Lenire — Bimodal Stimulation Treatment by Neuromod

[Lurius]

How is it not Neuromod's fault when they still do not deliver any other option than to go to the one clinic in the world that dispatches this "treatment"?

They should have realized the kind of demand should be answered by more than a single clinic that's not even opened 5 days a week, it's no wonder the waiting list is so huge, anyone with half a brain would realize that much.

If I add that, thus far, taking into account the testimonies from this forum, we see no improved benefits above placebo and we have no access to a peer reviewed study regarding Lenire and that the "testimonies" from Neuromod's own page appear to have been performed by paid actors, this is either scam 101 or a recipe for disaster, take your pick.

What proof do you have that the testimonies were made by "paid actors?" None.

 

[Mathieulh]

It isn't Neuromod's fault that they don't have the capital to open up 500 clinics worldwide nor the manpower to train people for those locations. Nor is it their fault that people choose to travel for it. Honestly now. Neuromod could have taken a completely different tactic and only accepted people from the Republic of Ireland. I'm sure they've enough demand to fill the slots. But they didn't do that. Be thankful.

Neuromod knew damn well what kind of demand they would generate and expect, when you sell something, including treatments or medical devices, you don't go blindly all in, you do a market study first.

The truth is Neuromod chose the Republic of Ireland for its generous tax policies as well as the rather lenient EU regulations (and its rather generous research subsidies/grants), when it comes to medical devices as opposed to the stricter ones from the FDA or many other regulatory agencies.

Now that we have a few more results from actual responders in the User Experiences thread and the result percentages are starting to favour Lenire better than before, I expect we'll see more of this "placebo" nonsense goalpost moving. Here's the thing chief.
Neuromod are not obliged to pass the Tinnitus Talk Skeptics Non-Placebo Certification in order for their product claims not to be bogus. You do not get to decide what level placebo sits at thankfully.

1. Neuromod actually is obligated to go through a peer review study to demonstrate the efficacy and safety of any medical devices they sell, so far we have seen none, all we have are testimonies from people on this forum which are a far cry from the over 60% improvement advertised by Neuromod. That's not "Tinnitus Talk Skeptics Non-Placebo Certification", it is however the law in most countries, around the world.

2. What "level placebo sits at" is actually "decided", as a standard and through scientific consensus, by the use of control groups (because, you know? "Science"?), of which there was actually no such thing because there is NO PEER REVIEWED STUDY from Neuromod or anyone/anywhere else on Lenire, at least none we can access (i.e., none that was published). Feel free to prove me wrong on that point.

Whereas you should actually read on the definition of placebo:
https://en.wikipedia.org/wiki/Placebo

That said, while Placebo is technically non linear by nature, it is usually estimated, through general consensus, that anything not offering over 20% changes (improvements or otherwise), is usually within the placebo range (or below).

Demonstrably untrue. That is all.

Says who? You? How is that "demonstrated" to be untrue?

 

[Ruse]

Neuromod knew damn well what kind of demand they would generate and expect, when you sell something, including treatments or medical devices, you don't go blindly all in, you do a market study first.

I'm sorry dude but it's incredibly naive to think that an Irish medtech start up with limited resources can somehow both launch worldwide and meet worldwide demand with a click of their fingers.

The truth is Neuromod chose the Republic of Ireland for its generous tax policies as well as the rather lenient EU regulations

Of course, this has absolutely nothing to do with the fact that the founders are Irish and that the company was founded as a spin-off from research at Maynooth University in... you guessed it, Ireland!

What "level placebo sits at" is actually "decided", as a standard and through scientific consensus

The irony in this is brilliant. You do realise that you have just chalked off every single person's experience on Tinnitus Talk as placebo without the use of any means described above as a requirement to gauge placebo?

Says who? You? How is that "demonstrated" to be untrue?

Say the patients from the testimonials who have been contacted by members on Tinnitus Talk.

 

[Bartoli]

Neuromod actually is obligated to go through a peer review study to demonstrate the efficacy and safety of any medical devices they sell, so far we have seen none,

How have they been able to commercialize if they are obliged to go through peer review first?

 

[Mathieulh]

How have they been able to commercialize if they are obliged to go through peer review first?

That's a good question, my guess is that they sell this as a "treatment" to forego the EU regulation on medical devices.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3326593/

As you can see from this document, should Lenire be sold as a medical device, they would have to sell it as class IIa (at the very least).

Which requires to undertake the following process:

"IIa Special controls required: may include special labelling, mandatory performance standards & post-market surveillance" ("mandatory performance standards", do require a study, or at the very least, a risk assessment);

Another link of interest:
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01993L0042-20071011

"Whereas it is necessary, essentially for the purpose of the conformity assessment procedures, to group the devices into four product classes; whereas the classification rules are based on the vulnerability of the human body taking account of the potential risks associated with the technical design and manufacture of the devices; whereas the conformity assessment procedures for Class I devices can be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of vulnerability associated with these products; whereas, for Class IIa devices, the intervention of a notified body should be compulsory at the production stage; whereas, for devices falling within Classes IIb and III which constitute a high risk potential, inspection by a notified body is required with regard to the design and manufacture of the devices; whereas Class III is set aside for the most critical devices for which explicit prior authorization with regard to conformity is required for them to be placed on the market;

Whereas in cases where the conformity of the devices can be assessed under the responsibility of the manufacturer the competent authorities must be able, particularly in emergencies, to contact a person responsible for placing the device on the market and established in the Community, whether the manufacturer or another person established in the Community and designated by the manufacturer for the purpose;"

That said, since Lenire is likely sold as a treatment, it likely follows other sets of rules (one may say stricter rules to some degree).

https://ec.europa.eu/health/human-use/legal-framework_en

I would have to review Lenire's own documentation to know for sure how the product is sold and advertised however.

 

[Mathieulh]

The irony in this is brilliant. You do realise that you have just chalked off every single person's experience on Tinnitus Talk as placebo without the use of any means described above as a requirement to gauge placebo?

So you've never heard of the Tinnitus Handicap Index then? (or, assuming you have the budget for it, even more precise measuring done through functional MRIs).

I shall add that, in the meantime, Neuromod has not provided any more proof of the efficacy of Lenire than Ring Ease and the Tonaki Tinnitus Protocol have of their own products (in case you did not know, both of these products are notorious scams); that says a lot.

 

[JohnAdams]

It isn't Neuromod's fault that they don't have the capital to open up 500 clinics worldwide nor the manpower to train people for those locations.

This is true.

 

[JohnAdams]

I think Tinnitus Mix is helping me a little, and it has sounds that are very similar to the high frequency noises in the Lenire thing. That leads me to believe that there is evidence to suggest that this thing probably does work for some cases.

I wonder what's better though, listening to the noises for ~8 hours while sleeping or the 30 minute sessions awake with your tongue getting zapped.

 

[JayBowson]

The irony in this is brilliant. You do realise that you have just chalked off every single person's experience on Tinnitus Talk as placebo without the use of any means described above as a requirement to gauge placebo?

I was about to type a longer reply but I don't think I need to. Most of the points have been dealt with in this post.

Just highlighting this part for particular lols. It takes some kind of cognitive dissonance to dismiss the positive user experiences under their own placebo criteria and in the same breath write what they did above. It's mind boggling.

 

[Agrajag364]

How have they been able to commercialize if they are obliged to go through peer review first?

Because of the crappy European medical devices regulations. Which are being tightened up in 2020 but not nearly enough.



Neuromod are not obliged to go through peer review before getting a CE mark and selling their device in the EU. They will probably need their trial published before getting past the FDA, according to my understanding. Scientific ethics are what oblige them to put their data through peer review and publish - and they have said for a while they are about to submit their 500 person trial for peer review - but we've not seen it published yet.

 

[GlennS]

You do not get to decide what level placebo sits at thankfully.
Demonstrably untrue. That is all.

The stats really aren't improving that much. You're seeing what you want to see... through a pair of these:

Every thread has a spectrum in the peanut gallery, some negative and some positive. You and Chris are going to be the die-hard evangelists. But don't for a moment think you represent the objective truth. You're both spinning. And that's fine. Spin if it makes you feel better. But people are going to call you out on it. Getting triggered won't change anyone's minds.

 

[Rogi Cetpla]

Neuromod knew damn well what kind of demand they would generate and expect, when you sell something, including treatments or medical devices, you don't go blindly all in, you do a market study first.

The truth is Neuromod chose the Republic of Ireland for its generous tax policies as well as the rather lenient EU regulations (and its rather generous research subsidies/grants), when it comes to medical devices as opposed to the stricter ones from the FDA or many other regulatory agencies.

1. Neuromod actually is obligated to go through a peer review study to demonstrate the efficacy and safety of any medical devices they sell, so far we have seen none, all we have are testimonies from people on this forum which are a far cry from the over 60% improvement advertised by Neuromod. That's not "Tinnitus Talk Skeptics Non-Placebo Certification", it is however the law in most countries, around the world.

2. What "level placebo sits at" is actually "decided", as a standard and through scientific consensus, by the use of control groups (because, you know? "Science"?), of which there was actually no such thing because there is NO PEER REVIEWED STUDY from Neuromod or anyone/anywhere else on Lenire, at least none we can access (i.e., none that was published). Feel free to prove me wrong on that point.

Whereas you should actually read on the definition of placebo:
https://en.wikipedia.org/wiki/Placebo

That said, while Placebo is technically non linear by nature, it is usually estimated, through general consensus, that anything not offering over 20% changes (improvements or otherwise), is usually within the placebo range (or below).

Says who? You? How is that "demonstrated" to be untrue?

Hi Mathieulh,

On the subject of treatment research... I have found that there is a "specialised tinnitus/hyperacusis" clinic in France... I am trying to find more information on this place.

As you are French I wondered if you had heard of it? Looked into it? Have any views/opinions/feedback/testimonies?

https://hearing-institute-of-resources.fr/en/

Thanks in advance,
Rogi

 

[threefirefour]

Neuromod knew damn well what kind of demand they would generate and expect, when you sell something, including treatments or medical devices, you don't go blindly all in, you do a market study first.

The truth is Neuromod chose the Republic of Ireland for its generous tax policies as well as the rather lenient EU regulations (and its rather generous research subsidies/grants), when it comes to medical devices as opposed to the stricter ones from the FDA or many other regulatory agencies.

1. Neuromod actually is obligated to go through a peer review study to demonstrate the efficacy and safety of any medical devices they sell, so far we have seen none, all we have are testimonies from people on this forum which are a far cry from the over 60% improvement advertised by Neuromod. That's not "Tinnitus Talk Skeptics Non-Placebo Certification", it is however the law in most countries, around the world.

2. What "level placebo sits at" is actually "decided", as a standard and through scientific consensus, by the use of control groups (because, you know? "Science"?), of which there was actually no such thing because there is NO PEER REVIEWED STUDY from Neuromod or anyone/anywhere else on Lenire, at least none we can access (i.e., none that was published). Feel free to prove me wrong on that point.

Whereas you should actually read on the definition of placebo:
https://en.wikipedia.org/wiki/Placebo

That said, while Placebo is technically non linear by nature, it is usually estimated, through general consensus, that anything not offering over 20% changes (improvements or otherwise), is usually within the placebo range (or below).

Says who? You? How is that "demonstrated" to be untrue?

1. As has been shown earlier, even if you go only by testimonials on this site, improvement is at 60% of people. Neuromod said it was 66%, but given our small sample size this is well within a standard deviation of error.

2. A peer review won't completely turn over the results Neuromod has. Susan Shore's theory for example is referenced in their paper, and she is peer reviewing it. She might at worst nitpick stuff like "that's not necessarily my theory, you should change it to say this" or "I think you're overstating the importance of the thalamus in tinnitus generation", not "oh my god the numbers don't add up this must be false!". People overestimate how big the peer review process is to the final paper. It's a speed bump, not a wall.

3. Placebo is filtered by clinical significance instead of statistical significance. To overcome this at a good sample size, standard is measured usually at p=.05. Clinical is p=.13, not 20.

And yes we tracked down one of the "paid actors" Ken. He confirmed he actually had a big reduction from Lenire and still uses it. What most likely happened was Neuromod found the people who responded the best and asked them to give positive reviews. And remember Neuromod his recorded reviews of people who said it helped them habituate because Neuromod wants this to be seen as a device that focuses on reducing tinnitus. If they were paid actors, why pay people to fabricate habituation stories, something that would harm Neuromod's reputation?

 

[Ruse]

So you've never heard of the Tinnitus Handicap Index then? (or, assuming you have the budget for it, even more precise measuring done through functional MRIs).

I have no idea why you're asking me whether I'm familiar with THI.

If you don't understand the irony in the fact that you have just chalked every user's experience as placebo based on your own personal opinion, before listing scientific criteria required to determine placebo, then there really is no hope in arguing with you.

 

[Bartoli]

Neuromod are not obliged to go through peer review before getting a CE mark and selling their device in the EU.

I suspected this to be untrue. How else could devices as low level laser light and that TinniTool have seen the light of day if they had to put their findings through objective peer review?

 

[JayBowson]

Every thread has a spectrum in the peanut gallery, some negative and some positive. You and Chris are going to be the die-hard evangelists. But don't for a moment think you represent the objective truth. You're both spinning. And that's fine. Spin if it makes you feel better.

I'm fine with you saying whatever you want about my biases. I don't think doesn't correlate to reality at all but so be it. You still have that quote of mine in your back pocket I'm assuming? Maybe have a look at it again?
As @threefirefour says we now have a swing in the responder stats. Even so for consistencies sake I'll say it again. Its still too early to judge, the sample is still too small and could go either way.

It's becoming a bit tedious Glenn. You accuse me of being biased almost every reply now.
Without actually addressing the content of my posts. Without any sort of self reflection, that is to say you're doing the exact same thing you accuse me of but for the Anti-Lenire crowd.

Getting triggered won't change anyone's minds.

Hah, that gave me a genuine chuckle Glenn. I'm in no way "triggered". I'm slightly too old to be part of the woke generation, thankfully. I have a low tolerance for nonsense and conspiracy theories is all and I enjoy a good debate.

 

[JohnAdams]

They could do well to release their trial data, or at least tell us why they won't. The last trial's data hasn't been released yet right?

 

[Bartoli]

She might at worst nitpick stuff like "that's not necessarily my theory, you should change it to say this" or "I think you're overstating the importance of the thalamus in tinnitus generation", not "oh my god the numbers don't add up this must be false!".

Agree, but let's not forget Shore's task in all this is to make certain the scientific research is properly conducted, as in checking whether they used correct methods to get to their results. She cannot compare to her own model or theory, as it's something else entirely, even if it's not to us.
If Lenire's paper were to contain weak elements then these can be challenged but she still has to be objective.

People shouldn't get too hung up on it. The results are already happening in front of our eyes. What one makes of it is up to the individual. If some want to wait out the peer review and recheck the numbers, they can. Actually, most of us WILL have to wait regardless with the current waiting list.

 

[Agrajag364]

They could do well to release their trial data, or at least tell us why they won't. The last trial's data hasn't been released yet right?

Needs to go through peer review. That can take three months or longer. They said a month or so ago they were about to do it. But to be fair they said the same thing in October 2018 on Twitter.

 

[ChrisBoyMonkey]

There are still people saying Neuromod is placebo?

It looks like they've traded in their tin hats for dunce hats.

 

[Ruse]

They could do well to release their trial data, or at least tell us why they won't. The last trial's data hasn't been released yet right?

Dr. Ross O'Neil said in the podcast that they were about to submit for peer review and the journal they are targeting has a fairly quick turnaround time.

 

[Mathieulh]

Hi Mathieulh,

On the subject of treatment research... I have found that there is a "specialised tinnitus/hyperacusis" clinic in France... I am trying to find more information on this place.

As you are French I wondered if you had heard of it? Looked into it? Have any views/opinions/feedback/testimonies?

https://hearing-institute-of-resources.fr/en/

Thanks in advance,
Rogi

I haven't heard of them before, that said, being in Paris myself, they aren't exactly nearby.

 

[threefirefour]

There are still people saying Neuromod is placebo?

It looks like they've traded in their tin hats for dunce hats.

Them: Lenire is clearly inaffective if you just ignore the examples of people who had a reduction from it. This is clearly placebo.

Everyone else: you're being irrational.

Them: You're irrational!

It's fine to have your opinions and I'm glad Neuromod isn't above criticism. But trutheriem is trutherism.

 

[GlennS]

Without actually addressing the content of my posts.

I already did. We're permanently stuck in a no-man's land where optimists perceive the user reports as more favorable than skeptics. To me, the data "objectively" looks a lot worse than their internal stats promised. To people like you, it matches or it's catching up. The math really isn't favoring the optimist case, so really the burden of proof ain't on the skeptics.

 

[GlennS]

Them: Lenire is clearly inaffective if you just ignore the examples of people who had a reduction from it. This is clearly placebo.

How many people were calling into question the wishy-washy testimonial videos many months ago? Now here we are with the same sort of wishy washy testimonials that can barely be qualified as positive movement on people's condition. And the response of optimists is... sarcasm? Mockery? Strawmen? None of this sort of debate is new.

We all wondered how to quantify "statistically significant" reductions and all we had to go by beyond the video testimonials were people like Clare B who said her tinnitus went away completely.

So we had every reason to believe a positive result should be more dramatic than what you and other optimists file as a "success" checkbox. But no, some people here are clinging to anything even remotely positive in the hopes of making the math work (which it still doesn't).

Excuse me for setting the bar higher. Look, you can go into many other threads where people are experimenting with other treatments (like supplements) and get just as many people claiming some marginal improvements. I don't know why in other threads people are rightfully skeptical and here you have some people circling the wagons.

 

[threefirefour]

How many people were calling into question the wishy-washy testimonial videos many months ago? Now here we are with the same sort of wishy washy testimonials that can barely be qualified as positive movement on people's condition. And the response of optimists is... sarcasm? Mockery? Strawmen? None of this sort of debate is new.

We all wondered how to quantify "statistically significant" reductions and all we had to go by beyond the video testimonials were people like Clare B who said her tinnitus went away completely.

So we had every reason to believe a positive result should be more dramatic than what you and other optimists file as a "success" checkbox. But no, some people here are clinging to anything even remotely positive in the hopes of making the math work (which it still doesn't).

Excuse me for setting the bar higher. Look, you can go into many other threads where people are experimenting with other treatments (like supplements) and get just as many people claiming some marginal improvements. I don't know why in other threads people are rightfully skeptical and here you have some people circling the wagons.

Exhibit A.

 

[JayBowson]

Strawmen?

You're contradicting yourself Glenn. Every time someone brings up the point that we think the skeptics were expecting miraculous changes in 60-70% of people you accuse people of building strawmen.

So we had every reason to believe a positive result should be more dramatic than what you and other optimists file as a "success" checkbox. But no, some people here are clinging to anything even remotely positive in the hopes of making the math work (which it still doesn't).

Excuse me for setting the bar higher.

Yet here you are plain as day. Written in ink. Clearly expecting miraculous results from the responders. Hinging your entire expectations off a few outlier stories.

You can't have your cake and eat it. Either people are building strawmen or the vast majority of responders are going to be moderate improvers. Take your pick.

 

[JayBowson]

I already did. We're permanently stuck in a no-man's land where optimists perceive the user reports as more favorable than skeptics.

We're perceiving the user reports as the users themselves perceive them. If a user feels like they got some improvement thent that's really all there is to it.

 

[LongWait]

There are still people saying Neuromod is placebo?

It looks like they've traded in their tin hats for dunce hats.

Provide any evidence it is not placebo please.

 

[Ruse]

Anyone given Neuromod a poke recently regarding appointments? I emailed this morning but waiting on a response.