Lenire — Bimodal Stimulation Treatment by Neuromod
- Thread starter Tinnitus Talk
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MemberIn the past I would drop an Eeyore GIF into the thread over @Heinrich_S7's sentiments but there's truth in what he's saying. From a business standpoint it looks like Neuromod is doing well closing more financing and announcing the German office, but from the standpoint of testimonials, it's still, as I said earlier, underwhelming.
Pitting Lenire against Susan Shore or Minnesota is speculative, though. We really don't know if those treatments will have better results on average.
Pitting Lenire against Susan Shore or Minnesota is speculative, though. We really don't know if those treatments will have better results on average.
The trial data they have is something, yes, but it's unreliable until it's been peer reviewed, everything we have heard in terms of outcomes statistically have all been from Neuromod. That's my question, we're coming up on October, why hasn't the peer review been released yet?
As far as the Michigan / Minnesota trials go, you're correct in that we haven't had as many people try them, but what we have heard is that no one has had a direct increase. Not. One. Single. Worsening. Yes Dr. Susan Shore's sample size is VERY small, but the fact is everyone had gradual reduction and there were no worsenings. Which leads me to 3 conclusions:
First, Lenire does work, it is legit, it's just the earliest weakest form of bimodal stimulation. Perhaps Michigan and Minnesota have a superior input method in terms of stimulation. Perhaps Neuromod will improve Lenire in the near future to be more effective. I think this is the likely scenario. Let's remember that Neuromod basically rented out Hubert Lim's skills and knowledge here. So I doubt they didn't hire him for nothing, they probably knew the Minnesota device was really good or had great potential and wanted to make a commercial version that just is not "as up to par" as Lim's actual team's methodology.
Second, Lenire IS just as effective as Michigan's and Minnesota's method, it's just that the result appear "after the 10-12 week treatment". Again, perhaps slightly different input with different nerves causing different side effects. But I'm going to be honest, I can forgive not seeing much improvement at the six week mark, but we're coming up on 10 weeks now for the first users on October 2nd, and to be completely honest with you the results don't look too good. Again, I'm only saying this because we're almost at 10 weeks.
Third, it's another Desyncra, and we're getting juked again. Perhaps they know this and that's why they're withholding the peer review. They might be thinking "Oh crap, we should probably make some return for the investors before we release the review from other institutions".
The testimonials don't really have anything to do with the effectiveness of the device, I've said this myself far earlier in this thread. But Ruse, you have to admit, some of them REALLY do tiptoe around the question. It makes me somewhat curious if Neuromod told them to make their statements this way so people wouldn't get their hopes up beyond anything but "infinitesimal" improvement. Perhaps Ross O'Neill knows it's not that potent (yet). Again the device might work, it's just that it's the first to market and it's the weakest of the three. If that's true, I don't see a point in slugging out several grand for 2 months of hell, just to get a teeny tiny reduction. Just doesn't seem worth it to me. @Allan1967's incident was horrible, I don't want that to happen to any of us. But we have to remember it's in early stages, perhaps Neuromod will iron these kinks out in the near future.
The Lenire trials were carried out by Neuromod themselves, so we don't know how much of that is true or not since no independent institution has repeated it so far. And the peer review is still an open question..
The current feedback by users sounds slightly positive, but nothing like a breakthrough.
No constant or real reduction in tinnitus yet. The placebo effect might play a role like in many treatments.
The whole story reminds me of the Desyncra launch in Germany. Everybody was asked to be patient and to wait the full treatment period before judging. There was also a person who experienced worsening and some who get better!
Bla bla exactly the same discussion as here.
At the end Desyncra failed (but is still sold).
I really do hope Lenire will make a difference! There is a perhaps a minimal chance that it works.
Every person is different and we unfortunately need to do "Trial & Error". Neuromod has absolutely no clue who will benefit and who will not, except for those with hyperacusis (super responders).
Everybody here is waiting for some relief.
But my expectation was also something like:
"I feel a permanent sound reduction" or
"The tinnitus changed to a slight hiss" or
"One of my various sounds disappeared"
The current feedback from Lenire users is similar to people who have undergone acupuncture, low level laser therapy or osteopathy.
The current feedback by users sounds slightly positive, but nothing like a breakthrough.
No constant or real reduction in tinnitus yet. The placebo effect might play a role like in many treatments.
The whole story reminds me of the Desyncra launch in Germany. Everybody was asked to be patient and to wait the full treatment period before judging. There was also a person who experienced worsening and some who get better!
Bla bla exactly the same discussion as here.
At the end Desyncra failed (but is still sold).
I really do hope Lenire will make a difference! There is a perhaps a minimal chance that it works.
Every person is different and we unfortunately need to do "Trial & Error". Neuromod has absolutely no clue who will benefit and who will not, except for those with hyperacusis (super responders).
Everybody here is waiting for some relief.
But my expectation was also something like:
"I feel a permanent sound reduction" or
"The tinnitus changed to a slight hiss" or
"One of my various sounds disappeared"
The current feedback from Lenire users is similar to people who have undergone acupuncture, low level laser therapy or osteopathy.
- Jul 17, 2019
- 87
- Tinnitus Since
- 2017
- Cause of Tinnitus
- Idiopathic/Bad shoes?
I mean it all depends on what you were expecting though Glenn. If you were expecting a forum full of users with dramatic or complete tinnitus reduction then I'd say, respectfully, you were being a bit naive.
AFAIR you mentioned earlier you'd have loved to have seen one or two users report dramatic reductions? But these were extreme outliers. Out of several hundred participants there were only what? A few of these. We only have about 10 or so people posting their experiences so far, so it would be unusual if there were any of these outliers thus far, statistically speaking. And we have @Redknight who has reported a fairly dramatic reduction. I can understand why you might be tempted to dismiss this as he's a relatively new sufferer but I'd urge you not to.
I initially had VERY low expectations for the user experience thread. I was expecting the device to be slammed and the actual numbers of responders in no way to reflect the trial data. Then I was going to go from there and see if I wanted to risk my hard earned cash on it.
But the overall results of the thread so far seem consistent enough with what Neuromod have claimed. Most people seem to get some sort of moderate reduction. And we aren't even at the end yet.
Have a little hope friend.
- May 22, 2019
- 257
- Tinnitus Since
- 01/2019
- Cause of Tinnitus
- NIHL & TMJ
For what it's worth I believe we should only really be comparing the other devices once we have peer reviewed trial results for all three.
Comparing one or two testimonials from the Michigan and Minnesota devices is going to be very unreliable and misleading.
At this stage there is nothing to suggest any one device is better or worse than the other.
If you do really believe that this won't work at all I implore you to consider how measurements like TLM and MML could be affected by placebo. We are talking about real volume measurements here rather than the perception of volume.
TLDR; I feel that a lot of people have seen two or three people get to week 6 or so without much improvement and hit the panic button.
I just can't help but wonder, how much money can realistically be made from a device that doesn't work before this becomes obvious to the general patient population?
Sure, Neuromod could keep this up for a little while, but once the first wave of patients has finished treatment and doesn't notice any improvement it would be all downhill from there for Neuromod. At their current rate of only 2 days per week where they do appointments, I honestly wonder if the company would get a return on investment before they go bust.
Imagine that they're in it for the money. Suppose they have this evil masterplan of knowingly scamming people. I just don't think much money is to be made this way... And what about Hubert Lim? Would he attach his name to something that wouldn't work?
Right now, all we can do is speculate. It'll become clear soon enough. Personally, I want to believe, albeit cautiously.
Sure, Neuromod could keep this up for a little while, but once the first wave of patients has finished treatment and doesn't notice any improvement it would be all downhill from there for Neuromod. At their current rate of only 2 days per week where they do appointments, I honestly wonder if the company would get a return on investment before they go bust.
Imagine that they're in it for the money. Suppose they have this evil masterplan of knowingly scamming people. I just don't think much money is to be made this way... And what about Hubert Lim? Would he attach his name to something that wouldn't work?
Right now, all we can do is speculate. It'll become clear soon enough. Personally, I want to believe, albeit cautiously.
JohnK
Member
- Nov 10, 2015
- 311
- Tinnitus Since
- 10/26/2015 (habituated) 5/13/2019
- Cause of Tinnitus
- Doxycycline (2015) Otimize ear drops [neomycin] (2019)
Less spiking which is nice, my hyperacusis also seems to be behaving - even around sounds that would usually trigger it. As for the overall volume, honestly, It's loud. My right ear has always been the prominent side with tinnitus but my left ear is now audibly louder. The increase in volume is unnerving but it's nothing that wasn't declared before starting treatment and should return back to baseline.
I have three weeks until my final assessment with Neuromod so I'm trying to bring myself to terms with being a "non-responder" to the treatment.
Currently debating whether to continue using the device after the 12 weeks is up or to cut losses and move on.
EDIT: I also want to disclose, I've got quite significant change of lifestyle coming up which is triggering a lot of anxiety and emotion. I suspect these are having an impact on my perception of my tinnitus and could even be contributing to the increase in volume.
This is a great argument. If Neuromod just wanted to fleece customers, they would be going full blast and running a pill mill handing out nonrefundable devices to anyone who walks through a door, before enough people notice that it's a scam and the jig is up.
Instead what they're doing is throttling the number of customers so that they can spend enough time with everyone, even rejecting people who they think won't fit the bill. This is not how a scam looks.
Lenire is a Generation 1 product of an entirely new medical technology. It is the iPhone in 2007. In time, Lenire itself will get better, and more devices will come to market, and we'll several perfectly polished devices competing with each other in a brand new branch of medicine.
But that is the future. Remember, this is a first-generation device, on the market for less than 3 months. Calling Lenire a dud and a scam because we are not inundated with stories of miraculous healings is just unrealistic and silly.
Question for the mods, how many of those reporting in have hyperacusis? I've gotta imagine a few. So I'm not yet sold even on the above.
Neuromod said the majority of people should expect a statistically significant improvement above and beyond placebo. They aren't promising complete tinnitus elimination and there were months of discussions here where we all mentally prepped for that kind of result. Please try to avoid exaggerating where I've set the bar.
Use some common sense. If after 12 weeks, NONE of the first batch of Tinnitus Talk users reporting in can report statistically significant improvement above and beyond placebo, we've got a problem. The sample size is large enough that at least a few should have success stories. I'm not really thrilled with @Redknight's reports so far. While improvement is not necessarily linear, the closer we get to the 12-month mark the less likely it will be that some of these people who have little positive to report will experience a sudden improvement. It's also likely that if that is how it goes down that the party line from optimists will be that these people may just need more time, and so we go into overtime week by week by week. 12 weeks becomes 24 weeks becomes a year. Expect if that happens to the forum to take a predictable turn into daily snipes from team optimist vs. team skeptic.
If I didn't have an appointment for early November already then I wouldn't feel hard-pressed to assess Neuromod now rather than a few months from now. But from my vantage point, and also considering the likelihood of a 2020 rollout in the US (should my concerns prove false) I will most likely cancel.
This is another thing, we know of course that not everyone is going to be a responder, I concede that, but the hyperacusis patients were said to have the best outcomes in the paper, so much so that they labeled them "super responders". It's generally accepted by Neuromod that this subgroup of tinnitus patients benefit the most from Lenire.
I'm sure a few of the people who got their Lenire in July who have hyperacusis would have reported back with at least some improvements by now, as I said, we're at 10 weeks as of October 2nd. Perhaps improvements will come after the initial treatment phase is over, but I'm going to be honest, it looks like something that can be chalked up to placebo.
It is pretty underwhelming for several thousand along with 2 months of worsening, which isn't uncommon in the slightest, I'm also curious as to why Neuromod never warned patients about this when commercialization began, they MUST have had this happen to SOME people in the TENT-A1 and A2 trials, I don't recall them mentioning this, which also concerns me. If anyone can correct me here, I don't recall the data they showed mentioning the increase in volume during the initial phase of treatment.
I'm not trying to be a downer here guys, I think bimodal stimulation works, it's just that we're in the "early days" right now. Improvements and refinements will be made later down the road, perhaps Lenire launched too early because of demand and that's why the results aren't too mind blowing yet.
But right now, I can't justify spending my money on this thing yet. Even the people who do have results seem do not notice all that much decrease. I wasn't expecting a "Miracle Cure", but I was expecting a moderate reduction in the responders group. Say 30-40% better post treatment. Right now, the improvements seem fairly insignificant.
What I am worried about now is that @Cojackb is also reporting some tinnitus increase or am I wrong? Sorry I am German, and sometimes can not 100% follow your meanings.
Perhaps the tinnitus increase is because of Lenire or due to his change in lifestyle combined with anxiety etc.
But if anxiety plays a role, why is only one ear affected... not both?!
Perhaps the tinnitus increase is because of Lenire or due to his change in lifestyle combined with anxiety etc.
But if anxiety plays a role, why is only one ear affected... not both?!
@Allan1967 certainly wasn't and isn't alone in this issue, and it's pretty terrifying how common it is, which is why waiting until they have it ironed out seems like a good idea at the moment.
This doesn't seem to be an issue over at Minnesota and Michigan though, so obviously the devices do function differently in their inputs to some extent, which is likely to yield different results.
This isn't limited to just tinnitus, this is the thing with any new treatment, technology or medical technology. It gets out into the world and people report side effects. We're finding out that bimodal stimulation can in fact have complications as a treatment, even if transient/temporary.
This is why I'm not going to get the "first generation" Neuralink. The first adopters will basically be guinea pigs.
- Jul 17, 2019
- 87
- Tinnitus Since
- 2017
- Cause of Tinnitus
- Idiopathic/Bad shoes?
Again it comes down to the numbers. In TENT-A1 they defined statistically significant as 7 or 10 THI points of improvement, I can't remember which. When they say significant what they meant was these numbers. Significant in a statistical sense. Not significant as in a dramatic/life altering improvement. But simple a line in the sand, with placebo/no intervention sitting on one side and minimally effective treatment sitting on the other.
While you might disagree with the line they draw they've never drawn it any differently and it has to be drawn at some point. Taking into account that TENT-A2 improved this to 20 points and that they've probably learned more since: You should know the risks of non-response and roughly what percentage improvement to expect given your baseline.
These were your words exactly.
I'm genuinely not trying to catch you out Glenn. I was just pointing out that these "outliers" or dramatic improvers were rare in a testbed of 500 odd subjects. So not seeing one yet in a group of 10 isn't unusual or worrying.
Again it comes down to expectations I think. I personally, am excited because 20 THI points from my 30-40 would be dramatic. That's assuming of course that I land in the majority of responders and inside the average improvement bracket. Someone with a baseline of 100 THI may have to have a long hard think about whether 20% is worth 2 grand? For some it will be. For others it may be best to wait a year and see how this thing pans out.
Maybe you should? I'm not trying to be mean but if you're this worried about it then maybe you should hold on to your cash and see how the dust settles.
Haven't been on Tinnitus Talk much recently because of personal commitments. However, today I have been looking through the Lenire thread to see what has changed. Firstly, I would like to congratulate Tinnitus Talk on their hard work producing the Lenire User Experience thread and other surveys which have been providing non-users such as myself with so much valuable data.
Although these are still relatively early days I think we can start to draw some conclusions from the user reviews we have. So far the hype around Lenire seems to be unjustified. The majority of users reporting appear to have little significant benefit - and unfortunately in some cases a few have reported an increase in loudness. It is true that a few users have reported some positive benefits though I note that the majority of these had tinnitus onset only recently and it is difficult to know whether this is not just natural habituation.
I'll continue to read the reports with interest and thank those who have taken part in surveys and written reviews.
Although these are still relatively early days I think we can start to draw some conclusions from the user reviews we have. So far the hype around Lenire seems to be unjustified. The majority of users reporting appear to have little significant benefit - and unfortunately in some cases a few have reported an increase in loudness. It is true that a few users have reported some positive benefits though I note that the majority of these had tinnitus onset only recently and it is difficult to know whether this is not just natural habituation.
I'll continue to read the reports with interest and thank those who have taken part in surveys and written reviews.
Haha, we have had that since the previous thread. By now I can just look at the username and immediately predict the tone of the reply with 90% certainty.
There's more data to evaluate now vs. months ago. At some point that has to shift people's opinions.Haha, we have had that since the previous thread. By now I can just look at the username and immediately predict the tone of the reply with 90% certainty.
Neuromod did warn us; more than once. It's also in the manual.
Only @Allan1967 has had a significant worsening since treatment started and he has had awful, unrelated issues, that are certainly factor into that worsening.
Some of the rest of us had mild worsening at the start and then benefits and some have had little benefit... You know, like the trial data showed.
It's important to remember what the leaked trial data showed; a general benefit of a few THI for most, with a few outliers who had fantastic results. A reduction of 10-12 THI for someone at 70 THI doesn't represent 40-50% noise reduction. It represents small changes, like the trial participants saw. Like, I notice my tinnitus less at work, or I get less irritated with my family.
It's hard to read the current wave of pessimism in this thread as I type now after my 3rd straight day of silence, preceded by weeks of drastically reduced volume. There will be those who write my reduction in volume off as "healing" or habituation, I can assure you this isn't habituation. Even if Lenire works best for new sufferers, is that not amazing news for future sufferers, even though it doesn't serve your own need?
Just my thoughts.
Attachments
Guys, it's far too early. I'm not counting for results until 1 month after the 3 (4?) months of treatment.
This is about neuroplasticity and it takes time.
This is about neuroplasticity and it takes time.
- Dec 18, 2015
- 618
- 45
- Tinnitus Since
- 03/2015
- Cause of Tinnitus
- Noise induced, loud rock concert
@Redknight sorry if this was mentioned already but what was your tinnitus like? Tonal or broadband/cricket and was it more in your ears or head?
Mostly tonal, but would get noisy when I'm stressed or tired. In head and ears, it varied.
Thank you @Redknight for clearing the waters. This thread can get so damn depressing and negative sometimes, and it's affecting me.
Is it really true Neuromod only sees people on two days each week? That little piece of information made me really worried that I will be on a waiting list for an extremely long time.
Is it really true Neuromod only sees people on two days each week? That little piece of information made me really worried that I will be on a waiting list for an extremely long time.
THI doesn't measure the loudness of tinnitus. You can have mild tinnitus and be very bothered.
I can hear my tinnitus over street noise, in cars , but I am still able to sleep and concentrate.
My opinion is, if your tinnitus goes from loud to moderate, or from moderate to mild, that will be a huge improvement.
- Dec 18, 2015
- 618
- 45
- Tinnitus Since
- 03/2015
- Cause of Tinnitus
- Noise induced, loud rock concert
They told me last week they only have device fitting appointments for Tuesdays and Fridays. I don't know if it applies as well to the first assessment visit but I suspect yes unfortunately. All my follow up visits are on Fridays.
I'm really glad that Lenire is working out well for you @Redknight. However, I note from your profile that your tinnitus dates from March 2019. It is not at all unusual during the first months after tinnitus for it to decrease significantly and it is quite likely that this is what is happening here - Lenire simply assisting the habituation process. I'm going to have to see quite a lot more positive reviews and feedback from those who have had tinnitus for a longer period to be convinced that there is more to it than that. So far I haven't. It is as I said before "early days" but the reviews on the User Experience Thread suggest that your experience currently is more of an outlier.
The way I see it, either it proves successful and they will expand their services and start up new treatment centres which should shorten the waiting list or it doesn't work and you will be glad not to be on the waiting list at all.
This problem should sort itself out.
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