Before the pandemic, rural Minnesota veterans had to trek to the Minneapolis VA Health Care System for hearing tests that required audiologists to operate. Auditory problems comprise some of the most common reasons veterans seek care.

That changed in 2021 when the Minneapolis VA started using a hearing test called the Automated Method for Testing Auditory Sensitivity, or AMTAS. Veterans can now go to outpatient clinics in Rochester and Hibbing to take the test remotely using hardware that includes a touchscreen and noise-canceling headphones, said Dr. Bridget Carlson, the system's chief of audiology.

Afterward, the audiologist can review the results and meet with the veteran in person before making a prescription. AMTAS eliminates unnecessary travel for the audiologist and veteran, Carlson said.

"We take pride in the quality of care that we provide, and this allows us to bring that same quality of care to those veterans in more rural areas." Carlson said. "They're just very fortunate to go to their local community where they're more comfortable without traveling to Minneapolis to receive the same quality care."

Carlson said AMTAS is accurate: She compared her own evaluation of a patient's hearing to the results of an AMTAS test, and they were exactly the same.

Outside the VA, insurers and Medicare have resisted efforts to expand access to the test by covering it, even though use of the system has begun to grow in other countries. The test is sold by Eden Prairie-based Grason-Stadler, which is owned by Danish hearing industry giant Demant.

Its inventor, Dr. Robert Margolis, said numerous articles in audiology research journals have shown that AMTAS is safe and effective.

After about a decade of use, though, Margolis said insurers won't pay for it in private health care settings because Medicare still considers the test experimental, which held back AMTAS' commercialization.

"There are a number of companies that we've had contact with that said, 'We're not gonna touch it until the reimbursement issue is resolved,'" Margolis said.

Finding a market

Margolis retired as the director of audiology at the University of Minnesota in 2016. The university's hearing clinic, he said, conducted hearing tests on thousands of patients per year when he ran it. In 2000, he wondered if the time-intensive tests needed so much human input.

"It could be automated in a way that adds value — that computers can do some things better than humans can do," he said. An audiologist could write down the rules that guide hearing tests and feed them to computers, he said.

Margolis created a company called Audiology Incorporated to compete for grants from the National Institutes of Health and build out his invention.

After building a prototype and pitching to Grason-Stadler, which initially turned it down, Audiology partnered with Otometrics, which was later acquired by Danish hearing company Natus. But Otometrics never brought the test to the market, Margolis said.

"I think they weren't convinced that it would be acceptable in the marketplace," Margolis said. He circled back to Grason-Stadler, which has operated in the Twin Cities for 75 years.

"'I said, 'Take another look at this,' and they did," Margolis said. "And they said, 'We want it.'"

Margolis said the VA awarded a large grant to start field testing AMTAS in clinics, and Grason-Stadler President Carolyn Valentine said the test launched across the health system in 2016.

"It really helps from an efficiency standpoint, allowing the audiologist to see more veterans ... and to spend more time with those who had that hearing loss and less time on the front-end testing," Valentine said.

Won't displace audiologists

AMTAS comes in two models: Flex and Pro. The Flex configuration operates through a tablet and doesn't require an audiometer, which is a device that produces controlled levels of test tones and signals intended for use in hearing evaluations. It performs more basic screening tests that suggest a patient needs a hearing aid.

The Pro version requires a complicated audiometer and can perform diagnostic testing. With both systems, patients indicate whether they hear sounds by touching screens without the guidance of an audiologist. Margolis said AMTAS Flex costs roughly $2,500 and AMTAS Pro stretches toward $10,000.

Unlike online tests, Margolis said the AMTAS system uses checks to verify that patients are not artificially manipulating their results.

Margolis received a lot of pushback at first, he said. He tried to convince audiologists that AMTAS doesn't replace their jobs.

"I didn't want to replace myself," said Margolis, who's an audiologist.

There are not enough audiologists to take care of people with hearing problems, Margolis said, so jobs are not in jeopardy due to the commercialization of the test.

Valentine said: "With demographics heading upward — and that's globally, not just in the U.S. — and the flat line of audiologists, anything that helps them be more efficient and [reliable] in their practice is important."

Commercialization

Valentine said the company is now working to help health care providers test a patient's hearing anywhere. Margolis said the test belongs in primary care offices and should be a part of standard care, especially for older patients.

Valentine declined to share sales figures, but said, "We continue to grow the amount of penetration that we have with AMTAS."

The system is catching on in countries like the United Kingdom, Sweden and Singapore, she said. The more clinicians are exposed to the technology, the more they see its benefit, Valentine said.

"It's slow in terms of the growth because it takes an education of the audiologist for them to say, 'Hey, do we trust this software? Is it meaningful? Is it going to work? Is it going to give me the confidence that it's providing reliable results?' And the answer to that is yes."

Paying for the test remains a hurdle, Margolis said.

Insurance typically doesn't cover a test or procedure until Medicare does, and Margolis said Medicare still doesn't cover the procedure, as it considers it an emerging technology. The American Medical Association has classified it under a code for procedures "that are not quite ready for prime time," he said.

Margolis, who is still a consultant for Grason-Stadler, said he is working to change the classification. Health care companies have said they're not willing to purchase the technology until Medicare agrees to cover the test, he said.

"This has been around long enough now that a very good case can be made that it's not an experimental procedure," Margolis said.