The device, which determines how much acoustic energy is reflected and absorbed in the middle ear, had been used only for research purposes prior to FDA approval.

Now Mimosa's president, Pat Jeng, and her husband, Jont Allen, hope it becomes a standard in helping hospitals and clinics analyze hearing problems.

The prime users: the 2,500 or so hospitals with infant hearing screening programs.

"Ultimately, every hospital should have it," said Allen, an associate professor of electrical and computer engineering at the University of Illinois. "When it's properly designed and priced, it should be in every pediatrician's office."

When newborn babies get hearing tests, one of the biggest difficulties is distinguishing major hearing problems from minor disorders, such as blockage in the ear canal that may disappear in days.

Allen said that for every 1,000 infants screened, two or three have major problems and 50 to 100 have minor disorders such as blockages.

The problem is, all those babies will fail the current screening test, causing many parents to fear unnecessarily that their child has a major hearing problem.

Mimosa's new device can distinguish between major and minor problems and help eliminate the high number of "false positives" in the screening, he said. It's a quick, objective test that's not uncomfortable, he added.

Patrick Feeney, chief of audiology at the University of Washington Medical Center in Seattle, said the technology appears useful for both adults and babies, but the greater application may be for infants.

"All babies get screened, and not all people end up in the ear doctor's office," said Feeney, who has worked with the Mimosa technology for two years.

Feeney has explored how the analyzer can help diagnose middle ear problems.

"It appears to be more sensitive to disorders of the ear than traditional (methods) we use," he said.

For example, the analyzer produced different reflectance patterns in a patient with otosclerosis than it did for patients with ear infections, he said. Otosclerosis is growth of a spongy bone in the inner ear that causes progressive deafness.

Lisa Hunter, an associate professor of audiology at the University of Utah, said she's done some clinical trials using the analyzer on children from birth to 4 years old.

"What we've seen is, children tolerate it very well. It doesn't require pressure in the ear like the older test did. It's a very quick test – it takes just a few seconds to get a reading on how much sound is being absorbed by their eardrum," Hunter said.

Hunter said the analyzer works well in detecting fluid in the ears of older children, and by year's end, she should have good indications of the results for newborns.

FDA approval for the analyzer came surprisingly quickly, Jeng said. She submitted an application Nov. 14, got a return call Dec. 11, took part in a conference call a week later and received final approval two weeks ago. The FDA has regulatory authority over medical devices, as well as food, drugs and cosmetics.

Founded in 1994, Mimosa Acoustics moved to Champaign in 2003 and is based in the EnterpriseWorks building in the UI Research Park.

The analyzer isn't Mimosa's first product. That distinction goes to CUBeDIS, a device that tests inner-ear function by monitoring "otoacoustic emission" – the small signal evoked by the ear after a signal comes in. There's a high correlation between the absence of otoacoustic emission and hearing loss.

Today Mimosa has three full-time and five part-time employees in Champaign, as well as two full-time researchers in Germany and France, Jeng said.

As the company prepares to move to the next level, Jeng said she'll need to expand her staff. She wants to add a marketing professional and either a chief executive officer or chief operating officer to help handle the rollout.

"We'll need more people right away," she said.

Jeng said audiologists need specialized training to understand how to use the device, so the company must arrange talks and workshops and publish articles in industry journals.

Jeng said she'll also have to make some quick decisions on how to distribute the product. Should she sell the product to another company, distribute it herself or license the technology?

The company also must identify potential funding sources, Jeng and Allen said. But it's not the kind of mass-market technology that automatically draws deep pockets.

"It's not a technology like iPod or cellphone technology," Allen said. "It's not a billion-dollar industry."

But Jeng said it could be "a tens of millions or hundred million-dollar industry." She called it a "technology that serves society ... and has its niche."

So far the price for the analyzer has been about $10,000 per unit, but Allen and Jeng said the pricing structure will be re-evaluated.

All in all, Jeng and Allen feel the company is in good position to market its technology.

"We're the only company with this product and the only one with approval," Allen said.

Now that the door has been opened, "somebody will be successful," he said. "We hope it will be us."

By Don Dodson
http://www.news-gazette.com/news/local/2006/02/26/homing_in_on_hearing_problems/