Firm cleared to market ear implants year after deaths.

A year after it pulled its cochlear ear implant for children from the market due to a series of meningitis cases related to the device, Valencia-based Advanced Bionics is rolling out its latest ear implant aimed at retaking its share of the market.

"It's a significant advance in the accuracy in reproducing acoustic sound," said Carla Woods, vice president of marketing for Advanced Bionics.

Last month, the U.S. Food and Drug Administration approved the HiRes 90K Bionic Ear for medical use, clearing the way for the product's introduction to the market.

In July 2002, the FDA reported that at least 25 cases of bacterial meningitis had been diagnosed in children and adults worldwide who had undergone surgery for the cochlear implant. Nine of those recipients had died.

The company stopped distributing the devices, but stopped short of removing them from patients already outfitted with them.

Douglas Lynch, an Advanced Bionics spokesman, said the company had implanted devices in about 10,000 patients, 500 of which contracted meningitis before the implantation though only 25 cases involved those who contracted the disease after the implantation.

Bacterial meningitis is an infection of spinal cord fluid and the fluid that surrounds the brain, which can result in brain damage, learning disability, hearing loss and sometimes death.

The company blamed the implant's attached surgical device that positions the electrode for the incidences of meningitis, and has eliminated it from the current device.

The new cochlear implant, which is smaller and with better sound capabilities, could help the company get back some of its lost market share.

"Because it's smaller and it has improved software and electronics than the competition it could get a lot of interest and market share," said Dr. Akira Ishiyama, a head and neck surgeon at UCLA Medical Center.

As it is, Advanced Bionics is the world's third largest cochlear implant company with about 10 percent of the implant market while Australia-based Cochlear Corp. has about 70 percent, followed by the Austrian firm, Med El Corp. with about 20 percent.

Miniaturized technology

Advanced Bionics' new device features miniaturized technology that allows it to be four times smaller than existing devices. Measuring just 26 millimeters by 56 millimeters, the device is just 5 millimeters thick, or about half the thickness of the company's existing ear implant.

"The smaller size makes it easier and more comfortable for children to wear the device since larger devices were not practical for many of them," Woods said.

The device is programmed then surgically implanted in patients' skulls, in a two-hour procedure that allows them to go home the same day and heal for four weeks before the device can begin working.

Since the implants are used for children with severe hearing loss, it would mean a potential market of tens of thousands, Woods said, though she would not elaborate on exact numbers or potential revenue figures, citing company policy.

"There are other devices out there that children could use, but it's always a difficult decision for parents so if you have something significantly smaller then it helps bring in patients who may not get the surgery otherwise," said UCLA's Ishiyama.

With implant surgery, bone and tissue needs to be removed in order to implant the device. A larger device means a larger recess must be drilled in a patient's skull, he said.

The implant would determine how much digitized sound information should be transmitted via electrodes to the hearing nerve which in turn sends the information directly to the brain which processes the sound.

In most people, sound is collected through the outer ear which sends the sound to the ear drum which vibrates, causing three tiny bones in the middle ear to vibrate and fluid to move inside the cochlea or inner ear where tiny hair cells move, sending electrical signals to the hearing nerve which are then turned into sound by the brain.

Improved technology

The new implant takes advantage of the company's new HiResolution technology that improves the way sound is processed and delivered to the hearing nerve.

HiResolution sound uses fast and efficient processing electronics which allows 90,000 bits of information to be transmitted per second, using a software program that will require a special certification by its users.

"This bionic ear implements sophisticated computer technology that is software driven, but allows patients to fine tune their devices," Woods said.

Although adults will also be able to use the new device, it will be initially targeted to young patients to give them a chance to use it ahead of older patients.

"This device will change every part of a child's life and their future and give them the opportunity to enter the world of sound," Woods said.

"The sooner we get them to use the device, the better will be their quality of life."

Most children receiving cochlear implants are under 6 and are often born deaf or have a severe case of hearing loss due to infection, metabolism problems or injury, Ishiyama.

"These implants are extremely important for these children and their families who will now have a child that can attend a regular school and do things that normal children do," he said.

The implant technology has been in development since 1990 at MiniMed, before its then owner, Alfred E. Mann, spun off the development unit into Advanced Bionics in 1993.

In 1996, the company developed the Clarion, a hearing implant to treat deafness using technology developed at the University of California, San Francisco.