Lenire is a completely different take on tinnitus management. For many people, hearing aids, sound maskers, tinnitus retraining therapy, counseling, or lifestyle modifications provide relief for bothersome tinnitus. But what if you’re ready to try something new? Bimodal stimulation is one of the most interesting developments in new tinnitus treatment research.
Bimodal tinnitus treatment involves two different types of simultaneous stimulation of the nervous system. In the case of Lenire, sound stimulation is paired with a mild electrical pulse on the tongue.
What Is Bimodal Neuromodulation?
The term “bimodal” refers to two types, while stimulation refers to triggering parts of your nervous system. Neuromodulation alters nerve activity by sparking electrical, chemical, or pharmaceutical changes on a target area. Essentially, neuromodulation changes the established neural pathways and adjusts the brain’s activity – and for many people, bimodal neural stimulation improves symptoms.
It may seem like the nerves in the ear and the tongue are completely unrelated, but clinical trials have shown that bimodal stimulation can boost the symptom-reducing effects when treating various conditions of the central nervous system.
"Treble Health helped me reduce my tinnitus by about 80%, and now I can live my life again!"
"Treble Health helped me reduce my tinnitus by about 80%, and now I can live my life again!"
– Steve D.
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The key to bimodal neuromodulation is neuroplasticity, which is your brain’s adaptability. When you experience new things, your brain changes its function or structure. This is how you learn, remember, and change the way you think. The experience of being exposed to bimodal stimulation using a simultaneous sound and electrical stimulation is shown to lead to positive neuroplasticity in the areas of the brain thought to be related to significant reduction in the tinnitus symptom severity.
New advancements in bimodal neuromodulation look very different from the pioneering days of this study. Early bimodal neuromodulation studies involved an invasive process of placing electrodes directly on the nerves in guinea pigs, however, today, electrodes can be placed on the skin, such as the tip of the tongue stimulation, and the process is much less invasive. Modern clinical trials in humans have led to an exciting new tinnitus treatment.
How Does Lenire Work?
The Ireland-based medical device company, Neuromod, recently released a tinnitus management device called Lenire. The innovative Lenire technology for tinnitus treatment uses two modes of neural stimulation: electrical stimulation of the tongue and sound stimulation of the ears.
Lenire stimulates the trigeminal nerve by placing small electrodes on the tip of the tongue, while at the same time, it stimulates the auditory system with sound therapy through over-the-ears headphones. Both parts of the device are connected to a handheld component that looks like an old-school iPop, so you can start, stop, pause, and resume treatment anytime.
You can adjust the sounds you hear when using Lenire – like high-pitched pure tones – and the tone stimulation is very gentle – like the crackling of Pop Rocks candy.
How Do You Use Lenire?
The Lenire tinnitus treatment device is intended for prescription use only, and must be configured and calibrated during an initial fitting with an appropriately qualified healthcare professional. It is recommended to use the device for 30 to 60 minutes per day for a minimum of 12 weeks, and to do treatments in a quiet, comfortable location — relaxation helps support its effectiveness.
Neuromod recommends meeting with your audiologist or healthcare professional to check your symptoms after 6 weeks.
Is Lenire the Best Treatment for Tinnitus?
Lenire has introduced an intriguing approach with its bimodal neuromodulation. However, it’s worth noting that the gold standard in tinnitus management is still considered to be Tinnitus Retraining Therapy (TRT), which is what we based our program on here at Treble Health. The clinical outcomes for Tinnitus Retraining Therapy have yet to be beat; if and when they are, our team will use whatever device produces those results. For now, it’s still TRT until proven otherwise.
Clinical Trials Examining Lenire Bimodal Neuromodulation Device
2020 Large Scale Tent A1 Clinical Trials
In 2020, a large randomized trial called the Tent a1 study followed 326 participants using a bimodal neuromodulation device. This study showed that after 12 weeks of treatment with the Lenire device, more than 80% of participants reported a reduction in tinnitus symptoms using two outcome measures: Tinnitus Handicap Inventory (THI) score and Tinnitus Functional index (TFI). The THI and TFI are industry-standard questionnaires used to measure tinnitus symptoms and tinnitus symptom severity and effectiveness of tinnitus intervention to relieve tinnitus.
It’s important to note that this reported improvement could have been as minimal as 1 to 2 points in their scores. A clinically significant difference would be 7 points or more, so further research would be necessary to confirm these statistics.
2022 German Hearing Center Clinical Trial On Lenire Device
More recently, in March 2022, the German Hearing Center at Hanover Medical School conducted a clinical trial on 20 patients who were administered treatment with Lenire. This study found that 85% of treatment compliant participants reported a reduction in their tinnitus handicap inventory score. However, it is important to note that in this clinical trial, only 50% of individuals had a clinically significant change in their THI score. Even though this trial showed a lower rate of improvement, the average THI score improvement was considerably higher than in the 2020 study.
Possible Limitations Of The Lenire Device Clinical Trials
Lenire is a new technology, so there is still a lot to learn from future studies. The current research is missing some potentially important information like the impact of severe hearing loss or whether or not participants wore hearing aids. Overall, these trials are in line with what has been reported by people who have tinnitus and their audiologists. Ultimately, Lenire is another alternative therapy that can be used to support other tinnitus therapy techniques and to long-term habituation.
At the moment, Lenire looks promising, but it probably won’t become the be-all-end-all solution to tinnitus. Instead, it has earned a place in treatment techniques that might include sound therapy, hearing aids, counseling, therapy, and holistic lifestyle changes. All of these methods—including Lenire—have the potential to help you find tinnitus relief.
1. Is Lenire Available In The US?
As of March 7th, 2023, Lenire has been granted FDA approval and can now be used by tinnitus patients in the United States. Lenire is also available in select countries in western Europe, including Germany, Ireland, Austria, Belgium, and Denmark. However, there are significant wait lists in many parts of the US, so you may not be able to get it at this time.
2. Does Insurance Cover Lenire For Tinnitus?
At the moment, no. However, there may be a time when insurance does cover Lenire, depending on your country and type of insurance.
3. Can I Get Lenire Now Or Do I Have To Put My Name On A Waiting List?
In some locations you can get Lenire, but in many areas obtaining Lenire requires placing your name on a waiting list, and the wait times are unknown. If you need help with tinnitus now, we at Treble Health offer same-day access to our tinnitus management program without any waiting lists, via telehealth.
4. Can Lenire Be Programmed Remotely, Or Can It Only Be Used In Person?
Lenire is by prescription only, so when you begin using this device, you will need a recent hearing test and a set-up appointment with your doctor. Then, any follow-up, counseling, instruction, or check-ins can be done remotely.
5. Does Lenire Work For Hyperacusis?
While people who suffer from both hyperacusis and tinnitus can use Lenire, this technique focuses on treating tinnitus. Some people have found success using it for both conditions, but it is not meant as a treatment for hyperacusis.
6. How Much Does Lenire Cost?
Actual prices vary by location, but based on information from multiple clinics offering Lenire, the typical cost of the device ranges between $3,500 to $4,000. It’s important to note that while Lenire is by prescription it isn’t covered by insurance, and this price doesn’t include the costs associated with tinnitus testing or programming of the device. Additionally, because the device is used on the tongue, there’s no trial period or money-back guarantee. As a reference point, our program here at Treble Health is available starting as low as $287/month (for 12 months, at 0% interest).
7. Does Lenire Have A Trial Period Or Money-Back Guarantee?
Lenire does not offer a trial period or a money-back guarantee.
8. Does Lenire Improve Unilateral Tinnitus?
Results so far suggest that Lenire is effective in treating unilateral tinnitus as well.
9. Does Lenire Improve Tinnitus For People Without Hearing Loss?
Lenire can still be used without diagnosed hearing loss. Even if your hearing test results are in normal range, you may still experience changes in hearing that you didn’t have earlier in life. Hidden hearing loss occurs when cells in the cochlea stop transferring sound to the auditory nerve, and traditional hearing tests don’t always pick up on these changes.
10. Are Lenire Audiologists Tinnitus Experts?
Not necessarily. Lenire has audiologists fit their device, but they are not necessarily tinnitus experts. In contrast, here at Treble Health we pride ourselves on our team of seasoned audiologists who specialize in tinnitus, ensuring you receive expert care, not just a device.
11. Is Lenire A Cure For Tinnitus?
There is no confirmed cure for tinnitus, but Lenire could be a good addition to your treatment techniques.
Lenire treatment is still in development, but it appears to be helping patients with tinnitus. More than 50% of patients who tried it would recommend it to someone with tinnitus. As Lenire continues to be rolled out—along with many other bimodal stimulation devices—continue practicing good health and wellness and managing anxiety and stress. Oftentimes, general wellness offers the biggest opportunities to treat tinnitus while we wait for new technology to emerge.
In Conclusion: Exploring The Landscape Of Tinnitus Management
Lenire has undoubtedly brought an innovative approach to tinnitus management with its bimodal neuromodulation technique. For many, it represents hope in a journey often marked by uncertainty and discomfort. As technology advances, it’s heartening to see more options become available for those in need. However, as you navigate these choices, remember to compare new treatments to the existing standard, in this case, 25 years of research on Tinnitus Retraining Therapy. In our opinion, that is still the gold standard, and it’s what we base our program on here at Treble Health. Our data-driven results, dedicated team of audiologists, and patient-centered approach, including telehealth conveniences and a risk-free trial, ensure that you have diverse and effective solutions at your fingertips. Whatever path you choose, know that there’s a community supporting your journey to relief from tinnitus.