Lenire Available in Otoneuro Monaco
Lenire Now Available in Otoneuro Monaco
- 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 Monaco 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. Lenire has been proven to provide clinically significant relief from tinnitus across multiple clinical trials and with real world evidence.1,2, 3
What is Tinnitus?
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 Monaco to Provide Lenire from Inauguration
Led by Dr. Pierre Lavagna, Otoneuro Monaco is the first hearing and balance clinic to provide Lenire as a tinnitus treatment option from the outset.
Prince Albert II of Monaco inaugurated Otoneuro 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. How lucky I was to be born in a country where our sovereigns have made science and medicine their biggest priority,” 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. The US FDA awarded Lenire a De Novo Grant. FDA Approval made the groundbreaking device available in the US.
“Tinnitus is one of the leading unaddressed global healthcare challenges and there are few solutions. Neuromod Devices is committed to growing the worldwide accessibility and availability of Lenire. This is only achievable through partnerships with leading hearing and tinnitus experts like Dr. Lavagna and the Otoneuro team.” Stated Dr. Ross O’Neill, Neuromod Devices Founding CEO.
Lenire: Clinically Proven Tinnitus Treatment Device
Demonstrable safety and effectiveness in three large scale clinical trials contributed to Lenire’s demand. These trials featured over 600 patients with an overwhelming prevalence of tinnitus.1,2,3
Lenire’s first clinical trial, TENT-A1, is one of the largest and longest followed-up clinical trials conducted in the tinnitus field. TENT-A1 was the cover story for the scientific journal Science Translational Medicine. TENT-A1 enrolled 326 participants. 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
Prestigious scientific journal, Nature – Scientific Reports, published the results from Lenire’s second clinical trial, TENT-A2. 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 these reported a sustained improvement for a year after the treatment ended.2
The US FDA awarded Lenire® a De Novo Grant 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® is proven to be more effective than sound-only therapy for 70.5% of patients with moderate and above tinnitus.3
What is Lenire? Tinnitus Treatment Device
Lenire® is a bimodal neuromodulation device which works by delivering mild tongue pulses, through an intra-oral component called the ‘Tonguetip®’.
Tonguetip stimulation is combined with auditory stimulation through headphones to drive long-term changes in the brain. Lenire’s dual action stimulus is proven to provide long term relief from tinnitus.1,2
Otoneuro Monaco is taking direct appointments and referrals for Lenire assessments in the Principality of Monaco, France and nearby 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 US. Neuromod specialises in the design and development of neuromodulation technologies. These technologies 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. 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 that has been shown to provide relief from tinnitus in large-scale clinical trials.
Lenire® has CE-mark certification for the treatment of tinnitus under the supervision of a qualified healthcare professional in Europe. As well as this, Lenire has received a De Novo Approval Grant by the US FDA.
Learn more about Lenire® and our list of providers at www.lenire.com.
