A clinical trial of Irish medtech company Neuromod Devices’s treatment for tinnitus has shown a significant improvement in symptoms after 12 weeks.
Some 86.2 per cent of treatment compliant participants said the severity of their symptoms improved after 12 weeks of treatment, with the company reporting that 80.1 per cent experienced sustained benefit 12 months after the treatment.
The company, which offers non-invasive neuromodulation technologies, has developed a stimulation device that delivers sound to the ears and electrical stimulation to the tongue. It carried out the trial of the device, known as Lenire, between 2016 and 2019, the largest and longest followed up clinical trial into the hearing condition. Monitoring 326 participants, it tracked changes in tinnitus symptom severity, investigating the bimodal neuromodulation approach offered by Neuromod.
The study was conducted at St James’s Hospital in Dublin, and the Tinnituszentrum of the University Regensburg, Germany. No serious adverse events were reported.
The Lenire device delivers a sequences of audio tones layered with wideband noise to both ears through Bluetooth headphone, combined with electrical stimulation pulses delivered to 32 electrodes on the tip of the tongue by a proprietary device.
“There is a globally recognised clinical need for evidence-based treatments for tinnitus, such as Lenire, due to the lack of effective options for this debilitating condition,” said Dr Ross O’Neill, chief executive of Neuromod. “Neuromod is proud to be at the cutting edge of efforts to research and develop new solutions that can contribute to solving this chronic condition that affects 10-15 per cent of the population worldwide. We are committed to continuing our research in the field and to advance our unique chronic tinnitus treatment technology.”
Participants were assessed at three follow-up visits up to 12 months. Almost 78 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, enrolling 326 participants to demonstrate the safety and efficacy of a new solution for tinnitus," said Hubert Lim, chief scientific officer of Neuromod. "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."
Neuromod raised €8 million in capital last year from existing investors Fountain Healthcare Partners, with participation from Moffett Investment Holdings and venture debt investors Kreos Capital and Silicon Valley Bank.
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