Meningitis Risk With Cochlear Implants
Risk Continues After FDA's First Warning in 2002
Feb. 8, 2006 -- Children with cochlear implants may be at increased risk of
bacterial meningitis, states the FDA.
The risk isn't new. It was first noted by the FDA in 2002. Now, the FDA is
updating its 2002 and 2003 warnings about the risk and issuing new
recommendations for children with cochlear implants.
Cochlear implants are devices implanted under the skin behind the ear, with
electrodes that go deep into the ear. The devices turn sound waves into
electric signals that are passed to nerve fibers leading into the brain.
. However, the process may take time as the brain adjusts and
the devices are fine-tuned in each patient. Kids often get the implants early
in life, to help them master language skills at a young age. Some cochlear
implants also have a positioner, which the FDA describes as a small rubber
wedge that helps position the implant during surgery.
More than 11,000 U.S. children with severe to profound hearing loss have
cochlear implants, CDC and FDA researchers report in Pediatrics.
Continued Meningitis Risk
A new study by the CDC and FDA shows that children whose cochlear implants
include a positioner remain at increased risk of bacterial meningitis caused by
the bacterium Streptococcus pneumoniae more than two years after the
device was implanted.
The study shows that a "higher risk of bacterial meningitis continued
for up to 24 months after implantation," the researchers write in
In 2002, those scientists found that children with cochlear implants had
higher rates of pneumococcal meningitis than children in the general public.
Meningitis was still rare in children with cochlear implants, but it was more
than 30 times more common in those kids. Children whose cochlear implants
included a positioner had the highest rates of bacterial meningitis.
Cochlear implants with a positioner were manufactured only by Advanced
Bionics Corp. None has been implanted since July 2002, states an FDA letter to