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bionic ear carries meningitis risk

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    Study: Bionic Ear Carries Meningitis Risk

    Wed July 30, 2003 05:04 PM ET
    By Gene Emery

    BOSTON (Reuters) - Receiving a cochlear implant to restore hearing dramatically increases the risk of developing bacterial meningitis, U.S. researchers warned Wednesday.

    The meningitis rate was 30 times higher among 4,264 children who received the bionic ear from 1997 to 2002 compared to the rate in the general population, said a team led by Jennita Reefhuis of the National Center on Birth Defects and Development Disabilities.

    They recommended in the New England Journal of Medicine, where the study was published, that no implants be undertaken until a child has been vaccinated against bacteria that can cause meningitis, a potentially fatal inflammation of the surface of the brain.

    Nearly 10,000 profoundly deaf children in the United States have received implants, allowing most of them to understand normal speech. In all, about 30,000 children worldwide have been given implants, as well as an equal number of adults.

    The device uses a microphone to pick up sounds and transfers those sounds to an implanted receiver that, in turn, delivers electrical impulses into the cochlea so they can be relayed to the brain. The surgery and rehabilitation cost about $60,000 in children.

    One year ago, the U.S. Food and Drug Administration warned consumers that the implants had been linked with bacterial meningitis, producing 17 deaths worldwide among 91 patients who developed meningitis.
    As a result, Advanced Bionics Corporation, a privately held company, withdrew two brands that contained a "positioner" that pushed the electrode against the wall of the cochlea, the spiral-shaped organ that normally translates sounds into electrical impulses the brain can understand.

    The Reefhuis study confirmed that the brands with the positioner caused a problem.
    However, they also concluded in the new study that meningitis rates were still 16 times higher than expected even among brands that did not have a "positioner," possibly because of a malformed cochlea or because of a leak involving the fluid that bathes the brain.

    The researchers said if a child has an implant with a positioner, it should not be removed because the risk of surgery might be greater than the risk of keeping the device.


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