Neuromod Devices has announced that it has successfully secured regulatory approval, CE Mark, for the sale of mutebuttonTM, a new multisensory medical device to treat Tinnitus.
Neuromod Devices, headquartered at NovaUCD, the Centre for New Ventures and Entrepreneurs at University College Dublin, anticipates the Irish launch of the mutebutton™ system in December, ahead of a wider European launch commencing early 2015.
Tinnitus affects 10% of the UK population, according to the British Tinnitus Association, with 1% reporting significant secondary symptoms such as sleep deprivation, anxiety and depression. At present there are limited avenues of treatment for subjective tinnitus sufferers and medical professionals alike.
Dr Ross O'Neill, CEO, Neuromod Devices said, "This certification is the culmination of 10 years of scientific and clinical research. The medical device CE Mark is required for the approved sale of any medical device in Europe. It certifies the safety and efficacy of the mutebutton™ tinnitus treatment and the competency of Neuromod Devices in being able to bring an approved medical device to market to treat this chronic condition."
The mutebuttonTM system has been developed to address significant patient and clinical needs. The product combines synchronous audio and lingual (tongue) stimulation to promote patient neuroplasticity. Used for a minimum of 30 minutes a day over a ten week period, the treatment has been shown to gradually reduce the sounds of tinnitus in clinical studies conducted by NUI Maynooth and the Hermitage Medical Centre Dublin.
The mutebutton™ system uses an innovative platform technology that has been developed by Neuromod Devices for the treatment of tinnitus but which offers much wider future applications.
Padraig Rushe, Chief Commercial Officer, Neuromod Devices said, "In the absence of clinically proven, readily available treatments many tinnitus sufferers may have felt forced to try less effective treatments before now. Many may have even tried lesser products or services which are sold without the necessary regulatory approval. We are delighted to have secured our medical device CE Mark for the mutebutton™ tinnitus treatment. We look forward to launching the product later this year and offering patients an approved treatment which they can trust."
"The global study of neuromodulation continues to unlock new and exciting surgical and non-surgical treatments for patients. Neuromod Devices is committed to unlocking the potential applications of this exciting technology while meeting the highest standards for our regulators and customers alike," added Dr O'Neill.
For more product information please visit http://www.mutebutton.ie/.