New Information From FDA/CDRH on Meningitis Risk for Patients With Cochlear Implants
MedSun: Newsletter #18, November 2007

Two cochlear implant patients, neither of whom was fully vaccinated, recently died from infections. A survey of parents of children with cochlear implants showed nearly half did not know whether their children had received all required vaccinations.

In response to these findings, a reminder of the increased and life-threatening risk of bacterial meningitis in cochlear implant patients and a restatement of the importance of full vaccination were posted by the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) in an “Advice for Patients” article on October 10, 2007.

Cochlear implant patients appear to be at increased risk of bacterial meningitis caused by Streptococcus pneumoniae. Children implanted with cochlear implants with a positioner component are at greatest risk.

Additional Information:

To read the full discussion of this topic, along with background information and recommendations, please go to
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062104.htm

FDA Public Health Notification: Importance of Vaccination in Cochlear Implant Recipients
http://www.fda.gov/cdrh/safety/101007-cochlear.html


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