Neuromod is a Dublin-based company founded to develop a treatment for chronic and persistent tinnitus (ringing of the ears). It is an ISO 13485 accredited medical device manufacturer.
Neuromod developed a medical device called Lenire that uses patented bi-modal neuromodulation to treat chronic tinnitus. Lenire is a medical device used in at-home settings for approximately 30 minutes daily to treat tinnitus symptoms. Patients utilizing this device must attend 2 follow-up appointments within a 3-month time span for device adjustments from a clinician. The adjustments made to the device are intended to optimize treatment efficacy. The Lenire device consists of three components: A controller, a tongue tip, and Bluetooth headphones. The controller is a handheld device that controls the intensity, timing, and synchronization of the sounds from headphones to the tongue stimuli. The tongue tip is responsible for providing an electronic "energy pulse," or stimuli, to the trigeminal nerve through the surface of the tip of the tongue. The Bluetooth headphones are used for customized sound that pairs to the tongue stimuli. The headphones are trademarked by Harman International, a subsidiary of Samsung Electronics.
Lenire was tested in a clinical trial at St. James Hospital in Dublin, Ireland, and Tinnituszentrum of the University Regensburg, Germany, between 2016 and 2019. The study was conducted with 326 participants over a 12-month period with a data collection point conducted in month 3. The study findings reported that approximately 86% of treatment-compliant patients experienced symptom improvement after 12 weeks of treatment. Additionally, the study showed that Lenire provided symptom relief in approximately 80% of treatment-compliant patients after a 12-month period.