Lenire Tinnitus Review | New Tinnitus Treatment By Neuromod

Lenire is one of the few FDA-approved devices available for tinnitus patients, with some even going so far as to call it a breakthrough treatment. With over 30 million Americans affected by phantom sounds, scientists are always looking for ways to help these patients overcome their tinnitus symptoms. 

Is Lenire the future for tinnitus patients, and how does it stack up against today’s leading tinnitus treatments? First, let’s explore how it works, what the manufacturers have to say about the device, and how medical experts feel about these claims.

Lenire by Neuromod

The name Lenire actually comes from the Latin term ‘Len-ear’, meaning soothe. This device was developed by Neuromod, a global medical technology business based in Ireland, Germany and the United States. Lenire was first approved in Europe in 2019, and by 2023 was approved in the US for medical use. 

The Lenire device uses bimodal stimulation to treat tinnitus, consisting of a tongue stimulation device along with over-the-ear headphones and a controller. The general idea is to retrain the brain to ignore the phantom sound, and more importantly, distinguish internal and external auditory signals. 

Bimodal stimulation devices aren’t new, and similar devices exist, such as Dr. Susan Shore’s Michigan Tinnitus Device and Neosensory’s Duo Device. Tinnitus patients are expected to wear their Lenire device for tinnitus at least an hour a day for 10 weeks.

Does Lenire Cure Tinnitus?

Any development in tinnitus treatment is exciting for tinnitus patients, especially those approved by the FDA. Many patients look to these devices as a potential cure, but not even Lenire touts the device as a cure for tinnitus. Here’s what Lenire has to say about their tinnitus device:

91% Of Users Had Sustained Relief

According to Lenire, 91% of people who used their device had tinnitus relief. At face value, this appears as if the overwhelming majority of tinnitus patients will benefit from the device. While this may be true for some, here’s what it really means:

91% of participants experienced any reduction in their Tinnitus Handicap Inventory (THI) score after a 12 month period. For some participants, this is as little as a 1-point improvement on a 100-point scale. This, however, fails to disclose the percentage of people with a clinically significant reduction in their tinnitus. Experts in the field do not consider an improvement by 1 or 2 points valid. 

An independent research study by the non-profit group Tinnitus Hub compared a percentage of their users who tried Lenire vs. Lenire’s own TENT-A1 research study. The study revealed that only 40% of the tinnitus patients had a clinically significant reduction in their tinnitus score on the Tinnitus Functional Index. Similarly, the TENTA2 Study from Lenire themselves reported that only 70% of their patients “indicated benefit” from using the device – 70% is far less than 91%. 

The 91% figure also excludes people with high anxiety, particularly those in the top 25% tier of anxiety levels. This does not mean Lenire does not work for someone with high anxiety, however, the data simply isn’t there. The same is true for people with somatic tinnitus caused by TMJ or head and neck injury. The success rate may be this high because these challenging cases are excluded.

Lenire Is Safe And Effective

The FDA has a multi-year multi-stage process for medical devices, meaning once Lenire has the FDA’s stamp of approval, it is certified safe and effective. Similarly, Lenire has a low risk of negative side effects (headaches, oral discomfort), and is a non-invasive approach to tinnitus treatment. 

Lenire can also be used alongside hearing aids for tinnitus patients who suffer from hearing loss. However, the manufacturers of the device advise waiting at least 90 days after being fitted with a hearing aid to try any new device.

Unless otherwise directed by your doctor, don’t use Lenire if you: 

• Have a pacemaker, defibrillator, or any other active implantable device
• Are pregnant
• Suffer from epilepsy or any other condition that may result in loss of consciousness
• Suffer from any condition that causes impaired sensitivity of the tongue
• Have lesions, sores, or inflammation of the oral cavity

Tested Against Sound Alone 

Sound therapy is one of the most common forms of tinnitus relief, and forms the basis of Tinnitus Retraining Therapy. Here, soothing sounds are played during waking hours with a sound machine or an ear-level sound therapy device with the ear canals open, allowing natural ambient sounds to the ear.

Lenire, on the other hand, uses over-the-ear headphones that block the ear canals and are used only one hour a day (twice a day in 30-minute increments). To date, there’s no proof that this is a better approach than sound therapy. Tinnitus Retraining Therapy has been the gold standard for treatment for over 25 years, with studies showing efficacy rates of over 80%. 

Is Lenire For Me?

The nature of tinnitus is largely subjective, which means all treatment methods are too. 

Lenire isn’t for everyone, as some Lenire reviews report minor to significant improvement, while others see none. While it’s designed to be used at home, patients still have to obtain it through an audiologist at a $4,000-$5,000 price tag. There’s also no trial period or return policy, so if it doesn’t work, that’s that. Lenire isn’t covered by insurance either. 

Patients with hearing loss and tinnitus stand to benefit more from addressing the cause of their hearing impairment, than using Lenire on its own. The Lenire tinnitus device does not address or manage hearing loss. 

Lenire is a good option for patients who haven’t had success with Tinnitus Retraining Therapy. With that said, it’s important to set realistic expectations. Many tinnitus patients use a multi-pronged approach to their treatment and are more successful under the guidance of a trained hearing health professional. 

Your audiologist is the only one who can prescribe Lenire, and they are the best person to advise you on its potential for tinnitus relief. With that said, keep an open mind. Most tinnitus patients find some sort of relief. 

Lenire FAQ

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. Our program has an 85% success rate, and begins with a free consultation. To schedule your free consultation and learn more, you can click here.

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 $4,000 to $5,000. 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 $391/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.

Treble Health Can Help You Find Tinnitus Relief

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 ensure that you have diverse and effective solutions at your fingertips.

If you are ready to start your journey towards tinnitus relief, we strongly encourage you to schedule a complimentary telehealth consultation with a tinnitus specialist on our team. This 20-minute Zoom call comes with no obligations, and is an opportunity for you to ask any questions that you may have, talk about your experience with tinnitus, and learn about the treatment options that would be most beneficial for your personal situation. To get start your path to tinnitus relief, click here.