Lenire — Bimodal Neuromodulation Treatment by Neuromod Devices

Discussion in 'Treatments' started by Tinnitus Talk, Apr 20, 2019.

    1. Tinnitus Talk
      Balanced

      Tinnitus Talk Knowledge Base

      Earlier today, Neuromod Devices announced the name of its soon to be launched tinnitus treatment: Lenire™. The device has a long history. We know that many of you have been eagerly awaiting Lenire’s arrival. But for those of you relatively new to the discussion, let us give you a recap of what has transpired so far.


      To Launch or Not to Launch?

      Here at Tinnitus Talk we have witnessed the device’s initial conception in 2011 as “MuteButton,” building up to a launch in 2015. The device was on sale for a couple of months in Dublin, before Neuromod pulled it from the market to conduct more thorough clinical studies and pursue FDA approval. Since then, the company has conducted one large scale clinical trial (TENT-A1), with a second one in progress (TENT-A2). Based on our Q&A with the company a few months ago, they seem to believe there is now enough substantiating evidence to bring the device to market, although we are still in the dark as to an exact launch date.


      How Does the Lenire Treatment Work?

      Lenire is based on “bimodal neuromodulation” technology. Neuromodulation is the use of electrical stimulation to modulate nervous system functionality for therapeutic benefit. Neuromodulation has been applied in different ways – and with some, but limited success – to treat tinnitus, for instance as repetitive transcranial magnetic stimulation (rTMS). With bimodal neuromodulation, two pathways are stimulated simultaneously. In the case of Lenire, this concerns auditory stimulation through sound, and somatosensory stimulation of the trigeminal nerve, through electrical pulses to the tongue.


      Is It a Cure? Is There Evidence That It Works?

      The protocol of Neuromod’s TENT-A1 study was already published in 2017 and can be found here. The results from that study are yet to be published, but Neuromod did discuss the outcomes with us during the video Q&A we conducted with them last December.

      During our Q&A, CEO Ross O’Neill spoke of 80% of patients who reported some level of improvement of their tinnitus after 12 weeks of treatment, and more than two-thirds who experienced a “clinically significant” improvement. He also reported that hyperacoustic patients in particular responded well to the device, with significant improvements in their tinnitus (not per se their hyperacusis though). However, it's hard to infer what this really means without seeing the full data, and getting answers to questions like: how significant improvement was defined, how the placebo effect was accounted for, and how response varied between different patient groups.

      The full results of Neuromod’s TENT-A1 clinical trial are yet to be published (supposedly sometime in 2019), and the follow-up TENT-A2 trial is still in progress. So, we will need to await the publication of the data before we can assess just how well this new device works, and for whom. And of course, we will need to hear some actual patient experiences once the device is on the market.


      At Least They've Done Their Homework — Study Design Seems Rigorous

      Regardless of the outcomes though, Neuromod should be commended for the rigorous manner in which its trials have been set up. TENT-A1 was a randomized, triple-blind study with 324 participants. Randomized means that patients were randomly assigned to different groups with different treatment regiments (in this case, three different device settings). Triple-blind refers to the fact that neither the subject, nor the person administering treatment, nor the person evaluating the response to treatment knows which subjects are receiving which treatment. TENT-A1 was designed to discover optimal parameter settings for the device and compare between different patient groups (tinnitus sub-types). The study protocol seems to suggest that the follow-up TENT-A2 study will be employing a control group as well.

      It’s particularly refreshing to see Neuromod take such a thorough approach, because the tinnitus research field has been plagued by a plethora of low-quality clinical trials, in terms of both design and reporting. This has unfortunately held back progress in developing effective treatments and new clinical practice standards. This problem was made all the clearer by the publication of the new European Clinical Practice Guidelines for tinnitus last month. The vast majority of treatments covered in the guidelines received a “no recommendation” verdict, because there simply isn’t enough high-quality evidence available to tell whether it works or not. [Spoiler: our next podcast episode, coming out in about a week, will cover this topic exactly.]


      The Waiting Continues…

      There has been criticism from the patient community about Neuromod’s lack of communication over the past few months. Whether that’s justified or not is hard to say, since we don’t know the reason for the radio silence. All we can hope for is that more information will be forthcoming soon.

      We look forward to the launch of the device, and hope to hear some patient testimonials from those of you who are able to get access to it in the short term – most likely members who are based in Ireland, since that’s where the device will be launched first. Please keep your fellow Tinnitus Talk informed of your experiences.

      Here’s to hoping that at least some of us will find relief from this affliction through Lenire.


      lenire-neuromod-devices-tinnitus-treatment.png
       
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    2. Contrast

      Contrast Member Benefactor Hall of Fame

      Location:
      Retrovile
      Tinnitus Since:
      late 2017
      Cause of Tinnitus:
      injury from noxious noise
      These are really exciting times. The only reason things like this are happening is because the community is vocal and challenging the status quo of what audiologists and the old guard are saying.

      However only time will tell how this fares, fingers crossed.
       
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    3. Rohov Dmytro
      Batty

      Rohov Dmytro Member

      Location:
      Kyiv
      Tinnitus Since:
      02/2019
      Cause of Tinnitus:
      Unknown
      Hey! They paid for the domain for 10 years upfront. Seems like tiny but a good sign for me.

      upload_2019-4-20_11-14-17.png
       
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    4. ZachB

      ZachB Member

      Tinnitus Since:
      01/2018
      Cause of Tinnitus:
      Unknown
      I will move to Ireland to get this. Get us a launch date ASAP Neuromod!
       
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    5. dayma
      Inactive

      dayma Member Benefactor

      Tinnitus Since:
      1/6/2018
      Cause of Tinnitus:
      UNKNOWN
      Seems like it's not just Ireland though right? When they say Europe I am curious what their timing with England will be.
       
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    6. hans799
      Mellow

      hans799 Member Benefactor

      Location:
      Hungary
      Tinnitus Since:
      Born with it
      Cause of Tinnitus:
      Worsened Dec 2016 by headphones
      Great news! Neuromod might be taking things slower than we'd prefer, but this is a sign that they still 100% intend to go ahead and come to market. Also, this happened a bit earlier than expected (opposition period for the trademark was supposed to end early May).

      Me (and my credit card ;) ) can't wait for more news!
       
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    7. winstona
      Balanced

      winstona Member

      Location:
      Toronto, Canada
      Tinnitus Since:
      Oct 2017
      Cause of Tinnitus:
      Loud noise exposure and excessive ear irrigation
      I remain optimistic that this device is going to make a difference. With the new trademark registration and a new name, I hope it’s close to being released.
       
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    8. Alex Matyjasek
      Not amused

      Alex Matyjasek Member

      Location:
      Sant Carles de la Ràpita, Spain
      Tinnitus Since:
      8 September 2018
      Cause of Tinnitus:
      Stress? Wish I knew!
      I'm not too optimistic. Remember the testimonial videos from Neuromod, and Markku not getting a reply from them. I think this device is basically going to be a lottery machine. It either will or will not work for you. And if it does, let's see how much relief we will get...
       
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    9. fade2black244
      Inspired

      fade2black244 Member Benefactor

      Location:
      TX
      Tinnitus Since:
      03/24/2017
      Cause of Tinnitus:
      Noise Induced
      Woah, times for tinnitus are changing fast. I don't even care, I will fly out to Europe to get treatment for this if it works.
       
      • Agree Agree x 8
    10. ZachB

      ZachB Member

      Tinnitus Since:
      01/2018
      Cause of Tinnitus:
      Unknown
      All these devices won’t help EVERYONE. Even the flu shot and surgeries involve risk and aren’t 100% effective.

      But if 2/3 of patients get significant reduction then that’s definitely worth trying to see what effect it might have for you.

      I only got tinnitus 4 months ago and can’t imagine living the rest of my life with it. I’ll try any legitimate treatment.
       
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    11. Soren

      Soren Member Benefactor

      Location:
      Denmark
      Tinnitus Since:
      12/2017
      Cause of Tinnitus:
      Loud sound
      What is wrong with the testimonials? To the second point we are not owed an answer. Third, yes it is a lottery, they have said as much. At the moment it works for 2/3 of people with tinnitus. As for the relief we just don't know, but if other bimodal neuromodulation tests are to be believed then it ranges from anywhere from 3 dB to 10 dB or more in some cases. Some even saying that their tinnitus is gone.
       
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    12. Allan1967

      Allan1967 Member Benefactor

      Tinnitus Since:
      1997
      Cause of Tinnitus:
      Ear infection
      Surely the fact that Susan Shore's team are working on a similar concept, this can only be a good thing, right?

      I also take some comfort from the fact that Neuromod employed some big names... I mean, would people like Hubert Lim put their professional reputations on the line for something that's a dud? The tours, the advertisement in the ATA, the €24 million investment.

      Anyway... I've registered and I believe from what I've read is it doesn't matter how many noises you have; what the cause was or how intense it is... provided you have reasonable hearing you're in with a chance. Please correct me if that's wrong.

      I intend to get this, for once in my sorry life this company isn't on the other side of the world (I'm an hour's flight time away) so however it gets released I'll do my best to get in there early on.
       
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    13. Allan1967

      Allan1967 Member Benefactor

      Tinnitus Since:
      1997
      Cause of Tinnitus:
      Ear infection
      I'd flop my wedding tackle in the mouth of a Great White Shark for 20% relief.
       
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    14. OnceUponaTime
      Fine

      OnceUponaTime Member Benefactor Hall of Fame

      Location:
      New York
      Tinnitus Since:
      11/11
      Cause of Tinnitus:
      Allergies or Acoustic Trauma, Stress
      This is great news! Here's to hope!
       
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    15. KotaDomowa
      Dreaming

      KotaDomowa Member

      Location:
      Poland
      Tinnitus Since:
      Februar 2018
      Cause of Tinnitus:
      Unknown
      It seemed to me that the average Neuromod improvement was 10 dB, but now I'm not sure where it came from.
       
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    16. Allan1967

      Allan1967 Member Benefactor

      Tinnitus Since:
      1997
      Cause of Tinnitus:
      Ear infection
      What does this 3 dB to 10 dB mean?
       
    17. Soren

      Soren Member Benefactor

      Location:
      Denmark
      Tinnitus Since:
      12/2017
      Cause of Tinnitus:
      Loud sound
      Reduction of how loud the tinnitus is.
       
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    18. fade2black244
      Inspired

      fade2black244 Member Benefactor

      Location:
      TX
      Tinnitus Since:
      03/24/2017
      Cause of Tinnitus:
      Noise Induced
      Noise perception - loudness level(s).
       
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    19. Bart
      Doh

      Bart Member

      Location:
      Antwerp
      Tinnitus Since:
      05/06/2014
      Cause of Tinnitus:
      2014 Noise / 2018 ototoxic meds
      If this is true, a 3 dB to 10 dB reduction might seem marginal but in terms of the actual tinnitus loudness it is huge.
       
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    20. Rohov Dmytro
      Batty

      Rohov Dmytro Member

      Location:
      Kyiv
      Tinnitus Since:
      02/2019
      Cause of Tinnitus:
      Unknown
      10 dB does not seem much.

      upload_2019-4-20_23-50-45.png

      Can you explain why it is huge?
       
      Last edited by a moderator: Apr 20, 2019
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    21. Bob den Hartog

      Bob den Hartog Member

      Tinnitus Since:
      11/2018
      Cause of Tinnitus:
      Noice induced
      Because in this case, the needle drops directly in your ear.
       
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    22. taco
      No Mood

      taco Member

      Tinnitus Since:
      06/2015
      Cause of Tinnitus:
      noise induced
      It seem to me the dB level is only important as it relates to your particular tinnitus noise level. 10 dB could be enough to suppress many people's tinnitus discomfort. And even if your tinnitus is super bad, it can only help.
       
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    23. Soren

      Soren Member Benefactor

      Location:
      Denmark
      Tinnitus Since:
      12/2017
      Cause of Tinnitus:
      Loud sound
      dB is exponential meaning that 40 dB is double the volume of 30 dB and 50 dB is double the volume of 40 dB and so on.
       
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    24. Manny
      Sad

      Manny Member Benefactor Hall of Fame

      Location:
      United States
      Tinnitus Since:
      1/2018
      Cause of Tinnitus:
      central gain << NIHL
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    25. dayma
      Inactive

      dayma Member Benefactor

      Tinnitus Since:
      1/6/2018
      Cause of Tinnitus:
      UNKNOWN
      You can play with dB levels online if you want to understand the difference. It’s hard to explain the difference. It is best experienced.
       
    26. taco
      No Mood

      taco Member

      Tinnitus Since:
      06/2015
      Cause of Tinnitus:
      noise induced
      Do we really know how to compare dB levels for external noise versus head ringing sound. I don't know the answer to this. But we may be trying to compare apples to oranges.
       
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    27. GregCA
      Jaded

      GregCA Member Benefactor Hall of Fame

      Tinnitus Since:
      03/2016
      Cause of Tinnitus:
      Otosclerosis
      Yes, we do.
       
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    28. Alberte

      Alberte Member

      Location:
      Canada
      Tinnitus Since:
      4 years
      Cause of Tinnitus:
      Unknown
      Thank you for the update. Neuromod device is very positive news.
       
    29. urgentresearch
      Probing

      urgentresearch Member

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Unknown (possibly withdrawal-induced)
      Lenire... as in... "Oui, oui, mes amis... this device will be available in le nire future!"

      :headphone:
      :woot:
       
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    30. Alue
      No Mood

      Alue Member

      Tinnitus Since:
      01/2016
      Cause of Tinnitus:
      Acoustic Trauma
      I remember reading somewhere that the majority of tinnitus cases are under 10 dB when you account for tone and hearing threshold level (dB SL). I don't know if I believe it as my tinnitus was consistently measured (matched) at around 30 dB multiple times, but I do think people overestimate the decibel level of their tinnitus. Minimum masking level (if you can mask it) is not the same at all.
       
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