On February 6, 2006, the FDA cautioned that children with an early version of the cochlear implant face an increased threat of bacterial meningitis beyond just the first two years following implantation of the hearing devices. This newly announced risk means that young implant patients must be monitored the entire time the implants are in place because infection of the fluid surrounding the brain and spinal cord can occur. This infection is sometimes fatal.
A Cochlear implant is an electronic hearing device that works by electrically stimulating nerves inside the inner ear. It is designed to produce useful hearing sensations to children and adults with severe to profound nerve deafness who get little or no benefit from hearing aids. The FDA approved the first commercial Cochlear devices during the mid-1980s.
The FDA said in separate letters to patients and doctors that deaf children who have a Cochlear implant
The FDA said in separate letters to patients and doctors that deaf children who have a Cochlear implant and a positioner get bacterial meningitis more frequently than either children with the implants that don’t have the small rubber wedge or those without implants at all. This specific rubber wedge was at first used to help doctors position the implants during surgery. Advanced Bionics Corp. was the only manufacturer to market the implants with positioners. None of these devices have been implanted in patients since July 2002.
An initial study found that 26 of 4,264 children with the implants developed meningitis during the first two years following surgery and that those with positioners were at greater risk. A recent new study that followed the same children for an additional two years found another six with infections. All with positioners had developed meningitis. The results appear in the February 2006 issue of the journal Pediatrics. Beyond monitoring cochlear implant patients for signs of meningitis, which include high fever and a stiff neck, the FDA recommends that the children receive proper vaccinations.
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