The technique, which combines sound and electrical stimulation of the tongue, could offer hope for the huge numbers of people (thought to be as much as 15 per cent of the global population) who suffer from the condition.
UK firm develops tinnitus-detecting headphones
The study is based on a clinical trial involving 326 enrolled participants across two sites (the Wellcome Trust-HRB Clinical Research Facility, at St. James's Hospital in Dublin; and the Tinnituszentrum of the University of Regensburg, Germany) and published in the journal Science Translational Medicine. It was conducted by researchers from the University of Minnesota, Trinity College, St. James's Hospital, University of Regensburg, Nottingham University, and Irish medical device company Neuromod Devices Limited.
Of the 326 enrolled trial participants, around 86 per cent reported an improvement in tinnitus symptom severity when evaluated after 12 weeks of treatment, with many experiencing sustained benefit 12 months post-treatment.
The device used in the study, now branded as Lenire, was developed by Neuromod Devices and consists of wireless Bluetooth headphones that deliver sequences of audio tones layered with wideband noise to both ears, combined with electrical stimulation pulses delivered to 32 electrodes on the tip of the tongue by a proprietary device trademarked as Tonguetip.
The timing, intensity, and delivery of the stimuli are controlled by an easy-to-use handheld controller that each participant is trained to operate. Before using the treatment for the first time, the device is configured to the patient's hearing profile and optimised to the patient's sensitivity level for tongue stimulation.
For the trial, participants were instructed to use the device for 60 minutes daily for 12 weeks.
When treatment was completed, participants returned their devices and were assessed at three follow-up visits for up to 12 months. Over 66 per cent of participants who filled out the exit survey affirmed they had benefited from using the device, and 77.8 per cent said they would recommend the treatment for other people with tinnitus.
"I am truly proud of our company's ability to perform such a large-scale randomised clinical trial in two countries," said University of Minnesota Associate Professor Hubert Lim. "This study 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 outcomes are very exciting and I look forward to continuing our work to develop a bimodal neuromodulation treatment to help as many tinnitus sufferers as possible."
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