Neuromod Devices has secured ISO 13485 certification of its Quality Management System ahead of the scheduled Irish launch of its multisensory tinnitus treatment, mutebutton, in December.
The company, headquartered at NovaUCD, is planning a wider European launch of the mutebutton system for 2015.
According to Dr Ross O’Neill, CEO, Neuromod Devices: “This is an important milestone for the company. This certification independently validates our ability to deliver medical devices and services while consistently meeting both customer and regulatory requirements. It is a testament to the quality of work ongoing within the company ahead of the company’s first product launch later this year.”
Tinnitus is estimated to affect 10% of the population with 1% suffering from severely disabling effects. At present there are limited avenues of treatment for subjective tinnitus sufferers and medical professionals.
The mutebutton system has been developed to address this need and 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.
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