COCHLEAR IMPLANT SALES HALTED DEVICES LINKED TO MENINGITIS.

Byline: Gregory J. Wilcox Staff Writer

VALENCIA - Advanced Bionics Inc. stopped selling its cochlear ear implants Tuesday amid concerns the device might be linked to an outbreak of deadly bacterial meningitis.

The Valencia-based company, founded by biotechnology pioneer Alfred Mann, has also implemented a reimbursement program for implant users who want to be vaccinated against meningitis but are not covered for the expense by their health plans, said Doug Lynch, director of corporate marketing.

``We want to encourage people who are using our cochlear implant to talk to their doctor about being vaccinated against bacterial meningitis,'' he said.

Meningitis is a potentially fatal infection of the lining of the surface of the brain. Early symptoms include fever, irritability, lethargy and loss of appetite in infants and young children. Older children and adults might also suffer from a headache, stiff neck, nausea, vomiting, confusion or loss of consciousness.

According to the national Centers for Disease Control, bacterial meningitis can be treated with a number of effective antibiotics, but the therapy must be started early.

This can reduce the risk of dying from meningitis to below 15 percent, though the risk remains higher among the elderly.

The implants are used to correct severe hearing loss, and the product, implant procedure and follow-up treatment can cost as much as $70,000.

Advanced Bionics officials notified the federal Food and Drug Administration about a potential problem in June after they had learned that four implant users had contracted meningitis since January, Lynch said.

Then, in late July, the FDA issued its own warning about a possible link between the implants and the disease.

So far, 43 implant users worldwide have been stricken, and 11 of them died. In the United States, there have been 20 cases reported and three deaths, said FDA spokeswoman Sharon Snyder.

The implants activate auditory nerve fibers and allow transmission of sound signals to the brain, and about 60,000 devices are being used worldwide.

Three companies market the devices, and one other besides Advanced Bionics has reported meningitis cases. Snyder did not know the name of the other company.

More meningitis cases are likely to surface, though.

Surveys of cochlear implant centers currently under way indicate there are additional, unreported cases of meningitis among users of the device, the FDA said.

Lynch said Advanced Bionics is focusing its probe on the part of the implant called an electrode positioner, which is used to guide the electrode toward nerve fibers in the inner ear, which is about the size of a pea.

The electrode positioner is unique to Advanced Bionics and was introduced in 1999. Prior to that, there had not been any cases of meningitis among implant users, he said.

About 6,000 people in the United States are using the Advanced Bionics product and 10,000 worldwide, Lynch said.