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A Quiet Innovation

Andrea Gibson
April 20, 2016

This article originally appeared on the Ohio University Office of Research Communications website. To view the story in its original form with pictures, click here.

It starts as a persistent white noise in the ears, and then it never stops. Buzzing and humming, whistling and popping, tinnitus can drive a person to distraction and distress, triggering depression and anxiety, interrupting sleep, and breaking the ability to concentrate at work.

The medical condition affects some 20 million Americans, and it’s the top service-related disability reported by military veterans. The U.S. Department of Veterans Affairs spends $1.5 billion annually on treating the condition, which impacts about one million service personnel. The causes of the condition are diverse: head trauma, the side effects of certain drugs, a companion to age-related hearing loss, and the exposure to a sudden or prolonged loud noise. There is no cure for tinnitus, which scientists have found to be rooted in the brain.

“It’s a difficult problem because it involves the whole neural pathway from the ear to the cortex,” says Jeff DiGiovanni, an Ohio University associate professor of communication sciences and disorders. “The focus is on therapies instead of cures, as it will take many decades to develop a cure.”

But DiGiovanni thinks that current therapies don’t completely meet the needs of patients with tinnitus. That’s why the professor decided to become an inventor and an entrepreneur to offer a better solution.

That solution—a 1 oz. medical device called Quietude—has received FDA approval and is moving toward the marketplace this year.  

Seeds of Innovation

During his 13 years on Ohio University’s faculty, DiGiovanni has studied how people hear and process speech in order to develop better algorithms for hearing aid technologies. He’s the author ofThe Hearing Aid Handbook, a reference to devices and manufacturers in the audiology field.

DiGiovanni noticed a gap in the market for devices that treat both hearing loss and tinnitus, as well as the lack of a product that could provide a more customized sound therapy for patients with the latter condition. The two most common treatments are tinnitus retraining therapy, which builds on the concept of brain elasticity—in other words, the idea that the brain can be coached to focus on other sounds—and tinnitus masking, which uses white noise to mask out the problem ringing.

Conventional products either mask tinnitus with white noise or are stand-alone MP3 sound players that don’t work with hearing aids, he explains. That’s a problem, as 85 percent of tinnitus sufferers have hearing loss as well, and don’t need a product that dilutes the effect of their hearing aids, he says.

DiGiovanni and Stephen Rizzo, who served as chief of the audiology section of the Chillicothe VA Medical Center, worked together to propose a solution: An all-in-one hearing aid and MP3 customized sound system that could be manufactured at a low cost.

To take the invention to the marketplace, DiGiovanni turned to TechGROWTH Ohio, an economic development program administered by Ohio University’s Voinovich School of Leadership and Public Affairs. The program assigned an executive-in-residence, Jeff Wiseman, to connect the professor to the manufacturing industry.

Wiseman recalls that the inventors had a strong idea, a good sense of the therapeutic needs, and a business advisor, but that “manufacturing was the big stumbling block,” given that this was the first time the scientist and clinician had tried to develop a product for the marketplace.

Wiseman, who has experience with biomedical start-ups, helped DiGiovanni navigate relationships with potential manufacturers. The audiologist formed a start-up company, Sanuthera, around the technology and established a headquarters at the Innovation Center, Ohio University’s small business incubator. TechGROWTH Ohio awarded the company a growth grant of $337,000 to develop a prototype and pursue testing of the new device in the hopes of attracting a manufacturer.

Serene Solution

The product, Quietude, is designed to train people with tinnitus to focus attention on other sounds in their environment to mitigate the persistent ringing noise. It plugs into and works with existing hearing aid devices and also uses natural sounds to provide users with a pleasant aural landscape.

“(The natural sound) helps your brain not attend to that tinnitus sound anymore. It gives you something to attach to,” DiGiovanni says.

The 1-oz. device fits on the bottom of a streamer, a small plastic power unit that hearing aid users wear around their necks. Quietude communicates with the streamer through a wireless connection, which means that it doesn’t need special hardware to work with existing medical devices, he explains. In addition, Sanuthera has developed an app that includes all of the assessments, customization, and therapeutic sounds with an incredibly intuitive interface, he says.

DiGiovanni also designed the device to automatically match the right pitch of the natural sounds to the patient’s tinnitus, which saves the audiologist time and effort during evaluations and fittings.

“The audiologist is the customer,” he explains. “If they don’t want to sell something, they won’t mention it to the patient.”

Moving to the Marketplace

By 2013, Sanuthera was ready to test the Quietude product on a sample pool of tinnitus patients. The company contracted with researchers at the Cleveland Clinic, which recruited about three dozen subjects to use the device for at least two hours per day in an effort to retrain their brains to focus on the soothing sounds generated. Each patient was tracked for six months.

“They found a very strong treatment effect with the device,” DiGiovanni says.

Study subjects reported a 36 percent average improvement in tinnitus symptoms, with some experiencing even higher benefits, according to a press release issued by Sanuthera in 2015. The interim research results were presented at the American Academy of Audiology’s annual conference.

In July, Quietude received a U.S. Food and Drug Administration (FDA) 510(k) clearance, a process of federal approval for lower-risk medical devices, DiGiovanni says. This clearance didn’t require a clinical trial with human subjects, but the Cleveland Clinic study will help the company show how effective the product is to prospective manufacturers, he explains.

The findings also bode well for individuals with tinnitus, which DiGiovanni notes can be a frustrating medical condition. Patients often are told by physicians to “live with it,” or endure years of trying to determine triggers or experiment with solutions with little to no improvement. That can be a greater problem for military veterans, as they tend to acquire tinnitus at a younger age than the rest of the population.

Now that the FDA has approved clearance of the device, Sanuthera can license the technology to a manufacturer for production and marketing. DiGiovanni’s goal is to find a company in Ohio so that Quietude can remain a Buckeye State product.

“We’re well poised to hit the market,” he says.

This article appears in Ohio University’s Perspectives magazine, which covers the research, scholarship and creative work of faculty, staff and students.