Neuromod Devices Wins European Approval of Multisensory Device

Irish medical devices firm Neuromod Devices Ltd. has secured CE Mark approval for the sale of mutebutton, its new multisensory medical device to treat Tinnitus.

“This certification is the culmination of 10 years of scientific and clinical research,” said Ross O’Neill, Ph.D., CEO of Neuromod. “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.”   

Using platform technology developed by Neuromod, the Mutebutton system 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 in Dublin.

O’Neill founded Neureomod Devices in 2010 as a spin-out from NUI Maynooth to develop non-surgical and innovative neurostimulation technologies for the treatment of unaddressed neurological conditions.

Roughly one in 10 people live with Tinnitus (often described as “ringing in the ears”), with 1 percent of the population suffering from anxiety, sleep deprivation and depression due to the condition. The effects can be significant for chronic cases: One clinical trial patient told researchers that it affected his concentration, fundamental quality of life and his overall feelings about life.”

The mutebutton device combines synchronous audio and lingual (tongue) stimulation to promote neuroplasticity amongst patients. The control device enables the patient to adjust the level of tongue stimulation and the loudness of the relaxing audio during the treatment, to their personal preference. The device is sold with Bluetooth headphones which have been carefully selected for comfort, safety and efficacy and the company’s own tonguetip, which is a small intra-oral. The mutebutton system has been designed to give an overall relaxing experience to the patient, the company noted.

There currently are limited treatment options for tinnitus. Once diagnosed with subjective tinnitus, most people may find themselves referred to an audiologist for standard hearing aids.

“The problem with hearing aids, however, is that they amplify the sounds around you. They don’t directly address the tinnitus symptoms. Noise maskers can offer some temporary relief by distracting the mind from the illusory sound, however, this is only temporarily masking the symptoms, not addressing the cause and providing lasting relief. That’s why we developed the mutebutton system,” O’Neill said.
 

Neuromod’s mutebutton product is based on neuromodulation, a branch of medicine that uses sensory stimulation to manipulate the brain’s ability to learn and re-learn, known as neuroplasticity.