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Advice for Patients with Cochlear Implants: New Information on Meningitis Risk

This FDA update gives the latest information on the risk of bacterial meningitis in children with cochlear implants and recommends steps to reduce the risk.

A study published in 2003 (NewEngJMed, 349.5: 435-445) by FDA and the Centers for Disease Control and Prevention (CDC) followed children with cochlear implants for two years after the device was implanted. The study showed that children whose implants have a positioner get bacterial meningitis more often than children with implants that don’t have positioners or children without implants. Only Advanced Bionics Corporation sold an implant that had a positioner, and none were implanted after July 2002.

Now a new study (Pediatrics February 2006), which followed the children for two more years, has found that the increased risk for meningitis persists beyond two years after implantation. This study highlights the importance of continuing to monitor children with cochlear implants for signs of middle ear infection and meningitis. Children need to be monitored for as long as the implant is in place.

For recommendations and further information on this update, please refer to the following link: http://www.fda.gov/cdrh/medicaldevicesafety/atp/020606-cochlear.pdf

If you have any comments regarding this update, please email: info@mdiconsultants.com

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