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Winter 2008

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FDA Issues Notices on Risk of Bacterial Meningitis in Children with Cochlear Implants

The U.S. Food and Drug Administration (FDA) is urging doctors and families to review vaccination records and ensure that children with cochlear implants receive all recommended vaccines.

A recent FDA notification to health care providers was prompted by the deaths of two children with cochlear implants. Neither child had received all the recommended pneumococcal vaccinations. The FDA notification stresses the importance of vaccination to prevent bacterial meningitis in children with cochlear implants. The two children used cochlear implants with a positioner, a component that had been added to one type of cochlear implant to aid in the transmission of the electrical signal. This type of cochlear implant was withdrawn from the market in July 2002.

The U.S. Centers for Disease Control and Prevention has recommended vaccination schedules, available online, for children, teens, and adults. Recommendations include pneumococcal vaccines for children at high risk, including those with cochlear implants. The pneumococcal vaccine can prevent meningitis caused by a type of bacteria known as Streptococcus pnuemoniae.

All people with cochlear implants appear to have some heightened risk of bacterial meningitis, according to the FDA. However, children with cochlear implants are at the greatest risk.

For more information see:

Oct. 10, 2007, FDA Advice for Patients with Cochlear Implants: New Information on Meningitis Risk

Oct. 10, 2007, FDA Public Health Notification: Importance of Vaccination in Cochlear Implant Recipients

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