Children with cochlear implants may be at increased risk of bacterial meningitis, states the FDA.

The risk isn’t new. It was first noted by the FDA in 2002. Now, the FDA is updating its 2002 and 2003 warnings about the risk and issuing new recommendations for children with cochlear implants.

Cochlear implants are devices implanted under the skin behind the ear, with electrodes that go deep into the ear. The devices turn sound waves into electric signals that are passed to nerve fibers leading into the brain.

Cochlear implants can allow deaf people to hear. However, the process may take time as the brain adjusts and the devices are fine-tuned in each patient. Kids often get the implants early in life, to help them master language skills at a young age. Some cochlear implants also have a positioner, which the FDA describes as a small rubber wedge that helps position the implant during surgery.

More than 11,000 U.S. children with severe to profound hearing loss have cochlear implants, CDC and FDA researchers report in Pediatrics.

Cochlear Implants are a Success for Once-Deaf Kids

Continued Meningitis Risk

A new study by the CDC and FDA shows that children whose cochlear implants include a positioner remain at increased risk of bacterial meningitis caused by the bacterium Streptococcus pneumoniae more than two years after the device was implanted.

The study shows that a “higher risk of bacterial meningitis continued for up to 24 months after implantation,” the researchers write in Pediatrics.

In 2002, those scientists found that children with cochlear implants had higher rates of pneumococcal meningitis than children in the general public. Meningitis was still rare in children with cochlear implants, but it was more than 30 times more common in those kids. Children whose cochlear implants included a positioner had the highest rates of bacterial meningitis.

Cochlear implants with a positioner were manufactured only by Advanced Bionics Corp. None has been implanted since July 2002, states an FDA letter to doctors.

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FDA’s Advice About Lowering Risk

The FDA posted the following advice on its web site about lowering the risk of bacterial meningitis in children with cochlear implants:

—Continue close monitoring for meningitis and middle-ear infections for all children with a cochlear implant, but particularly for children whose implants have a positioner.

—Consult the doctor who performed the implant to determine if the patient has a positioner.

—Remember, it’s important to monitor all patients with cochlear implants, even if their implant doesn’t include a positioner.

—Check the patient’s record of vaccinations. The CDC’s vaccine recommendations specify which vaccines should be given to patients with cochlear implants and when those vaccines should be given. The CDC’s information is available online at www.cdc.gov/nip/issues/cochlear/cochlear-gen.htm.

—Contact your doctor immediately if the patient has any symptoms of meningitis or middle-ear infections. Those symptoms may include high fever, headache, stiff neck, nausea, vomiting, irritability, discomfort looking into bright lights, sleepiness or tiredness, confusion, ear pain, hearing loss, and appetite loss.

—Follow your doctor’s prescription for antibiotics very carefully. It is very important that you make sure the patient takes the antibiotic as often as prescribed and for as long as prescribed, so the antibiotic can work properly.

By Miranda Hitti, reviewed by Louise Chang, MD

SOURCES: News release, FDA. WebMD Medical News: “Cochlear Implants a Success for Once-Deaf Kids.” WebMD Medical News: “Cochlear Implants Are Better Early in Life.” Biernath, K. Pediatrics, February 2006; vol 117: pp 284-289. FDA: “Public Health Notification: Continued Risk of Bacterial Meningitis in Children with Cochlear Implants with a Positioner Beyond 24 Months Post-Implantation.” FDA: “Advice for Patients with Cochlear Implants: New Information on Meningitis Risk.”