• Roughly 10 percent of the U.S. adult population, or about 25 million Americans, has experienced tinnitus lasting at least five minutes in the past year.
• About 28.8 million U.S. adults could benefit from using hearing aids.
• Among adults aged 70 and older with hearing loss who could benefit from hearing aids, fewer than one in three (30 percent) has ever used them. Even fewer adults aged 20 to 69 (approximately 16 percent) who could benefit from wearing hearing aids have ever used them.
• As of December 2019, approximately 736,900 cochlear implants have been implanted worldwide. In the United States, roughly 118,100 devices have been implanted in adults and 65,000 in children.
• Five out of 6 children experience ear infection (otitis media) by the time they are 3 years old.

The NIDCD supports research to enhance the benefits of cochlear implants. Scientists are exploring whether using a shortened electrode array, inserted into a portion of the cochlea, for example, can help individuals whose hearing loss is limited to the higher frequencies while preserving their hearing of lower frequencies. 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.

Children and adults who are deaf or severely hard-of-hearing can be fitted for cochlear implants. As of December 2012, approximately 324,200 registered devices have been implanted worldwide. In the United States, roughly 58,000 devices have been implanted in adults and 38,000 in children. (Estimates provided by the U.S. Food and Drug Administration [FDA], as reported by cochlear implant manufacturers.)

The FDA first approved cochlear implants in the mid-1980s to treat hearing loss in adults. Since 2000, cochlear implants have been FDA-approved for use in eligible children beginning at 12 months of age. For young children who are deaf or severely hard-of-hearing, using a cochlear implant while they are young exposes them to sounds during an optimal period to develop speech and language skills. Research has shown that when these children receive a cochlear implant followed by intensive therapy before they are 18 months old, they are better able to hear, comprehend sound and music, and speak than their peers who receive implants when they are older. Studies have also shown that eligible children who receive a cochlear implant before 18 months of age develop language skills at a rate comparable to children with normal hearing, and many succeed in mainstream classrooms.

Some adults who have lost all or most of their hearing later in life can also benefit from cochlear implants. They learn to associate the signals from the implant with sounds they remember, including speech, without requiring any visual cues such as those provided by lipreading or sign language.

Do insurance companies pay for cochlear implants?

Because cochlear implants are recognized as standard treatment for severe-to-profound nerve deafness, most insurance companies cover them. In 2004, Medicare, Medicaid, the Veteran's Administration and other public health care plans cover cochlear implants. In 2004, more than 90 percent of all commercial health plans cover cochlear implants. Cochlear implant centers usually take the responsibility of obtaining prior authorization from the appropriate insurance company before proceeding with surgery.

Do I pay for the repairs?

Maybe. You will not have to pay for repairs if they are covered by a warranty or if you have insurance that covers repairs. Many health plans do not include specific benefits to cover repairs and replacement of parts for cochlear implants. However, the policy may have durable medical equipment (DME) benefits that can be applied. Read your benefits booklet for DME or prosthetic repair benefits, or check with the health plan.

My health plan has denied coverage for a cochlear implant. How can I appeal?

First, determine specifically why the cochlear implant was denied. Make sure you have the denial in writing. If you do not receive a written denial, ask for one. An appeal is most effective when structured in response to the specific reason for denial of coverage. If a specific denial reason is not provided, contact the plan and ask for clarification. Second, contact your cochlear implant center and advocacy groups and ask for help.

My health plan informs me that I have exhausted my rehabilitation benefits. How can I appeal this decision and obtain coverage for additional audiology or speech therapy services?

Many health plans have limited rehabilitation services. They have a predetermined cut-off point for post-operative cochlear implant services. However, you may be able to get extended medical benefits based on your need for more services by having your clinician argue your case. You may have an easier case if your child is the implant user. The manufacturer of your implant may help your clinician develop the case.

How can I insure my external parts against theft, damage or loss?

External parts, if purchased new, probably carry a warranty from the manufacturer against defects and materials. Usually, under such warranties, equipment lost, damaged beyond repair, or stolen will be replaced one time at no cost.

After the warranty expires, you may have some options, such as

• buying a service contract from the implant manufacturer
• getting repair and replacement coverage through your health plan
• getting coverage through your personal home property and casualty or homeowner's policy

A cochlear implant is very different from a hearing aid. Hearing aids amplify sounds so they may be detected by damaged ears. Cochlear implants bypass damaged portions of the ear and directly stimulate the auditory nerve. Signals generated by the implant are sent by way of the auditory nerve to the brain, which recognizes the signals as sound. Hearing through a cochlear implant is different from normal hearing and takes time to learn or relearn. However, it allows many people to recognize warning signals, understand other sounds in the environment, and understand speech in person or over the telephone.

How is the external transmitter held in place correctly?

Usually, the transmitter and receiver contain magnets, which attract each other to stay aligned.

Can the sound processor be removed at night?

Yes. But you should turn it off to save the battery. Some users wear the sound processor all night so they can hear.

Can I use the implant while playing sports?

Probably. Most implants are durable enough to allow playing sports. However, the external parts of most are not waterproof, so you would have to remove them before swimming or other water sports. Deep water diving may harm the internal implant due to the high water pressure.

How long does it take me to get maximum benefit from a cochlear implant?

It depends a lot on you and your rehabilitation group. It depends on how long you have been without hearing. It depends on whether you could speak well before you lost your hearing. Usually, there is a rapid rise in your ability to interpret the sounds after receiving an implant. This rapid rise slows after about 3 months but continues.

What sounds can be heard with a cochlear implant?

You will probably hear most sounds of medium-to-high loudness. Patients often report that they can hear footsteps, slamming of doors, ringing telephones car engines, barking dogs, lawn mowers, and various other environmental sounds. You may hear some softer sounds too.

Will the cochlear implant help me control the loudness of my voice?

Yes. The cochlear implant usually helps the wearer control the loudness because you can hear your voice in relation to background sounds.

Do those who have an implant system use it?

Yes. Most people use their processors routinely from morning to night. Adults who have never been able to hear have the most difficult time learning spoken language and dealing with the sensation of hearing. Some of these adults may give up and stop using their implant.

Use of a cochlear implant requires both a surgical procedure and significant therapy to learn or relearn the sense of hearing. Not everyone performs at the same level with this device. The decision to receive an implant should involve discussions with medical specialists, including an experienced cochlear-implant surgeon. The process can be expensive. For example, a person’s health insurance may cover the expense, but not always. Some individuals may choose not to have a cochlear implant for a variety of personal reasons. Surgical implantations are almost always safe, although complications are a risk factor, just as with any kind of surgery. An additional consideration is learning to interpret the sounds created by an implant. This process takes time and practice. Speech-language pathologists and audiologists are frequently involved in this learning process. Prior to implantation, all of these factors need to be considered.

For people with implants:

• Hearing ranges from near normal ability to understand speech to no hearing benefit at all.
• Adults often benefit immediately and continue to improve for about 3 months after the initial tuning sessions. Then, although performance continues to improve, improvements are slower. Cochlear implant users' performances may continue to improve for several years.
• Children may improve at a slower pace. A lot of training is needed after implantation to help the child use the new 'hearing' he or she now experiences.
• Most perceive loud, medium and soft sounds. People report that they can perceive different types of sounds, such as footsteps, slamming of doors, sounds of engines, ringing of the telephone, barking of dogs, whistling of the tea kettle, rustling of leaves, the sound of a light switch being switched on and off, and so on.
• Many understand speech without lip-reading. However, even if this is not possible, using the implant helps lip-reading.
• Many can make telephone calls and understand familiar voices over the telephone. Some good performers can make normal telephone calls and even understand an unfamiliar speaker. However, not all people who have implants are able to use the phone.
• Many can watch TV more easily, especially when they can also see the speaker's face. However, listening to the radio is often more difficult as there are no visual cues available.
• Some can enjoy music. Some enjoy the sound of certain instruments (piano or guitar, for example) and certain voices. Others do not hear well enough to enjoy music.

General Anesthesia Risks

• General anesthesia is drug-induced sleep. The drugs, such as anesthetic gases and injected drugs, may affect people differently. For most people, the risk of general anesthesia is very low. However, for some people with certain medical conditions, it is more risky.

Risks from the Surgical Implant Procedure

• Injury to the facial nerve --this nerve goes through the middle ear to give movement to the muscles of the face. It lies close to where the surgeon needs to place the implant, and thus it can be injured during the surgery. An injury can cause a temporary or permanent weakening or full paralysis on the same side of the face as the implant.
• Meningitis --this is an infection of the lining of the surface of the brain. People who have abnormally formed inner ear structures appear to be at greater risk of this rare, but serious complication. For more information on the risk of meningitis in cochlear recipients, see the nearby Useful Links.
• Cerebrospinal fluid leakage --the brain is surrounded by fluid that may leak from a hole created in the inner ear or elsewhere from a hole in the covering of the brain as a result of the surgical procedure.
• Perilymph fluid leak --the inner ear or cochlea contains fluid. This fluid can leak through the hole that was created to place the implant.
• Infection of the skin wound.
• Blood or fluid collection at the site of surgery.
• Attacks of dizziness or vertigo.
• Tinnitus, which is a ringing or buzzing sound in the ear.
• Taste disturbances --the nerve that gives taste sensation to the tongue also goes through the middle ear and might be injured during the surgery.
• Numbness around the ear.
• Reparative granuloma --this is the result of localized inflammation that can occur if the body rejects the implant.
• There may be other unforeseen complications that could occur with long term implantation that we cannot now predict.

Other Risks Associated with the Use of Cochlear Implants

People with a cochlear implant:

• May hear sounds differently. Sound impressions from an implant differ from normal hearing, according to people who could hear before they became deaf. At first, users describe the sound as "mechanical", "technical", or "synthetic". This perception changes over time, and most users do not notice this artificial sound quality after a few weeks of cochlear implant use.
• May lose residual hearing. The implant may destroy any remaining hearing in the implanted ear.
• May have unknown and uncertain effects. The cochlear implant stimulates the nerves directly with electrical currents. Although this stimulation appears to be safe, the long term effect of these electrical currents on the nerves is unknown.
• May not hear as well as others who have had successful outcomes with their implants.
• May not be able to understand language well. There is no test a person can take before surgery that will predict how well he or she will understand language after surgery.
• May have to have it removed temporarily or permanently if an infection develops after the implant surgery. However, this is a rare complication.
• May have their implant fail. In this situation, a person with an implant would need to have additional surgery to resolve this problem and would be exposed to the risks of surgery again.
• May not be able to upgrade their implant when new external components become available. Implanted parts are usually compatible with improved external parts. That way, as advances in technology develop, one can upgrade his or her implant by changing only its external parts. In some cases, though, this won't work and the implant will need changing.
• May not be able to have some medical examinations and treatments. These treatments include:
  • MRI imaging. MRI is becoming a more routine diagnostic method for early detection of medical problems. Even being close to an MRI imaging unit will be dangerous because it may dislodge the implant or demagnetize its internal magnet. FDA has approved some implants, however, for some types of MRI studies done under controlled conditions.
  • neurostimulation.
  • electrical surgery.
  • electroconvulsive therapy.
  • ionic radiation therapy.
• Will depend on batteries for hearing. For some devices new or recharged batteries are needed every day.
• May damage their implant. Contact sports, automobile accidents, slips and falls, or other impacts near the ear can damage the implant. This may mean needing a new implant and more surgery. It is unknown whether a new implant would work as well as the old one.
• May find them expensive. Replacing damaged or lost parts may be expensive.
• Will have to use it for the rest of life. During a person's lifetime, the manufacturer of the cochlear implant could go out of business. Whether a person will be able to get replacement parts or other customer service in the future is uncertain.
• May have lifestyle changes because their implant will interact with the electronic environment. An implant may
  • set off theft detection systems
  • set off metal detectors or other security systems
  • be affected by cellular phone users or other radio transmitters
  • have to be turned off during take offs and landings in aircraft
  • interact in unpredictable ways with other computer systems
• Will have to be careful of static electricity. Static electricity may temporarily or permanently damage a cochlear implant. It may be good practice to remove the processor and headset before contact with static generating materials such as children's plastic play equipment, TV screens, computer monitors, or synthetic fabric. For more details regarding how to deal with static electricity, contact the manufacturer or implant center.
• Have less ability to hear both soft sounds and loud sounds without changing the sensitivity of the implant. The sensitivity of normal hearing is adjusted continuously by the brain, but the design of cochlear implants requires that a person manually change sensitivity setting of the device as the sound environment changes.
• May develop irritation where the external part rubs on the skin and have to remove it for a while.
• Can't let the external parts get wet. Damage from water may be expensive to repair and the person may be without hearing until the implant is repaired. Thus, the person will need to remove the external parts of the device when bathing, showering, swimming, or participating in water sports.
• May hear strange sounds caused by its interaction with magnetic fields, like those near airport passenger screening machines.

What You Should Know

• People with cochlear implants are more likely to get bacterial meningitis than people without cochlear implants. In addition, some people who are candidates for cochlear implants have anatomic factors that may increase their risk for meningitis. These factors include facial and cranial abnormalities, including of the temporal bone and cochlea.
• The bacteria Streptococcus pneumoniae (pneumococcus) causes most cases of meningitis in people with cochlear implants.
• Due to their increased risk, CDC recommends pneumococcal vaccination for people who have or are candidates for cochlear implants. Clinicians should follow the pneumococcal vaccine recommendations that apply to other groups at increased risk.
• Recommendations for the timing and type of pneumococcal vaccination vary with age and vaccination history.

Pneumococcal Vaccine Recommendations by Age and Vaccination History

CDC recommends a pneumococcal conjugate vaccine (PCV13 for children and PCV15 or PCV20 for adults) for people who have or are candidates for cochlear implants. CDC also recommends pneumococcal polysaccharide vaccine (PPSV23) for some people 2 years and older who have or are candidates for cochlear implants. Specifically, PPSV23 is recommended for children once all recommended doses of PCV13 have been administered and for adults who received PCV15.

ACIP Pneumococcal Vaccine Recommendations

• Pneumococcal Vaccination for Cochlear Implant Candidates and Recipients
• Use of PCV13 and PPSV23 Vaccines Among Persons Ages 6–18 Years with Immunocompromising Conditions
• Licensure of PCV13 and Recommendations for Use Among Children

• Childhood and adolescent immunization schedule
• Adult immunization schedule

See Pneumococcal Vaccination: Summary of Who and When to Vaccinate for more detail. Download the PneumoRecs VaxAdvisor Mobile App for Vaccine Providers for help determining which pneumococcal vaccines a patient needs and when.

Other Vaccines Can Help Protect against Meningitis

There is no evidence people with cochlear implants are more likely to get Haemophilusinfluenzae type b (Hib) meningitis or meningococcal meningitis than people who do not have cochlear implants. However, Hib and meningococcal vaccines are routinely recommended based on age and other risk factors.

• The following Hib and meningococcal vaccines are available in the United States:
  • Hib conjugate (ActHIB®, Hiberix®, PedvaxHIB®, Pentacel®, Vaxelis®)
  • Meningococcal conjugate (Menactra® and Menveo®)
  • Serogroup B meningococcal (Bexsero® and Trumenba®)

What happens before surgery?

Primary care doctors usually refer patients to ear, nose and throat doctors (ENT doctors or otolaryngologists) to test them to see if they are candidates for cochlear implants.

Tests often done are:

• examination of external, middle, and inner ear for signs of infection or abnormality
• various tests of hearing, such as an audiogram
• a trial of hearing aid use to assess its potential benefit
• exams to evaluate middle and inner ear structures
  • CT (computerized tomography) scan. This type of x-ray helps the doctor see if the cochlea has a normal shape. This scan is especially important if the patient has a history of meningitis because it helps see if there is new bone growth in the cochlea that could interfere with the insertion of the implant. This scan also may indicate which ear should be implanted.
  • MRI (magnetic resonance imaging) scan
• psychological examination to see if the patient can cope with the implant
• physical exam to prepare for general anesthesia

What happens during surgery?

The doctor or other hospital staff may:

• insert some intravenous (i.v.) lines
• shave or clean the scalp around the site of the implant
• attach cables, monitors and patches to the patient's skin to monitor vital signs
• put a mask on the patient's face to provide oxygen and anesthetic gas
• administer drugs through the i.v. and the face mask to cause sleep and general anesthesia
• awaken the patient in the operating room and take him or her to a recovery room until all the anesthesia is gone

What happens after surgery?

Immediately after waking, a patient may feel:

• pressure or discomfort over his (or her) implanted ear
• dizziness
• sick to the stomach (have nausea)
• disoriented or confused for a while
• a sore throat for a while from the breathing tube used during general anesthesia

Then, a patient can expect to:

• keep the bandages on for a while
• have the bandages be stained with some blood or fluid
• go home in about a day after surgery
• have stitches for a while
• get instructions about caring for the stitches, washing the head, showering, and general care and diet
• have an appointment in about a week to the stitches removed and have the implant site examined
• have the implant "turned on" (activated) about 3-6 weeks later

Can a patient hear immediately after the operation?

No. Without the external transmitter part of the implant a patient cannot hear. The clinic will give the patient the external components about a month after the implant surgery in the first programming session.

Why is it necessary to wait 3 to 6 weeks after the operation before receiving the external transmitter and sound processor?

The waiting period provides time for the operative incision to heal completely. This usually takes 3 to 6 weeks. After the swelling is gone, your clinician can do the first fitting and programming.

What happens during the initial programming session?

An audiologist adjusts the sound processor to fit the implanted patient, tests the patient to ensure that the adjustments are correct, determines what sounds the patient hears, and gives information on the proper care and use of the device.

Is it beneficial if a family member participates in the training program?

Yes! A family member should be included in the training program whenever possible to provide assistance. The family member should know how to manage the operations of the sound processor.

Do patients have more than one implant?

Usually, patients have only one ear implanted, though a few patients have implants in both ears.

How can I help my child receive the most benefit from their cochlear implant?

• try to make hearing and listening as interesting and fun as possible
• encourage your child to make noises
• talk about things you do as you do them
• Show your child that he or she can consciously use and evaluate the sounds he or she receives from his or her cochlear implant
• realize that the more committed you, your child's teachers, and your health professionals are to helping your child, the more successful he or she will be

What can I expect a cochlear implant to achieve in my child?

As a group, children are more adaptable and better able to learn than adults. Thus, they can benefit more from a cochlear implant. Significant hearing loss slows a child's ability to learn to talk and affects overall language development. The vocal quality and intelligibility of speech from children using cochlear implants seems to be better than from children who only have acoustic hearing aids.

How important is the active cooperation of the patient?

Extremely important. The patient's willingness to experience new acoustic sounds and cooperate in an auditory training program are critical to the degree of success with the implant. The duration and complexity of the training varies from patient to patient.

The FDA advises patients, caregivers, healthcare providers, and MR technologists to be aware of the risks that an MRI may pose to patients with cochlear implants, take precautions to avoid these risks, and report any adverse events that may occur in the MRI environment.

MRIs and Implants Containing Metal or Magnets

Magnetic Resonance Imaging (MRI) is a medical imaging procedure for making images of the internal structures of the body. MRI scanners use strong magnetic fields and radio waves (radiofrequency energy) to make images.

The strong magnetic field of an MRI scanner can affect medical implants that contain metal or magnets. When this happens, the implant may move or twist inside of the patient’s body, causing discomfort, pain, or injury. Patients with metal-containing implants such as cochlear implants (which also typically contain a magnet) need to be aware of this risk and ensure that health care providers and MR technologists are aware of their implant so that they can take proper precautions when receiving an MRI exam. In addition, the radio waves of an MRI scanner may cause heating of the implant.

Cochlear Implant Card for Patients

Following surgical placement of a cochlear implant, the patient or caregiver receives an implant card like the example below for a hypothetical MR Conditional implant. This card has important information about the implant and MRI safety.

Each type of cochlear implant has specific recommendations for undergoing MRI exams. Health care providers and MR technologists should always follow the cochlear implant manufacturer’s recommendations and instructions for use.

Cochlear Implants and MRI Safety

Cochlear implants have different types of ratings for MRI safety.

• MR Unsafe means that a patient with that type of implant should not receive an MRI exam while they have the implant.
• MR Conditional means the patient can have an MRI exam under certain specific conditions.

For example, some newer cochlear implants that are MR Conditional are designed to allow the implant magnet to turn and reorient in place. The reorienting of the magnet within the cochlear implant reduces the twisting forces on the implant and surrounding tissue when exposed to the magnetic field of the MRI scanner.

Some MR Conditional cochlear implants may require the magnet to be surgically removed before an MRI can take place. The magnet will need to be surgically replaced following the MRI procedure.

For other MR Conditional cochlear implants, splint/bandaging kits may be available from the manufacturer for use during MRI. If these kits are used, it is important to use the kit designed for the cochlear implant and to follow manufacturer instructions.

Adverse Events Associated with Cochlear Implants and MRIs

When a patient with a cochlear implant receives an MRI exam, there is potential for adverse events to occur. Adverse events can include:

• Pain during or after the scan
• Skin swelling or breakdown over implant magnet
• Surgical procedure to reposition or replace the implant magnet after the scan
• Surgical procedure to replace the cochlear implant because the device failed after the scan
• Infection after a surgical procedure for one of the reasons above

How often these types of events occur is unknown and depends on the cochlear implant, the surgical placement, and the MR procedures used for the scan.

Recommendations for Patients and Caregivers

• Know the brand and model of the cochlear implant.
• Always carry the implant card you were given with you. If you do not have an implant card, contact the manufacturer to obtain one.
• If you need an MRI, tell the health care provider and the MR technologist about your implant and share the information on the implant card.

Recommendations for Health Care Providers and MR Technologists

• Follow the MRI instructions provided by the manufacturer of the patient’s cochlear implant. Ensure that the static magnetic field strength (for example, 0.2T, 1.5T, 3.0T) of the scanner is compatible with the implant. Some cochlear implants require the surgical removal of the magnet before the scan, and magnet replacement after the scan. Other cochlear implants may not require magnet removal, but have specific MRI instructions that should be followed. Instructions may be included in device labeling, posted on the manufacturer’s website, or both.
• Consider other types of imaging, if clinically appropriate.
• For MR Conditional cochlear implants that are used with splint/bandaging kits, only use the FDA-approved splint/bandaging kits designed to be used with the patient’s specific cochlear implant. Follow the manufacturer’s instructions for use. Do not use other bandaging that is not intended for this purpose.
• There are some magnet-containing implants for hearing impairment that are not cochlear implants. Examples include bone-anchored or bone conduction hearing aids or middle ear implants. Follow the manufacturer’s instructions for use.

Reporting Adverse Events with Cochlear Implants

Report any adverse events associated with MRI and cochlear implants. Reporting these events can help the FDA identify and better understand the risks related to the use of medical devices.

If you suspect or experience a problem with cochlear implants or accessories during MRI, file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.