Updated Information About Patient Safety

On February 6, 2006 the Center for Disease Control (CDC) published the results of a follow-up investigation¹ to a 2002 report on the relationship between meningitis and cochlear implants in children. The study included over 4000 implanted children (the same group of children who were studied in 2002) and evaluated all new reports of bacterial meningitis.

After following these children for two more years, the authors concluded that the children who received cochlear implants with electrode positioners remained at a higher risk for meningitis and, importantly, that this elevated risk continued for as long as 48 months, post-implant. Specifically, the study found that the incidence of meningitis (occurring 24 months or longer, post-implant) was 450 cases per 100,000 persons years in children implanted with devices with positioners, compared to no cases in children implanted with devices without positioners.

Based on this finding, the CDC recommended that parents and health care providers continue to monitor implanted children for symptoms of meningitis for up to 48 months post-implant, particularly children with electrode positioners, and that health care professionals continue to immunize both current and potential cochlear implant recipients.

Summary for Nucleus cochlear implant recipients:

1. The CDC's first study showed that young children who have implants with electrode positioners are more likely to contract meningitis, compared to children implanted with our Nucleus cochlear implants, which DO NOT have electrode positioners. The CDC's latest study found that this increased risk with a positioner continues to remain higher for as long as 4 years after cochlear implant surgery.
   
   
2. Nucleus cochlear implants do not have electrode positioners.
   
   
3. All cochlear implant recipients should be vaccinated (see the CDC website and your physician for recommendations). Parents of implanted children should know the symptoms of meningitis and seek immediate medical treatment, should symptoms arise.
   
   
4. If you have questions about vaccinations - please contact your health care professional.

For more information about this announcement:

• The official announcement from the FDA, February 6, 2006
  
  
• Advice for patients with cochlear implants
  
  
• Please read the background information from the 2002 report
  
  
• Frequently Asked Questions and Answers about Meningitis (download PDF)

Additional information may be found on the following websites:
Much of this information was taken from the Meningitis Foundation of America, a good resource for further reading. www.musa.org

Centers for Disease Control
American Academy of Pediatrics
U.S. Food and Drug Administration

For more information please contact your health care professional.

¹Biernath KR, Reefhuis J, Whitney CG et al. Bacterial meningitis among children with cochlear implants beyond 24 months after implantation. Pediatrics. 2006;117:284-289

Taken from www.cochlearamericas.com/News/909.asp