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The Food and Drug Administration (FDA) has released a new Public Health Notification

The Food and Drug Administration (FDA) has released a new Public Health Notification

October 12, 2007 Press Releases

The Food and Drug Administration (FDA) has released a new Public Health Notification, Importance of Vaccination in Cochlear Implant Recipients. This Notification can be found on their website. An accompanying document, Advice for Patients, is also available on their Web site (see links below)

Background: FDA has become aware of two deaths from meningitis within the past year in children implanted with the cochlear implant with positioner. Neither of these children was fully immunized according to the CDC recommended vaccination schedule. These children, ages 9 and 11, had completed only part of the recommended pneumococcal vaccinations for their age group. At least one of these children had meningitis caused by a serotype of Streptococcus pneumoniae that may have been prevented by proper vaccinations.

The FDA recognized that this information is particularly important for audiologists who work with cochlear implant recipients. They further recognized that it is an audiologist that sees the cochlear implant recipient on the most regular basis and can remind patients and/or parents about the need for appropriate vaccinations specific to cochlear implant recipients. To assure that appropriate audiologists have the latest information about the importance of fully vaccinating cochlear implant recipients, the FDA has asked us to help in disseminating this information to Academy members. Please disseminate to your colleagues working with cochlear implant recipients.

If you have questions about this web notification, please contact the FDA, by phone at 240-276-3357, fax at 240-276-3356, or e-mail at phann@cdrh.fda.gov

FDA Links
http://www.fda.gov/cdrh/safety/101007-cochlear.html - Healthcare Provider
http://www.fda.gov/cdrh/medicaldevicesafety/atp/101007-cochlear.html - Advice for Patients

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