- Lenire is now available in the Principality of Monaco through Otoneuro Monaco.
- Otoneuro is a state of the art hearing and balance center based, led by Dr. Pierre Lavagna.
- H.S.H. Prince Albert II of Monaco presided over the inauguration of Otoneuro Monaco in February, 2024.
- Otoneuro is the first independent clinic to open with Lenire as a treatment option from the outset.
Principality of Monaco, February 22, 2024: Neuromod Devices, the medical technology business behind tinnitus treatment device, Lenire, has partnered with state-of-the-art hearing and balance centre, Otoneuro, to make Lenire available in Monaco.
Lenire® is a groundbreaking bimodal neuromodulation device which has been proven to provide clinically significant relief from tinnitus across multiple clinical trials and with real world evidence.1,2,3
Tinnitus, commonly known as “ringing in the ears”, is a complex brain signalling condition that causes people to perceive sound with no external source.
Landmark tinnitus research, published in the renowned scientific journal, The Lancet, found that the European population prevalence of any tinnitus was nearly 15%4. As a result, more than 10 million people in Monaco and France could be living with the condition.
Otoneuro, led by Dr. Pierre Lavagna, is the first hearing and balance clinic to provide Lenire as a tinnitus treatment option from the outset.
Otoneuro Monaco’s grand opening was inaugurated by Prince Albert II of Monaco. He was accompanied by Mr Christophe Robino, Government Councillor, Minister of Social Affairs and Health, and many other personalities. Attendance by Prince Albert II and Mr Christophe Robine underscores the progress and change in attitudes towards tinnitus and hearing care.
"Otoneuro invests in the most efficient and innovative techniques and technologies, such as Lenire, for the exploration and treatment of tinnitus and other pathologies. How lucky I was to be born in a country where our sovereigns, for a long time, have made science and medicine one of their greatest priorities," said Dr. Pierre Lavagna.
Monaco is the latest location to make Lenire® available, following successful launches in Denmark, Norway, Spain, Italy, Poland, Switzerland, and the UK. Neuromod Devices continued this rapid expansion in 2023 as Lenire® was awarded a De Novo Grant from the US FDA, making the tinnitus treatment device available in the United States of America.
“Tinnitus is one of the leading unaddressed global healthcare challenges and there are few solutions. Partnership with leading experts like Dr. Lavagna and the Otoneuro team allows us to broaden Lenire’s accessibility and availability while maintaining the highest quality of care for tinnitus patients,” stated Dr. Ross O'Neill, Neuromod Devices Founding CEO.
Lenire’s demand is owed to being proven safe and effective across three large-scale clinical trials that featured over 600 patients with an overwhelming prevalence of tinnitus.1,2,3
The first of Lenire’s clinical trials, TENT-A1, represents one of the largest and longest followed-up clinical trials ever conducted in the tinnitus field and was the cover story for the scientific journal Science Translational Medicine. The trial enrolled 326 participants and 86.2% of compliant participants reported an improvement in their tinnitus severity after a 12-week treatment period1. When followed up with 12 months post treatment, 80.1% of compliant participants had sustained improvement.1
Results from Lenire’s second large-scale clinical trial, TENT-A2, were published in the prestigious scientific journal, Nature – Scientific Reports. TENT-A2 showed that modifying stimuli halfway through treatment resulted in a greater clinically significant improvement in tinnitus severity.2 95% of compliant patients reported a tinnitus improvement, 91% of whom reported a sustained improvement for a year after the treatment ended.2
Lenire® US FDA’s De Novo Grant was awarded based on the success of Lenire’s third large-scale clinical trial, TENT-A3. During this controlled clinical trial, 79.4% of the patients had a clinically significant reduction in tinnitus severity and 88.6% responded that they would recommend Lenire®3. Importantly, Lenire® was proven to be more effective than sound-only therapy for 70.5% of patients with moderate and above tinnitus.3
Lenire® is a bimodal neuromodulation device which works by delivering mild electrical pulses to the tongue, through an intra-oral component called the ‘Tonguetip®’, combined with auditory stimulation through headphones to drive long-term changes in the brain to treat tinnitus. This dual action stimulus is proven to provide long term relief from tinnitus.1,2
Otoneuro Monaco is now taking direct appointment bookings and referrals for Lenire assessments for tinnitus patients in the Principality of Monaco, France and nearby European regions. Learn more by visiting https://otoneuromonaco.com.
About Neuromod Devices
Founded in 2010, Neuromod Devices is a global medical technology company with offices in Ireland, and the United States of America. 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.
For more information visit www.neuromoddevices.com.
About Lenire®
Lenire® is the first non-invasive bimodal neuromodulation tinnitus treatment device shown to soothe and relieve tinnitus in large-scale clinical trials
Lenire® has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe and has received a De Novo Approval Grant by the US FDA.
Further details about Lenire® including a list of providers can be found at www.lenire.com.
About Otoneuro Monaco
Otoneuro Monaco is an otoneurology centre of excellence located in the Principality of Monaco, dedicated to the treatment of hearing disorders (deafness, tinnitus, hyperacusis), dizziness and balance disorders.
Otoneuro brings together multi-discipline practitioners who possess extensive experience, and a platform for technological exploration at the highest level.
Otoneuro participates in otoneurology research programs and offers the most efficient and innovative techniques for the exploration and treatment of these pathologies.
Learn more about Otoneuro Monaco’s state-of-the-art facilities and services by visiting www.otoneuromonaco.com.
References & Notes
1. Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)
2. Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, https://www.nature.com/articles/s41598-022-13875-x (2022)
3. TENT-A3 clinical trial data in preparation for publication. https://clinicaltrials.gov/ct2/show/NCT05227365
4. R. Biswas et al., Tinnitus prevalence in Europe: a multi-country cross-sectional population study, The Lancet Regional Health (2021), https://doi.org/10.1016/j.lanepe.2021.100250
