Magazine article FDA Consumer

Cochlear Implants and Bacterial Meningitis

Magazine article FDA Consumer

Cochlear Implants and Bacterial Meningitis

Article excerpt

Children with a cochlear implant to treat hearing loss have a greater risk of developing bacterial meningitis compared to children in the general population, according to a study conducted by the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration, and state and local health departments.

The study, published in the July 31, 2003, issue of The New England Journal of Medicine, also found that children with a specific type of cochlear implant that had an extra piece called a "positioner" had 4.5 times the risk of developing meningitis compared to those who had other cochlear implant types. However, the study authors note that individuals who are candidates for cochlear implants may have factors that increase their risk of meningitis compared to the general population even prior to being implanted with the device. The study was not able to deter mine whether the implant, the pre-existing risk factors, or perhaps a combination of both caused the increased occurrence of meningitis in the cochlear implant population studied.

Meningitis is an infection in the fluid that surrounds the brain and spinal cord. Of the two types of meningitis viral and bacterial--bacterial is the more serious of the two and is the type that has been reported in people with cochlear implants.

The FDA and the CDC began investigating this possible link between cochlear implants and meningitis in July 2002 after receiving reports of bacterial meningitis among children who had received the implants. As soon as the FDA became aware of a possible association between the implants and bacterial meningitis, the agency issued a public health Web notice and began working with manufacturers of cochlear implants to determine the nature and extent of the problem. Because early available information suggested that more cases of meningitis occurred in children with the implant that had the positioner than with other devices, the manufacturer of dais implant voluntarily withdrew it from the market in July 2002.

"Working closely with CDC's network for monitoring infection outbreaks is an important part of how we monitor the safety of medical products in use in the population," says FDA Commissioner Mark B. McClellan, M.D., Ph.D. "In this case, we identified a heightened risk of meningitis that demanded prompt action, and the FDA was able to take it."

Nearly 10,000 children and 13,000 adults in the United States with severe to profound hearing loss have a cochlear implant. …

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