In the largest clinical study of its kind, researchers show that the combination of sound and electrical stimulation of the tongue can significantly reduce tinnitus, commonly known as “ringing in the ears”. They also found that therapeutic effects can be sustained for up to 12 months after treatment.
The research was recently published as the cover story of Scientific translational medicine.
Associate Professor Hubert Lim of the University of Minnesota in the Department of Biomedical Engineering and the Department of Otolaryngology (Medical School) was the lead author of the Neuromod Devices-sponsored study. Lim is also the Scientific Director of Neuromod Devices.
The study is the largest and longest clinical follow-up ever conducted in the tinnitus field for a medical device with 326 participants. It provides evidence of the safety, efficacy and tolerability of bimodal neuromodulation in the treatment of tinnitus. Approximately 86 percent of treatment-compliant participants reported improvement in tinnitus symptom severity when assessed after 12 weeks of treatment, with many having continued benefit 12 months after treatment.
“I’m really proud of our company’s ability to conduct such a large randomized clinical trial in two countries,” said Lim. “This study followed the therapeutic effects after treatment for 12 months. This is a first for the tinnitus field in evaluating the long-term results of a medical device approach. The results are very exciting and I look forward to further developing our work on a bimodal neuromodulation treatment to help as many tinnitus sufferers as possible. ”
The study was carried out at the Wellcome Trust-HRB clinical research facility, St. James’s Hospital in Dublin, Ireland, and the Tinnitus Center at the University of Regensburg. There were consistent therapeutic results with no serious adverse events at both clinical sites. The Minneapolis-based office of NAMSA, the world’s only medical research organization, directed and supported the closing process of the Neuromod Device clinical trial.
The tinnitus treatment device used in the study, now referred to as Lenire®, was developed by Neuromod Devices and consists of wireless (Bluetooth®) headphones that deliver sequences of audio tones with broadband noise to both ears, combined with electrical stimulation pulses applied to 32 electrodes are sent to the tip of the tongue from a proprietary device under the Tonguetip® brand. The timing, intensity and delivery of the stimuli are controlled by a user-friendly hand controller, which every participant is trained to operate. Before the first treatment, the device is adapted to the patient’s hearing profile and optimized to the patient’s level of sensitivity for tongue stimulation.
For the study, participants were instructed to use the Lenire® device for 60 minutes a day for 12 weeks. Of 326 participants enrolled, 83.7 percent used the device at or above the minimum compliance level of 36 hours during the 12-week treatment period. For the primary endpoints, participants achieved statistically and clinically significant reductions in the severity of tinnitus symptoms.
Upon completion of treatment, participants returned their devices and were examined at three follow-up visits for up to 12 months. Only more than 66 percent of respondents who took the Exit survey (n = 272) said they had benefited from using the device, and 77.8 percent (n = 270) said they had treated others Recommended for people with tinnitus.
Participants in the study were screened and selected using a pre-defined list of inclusion and exclusion criteria to ensure that the study included a broad sample of the tinnitus population.
Materials provided by University of Minnesota. Note: the content can be edited by style and length.
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