UTRECHT, THE NETHERLANDS — In a significant advancement for audiological care in the Netherlands, Neuromod Devices, a global medical technology company specializing in tinnitus treatment, has officially partnered with HearConsult, a leading Dutch audiology practice, to make its innovative Lenire tinnitus treatment device available to patients nationwide. This collaboration marks a crucial step in addressing the growing challenge of tinnitus, a debilitating condition affecting millions, particularly in a country where its incidence has seen a sharp increase over the past decade. The introduction of Lenire, a non-invasive bimodal neuromodulation device, offers a clinically validated therapeutic option to Dutch adults seeking relief from the persistent ringing, buzzing, or hissing sounds that disrupt their daily lives.
The Silent Epidemic: Tinnitus in the Netherlands
Tinnitus, commonly characterized by the perception of sound in the absence of an external source, is more than just a nuisance; it is a complex neurological condition that can severely impact an individual’s quality of life. Affecting an estimated 2 million adults in the Netherlands, this condition often leads to sleep disturbances, difficulty concentrating, anxiety, and depression. A recently published paper in PLOS ONE highlighted the escalating scale of this public health concern, reporting a staggering 33% increase in tinnitus incidence in the Netherlands between 2012 and 2021. This alarming rise has been largely attributed to a combination of modern lifestyle factors, including increased exposure to loud music, pervasive noise pollution in urban environments, and evolving personal listening habits. Of particular concern is the demographic shift observed in these statistics, with the largest increase in tinnitus diagnoses reported among younger adults aged between 20 and 44 years old, signaling a potential long-term public health crisis. The economic burden associated with tinnitus, encompassing healthcare costs, lost productivity, and diminished well-being, further underscores the urgent need for effective and accessible treatment solutions.
Lenire: Pioneering a New Era in Tinnitus Treatment
At the heart of this new partnership is Lenire, a groundbreaking bimodal neuromodulation device that has demonstrated clinically significant relief from tinnitus across multiple rigorous clinical trials and real-world patient analyses. Unlike traditional sound therapies or masking devices, Lenire employs a unique dual-stimulation approach, combining precisely timed audio tones delivered through wireless headphones with gentle electrical pulses administered to the tongue via a proprietary component known as Tonguetip®. This innovative bimodal stimulation is designed to induce neuroplastic changes in the brain, effectively "re-tuning" the neural networks associated with tinnitus perception and reducing its severity.
Dr. Ross O’Neill, CEO of Neuromod Devices, expressed his enthusiasm for the expansion into the Dutch market. "Bringing Lenire to the Netherlands, a country grappling with a significant and growing tinnitus population, is a pivotal moment for Neuromod Devices," he stated. "Our mission is to provide clinically proven, accessible solutions to those suffering from tinnitus. Partnering with a respected and patient-focused clinic like HearConsult allows us to extend the reach of Lenire’s life-changing therapy to a community that desperately needs it. We are committed to empowering individuals to regain control over their lives from the burden of chronic tinnitus."
A Journey of Validation: Clinical Evidence and Regulatory Milestones
The development of Lenire has been underpinned by extensive scientific research and rigorous clinical validation, setting it apart in the landscape of tinnitus treatments. Its efficacy and safety have been confirmed through multiple large-scale studies, culminating in significant regulatory achievements.
One of the foundational studies, TENT-A2, published in Scientific Reports by Nature in 2022, provided compelling evidence of Lenire’s effectiveness. This large-scale clinical trial demonstrated that 95% of compliant patients reported an improvement in their tinnitus symptoms, with an impressive 91% experiencing long-term relief that sustained for at least one year after the conclusion of their treatment. This sustained improvement is a critical factor for chronic conditions like tinnitus, offering hope beyond temporary symptom management.
Further solidifying its clinical standing, Lenire’s TENT-A3 controlled clinical trial, results of which were published in Nature Communications Medicine in 2024, proved the device to be clinically superior to sound-only therapy, which served as the control treatment in the study. This head-to-head comparison underscored the added benefit and unique mechanism of bimodal neuromodulation over conventional approaches. The findings from TENT-A3 were instrumental in Lenire achieving a landmark De Novo approval from the U.S. Food and Drug Administration (FDA) in 2023. This approval was a monumental achievement, making Lenire the first and only bimodal neuromodulation device to receive such a designation for tinnitus treatment in the United States. A De Novo approval signifies that a device is novel and provides a reasonable assurance of safety and effectiveness for a new intended use, setting a new benchmark for tinnitus therapies globally.
Beyond controlled clinical environments, Lenire’s effectiveness has also been validated in real-world patient settings. A retrospective chart review published in Communications Medicine (2025) detailed outcomes from 220 tinnitus patients treated with Lenire at the Alaska Hearing & Tinnitus Center. This analysis revealed that 91.5% of patients reported clinically meaningful reductions in their tinnitus severity after completing treatment, reinforcing the device’s consistent performance outside of trial conditions. These cumulative data points provide a robust evidence base for Lenire’s therapeutic claims, offering reassurance to both clinicians and patients considering this innovative treatment option.
Expanding Horizons: Lenire’s Growing European Footprint
The launch in the Netherlands is part of Neuromod Devices’ strategic expansion across Europe and the United States, making Lenire accessible to a broader international patient base. Prior to its availability in the Netherlands, Lenire has successfully launched in several other European countries, including Denmark, Norway, Spain, Italy, Poland, Sweden, Switzerland, and has seen further expansion within the United Kingdom. This steady growth reflects the increasing demand for effective tinnitus treatments and the device’s proven track record.
For Dutch patients, this expansion brings a much-anticipated local solution. Utrecht-based researcher Jan van Dam shared his personal journey with tinnitus and his experience seeking treatment with Lenire prior to its availability in his home country. "As a researcher, I spend quite a lot of time focusing in quiet spaces, and the noise from my tinnitus was incredibly distracting. It also made socialising difficult, as the internal sounds often masked external conversations," van Dam recounted. "I found Lenire’s clinical research compelling, so I traveled to Belgium for treatment. Now, after treating my tinnitus with the device, the tinnitus is much quieter, and it no longer annoys me. The ability to access this treatment locally in the Netherlands will be a tremendous relief for many." His testimonial underscores the significant impact chronic tinnitus can have on daily life and the transformative potential of effective treatment.
HearConsult: The Local Partner for Specialized Care
In the Netherlands, Lenire is exclusively available through HearConsult, a specialized tinnitus care clinic with locations in Mijdrecht and Utrecht. Founded by Koen Vernooij, Au.D., a practitioner with over three decades of experience in the hearing care sector, HearConsult is dedicated to providing personalized care, transparency, and comprehensive education for tinnitus patients. This patient-centric philosophy aligns perfectly with Neuromod’s commitment to delivering high-quality, evidence-based solutions.
Koen Vernooij, Au.D., owner of HearConsult, articulated the pressing need for Lenire in the Dutch market. "There has been a significant increase of people whose primary concern is tinnitus in our clinic, and this trend is common across all Dutch audiology practices," Vernooij observed. "We have closely followed the remarkable evidence emerging from clinics across Europe and the United States regarding Lenire’s efficacy. We are incredibly excited and proud to make this proven treatment option available at our clinic, offering new hope to our patients who have often felt that there were no effective solutions for their tinnitus." Patients interested in Lenire will undergo a thorough suitability assessment by a qualified healthcare professional at HearConsult to ensure the treatment is appropriate for their specific condition.
Empowering Patients: Tinnitus Information Sessions in Mijdrecht
To further educate the public and provide accessible information about tinnitus and its treatment options, HearConsult is hosting a series of free information sessions. These sessions are scheduled for March 26 and 27 in Mijdrecht, with two opportunities each day at 14:00 and 20:00. The comprehensive agenda will cover the various causes of tinnitus, an overview of available treatment options, and practical tips for managing the condition. This initiative reflects HearConsult’s commitment to patient education and empowerment. Attendance is free of charge, but due to limited capacity, advanced reservations are required and can be made through the HearConsult website at https://www.hearconsult.nl/. Complimentary parking and refreshments will be provided, ensuring a comfortable and informative experience for all attendees.
The Broader Impact and Future Implications
The availability of Lenire in the Netherlands represents a significant step forward in the global fight against tinnitus. For Dutch patients, it means access to a clinically validated, non-invasive treatment option that has demonstrated long-term relief. For the Dutch healthcare system, it offers a new tool in managing a growing public health challenge, potentially reducing the burden on primary care and mental health services often strained by chronic tinnitus sufferers.
From a broader perspective, Neuromod Devices’ continued expansion, particularly with an FDA De Novo approved device, solidifies its position as a leader in neuromodulation technology for tinnitus. This could encourage further research and development in the field, fostering a more innovative and patient-focused approach to a condition that has historically lacked effective treatments. The success of bimodal neuromodulation also opens doors for similar therapeutic applications in other neurological disorders, showcasing the potential of targeted neural stimulation. As the understanding of neuroplasticity evolves, devices like Lenire are paving the way for non-pharmacological, patient-controlled interventions that empower individuals to actively participate in their own recovery and well-being. The long-term implications for improved quality of life for millions suffering from tinnitus worldwide are profound, offering a future where the persistent internal sounds no longer dictate daily existence.
About Neuromod Devices
Neuromod Devices is a global medical technology company with offices in Ireland and the USA, specializing in the design and development of neuromodulation technologies to address the clinical needs of tinnitus patients. The company has completed extensive clinical trials to confirm the safety and effectiveness of its non-invasive bimodal neuromodulation tinnitus treatment device, Lenire, to treat this common but underserved disorder. For more information about Neuromod, visit www.neuromod.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. The device consists of wireless (Bluetooth®) headphones that deliver sequences of audio tones to both ears, combined with electrical stimulation pulses delivered to the surface of the tongue via 32 electrodes on a proprietary device trademarked as Tonguetip®. The device’s settings can be configured to provide treatment with different combinations of audio and electrical stimuli. The timing, intensity, and delivery of the stimuli are controlled by an easy-to-use handheld controller, allowing patients to complete treatment from home in between follow-up appointments with their clinician, after being prescribed by an appropriately qualified healthcare professional.
About HearConsult
HearConsult is a specialty tinnitus care clinic with locations in Mijdrecht and Utrecht. Founded by Koen Vernooij, Au.D., a practitioner with over 30 years of experience in the hearing care sector, HearConsult focuses on personalized care, honesty, and education for tinnitus patients.
About Tinnitus
Tinnitus, commonly known as ‘ringing in the ears’, is a complex neurological condition that causes a perception of sound when there is no external source. It is estimated that at least 2 million people in The Netherlands are currently living with tinnitus.
References
- Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep, nature.com/articles/s41598-022-13875-x (2022).
- Mc Mahan, E., and Lim, H. Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment, Commun Med (2025).
- R. Biswas et al., Tinnitus prevalence in Europe: a multi-country cross-sectional population study, The Lancet Regional Health (2021).
- Bes, J. et al, The impact of tinnitus on Dutch GPs: A retrospective study using routine healthcare data, https://doi.org/10.1371/journal.pone.0313630 (2024).
- Boedts, M., Beuchner, A., Khoo, S.G. et al Combining sound with tongue stimulation for the treatment of tinnitus. A multi-site single-arm controlled pivotal trial. Nature Comms. (2024).
Source: Neuromod