- More than a million Hungarians may suffer from tinnitus
- The 3 clinics of Tinnitus Klinika will provide Lenire throughout Hungary
- Availability in Hungary follows the release of results from a second large-scale clinical trial, showing greater improvement in tinnitus symptoms
Budapest, Hungary, September 29, 2022 /PRNewswire/ — Irish medical device company Neuromod Devices Ltd., specializing in the treatment of tinnitus, has entered into an agreement with Tinnitus Klinika kft, a specialist tinnitus care provider, to make its Lenire device available in Hungary.
Lenire is a bimodal neuromodulation device that has been shown in real-world patient analysis and in multiple large-scale clinical trials to reduce the severity of tinnitus symptoms. Tinnitus, commonly known as “ringing in the ears”, is a complex neurological condition resulting in the perception of sound without an external source.
Historical research on the prevalence of tinnitus in Europe was published in a renowned scientific journal, The Lancet, at the end of 2021. It revealed that the prevalence of any tinnitus was 14.7%Iwhich could mean that 1.4 million Hungarians suffer from the disease.
Through this distribution agreement, the team of specialists at Tinnitus Klinika has an exclusive license from Neuromod to supply Lenire throughout Hungary appropriate patients for the treatment of their tinnitus.
“I am delighted to work with Tinnitus Klinika at make Lenire available to people living with tinnitus in Hungary. Tinnitus is globally recognized as an important health problem and many people with this condition have unmet clinical needs. Tinnitus specialists like Tinnitus Klinika deeply understand the needs of tinnitus patients and we are proud to be able to help them improve treatment outcomes for their patients,” explains the doctor Ross O’NeillFounder and CEO of Neuromod Devices.
Over the past 12 months, Neuromod has expanded the availability of Lenire by Europethrowing it in Denmark, Norway, Spain, Swiss, and the United Kingdom. Earlier in 2022, the results of an independent real-world analysis were published in the peer-reviewed scientific journal, Brain Stimulation, demonstrating the safety and effectiveness of the Lenire device in improving symptoms in patients with tinnitus. The study found that 85% of tinnitus patients experienced a reduction in their tinnitus symptoms, as measured by the THIiiafter 6 to 12 weeks of treatment with Lenireiii.
The device has also been used in large-scale clinical trials with over 500 patients. In June, the results of Lenire’s second large-scale clinical trial were published in the highly regarded scientific journal, Nature – Scientific Reports. They showed a significant new breakthrough in improving the severity of tinnitus symptoms with Lenireiv. By modifying the stimuli that patients received midway through their treatment plan, a larger, clinically meaningful mean improvement in the severity of tinnitus symptoms was demonstrated.iv. 95% of treatment-compliant participants reported improvement in their tinnitus symptoms, as measured by the THIii, iv. 91% of participants adhering to treatment reported improvement that was maintained for at least 12 months after treatment endediv.
The Tinnitus Klinika team has been providing specialist care to people living with tinnitus since its inception in 2008 by Tamás Nagy, who holds a degree in audiology from Oxford Brookes University. The organization operates 3 clinics in Hungary at the Czeizel Institute in Budapest, Hallomás Center in Veszprém, and at the University of Debrecen in partnership with the medical faculty of the University. Tinnitus Klinika offers a suite of therapeutic interventions for people with tinnitus, which now includes Lenire, and has facilitated research into these interventions in their clinical practices under the guidance of the organization’s advisory board.
“Tinnitus Klinika’s partnership with Neuromod is a significant step forward for our tinnitus patients. I am delighted to be able to offer an evidence-based treatment option that has seen encouraging results for patients in large-scale clinical trials and in the real world as part of our suite of services for people living with the condition. I look forward to working closely with the Neuromod team to achieve the best possible patient outcomes in our clinics.“, explains Tamás Nagy, CEO of Tinnitus Klinika.
Lenire is a bimodal neuromodulation device that combines mild electrical impulses on the tongue with sound stimulation to stimulate neuroplasticity in the brain, which reduces symptoms of tinnitus. It is CE certified for the treatment of tinnitus under the supervision of a suitably qualified healthcare professional and is currently available in all Europe.
The device consists of Bluetooth® headphones that emit personalized sounds to activate the auditory nerve, a proprietary intra-oral device that delivers mild electrical stimulation to the surface of the tongue, known as the Tonguetip®and a controller that 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 examination. The supervising healthcare professional demonstrates how to use the device and provides the patient with instructions for use. Thereafter, patients use Lenire for 60 minutes a day, usually for at least 10 weeks. Follow-up visits with the healthcare professional take place during treatment to monitor the progress of patients.
At the end of the prescribed treatment plan, the healthcare professional informs the patient to continue using Lenire.
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About Neuromod Devices Ltd
Founded in 2010, Neuromod Devices Ltd. is a medical technology company headquartered in Dublin, Ireland. Neuromod specializes in the design and development of neuromodulation technologies to meet the clinical needs of underserved patient populations living with chronic and debilitating diseases. The primary application of Neuromod’s technology is in the area of tinnitus, where Neuromod has conducted extensive clinical trials to confirm the effectiveness of its non-invasive neuromodulation platform in this common disorder. Neuromod’s tinnitus device, Lenire, is currently available everywhere Europe. For more information, visit www.neuromoddevices.com.
About tinnitus Klinika kft
Tinnitus Klinika kft, established in 2008, is a specialist tinnitus care provider that operates 3 clinics across Hungary at the Czeizel Institute in Budapest, Hallomás Center in Veszprém and at the University of Debrecen. Tinnitus Klinika offers a range of treatment interventions for people living with tinnitus.
Lenire is the first non-invasive bimodal neuromodulation tinnitus therapy device demonstrated to soothe and relieve tinnitus in a large-scale clinical trial. Lenire is CE certified for the treatment of tinnitus under the supervision of a suitably qualified healthcare professional in Europe. Further details of Lenire, including a list of suppliers, can be found at www.lenire.com.
(i) R. Biswas et al., Prevalence of tinnitus in Europe: a multi-country cross-sectional population study, The Lancet Regional Health (2021), https://doi.org/10.1016/j.lanepe.2021.100250
(ii) THI or Tinnitus Handicap Inventory is a clinical standard for measuring the impact of tinnitus on a person’s daily 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 a better quality of life by reducing how their tinnitus affects them.
(iii) Buechner A, Lesinski-Schiedat A, Becker P, Lenarz T, Real 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.
(iv) Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Scientific representative, https://doi.org/10.1038/s41598-022-13875-x (2022)
SOURCE Neuromod Devices Ltd