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January 20, 2003

Bionic ear gets redesign

From: Los Angeles Daily News, CA - 20 Jan 2003

By Evan Pondel
Staff Writer

VALENCIA -- Advanced Bionics is one of the few companies that measures its success by what other people hear.

Headquartered in the brittle hills of Valencia, Advanced Bionics is abuzz as the company repositions itself as a formidable player in cochlear implants -- bionic ears that help the profoundly deaf hear. Another biomedical creation by San Fernando Valley magnate Alfred E. Mann, the company is in the process of introducing software to literally enhance the sound of music for the deaf.

"People were able to hear sounds with our previous model, but now they are able to hear musical instruments like the guitar," said Carla Woods, Advanced Bionic's director of marketing, who is also Mann's daughter.

Founded in 1993, the company makes its money by manufacturing and distributing the Clarion cochlear implant to treat deafness. Created in a university research laboratory, the device enables deaf people to process sound information through the auditory nerve.

To do that, candidates must undergo a surgical procedure in which receivers and electrodes are wired throughout the ear. The process, including the equipment, costs up to $60,000, with several insurance policies covering the surgery.

"The toughest part is explaining to the insurance companies that these devices are not hearing aids," Woods said.

That becomes fairly evident upon seeing the device.

Scott Hebl, 25, has been wearing a cochlear implant for several years. After contracting meningitis when he was 18 years old, Hebl's hearing began to wane. "I was able to hear partially in one ear, but then that went away, too. So, I looked into my options and cochlear implants seemed the right thing to do," he said. "My only fear was what happens if the implant doesn't work ... then what?"

So far, Hebl's cochlear implant has worked. He's able to hear most sounds, though large crowds create some interference.

The company has weathered its own interference in the past six months. In August, the company halted sales of its implants amid concerns the device might be linked to an outbreak of deadly bacterial meningitis.

The company notified the Food and Drug Administration about a potential problem in June after it had learned that four implant users had contracted meningitis since January 2002. "It was like fighting a phantom for us," Woods said. "The problem wasn't easy to target."

The company decided to recommend meningitis vaccinations and subsequently created the U.S. Bacterial Meningitis Vaccination Reimbursement Program. As part of the program, the company said it would reimburse U.S. implant users who made uninsured payments for vaccinations through Jan. 1 of this year.

Woods said the most frustrating aspect of the meningitis scare was that not only was the virus highly dangerous, it was the reason many implant users were wearing the device in the first place.

Unable to articulate the cause of the virus and its relation to cochlear implants, the company focused on the CI's structure. What they found was an area where the device crowded a section of the cochlea, a spiral duct that connects to the hearing nerve.

"We thought this might be the problem," Woods said.

The CII Bionic Ear, a newer-model cochlear implant, does not crowd the cochlea.

About 40,000 Americans are wearing cochlear implants, with an additional 25,000 users residing in other countries. Kim Schafer, Advance Bionics' pediatric coordinator, has a daughter who's been wearing an implant since she was 3.

With her child now in the second grade, Schafer said there were obvious fears surrounding cochlear implants, such as the surgical procedure and "how your kiddo is going to react to hearing sound for the first time," she said.

Another factor is the deaf community's reaction toward cochlear implants. Schafer said there are those within the community who are against the implants because they imply something is wrong with not being able to hear.

"But I could see that my daughter was very frustrated. And we had the opportunity to change that," Schafer said.

According to the Rochester Institute of Technology, the deaf community generally understands and supports the choice to receive a cochlear implant "when the individual is late-deafened (becoming deaf as an adult)."

For Schafer, watching her daughter experience sound has been emotional. She said four weeks after surgery her daughter was able to make out sounds. "I remember we were in a public bathroom and my daughter flushed the toilet and she signed back to me, did you hear that?" Schafer said.

Aside from cochlear implants, Advanced Bionics is in the process of developing technology to treat incontinence. Utilizing a piece of technology called the "Bion," the company is helping people regulate the urge to urinate.

The company is working with a few patients in Europe to develop the technology, which is a couple of years away from federal approval.

"And while it's not in the same league as the cochlear implant, we're hoping the Bion will be the major income generator for the company within five years," said Jim McGivern, director of marketing for the Bion.

Copyright © 2003 Los Angeles Daily News