Dublin-based medical devices company Neuromod Devices is set to launch its tinnitus treatment Mutebutton in Ireland on schedule in December further to securing ISO 13485 certification for its quality management system.
Founded by Dr Ross O’Neill in 2010 as a spin-out from NUI Maynooth, Neuromod Devices has been headquartered at NovaUCD since 2011 and plans a wider European launch of the Mutebutton system for 2015.
O’Neill said the certification was an important milestone for the company: “It independently validates our ability to deliver medical devices and services while consistently meeting both customer and regulatory requirements.”
Tinnitus is estimated to affect 10pc of the population with 1pc suffering from severely disabling effects. At present there are limited avenues of treatment for subjective tinnitus sufferers and medical professionals alike, according to O’Neill.
Developed to address this need, the Mutebutton system combines synchronous audio and lingual (tongue) stimulation to promote patient neuroplasticity, the manipulation of the brain’s ability to learn and re-learn.
Used for a minimum of 30 minutes a day, over a 10-week period, the treatment has been shown to gradually reduce the sounds of tinnitus in clinical studies conducted at NUI Maynooth and at the Hermitage Medical Centre in Dublin.