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New York Times Article

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    Drug Agency Is Studying Ear Implants' Links to Meningitis

    [T] he Food and Drug Administration is investigating what appears to be an increase in meningitis among deaf patients who have had tiny devices called cochlear implants surgically inserted deep inside their ears to help them hear.

    About 55,000 of the implants are in use around the world, 22,000 of them in the United States.

    Dr. Eric Mann, chief of the F.D.A. branch that reviews ear, nose and throat devices, said this week that there had been about 25 confirmed cases of meningitis worldwide, 9 of them fatal, among people with the implants in the last 18 years. The exact number of cases in the United States is uncertain, though a recent survey by two American doctors put it at 22 in the same period; the survey also estimated 26 unconfirmed cases in Europe, for a total of 48 worldwide so far.

    Dr. Mann added that it was hard to determine whether the meningitis cases were linked to the implants. Some people with cochlear defects are susceptible to meningitis, which is a leading cause of deafness, and recurrences are not uncommon.

    Still, in an alert issued on July 24, the drug agency advised those with implants to consider being vaccinated against the bacteria that can cause meningitis. It also suggested that doctors inserting the implants be alert to the symptoms of meningitis: fever, lethargy, stiff neck, headache and irritability.

    An implant maker, the Advanced Bionics Corporation of Sylmar, Calif., removed one of its models, called the Clarion, from the market in France, Germany, Japan and Spain after concerns were raised about a possible link to meningitis. It is now discussing with the drug agency whether to take similar action in the United States, Dr. Mann said.

    But Douglas Lynch, the company's director of corporate marketing, said any link to meningitis "at this point is speculation" and added that the Clarion was taken off the market in some countries "just to be extra cautious."

    At Cochlear Limited, an Australian company that makes more than half of the implants sold both worldwide and in the United States, Dr. Steve Stoller, a vice president, said the company believed the people with its implants ran the same risk of contracting meningitis as other deaf people.

    Cochlear devices are surgically implanted in the spiral-shaped seat of hearing called the cochlea. Normally, waves of sound from outside the ear are transmitted through the cochlea to the hairlike receptor cells that send the message of frequencies directly to nerves connected to the hearing centers of the brain.

    When the receptor cells or other parts of the ear are damaged, implants transmit electrical impulses that can bypass the damage.

    Besides the 22,000 Americans who have them, several hundred thousand more are considered good candidates for from the implants. But there is great debate among deaf people about the implants, with some questioning their effectiveness and arguing that the use of sign language is preferable because it produces a sense of community.

    Two American doctors — Dr. Thomas J. Balkany, a surgeon and chairman of otolaryngology at the University of Miami, and Dr. Noel Cohen of New York University Medical Center — recently completed a survey of surgeons to discover all the known cases of meningitis in those with implants. It showed 22 confirmed cases in this country, 14 among those with devices made by Cochlear and 8 with devices from Advanced Bionics.

    From 1984 to 1999 the annual number of cases in the United States was sporadic, Dr. Balkany and Dr. Cohen said — zero in some years, two in others, for example. But since 2000, they said, there have been eight.

    Some doctors say they are troubled by the design of Advanced Bionics' Clarion model. They say that part of the device, the electrodes in the cochlea, may be more difficult to implant without leaving gaps. There, in theory, bacteria can grow and then make their way to the fluid that bathes the brain. An infection there, usually by pneumococcal bacteria, is defined as meningitis.

    If caught early, it can be treated with antibiotics, but if diagnosis is delayed, the infection can be fatal.

    Dr. Mann, of the F.D.A., said the case against the Clarion implant is "circumstantial only" and added: "There is no direct cause and effect that we have found. And there are other possibilities."
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