Lenire — Bimodal Stimulation Treatment by Neuromod

[UKBloke]

@hans799 I just want to say that I think you've been a real trooper during this past year. Putting yourself out there, being public with your experience all the while keeping a level head has given this community a stretch of clear data that I just don't think we would have gotten otherwise. Thank you for everything you've done.

I agree with you. Regarding Lenire at this point, it seems enough is enough. For what it's worth, my own tinnitus has been a real bitch these past few months too. All over the place. Having said that, I, like you have been in a much better place with it in the past. I'm sure those level days will come again for both.

Take care man.

 

[UKBloke]

I remain thoroughly confused on this point.

Me too. Thoroughly, thoroughly confused.

 

[Chinmoku]

Lenire definitely does something - it affects tinnitus; it did give me extraordinarily quiet days; I did have a few magical weeks back in December 2019. However, I also think that the device is very poorly understood. Those magical weeks never come back and Neuromod doesn't seem to be able to offer meaningful advice. They're well-intentioned, courteous and professional, and their device has great potential, but it needs a lot more data and refinement. I hope they'll be able to release an improved version that lives up to that potential.

This is an excellent summary, which perfectly captures the situation in my view. Thank you for all your work and your testimony, and I completely understand your decision to take a break.

 

[Krolo]

@hans799 Thank you for your testimony here. Made me pull my thumb out of my ass and write a little bit of an overdue user report <3 Hope your tinnitus dies down to the regular level!

I hope that the Neuromodulation gets paired with proper Machine learning and EEG monitoring. This is probably our best bet of getting something that works properly. Neuromodulation is definitely a way I think. But we are at Medieval times at this moment and need the tech to be less into the quick buck and be more about going the extra mile to get individual based treatments.

I find Lenire as a very blunt instrument at this point in time. It does something but it´s not hitting the problem, it is hitting it and everything else at the same time. That´s probably why we are getting these adverse events that not only me have experienced.

But if I would take a test how I feel it would be much better now than before starting Lenire. Tinnitus is not really better but my mind does. Habituation or Lenire. No answer possible since I can´t go back in time.

I truly wish that we all get something that can cure us <3

 

[hans799]

I'd like to see Tinnitus Talk gather data to determine how long-lasting Lenire's effect is because I remain thoroughly confused on this point. Neuromod said improvement should last whereas disimprovement should fade which never made any sense.

I agree, this is baffling. This needs to be addressed, especially in light of the Tinnitus Talk study which showed a 20% chance of adverse events.

@UKBloke @Chinmoku @Krolo Thank you. Your words mean a lot. We may never meet (well, except with Krolo - thanks for that Guinness, man!) but as tinnitus sufferers we understand each other on levels not possible with other people.

I find Lenire as a very blunt instrument at this point in time. It does something but it´s not hitting the problem, it is hitting it and everything else at the same time. That´s probably why we are getting these adverse events that not only me have experienced.

Perfect metaphor. Previous treatments were snake oil, did absolutely nothing. Lenire's a blunt instrument which does work for at least some people. That's a step up, in my book.

 

[GlennS]

Lenire's a blunt instrument which does work for at least some people. That's a step up, in my book.

I don't think so on the basis that it's irresponsible to sell a product with such a high probability of worsening someone's condition. It's also scandal-grade that they overstated the efficacy and downplayed the risks. They deserve to be called on this. I mean, I know first adopters were aware they were taking a risk but they took MORE risks than the Neuromod's claims suggested. There needs to be some accountability there rather than just:

"Oopsies. Sorry your tinnitus is now suicidal-grade. Buh bye and good luck."

 

[Phendran]

Where could I find out more about this?

I got them via a Swedish audiologist company called Audika, and the company that makes these kinds of earplugs are called Bellman & Symfon.

Here is their page with offices around the world. There are a bunch of different models of plugs(General dampening, for motorcyclists, construction workers, etc), and an audiologist is supposed to help you find the right kind of plug in case you are unsure of what to get.
Mine are of the ER-model. They are "regular" musician's plugs, with 15dB filters in them.

I'm not sure if they provide custom plugs where you are, but if not I hope there is a similar entity you could turn to.

 

[davidmp]

My part-time PhD student who oversaw that study is still analyzing those data and will prepare a manuscript for journal submission.

So as we can see, the resources committed to the research are a part time PhD student. It does not look really promising.

 

[Agrajag364]

I don't think so on the basis that it's irresponsible to sell a product with such a high probability of worsening someone's condition. It's also scandal-grade that they overstated the efficacy and downplayed the risks. They deserve to be called on this. I mean, I know first adopters were aware they were taking a risk but they took MORE risks than the Neuromod's claims suggested. There needs to be some accountability there rather than just:

View attachment 39339
"Oopsies. Sorry your tinnitus is now suicidal-grade. Buh bye and good luck."

In the run up to Lenire coming out I mentioned on the thread I'd had a surgery that made another condition far worse. I'd asked many times about the risk of getting worse and was told it was not an issue. Subsequently I found many other people whose condition had also worsened, who'd had surgery with that same surgeon. Plenty who'd worsened who'd had it elsewhere. Yet the scientific literature on that surgery still says it doesn't worsen the condition, or that the risks of this happening are minimal. There is commercial corruption of much of the scientific literature, of the data underpinning many "innovative" drugs and devices, such that side effects and worsenings are often played down.

For that reason I never wanted to have Lenire until Tinnitus Talk had come up with their own data showing how common worsenings were. I did think the Neuromod guy was evasive on the point of worsening in his interview with Tinnitus Talk.

Sorry this sounds like an ITYS, just fed up with the harms of interventions being played down, could not be more cynical at this point.

 

[DaveFromChicago]

Once again, GlennS has zeroed in on the core of this problem.

What on earth is going on with Lenire now that we have our own carefully compiled survey?

When are they going to deliver a point-by-point response?

Do they actually think that the results we found will not affect the decisions of many (for example, over 30,000 of our subscribers and those who read on line) regarding the actual purchase of this?

Did it ever dawn on them how our posted results may affect their sales when this is made available in the US?

Are they nonetheless banking on sufferer's desperation to motivate them to still try this in spite of recent reports?

What was their reaction when they were notified about @Allan1967's worsening and the tragic consequences?

Did they have a conference to reconsider the safety of this device?

After all this time, can they not find better testimonials to post on YouTube that appear to be more than just placebo-based, slightly incremental improvements?

Has all of the above galvanized them into forming a plan to investigate and improve this?

 

[Lurius]

I had a remote meeting with Neuromod through webcam yesterday and they basically want me to make a decision on whether I should take a break or continue with the 2nd setting.

Considering that so many people here on Tinnitus Talk have really bad experience with the 2nd setting, I'm really torn. I realize that this is my decision in the end, so I'm not asking you to make it for me. But it would be nice with some input on this.

Right now I'm thinking that I should leave no stone unturned, so I'm inclined to try it. But also a little worried that I might make it worse. The Neuromod representative I spoke with said that they have people who benefited from the 2nd setting and they don't know why such a mass of people from Tinnitus Talk are not among them. Coincidence, maybe, she said. I'm a big believer in coincidence, so I took her word for it.

 

[GlennS]

What on earth is going on with Lenire now that we have our own carefully compiled survey?
...

There was a conference Tinnitus Talk was going to attend in order to confront Neuromod with their report. I'm assuming that conference is not going to happen or it will be some lame internet-only thing now.

But this has the effect of shielding Neuromod unless Tinnitus Talk attempts to conduct a remote interview instead (which I would suggest).

 

[Krolo]

I had a remote meeting with Neuromod through webcam yesterday and they basically want me to make a decision on whether I should take a break or continue with the 2nd setting.

Considering that so many people here on Tinnitus Talk have really bad experience with the 2nd setting, I'm really torn. I realize that this is my decision in the end, so I'm not asking you to make it for me. But it would be nice with some input on this.

Right now I'm thinking that I should leave no stone unturned, so I'm inclined to try it. But also a little worried that I might make it worse. The Neuromod representative I spoke with said that they have people who benefited from the 2nd setting and they don't know why such a mass of people from Tinnitus Talk are not among them. Coincidence, maybe, she said. I'm a big believer in coincidence, so I took her word for it.

Hey Lurius,

In regards to the 2nd setting, I had about 2 days of extreme quiet on that setting at the beginning but it quickly turned into a really bad experience so I was using it for about 7 days before calling it quits. Things did stabilize after that and feels like any bad things from 2nd setting disappeared on end of use after about 2 weeks. Bear in mind to that each person will definitely react differently to this and it is really just a crapshoot if it does good / bad or nothing.

Best of luck on whichever choice you make!

 

[MadsWithT]

I was just off the phone with the director of Neuromod/Lenire. When I asked about why the clinical study results were not yet released, she said the results would be made public in the next 14 days.

What's interesting is that customers apparently had great success with the device, and Neuromod was dismissive of my experience. The conversation was short and not so cordial. The director's only issue was to get me to send back the device to Ireland.

I think the results of the clinical study will be positive, in a bland way, and there will be about 20 percent of "non-compliant" participants which will be omitted from the conclusion.

 

[Tanni]

Hi guys,

Very excited to see the study results -- I have been waiting on them to help decide whether or not I should dust off my Lenire and give it a try! Thanks to all involved in putting this together.

My brain doesn't understand statistics very well, so I'm hoping someone can kindly answer the below for me? (Apologies if it has already been discussed):

At the end of the 12 weeks, what percentage of people had a positive outcome, a neutral outcome, and a negative outcome, excluding the drop outs, please?

In case anyone wonders, I exclude the drop outs because they didn't complete the full 12 weeks, so there's no way of knowing what their final outcome would be (especially as Neuromod claimed with me that most will experience worsened tinnitus at first before allegedly improving.)

Thanks!

 

[david c]

The Neuromod representative I spoke with said that they have people who benefited from the 2nd setting and they don't know why such a mass of people from Tinnitus Talk are not among them. Coincidence, maybe, she said. I'm a big believer in coincidence, so I took her word for it.

I really would be careful about taking what Neuromod say at face value. The evidence from Tinnitus Talk's report on Lenire suggests that around 20% of participants found that Lenire had worsened their tinnitus, not just initially but at least three months or so afterwards. Yet Lenire were claiming that none of their customers had lasting adverse reactions to Lenire. On that basis I would trust what people on here are saying about a 2nd setting rather than what Neuromod are saying.

 

[Phi]

I was just off the phone with the director of Neuromod/Lenire. When I asked about why the clinical study results were not yet released, she said the results would be made public in the next 14 days.

What's interesting is that customers apparently had great success with the device, and Neuromod was dismissive of my experience. The conversation was short and not so cordial. The director's only issue was to get me to send back the device to Ireland.

I think the results of the clinical study will be positive, in a bland way, and there will be about 20 percent of "non-compliant" participants which will be omitted from the conclusion.

Hi,

What clinical study results are you referring to?

Thanks.

 

[Chinmoku]

What clinical study results are you referring to?

Results of the clinical trials Neuromod ran in the past with analysis. From what we know they are somewhat at odds with Tinnitus Talk's report. Sample sizes are rather different but what worries me in the Neuromod report are the non-compliant cases. Have they dropped out because of worsening?

 

[Darktale]

Hi there,

What is key to me is to know if the people who experienced worsening while using the device finally went back to normal after a while... be it few weeks or be it even a few months.

Is there any way to track this with people who filled the Tinnitus Talk survey?
Do we know if their tinnitus eventually went down back to baseline at some point after stopping the treatment?

Because I would be much less worried if I knew that the worsening which may occur will eventually in any case disappear with time... even if it takes a few weeks or even months.

 

[Phi]

Results of the clinical trials Neuromod ran in the past with analysis. From what we know they are somewhat at odds with Tinnitus Talk's report. Sample sizes are rather different but what worries me in the Neuromod report are the non-compliant cases. Have they dropped out because of worsening?

In the post I quoted @MadsWithT mentioned clinical study results that have not yet been released. Is there still unreleased trial data?

 

[annV]

In the post I quoted @MadsWithT mentioned clinical study results that have not yet been released. Is there still unreleased trial data?

All of it is unreleased. Neuromod hasn't released any data from their clinical trials.

 

[DaveFromChicago]

Thanks very much for clarifying this, annV.

Will they ever release this?
What is their motivation for not having done so?
What are they afraid of having revealed?
Is this just another elaborated, inflated, placebo treatment similar to Desyncra?

 

[Phi]

All of it is unreleased. Neuromod hasn't released any data from their clinical trials.

Thanks for clarifying. So the only data we have is from the leaked presentation?

 

[PeterPan]

At the end of the 12 weeks, what percentage of people had a positive outcome, a neutral outcome, and a negative outcome, excluding the drop outs, please?

In the Tinnitus Talk study, we measured outcomes in two ways.

Method 1 - We asked people to provide a subjective rating of their tinnitus (Borderline, Mild, Moderate, Severe, Substantial) at baseline, 6 weeks and 12 weeks. We then compared the rating between baseline and 12 weeks.

Using this method:

15 improved, 13 did not change and 2 got worse.

Method 2 - We asked people to answer a TFI survey at baseline, 6 weeks, and 12 weeks. We compared their baseline score with their 12 week score. A change in TFI of 13 or more points indicates a meaningful change (reduction of 13 or more an improvement, increase of 13 or more a worsening):

Using this method:

14 improved, 15 did not change and 0 got worse.

All of the above excludes dropouts.

 

[GlennS]

customers apparently had great success with the device, and Neuromod was dismissive of my experience. The conversation was short and not so cordial.

This is raising alarm bells with me.

My gut is telling me that we are really on the cusp of Neuromod circling the wagons and adopting a denialist smokescreen. The veracity of their official data and its apparent disconnect with independent data will become a flashpoint. The only question is how hard Tinnitus Talk is going to want to push them on this. But if they don't, there will still be collective plate-banging online which may need to escalate up to action on the part of EU regulators. If it gets messy fast enough then you can probably kiss FDA approval goodbye.

 

[Chinmoku]

This is raising alarm bells with me.

My gut is telling me that we are really on the cusp of Neuromod circling the wagons and adopting a denialist smokescreen. The veracity of their official data and its apparent disconnect with independent data will become a flashpoint. The only question is how hard Tinnitus Talk is going to want to push them on this. But if they don't, there will still be collective plate-banging online which may need to escalate up to action on the part of EU regulators. If it gets messy fast enough then you can probably kiss FDA approval goodbye.

I fear that the sample size will be an issue. They had a trial with 500 people, the survey here - however admirable and high quality - is based on one tenth of that. What they should be challenged on, though, is their claim of no permanent worsening, as you say. We have examples of that.

I find it hard to believe they lied, the reputational risk would be a killer. However, I fear the permanent worsening people they didn't see in their studies might be hidden in the dropout, which was rather large.

I'm trying Lenire anyway because I am desperate, but I'm rather concerned. Perhaps one can start with 30 min a day rather than 60 min and see how it goes. If I understand correctly their leaked data, 60% of the compliant 80% had statistically significant benefits. That corresponds roughly to 50% of the people. So we are basically tossing a coin and hoping for some luck. Unfortunately for better or for worse this remains the only treatment that seems to be doing something right now.

Again I'm very saddened by Hubert Lim giving up on the Minnesota device for now.

 

[Tanni]

In the Tinnitus Talk study, we measured outcomes in two ways.

Method 1 - We asked people to provide a subjective rating of their tinnitus (Borderline, Mild, Moderate, Severe, Substantial) at baseline, 6 weeks and 12 weeks. We then compared the rating between baseline and 12 weeks.

Using this method:

15 improved, 13 did not change and 2 got worse.

Method 2 - We asked people to answer a TFI survey at baseline, 6 weeks, and 12 weeks. We compared their baseline score with their 12 week score. A change in TFI of 13 or more points indicates a meaningful change (reduction of 13 or more an improvement, increase of 13 or more a worsening):

Using this method:

14 improved, 15 did not change and 0 got worse.

All of the above excludes dropouts.

Thanks @PeterPan! And thanks again for all your hard work on the study.

So, roughly 50/50 between improvement and no change I guess. The two negative results register less than 13 on the TFI scale, which is arguably quite an insignificant change that could be down to a number of other factors.

Considering only the data from the people who completed the trial in full, the risk/reward gamble is not so terrible and the worst outcome seems to be potentially paying a lot of money for no improvement.

However -- although they should technically be discounted, it's very hard not to take into account the sheer amount of drop outs. The worsened Tinnitus levels were potentially very significant for them to discontinue treatment part way through -- it would have been great to know if they would have stabilised/improved with continued treatment, as Neuromod claim. Do we at least know if they have since returned to their pre-treatment level of tinnitus?

The results are significantly worse if you take their experience into account, and there's a big difference between a temporary spike that settles if treatment is continued or stopped, and a permanent worsening. I think until we know which it is, it's difficult to access the risks of the treatment accurately.

Please let me know if I've misinterpreted the data you've provided

 

[GlennS]

I find it hard to believe they lied

Of course not. They'd equivocate, which isn't much better.

 

[UKBloke]

They had a trial with 500 people, the survey here - however admirable and high quality - is based on one tenth of that. What they should be challenged on, though, is their claim of no permanent worsening, as you say. We have examples of that.

...and herein lies the central issue with that. With our tiny survey number, one tenth of Neuromod's, we had at least two cases of very serious worsening, which is significant. I don't believe this was reflected in Neuromod's large trial data so the only conclusion I can reach is, it's either a statistical anomaly or something else is at play. I fear we'll never really know.

 

[Agrajag364]

This is raising alarm bells with me.

My gut is telling me that we are really on the cusp of Neuromod circling the wagons and adopting a denialist smokescreen. The veracity of their official data and its apparent disconnect with independent data will become a flashpoint. The only question is how hard Tinnitus Talk is going to want to push them on this. But if they don't, there will still be collective plate-banging online which may need to escalate up to action on the part of EU regulators. If it gets messy fast enough then you can probably kiss FDA approval goodbye.

EU device regulators