Neuromod Devices has partnered with HearConsult to introduce the bimodal neuromodulation system, addressing a reported 33% rise in tinnitus cases in the country.
Neuromod Devices has partnered with specialty tinnitus care clinic HearConsult to make the Lenire tinnitus treatment device available in The Netherlands. The device will be offered through HearConsult’s locations in Utrecht and Mijdrecht, expanding access to the treatment in a country where over 2 million adults are affected by tinnitus.
According to a recently published paper, the incidence of tinnitus in The Netherlands increased by 33% between 2012 and 2021, with the largest increase seen in adults aged 20 to 44.
“There has been a significant increase of people whose primary concern is tinnitus in our clinic and this is common across all Dutch audiology practices,” says Koen Vernooij, AuD, owner of HearConsult, in a release. “We have seen the remarkable evidence from clinics across Europe and the United States and we are excited to make this proven treatment option available at our clinic.”
Lenire is a non-invasive bimodal neuromodulation device that combines auditory stimulation via Bluetooth headphones with electrical stimulation pulses delivered to the tongue. The system is designed to drive long-term changes in the brain to relieve tinnitus severity. In 2023, the device was granted De Novo approval by the US Food and Drug Administration (FDA).
The FDA approval was based on the TENT-A3 controlled clinical trial, which demonstrated Lenire was clinically superior for tinnitus treatment compared to sound-therapy alone. Further evidence includes the TENT-A2 trial, with results published in Nature – Scientific Reports, which showed 91% of compliant patients reported long-term relief that sustained for at least one year after treatment. A real-world analysis of 220 patients published in Nature Communications Medicine found that 91.5% reported clinically meaningful reductions in tinnitus after treatment.
The Netherlands is the latest European country to offer Lenire, following launches in Denmark, Norway, Spain, Italy, and the UK, among others.
“As a researcher, I spend quite a lot of time focusing in quiet spaces, and the noise from my tinnitus was very distracting, and it also made socializing difficult,” says Jan van Dam, an Utrecht-based researcher who used the device, in a release. “I found Lenire’s clinical research compelling and now, after treating my tinnitus with the device, the tinnitus is much quieter, and it no longer annoys me.”
Lenire is available to patients through HearConsult following a suitability assessment. To support the launch, HearConsult is hosting four free patient information sessions in Mijdrecht on March 26 and 27.
Featured image: Man using Neuromod’s Lenire device to treat tinnitus while sitting in a chair. Photo: Eoin Holland
