NUI Maynooth Researchers complete Pilot Clinical Study
Researchers at NUI Maynooth announce the successful completion of Pilot Clinical Study.
Researchers at NUI Maynooth have announced the successful completion of the pilot clinical study of the mutebutton® device. The study clinically validated the device with 54 patients who fully completed the study. A range of patient tinnitus measures were captured to assess the effects of the treatment, which ran for 10 weeks. These included subjective measures, such as Tinnitus Handicap Inventory (THI), and objective measures, such as Mnimium Masking Level (MML) and Tinnitus Loudness Matching (TLM).
Speaking of the results, Neuromod CEO, Dr. O’Neill said, "We believe that the results of this study constitute promising evidence and a compelling case for continuing to research and develop this unique approach to tinnitus treatment. We are committed to addressing the unmet needs of tinnitus suffers globally and believe that this study offers a positive first step towards realising that goal. "
Neuromod now plans to secure ISO 13485 accreditation to certify the company’s ability to design and manufacture neuromodulation devices to the highest international standards. Following this, the company will pursue a medical device CE mark for mutebutton to certify the safety and efficacy of the device.