U.S. FDA Warns Cochlear Implants May Carry Risk of Meningitis
Washington, July 25 (Bloomberg) -- The U.S. Food and Drug Administration warned that cochlear implants, devices used to restore hearing, might be linked to meningitis.
At least 25 cases of the sometimes fatal infection of membranes covering the brain have been diagnosed worldwide, the agency said. Those patients had the electronic devices implanted for severe to profound deafness, the FDA said. The onset of meningitis ranged from less than 24 hours to more than five years
after the implant procedure, according to the FDA.
Australia's Cochlear Ltd. confirmed that it was one of the two cochlear-implant makers that reported cases of meningitis to the FDA. The company's U.S. unit said the last known case of meningitis occurred in 2000.
Surveys at medical centers that implant these devices suggest that there could be unreported cases of meningitis, the FDA said.
Nine meningitis deaths have occurred in about 60,000 people who have received cochlear implants worldwide, the FDA said.
Symptoms of meningitis include headache, stiff neck, nausea, fever and irritability. A small percentage of deaf people are born with abnormalities in the inner ear that may make them more susceptible to meningitis, the agency said.
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