Combining tongue sounds with electrical stimulation can reduce tinnitus

Review by Emily Henderson, Bachelor of ScienceOctober 16, 2020

In the largest clinical trials of this type, researchers have shown that the combination of coronal consonant sounds and electrical stimulation can significantly reduce tinnitus, commonly referred to as “tinnitus.” They also found that the therapeutic effect could last up to 12 months after treatment.

Tinnitus affects about 10-15% of the world’s population, so the findings could help millions of people. The study was conducted by researchers at the University of Minnesota, Trinity College, St. James Hospital, University of Regensburg, University of Nottingham, and the Irish medical equipment company Neuromod Devices Limited.

The study was published as a cover story of Scientific translation medicine, An interdisciplinary medical journal by the American Association for the Advancement of Science (AAAS).

Associate Professor Hubert Lim of the University of Minnesota’s Department of Biomedical Engineering (Faculty of Science and Engineering) and Department of Otolaryngology (Faculty of Medicine) was a senior author of a study sponsored by Neuromod Devices. Lim is also Chief Scientific Officer of Neuromod Devices.

The study is the largest and longest follow-up clinical trial ever conducted in the field of tinnitus in medical devices with 326 participants and provides evidence of safety. Effectiveness, And the patient’s tolerability of bimodal neuromodulation for the treatment of tinnitus. Approximately 86% of treatment-compliant participants reported an improvement in the severity of tinnitus symptoms when evaluated after 12 weeks of treatment, often experiencing sustained benefits 12 months after treatment.

We are truly proud of our ability to conduct such large-scale randomized clinical trials in two countries. In this study, the therapeutic effect after treatment was followed for 12 months. This is the first time in the tinnitus field to evaluate the long-term outcomes of the medical device approach. The results are very exciting and we look forward to continuing our work to develop bimodal neuromodulatory therapies to help as many tinnitus patients as possible. “

Hubert Lim, Associate Professor, Department of Otolaryngology, Faculty of Biomedical Engineering, University of Minnesota

The study was conducted at the Wellcome Trust-HRB Clinical Research Facility at St. James Hospital in Dublin, Ireland, and at the Tinnituszentrum at the University of Regensburg, Germany.

There were no serious adverse events and consistent treatment results at both clinical sites. The Minneapolis-based branch of NAMSA, the only medical research organization in the world, guided and assisted in the process of completing clinical trials for Neuromod Device.

The tinnitus treatment device used in this study, now branded as Lenire®, was developed by Neuromod Devices and includes wireless (Bluetooth®) headphones that transmit a sequence of broadband noisy audio tones to both ears. 32 electrodes on the tip of the tongue with a unique device branded as Tonguetip®.

Stimulation timing, intensity, and delivery are controlled by an easy-to-use handheld controller that is trained to operate by each participant. Before using the treatment for the first time, the device is configured for the patient’s auditory profile and optimized for the patient’s level of sensitivity to tongue stimulation.

In the study, participants were instructed to use the Lenire® device for 60 minutes daily for 12 weeks. Of the 326 enrolled participants, 83.7% used the device at a minimum compliance level of 36 hours over a 12-week treatment period. For the primary endpoint, participants achieved a statistically and clinically significant reduction in the severity of tinnitus symptoms.

Upon completion of treatment, participants returned the device and were evaluated on three follow-up visits for up to 12 months. Over 66% (n = 272) of participants who responded to exit polls said they benefited from using the device, and 77.8% (n = 270) recommended treatment to other people with tinnitus. Said.

Participants in the study were screened and selected based on a list of pre-defined inclusion and exclusion criteria to ensure that the study included a broad distribution sample of the tinnitus population.