University College Dublin (UCD) spinout Neuromod Devices has secured the CE mark of regulatory approval for its multi-sensory medical device Mutebutton, which is used to treat tinnitus.
The company plans to launch the device in Ireland in December ahead of a wider European launch in early 2015.
Tinnitus affects 10pc of the UK population, according to the British Tinnitus Association, with 1pc reporting significant secondary symptoms, such as anxiety, depression and sleep deprivation.
At present there are limited avenues of treatment for subjective tinnitus sufferers and medical professionals alike.
The Mutebutton 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 10-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.
“This certification is the culmination of 10 years of scientific and clinical research,” said Dr Ross O’Neill, chief executive of Neuromod Devices.
“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.”