TUE AM News: UWM engineer developing more accessible hearing aid; Clinical trial aims to improve diabetic eye screening rates

— A UW-Milwaukee engineer aims to introduce a new cheaper and more accessible hearing aid to the market next year. 

Yi Hu is an associate professor of electrical engineering at UWM and founder of a startup called My Hearing Care. He has created a prototype over-the-counter device that, when paired with a smartphone app, would allow patients to test their own hearing and adjust the device to meet their needs. 

“The major factor that a hearing aid is very expensive is because of the medical exams involved by the audiologist,” he said in a recent interview. “If you don’t visit the audiologist, then the price will be much lower … that removes the barrier to use the hearing aids.” 

According to the Department of Health Services, adults in Wisconsin can currently purchase traditional hearing aids from an audiologist or hearing instrument specialist, while children under 18 must be seen by an audiologist. DHS says federal officials in October 2021 proposed regulations for over-the-counter hearing aids and have been in the process of gathering feedback before issuing final guidance. 

“These devices are not yet available and will be intended for those with mild to moderate hearing loss, similar to non-prescription reading glasses,” DHS said in a statement to WisBusiness.com. “Concerns raised relate to people getting hearing aids that may or may not meet their needs without appropriate hearing evaluations.” 

Hu said he expects the Food and Drug Administration will release the guidelines on these products in the near future and has been preparing for a 2023 product launch in Wisconsin in the meantime. 

“At this moment, we really don’t know how the guideline looks like,” he said. “For the new over-the-counter hearing aids, I think the FDA probably will issue some guideline for how the efficacy will be evaluated. For instance, maybe they will require hearing aid companies to submit some clinical trial data.” 

If that’s the case, Hu says My Hearing Care will need to conduct clinical trials to show the device can improve patients’ hearing ability. For now, he says he’s consulting with mentors and raising seed funds for the business. He has also created an Android app to go along with the device and is in the process of creating an iPhone app as well. 

He said his entry-level device will ideally be priced below $150 and marketed as a lower-cost option for those with hearing loss. 

Hu estimates less than 20 percent of people who would benefit from hearing aids are currently using them. He says the forthcoming FDA guidelines “could really open up” the market for over-the-counter products. 

Hu has been researching assistive hearing technology for over 20 years, starting with work on cochlear implants as a doctoral student. He said the challenge of accessibility drove him to explore hearing aid technologies, as well as his own grandfather’s struggles with hearing loss. 

“Along the years, I learned more and more about hearing aids,” he said. “In 2015, NIH issued some documents showing that accessibility is an issue that prevents American adults with mild to moderate hearing loss to access hearing aids. That gave me more motivation to get into this field.” 

— The UW School of Medicine and Public Health is getting $4.4 million for a clinical trial aimed at improving diabetic eye screening rates in rural areas. 

A release shows only about half of the 34 million U.S. residents with diabetes get yearly eye screenings as recommended by the American Diabetes Association. The disease can lead to various eye problems including diabetic retinopathy, which is caused by blood vessels in the retina being damaged. 

Dr. Yao Liu, an ophthalmologist and director of the UW Health Teleophthalmology Program, says screening rates tend to be lower in rural areas. 

“Because patients often have no symptoms until very late in the disease, we tend to see patients with diabetic eye disease at a point where we’ve lost a critical opportunity to intervene earlier,” she said in the release. “Regular eye screening and early treatment makes it much more likely that we can prevent blindness from diabetes, preserving a patient’s vision.”

She will lead the multicenter clinical trial — called Implementation of Teleophthalmology in Rural Health Systems, or I-TRUST — with funding from the National Institutes of Health’s National Eye Institute. 

Liu has been working to enable earlier detection of diabetic vision complications since at least 2015, when she launched a remote eye screening program for patients at the Mile Bluff Medical Center in Mauston. She also helped create the Implementation for Sustained Impact in Teleophthalmology program, or I-SITE, in 2017 to integrate the remote screening technology into clinical practice. 

According to the release, these efforts led to a 35 percent increase in diabetic eye screenings at the medical center over three years. 

As part of the clinical trial, Liu aims to enroll between eight and 10 rural health systems across the country to learn how the initiative could be expanded for greater impact. 

“With the I-TRUST study, we’re building upon our unique expertise in diabetic eye disease and implementation science to benefit rural communities here in the U.S. and around the world,” Liu said. 

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— The state Department of Justice says it has filed a civil enforcement action against a New Jersey firm for violating the state’s telemarketing laws. 

According to a DOJ release, N.C.W.C made thousands of telemarketing calls between 2017 and 2018 to Wisconsin numbers without being registered as a telephone solicitor. That included many calls to consumers whose numbers were listed on the Do-Not-Call registry. 

The company markets extended vehicle service plans to owners around the country. The plans are administered by Palmer Administrative Services, which operates out of the same New Jersey office as N.C.W.C., the release shows. 

The DOJ says the company has sales agreements with 42 other companies, two of which have made “several hundred thousand telemarketing calls” to Wisconsin numbers on the Do-Not-Call registry. The agency says the total number of illegal calls by the other 40 vendors may be much larger. 

The move comes after the issue was referred to the DOJ by DATCP. Telemarketing was the state’s top consumer complaint in 2021, with 2,765 complaints registered by DATCP. 

“Wisconsin consumers are tired of being illegally solicited by these telemarketers regarding their ‘extended auto-warranties,’ and today’s joint effort shows the State of Wisconsin is committed to addressing these illegal telephone solicitations,” DATCP Secretary Randy Romanski said in the release. 

See the release: https://www.wispolitics.com/2022/dept-of-justice-ag-kaul-datcp-announce-enforcement-action-against-extended-vehicle-warranty-telemarketer/ 

See the DOJ complaint: https://www.doj.state.wi.us/sites/default/files/news-media/4.4.22_NCWC_Complaint.pdf 

— Three former U.S. ambassadors from Wisconsin will headline a free virtual event April 20 on the impact of the war in Ukraine on trade and the economy. 

The noon webinar is part of the Trade Policy Initiative of WisBusiness.com and the Wisconsin Technology Council. 

Panelists include: Richard Graber, who was ambassador to the Czech Republic from 2006 to 2009; Mark Green, who was ambassador to Tanzania from 2007 to 2009 and former administrator of the U.S. Agency for International Development; and Tom Loftus, who was ambassador to Norway from 1993 to 1998 and later served as a special advisor to the head of the World Health Organization.

Register here: https://docs.google.com/forms/d/e/1FAIpQLSeLM1JVSSS6UPnKXaYWlXOrUZ2H0MYpgtWKmUTYYuOVNVN1kw/viewform 


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