Cutting-edge tinnitus treatment could substantially improve the lives of 40 million US adults
15% of adults in the United States have tinnitus, where nearly 40% of sufferers have the condition chronically and actively seek relief.
Up to 15% of adults in the United States have tinnitus, where nearly 40% of sufferers have the condition chronically and actively seek relief. (CREDIT: Creative Commons)
Up to 15% of adults in the United States hear a constant companion: tinnitus. This medical condition manifests as an incessant ringing, buzzing, or hissing in the ears, and for many, it's a mere annoyance.
Yet, for nearly 40% of those afflicted, tinnitus is a chronic ailment that severely impacts their quality of life. There's a desperate search for relief, and now, thanks to pioneering research from the University of Michigan’s Kresge Hearing Research Institute, hope appears on the horizon.
The latest study spearheaded by Susan Shore, Ph.D., Professor Emerita at Michigan Medicine’s Department of Otolaryngology and U-M’s Departments of Physiology and Biomedical Engineering, dives deep into the intricacies of how our brain processes bi-sensory information. The central tenet of this research is whether it's possible to utilize these processes in developing personalized treatments for tinnitus.
"We have always known that the solution lies within understanding the brain's mechanisms. It's about personalizing the approach to harness these mechanisms for alleviating tinnitus," remarks Shore.
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Published in the reputed JAMA Network Open, the study involved a robust double-blind, randomized clinical trial design. Out of a broad spectrum of tinnitus types, the research zoomed in on somatic tinnitus. This particular variant, experienced by approximately 70% of all tinnitus sufferers, sees a significant change in the pitch or loudness of the phantom sounds upon physical movements, such as clenching the jaw or pressing the forehead.
“Eligibility was clear-cut. We were looking for individuals who grapple with particularly bothersome somatic tinnitus combined with normal-to-moderate hearing loss,” Shore said.
The enrolled participants, all 99 of them, were handed a groundbreaking device for their treatment, designed and built by in2being, LLC. The uniqueness of these devices lay in their programmability: they could be tailored to represent each user’s personal tinnitus spectrum.
Tinnitus Functional Index (TFI) Scores in the Intent-to-Treat (ITT) and Per Protocol (PP) Populations. (CREDIT: JAMA Network Open)
Shore elaborated, “The devices presented each user with their personal tinnitus spectrum, but here's the twist: this was amalgamated with electrical stimulation to produce a bi-sensory stimulus. Throughout this process, both the study team and the participants remained unaware of the specific programming.”
Over a span of 18 weeks, participants underwent two distinct treatments in phases. Initially, they were divided into two groups: one received the bi-sensory or active treatment while the other was subjected to a sound-alone or control treatment. For half of this period, they utilized their devices for half an hour daily, followed by a break, and then a switch in their treatment type.
Tinnitus Loudness in the Intent-to-Treat (ITT) and Per Protocol (PP) Populations. Error bars represent the SEM. dB SL indicates decibel sensation level. The solid horizontal line represents mean baseline value/normalized reference at week 0. (CREDIT: JAMA Network Open)
But how does one measure the intangible? This is where the Tinnitus Functional Index (TFI) and Tinnitus Handicap Inventory (THI) came into play. These tools, in the form of questionnaires, gauged the effect of tinnitus on the lives of the participants. Additionally, the loudness of their tinnitus was also periodically assessed.
The results were unequivocal.
On receiving bi-sensory treatment, participants unanimously reported significant enhancements in their quality of life. The handicap scores plummeted, and the perceived loudness of tinnitus decreased markedly. Such effects were conspicuously absent in the sound-only stimulation phase.
Tinnitus Handicap Inventory (THI) Scores in the Intent-to-Treat (ITT) and Per Protocol (PP) Populations. Error bars represent the SEM. The solid horizontal line represents the mean baseline value/normalized reference at week 0. (CREDIT: JAMA Network Open)
Digging deeper, the numbers painted an even more promising picture. A staggering 60% of participants discerned a remarkable reduction in their tinnitus symptoms post the six weeks of active treatment. This was not the case with the control treatment. “Our previous studies hinted at this outcome. The more extended the bi-sensory treatment, the more profound the relief," Shore observed.
In a world where millions grapple with the persistent noise of tinnitus, this study emerges as a beacon of hope. "The horizon looks promising. Our findings open the doors for employing personalized, bi-sensory stimulation as an efficacious tinnitus remedy," Shore concluded with a note of optimism.
And the future looks even brighter. Auricle Inc., granted exclusive licensing rights for the bi-sensory stimulation patents, has already sprung into action. Established with the backing of Innovation Partnerships, the epicenter of research commercialization endeavors at the University of Michigan, Auricle is blazing the trail. Their mission? Acquiring regulatory approvals and bringing to the world Shore’s innovative bi-sensory tinnitus treatment.
For tinnitus sufferers, the days of silent agony might soon be a thing of the past.
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