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Stimulation Device Shown to Reduce Tinnitus Symptoms

Lenire system

Lenire system (Neuromod Devices Ltd.)

8 Oct. 2020. Results from a clinical trial show a device that sends audio and electrical signals to the ears and tongue reduces tinnitus symptoms for as long as one year. Researchers from the company Neuromod Devices Ltd. in Dublin, Ireland, and academic labs in Europe and the U.S. describe the device and trial results in yesterday’s issue of the journal Science Translational Medicine (paid subscription required).

Tinnitus is characterized by a constant sound pattern in the ears, like ringing, buzzing, or even roaring. National Institute on Deafness and Other Communication Disorders (NIDCD) at National Institutes of Health says tinnitus can be a symptom of a minor disorder, like an ear infection, or of more serious conditions, such as noise-induced hearing loss or a brain tumor. NIDCD says about 25 million Americans, or 10 percent of the U.S. population experiences tinnitus for at least five minutes in the previous year.

Neuromod Devices is developer of a system that reduces tinnitus symptoms by sending audio signals and electronic stimulation to the ears and tongue. The system, marketed under the brand name Lenire, sends audio tones and wideband noise — signals covering all or most of the audio spectrum — through headphones, as well as mild electrical stimulation to the tongue. The tongue attachment stimulates the trigeminal nerve that transmits sensory information to skin and tissues in the face and jaw. A handheld controller allows the user to control and synchronize the timing and intensity of audio and tongue-stimulation signals.

The clinical trial enrolled 326 adults with tinnitus in Ireland and Germany, randomly assigned to receive one of three stimulation settings on the Neuromod system. The trial had no sham or placebo group. Participants were instructed on the use of the device, then received treatments for one hour a day for 12 weeks. The study team measured tinnitus symptoms and effects with two standard rating scales — Tinnitus Handicap Inventory and Tinnitus Functional Index — after 12 weeks, and in three follow-up sessions over the next 12 months.

The results show a high rate of compliance, 84 percent, among participants during the 12 week treatment period. In addition, device users experienced reductions in scores on both rating scales for tinnitus symptoms and severity after 12 weeks, compared to the start of the trial. And those lower symptom severity scores were sustained over the next 12 months. Moreover, two-thirds (67%) of participants completing the 12-month follow-up said they benefited from using the Neuromod system, and nearly eight in 10 (78%) would recommend the treatment for others with tinnitus.

The researchers say participants reported 155 mild or moderate adverse effects during the study, of which 106 were expected effects from the nature of the device. No serious adverse effects related to the treatments were reported.

The Neuromod system is based on research at University of Minnesota by biomedical engineering and neuroscience professor Hubert Lim, Neuromod’s chief scientist and senior author of the Science Translational Medicine paper. “This study,” says Lim in a Neuromod statement, “tracked the post-treatment therapeutic effects for 12 months, which is a first for the tinnitus field in evaluating the long-term outcomes of a medical device approach.”

The Lenire device has a CE mark, authorizing its marketing in most of Europe, when used as part of a professional treatment program.

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