BARCELONA, SPAIN — Irish medical device company, Neuromod Devices Ltd., which specializes in the treatment of tinnitus has reached a distribution agreement with TRUSBIN to make its Lenire tinnitus treatment device available in Spain.
Lenire is a bimodal neuromodulation device which has shown in clinical trials to reduce the symptoms of tinnitus. Tinnitus, commonly known as “ringing in the ears”, is a complex neurological condition resulting in the perception of sound without an external source. It’s thought to affect 10-15% of the adult population globallyi.
Expanding Availability of Lenire Device
Through this agreement, TRUSBIN’s multidisciplinary team has license from Neuromod and necessary training to distribute Lenire in Spain. Initially Lenire will be available in Barcelona with plans to expand availability of the device.
TRUSBIN have reached an agreement with the renowned otorhinolaryngologist Dr Jordi Coromina of the Teknon Clinic in Barcelona to be the first clinician in Spain providing treatment with the device.
“I’m delighted that by working with TRUSBIN we can make Lenire available to people living with tinnitus in Spain. We consider Barcelona to be an ideal starting point due to its tradition in the medical field and its concentration of clinical expertise and we’re looking forward to continually expanding the availability of Lenire throughout the country”
–Dr Ross O’Neill, Founder and CEO of Neuromod Devices
The agreement comes following the publication of an independent real-world study demonstrating the safety and efficacy of the Lenire device for improving symptoms in tinnitus patients. The study found that 85% of tinnitus patients experienced a reduction in their tinnitus symptoms, as measured by THIii, following six to 12 weeks of treatment using Lenireiii. The results were recently published in the highly ranked scientific journal, Brain Stimulation.
The device has also been used in large-scale clinical trials with over 500 patients. The first of these clinical trials, involving 326 participants, was published in October 2020 as the cover story in the internationally renowned journal Science Translational Medicine and reported improvements in patients’ tinnitus symptoms. 86.2% of treatment-compliant participants reported an improvement in their tinnitus symptoms, measured by THI, after a 12-week treatment periodiv. When followed up 12 months post treatment, 80.1% of these participants had sustained the improvementsiv. This study represents one of the largest and longest followed-up clinical trials ever conducted in the field of tinnitus devices.
“After suffering from tinnitus for years and trying different treatments with unsuccessful results, I discovered Lenire. The treatment was such a resounding success that it encouraged me to bring it to Spain through TRUSBIN, which has a medical and multidisciplinary team suitable to offering the treatment,” explains Xavier Cirera, founder of TRUSBIN.
Lenire is a bimodal neuromodulation device which combines mild electrical pulses to the tongue with sound stimulation to drive neuroplasticity in the brain which reduces the symptoms of tinnitus. It has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe.
The device consists of Bluetooth® headphones which play customised sounds to activate the auditory nerve, a proprietary intra-oral device which provides mild electrical stimulation to the surface of the tongue, known as a TongueTip®, and a controller which controls the duration and intensity of treatment with the device.
The device’s sound and electrical stimuli can be calibrated to suit a patient’s tinnitus after an initial assessment of their condition which includes an audiological exam. The supervising healthcare professional demonstrates how to use the device and provides the patient with instructions for use. Subsequently, patients use Lenire for 60 minutes per day typically for at least 10 weeks. Follow-up visits with the healthcare professional occur during treatment to monitor patients’ progress.
At the end of the prescribed treatment plan, the healthcare professional advises the patient about their continued use of Lenire.
About Neuromod Devices Ltd
Founded in 2010, Neuromod Devices Ltd. is a medical technology company headquartered in Dublin, Ireland. Neuromod specialises in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating conditions. The lead application of Neuromod’s technology is in the field of tinnitus, where Neuromod has completed extensive clinical trials to confirm the efficacy of its non-invasive neuromodulation platform in this common disorder. Neuromod’s tinnitus treatment device, Lenire, is currently available throughout Europe. For more information visit www.neuromoddevices.com.
About Trusbin
TRUSBIN is a medical distribution company made up of a multidisciplinary team of commercial and medical professionals. The organisation is Neuromod’s partner in Spain, holding a licence to distribute the Lenire device.
About Lenire
Lenire is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in a large-scale clinical trial. Lenire has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe. Further details about Lenire including a list of providers can be found at www.lenire.com.
References
- Baguely et al., Tinnitus, The Lancet (2013), https://www.sciencedirect.com/science/article/pii/S0140673613601427
- THI or Tinnitus Handicap Inventory is a clinical standard for measuring the impact of tinnitus on someone’s day-to-day life. Measured on a scale of 100, the higher the score, the greater the impact of tinnitus. Reducing a person’s THI score should correspond to improved quality of life by reducing how their tinnitus is affecting them.
- Buechner A, Lesinski-Schiedat A, Becker P, Lenarz T, Real-world clinical experience with bimodal neuromodulation for the treatment of tinnitus – A case series, Brain Stimulation (2022), doi: https://doi.org/10.1016/j.brs.2022.01.022.
- Conlon et al., Sci. Transl. 12, eabb2830 (2020)
Source: Neuromod
