Blog

Increase your knowledge base.

Here's Why the Jury's Still Out on Lenire

Here’s Why the Jury’s Still Out on Lenire

By Hazel Goedhart, Director of Tinnitus Hub

You’re suffering from tinnitus and you’ve heard of this new treatment called Lenire. You’re wondering if it might be right for you. You might have found the Lenire thread on our support forum Tinnitus Talk but gotten discouraged at the thought of reading 7.000+ posts. You just want a quick, easy and, most importantly, independent assessment of this device. That’s why we compiled this article for you.


We cover:


What Is Lenire?

The tinnitus treatment device called Lenire® was launched by Neuromod Devices in June 2019. It has been the only serious attempt at a new tinnitus treatment of the past few years – ignoring of course the plethora of obvious scam products hitting the market every day.

Lenire is based on “bimodal neuromodulation” technology, which means stimulating two neural pathways simultaneously. In the case of Lenire, we are talking about sound stimulation through headphones at the same time as the trigeminal nerve being stimulated through electrical pulses to the tongue.


How to Get Lenire?

Lenire is only available by recommendation from an appropriately qualified healthcare professional. The device is currently offered through clinics in Ireland, Germany and Belgium. Whereas several visits to one of the clinics were previously required, due to the impact of COVID-19, Neuromod has been offering remote appointments for residents of Ireland and other EU countries since June 2020 from its clinic in Dublin, thus removing the need to travel.

Neuromod applies a pre-treatment screening, so beware that you may be told during/after your first appointment that you are not eligible (for instance due to severe hearing loss).

The device is priced at a steep EUR 2.500 – which is currently not covered or reimbursed by any public healthcare schemes.


How Was Lenire Tested?

The tinnitus community has long awaited the release of clinical trial data to support Neuromod’s claims about Lenire’s benefits. A group of researchers published their analysis of the company’s TENT-A1 trial in Science Translational Medicine (STM) – a highly regarded and peer-reviewed academic journal – earlier this month. You can find the article here.

It’s clear from the STM article, and the previously published trial protocol, that we are dealing with a clinical trial where the methodology is clearly described, the sample size is adequately large, outcomes are reported in detail, and long-term follow-up of participants was conducted. Such rigor has been sorely lacking in many tinnitus studies for the past few decades; hence, we applaud Neuromod for its diligence in this regard. However, we also identified some weaknesses in study design and reporting, which we will discuss below.


Does Lenire Work?

This is of course the million dollar question. Neuromod summarizes the results of their trial as follows: “86% of treatment-compliant participants experienced an improvement in tinnitus symptoms after 12 weeks of treatment.” This sounds promising at face value. But we have some caveats to the clinical trial results as reported in the STM article:

  • 86% refers to participants that showed ANY improvement, no matter how little. It has been demonstrated that natural improvement occurs for most people with tinnitus over time, so some of those 86% might have improved anyway without the device. See this study for instance, which attempts to quantify the degree of natural improvement for tinnitus.
  • Furthermore, an improvement of a few points on the Tinnitus Functional Index (TFI) or Tinnitus Handicap Inventory (THI) scale is not very meaningful. One could expect to see at least 50% “improvers” just from small variations in before/after questionnaire responses, unrelated to any kind of treatment. For both the TFI and THI scales ‘clinically significant’ improvement thresholds have been defined – reported here for TFI and here for THI. Although Neuromod has previously spoken of the minimally clinical important difference (MCID) outcomes of their clinical trials, for instance in the Tinnitus Talk Podcast, the STM article unfortunately does not report what percentage of participants experienced such a meaningful improvement.
  • The article also does not report what types of patients were more likely to benefit. Is tinnitus duration a factor? Is hyperacusis a factor? (Neuromod has previously stated that it is.) These questions remain unanswered until further analysis is done on the clinical trial data, which apparently is planned for a future paper.
  • Lack of placebo control: It is well-documented and proven many times over that ANY intervention (no matter how useless) will lead to SOME improvement simply because of the participant’s expectations or because they are given personal attention by an authority figure. In this study, however, no placebo group was used to correct for that effect. Neuromod CEO Ross O’Neill has previously stated in the Tinnitus Talk Podcast that designing a placebo for a bimodal stimulation treatment is challenging. However, Dr. Susan Shore, who is also working on a bimodal stimulation treatment, has designed a placebo version of her treatment, as described in this paper, which she also talks about in our video interview with her.
  • The STM article does not report on whether Lenire resulted in a reduction of tinnitus loudness. As tinnitus expert Dr. Richard Tyler stated: “You have tinnitus, and you have your reactions to tinnitus. Those are two different things. If you’re going to try and decrease the tinnitus, then you should be measuring the tinnitus.” Neuromod has previously spoken of their efforts to measure loudness with Minimum Masking Levels (MML) but those results have not (yet) been reported.

That might seem like a lot of criticism, considering that there are other tinnitus treatments on the market with much poorer supporting evidence. That is true, and trust me, we would love to conduct comprehensive reviews of all those treatments (and maybe we will). But as a small volunteer organization, we have to focus on what is currently new or generating interest. What is more, we are confident that the last word has not been spoken on bimodal stimulation. More data will come out, new players will join, treatments will be tweaked. So, we certainly hold out hope, but for now would not consider Lenire a breakthrough.


Is There Any Independent Study on Lenire?

Tinnitus Hub has conducted its own, independent, patient-led study on Lenire.

Comparison of Lenire Study Results

Please check here (PDF) for more details on the calculations behind this table.


Should You Buy Lenire?

There is no straightforward answer to that question. In our opinion – based on the currently available evidence – Lenire is not proven to be meaningfully more effective than (a combination of) existing treatment options such as sound therapy, hearing aids and counselling. We await and welcome more evidence on the efficacy of the device, and in fact Neuromod has assured us that more evidence is coming.

Nevertheless, it is clear that Lenire certainly might benefit some tinnitus patients; so, you will have to decide for yourself whether it could be right for you. Consider the following:

  • If you are hoping to be cured from your tinnitus, beware that this is very unlikely to happen with Lenire, but you might experience relief from your tinnitus in terms of distress (and maybe also loudness, but evidence on this is not yet published).
  • If you suffer from hyperacusis and you have no (perceivable) hearing loss, you are more likely to benefit* from Lenire, according to our study.
  • Ask yourself whether the potential benefits outweigh the financial costs and potential risks? Only you can make this judgement for yourself, based on your personal situation, the evidence presented so far, and the advice of your doctor.

If you decide to give Lenire a try, don’t forget to tell the rest of us how it worked for you!

* Please note that we are talking about potential benefits regarding your tinnitus symptoms; there is no evidence that Lenire improves hyperacusis in any way.


Help Us Continue to Inform You

This blog and the additional resources below are the result of literally thousands of hours of volunteer labor conducted by people who suffer from tinnitus, just like yourself. Please help us to continue to deliver the independent resources you seek, by making a donation of any size.
 


Learn More About Lenire

What do Lenire users say?

Tinnitus Hub’s Independent User Experience Study – June 2020

Our interviews with Neuromod’s CEO Ross O’Neill

Tinnitus Hub Lenire Study Infographic

18 Comments

  • Kendra Clendineng

    Thanks for putting this all together! All the information is much easier to digest this way.

    • Tinnitus Hub

      Thanks for the nice feedback, Kendra, that’s good to hear!

  • Jan D

    I spent a big part of my savings on Lenire last year, and it did nothing for me. I think I’m actually a little worse now, I get this sensitive feeling in my ears when I’m out and about.

    I’m also worried about the Bluetooth connection. They should have made the device wired.

    I haven’t given up on bimodal stimulation yet. Waiting for Dr. Shore’s device from University of Michigan.

    • Richard Howram

      Me too!

      I’m not as active on the forums anymore, but my tinnitus is as bad as ever after 18 months of diligent Lenire use. I’ve sent an e-mail today to the University of Michigan asking to be added to their mailing list regarding their version of this technology. Can you imagine how much you’d be willing to pay if someone said ‘guaranteed to work or your money back’?

      Here’s to a quieter 2021.

  • Mavick

    Thank you for the informative summation! Keep up the good work.

    I wonder when Lenire could see US launch? FDA is taking their sweet time. Not that I would be trying this… feels like a beta product.

  • Leviathan

    This is the kind of content British Tinnitus Association and American Tinnitus Association should put out too.

    MAD RESPECT FOR THE TINNITUS HUB TEAM!

    • Hazel Goedhart

      Thanks for the kind words; that’s the kind of stuff that keeps us going! 🙂

      • Richard Howram

        The BTA have been banging on for ages about a ‘biobank’ for tinnitus. What’s stopping them doing it? It’s not like they don’t know where to find 100s / 1000s of tinnitus sufferers.

  • Alex. C

    Nice review. Thanks for your time.

  • Sally Jackson

    Great balanced analysis, thanks so much. I’m an audiologist and have the same concerns with the current study (placebo and definition of “improvement”). I am bookmarking your site!

  • Deb

    Very helpful and succinct summary Hazel. Thank you.

  • Chuck Marshall

    Let me know when they can repair or re-grow the microscopic hair cells in the cochlea. Then I’ll have hope a *real* treatment is at hand.

    Of course, by then my great (to the tenth power)-grandchildren will be living on a planet thousands of light years from what’s left of earth.

    In other words, I don’t see this happening in my lifetime.

    • Frans Beentjes

      Hi Chuck,

      Tinnitus has all to do with the brain, hearing loss is just a trigger in my point of view, where parts of the brain lose control of signal processing. I haven’t got any hearing loss, my tinnitus is caused by a clogged ear after a cold. Just another trigger. That’s why it’s such a difficult condition to cure. Take care and all the best.

      Kind regards,
      Frans

  • Martin69

    Great summary. Thanks Hazel.

    They asked me to have Lenire treatment in Germany. But I rejected that since there is not a lot of evidence it’s working. I don’t want to spend the money for nothing.

    Today there will be a Webinar with Professor Lenarz and Professor Langguth about the “promising results” (as it is described) of the tinnitus therapy with Lenire. I’m looking forward to attend this. But I assume it is more promotion and marketing.

    Keep up the good work and take care,
    Martin69 from Tinnitus Talk

  • John Shurey

    Why don’t we fund four tinnitus sufferers that have differing variations and symptoms of the ailment and test the outcomes ourselves? Cost would be €10,000 EUR.

    We would then have factual information and be able to make a decision based on facts.

  • WAPPEL857

    Thank you!

  • Betty johnson

    I have had tinnitus since my stroke 10 years ago. This is very interesting to me. I have used some medication but no help.

    I use an ear vibration device when it is real bad. I get a little help from that. Nothing like holding your ears and crying for the tinnitus to stop.

    When do you think Lenire will come to the USA?

  • Henry batz

    I tore the ligaments in my rotator cuff. I had a lot of pain for three months. I think it triggered the tinnitus.

  • Write a Comment

    Your email address will not be published. Required fields are marked *

    Here's Why the Jury's Still Out on Lenire

    Here’s Why the Jury’s Still Out on Lenire

    By Hazel Goedhart, Director of Tinnitus Hub You’re suffering from tinnitus and you’ve heard of this new treatment called …

    Towards Tinnitus Subtyping

    Toward Tinnitus Subtyping: or Finding a Key for Each Keylock

    By Jorge P. Simoes, University of Regensburg Dearest members of the Tinnitus Talk community, My name is Jorge Simoes and …

    Citizen Science Tinnitus

    Why Tinnitus Needs Citizen Science: A Researcher’s Perspective

    By Deborah Hall, University of Nottingham, UK and Malaysia Citizen Science reflects a radical twist on the conventions of …