Lenire — Bimodal Stimulation Treatment by Neuromod

[F-u-T]

Statistics. My college Stat professor used to tell us: Figures Lie and Liars Figure.

 

[UKBloke]

Unless they actually commit to a figure then it's just a rhetorical gimmick and holds no weight.

It seems the thread has reached an impasse on these matters. Before signing out for a while I have to say I think the concerns are legitimate:

• Sample sizes (Neuromod must now have valid data across their entire base of paying clients)
• Current results across the entire base of Lenire clients
• Peer review data
• The 12 week thing

Hopefully @Hazel has grilled Dr. Ross O'Neill on such issues in the upcoming podcast.

 

[GlennS]

Allan1967 never finished treatment so wouldn't have been included in those statistics.

How convenient. That means there's no way of knowing how many dropped out because Lenire made them suicidal.

I said it in my previous post on this. If we get into the 30/40/50 patients and the majority are like @Cojackb and @ruud1boy then you won't find me leaping to Neuromod's defense.

Fair enough. I'll bookmark your post for posterity.

 

[ChrisBoyMonkey]

@Bndsmheowqhe
Actually most of my time in school after that and much of my work life required me going back to the same concepts I did in this one "class". It's more than just a class, it's an important concept to grasp in life and you don't appear to be grasping it.

It would be enough when we have @PeterPan's data to work with. I'm guessing that'll be about 30-40 people. I would hope for another 10 users posting but I don't think that's going to be happening.

When is the earliest we can expect the data from the first participants?

 

[PeterPan]

And since we are talking statistics, when do you @PeterPan think that we could have a first look on the first results of the Lenire User Experience survey?

We're waiting to get the full 12 week results for the patients who started their treatment in 2019. Which means the results will be published in April 2020. There will be about 35 patients. In Jan 2020 we will publish summary data on the patient characteristics pre-treatment.

 

[linearb]

Either you take no improvement of 3 people, or only 2 out of nine, the success rate according to the experiences of Tinnitus Talk members at this point in time doesn't look good.

I really wish and hope that this is the treatment that can relieve us all....

Self-reported anecdotes are not data, and a sample size of 9 is useless anyway.

Anyone who thought this would work amazingly well or be a cure for all / the significant majority of tinnitus patients hasn't been following the data. I am sorry if that sounds harsh but I believe it's accurate.

 

[Hazel]

• Sample sizes (Neuromod must now have valid data across their entire base of paying clients)
• Current results across the entire base of Lenire clients
• Peer review data
• The 12 week thing

Hopefully @Hazel has grilled Dr. Ross O'Neill on such issues in the upcoming podcast.

I think we covered all this, though not sure what you mean with the "12 week thing."

That doesn't mean of course you will get all the answers you seek or in the detail you seek. In the end, it was up to Neuromod how much they wanted to say about all this.

I wouldn't say I "grilled" him per se. My aim was to be an impartial interviewer. But I'm a mere amateur, so how it comes across in the end I can't say.

And, to be fair, I also felt rather pressed for time, since my list of questions (gleaned from this thread) seemed endless and I wanted to get through them all. So I probably failed to ask the follow-up questions that I should have, here and there. You'll have to forgive me

 

[Bndsmheowqhe]

It's more than just a class, it's an important concept to grasp in life and you don't appear to be grasping it.

If you want to play that game I've been self-employed, run multiple businesses and owned a dozen rental properties. The type of excuses that you're offering on behalf of an underperforming device are eerily similar to the excuses I would hear over and over again from tenants that were chronically late with their rent. I suspect you will have as much success in reducing your tinnitus with statistics as I would've had paying my mortgages with deadbeat tenants' tales of woe.

 

[Bartoli]

Depends on what the hype was and who was creating it. It wasn't Neuromod. They've only ever gone by their statistics.

Statistics are just that. They launched a treatment that would improve the majority of tinnitus cases according to their statistics. That's what they claimed and we're not seeing that in real life.

Also, what good is a trial of there's no peer review yet?

They must've been so sure it was too good to keep this treatment from the crowd any longer.

Jeez it's the second time they've launched. Haven't they learned anything from MuteButton?

 

[JayBowson]

You're playing Semitic games. The company has spent the past several years directly and indirectly attempting to generate excitement in their product in order to attract additional investors. That appears to be the one thing they've been very successful at. I'm starting to suspect that has been their primary focus all along and the effectiveness of the device is secondary to that.

The company has the exact stats on their website and you can watch the interview. Front and center. The only reason to be hyped is because its the first treatment going that actually affects tinnitus itself. Any expectations beyond that is wishful thinking.

It now seems likely that the device was underperforming in the trials. That would explain why they brought in Dr. Lim and offered him a financial stake in the company to help them "conclude" the trials. It's also worth noting that the release of the trial data has been pushed back another year.

I suspect that the "real world cases" are producing results similar to the results they were initially experiencing during the trials prior to bringing in Dr. Lim to bail them out. The lackluster testimonials are a strong indication of that.

Pure guess work and conjecture. Nothing more.

You're desperately clinging to the hope that invoking the term "statistics" and waving it around like a magic wand is going to overcome the reality of this situation. That in addition to your dismissive use of "LOL" is basically a tacit admission that you're on the losing end of this argument.

Its a tacit admission that I'm laughing and nothing more. Sorry if that confuses you. That you can't see we've had a negligible number of reports is a failing on your part and not mine. You don't need to be a statistician to count to 3 nor understand what a small sample size is.

There have been literally dozens.

I suggest you go back and read this entire thread.

No. I'm not going back and reading 168 pages to do your work for you. If you have a good reason or argument as to why small sample sizes should be cast aside in favour of bottomless negativity I'm all ears. Or I guess you could keep mindlessly parroting that everyone around you is losing the argument? See how far you get?

 

[Hazel]

Ok, then...

We finally managed to publish the podcast episode featuring the Neuromod interview!

As announced previously, for the coming week it will be available exclusively to our Patreon supporters. After that, it will be freely available to all

If you want advance access too, it's not too late. For only 2 dollars per month you can support our volunteer work and get access to the episode now.

 

[Markku]

Thanks guys for the support!

The work on this episode was, once again, the culmination of some excellent team effort.

• @Hazel, the incredibly talented person that she is, did an amazing interview under time pressure.
  
• @Autumnly, our trusted tinnitus warrior, spent a significant amount of time going over the interview and coming up with an excellent plan for editing the podcast.
• @Liz Windsor, I so want to meet this superhuman! She's not only one of the kindest persons on earth, but always goes above and beyond with her transcription work.
  
• I again spent several long nights editing & tinkering, hopefully producing somewhat of a good end experience for all of you.

Later next week, we'll publish the episode to everyone; now we wanted to give this exclusive pre-release as a gesture to our Patreons. We want to make all the content free for everyone to enjoy, so stay tuned for the public release.

Have a great weekend everyone!

 

[UKBloke]

I think we covered all this, though not sure what you mean with the "12 week thing."

That doesn't mean of course you will get all the answers you seek or in the detail you seek. In the end, it was up to Neuromod how much they wanted to say about all this.

I wouldn't say I "grilled" him per se. My aim was to be an impartial interviewer. But I'm a mere amateur, so how it comes across in the end I can't say.

And, to be fair, I also felt rather pressed for time, since my list of questions (gleaned from this thread) seemed endless and I wanted to get through them all. So I probably failed to ask the follow-up questions that I should have, here and there. You'll have to forgive me

The "12 week thing" refers to the situation where those patients who've reached the end of their 12 week treatment period and haven't seen any improvement are being urged by Neuromod to continue treatment on the basis (although there doesn't seem to be any scientific grounding for it at the moment) that their tinnitus may get better.

Please also forgive me. I'm not particularly technical when it comes to conveying such points as those relating to the technical and statistical side of Neuromod's offering. I'm just one of many on here with ringing in his ears looking for a bit of peace and quiet.

Good work on the podcast BTW - I'm listening to it now.

 

[Ruse]

Some interesting questions & answers surrounding Dr. Lim / the University of Minnesota's relationship with Neuromod, Neuromod's obligation to supply regulators with 'post market clinical follow up data' and bluetooth latency!

Can't think of much more that could have been asked - good job guys!

 

[Daniel Lion]

View attachment 32673

Thanks guys for the support!

The work on this episode was, once again, the culmination of some excellent team effort.

• @Hazel, the incredibly talented person that she is, did an amazing interview under time pressure.
  
• @Autumnly, our trusted tinnitus warrior, spent a significant amount of time going over the interview and coming up with an excellent plan for editing the podcast.
• @Liz Windsor, I so want to meet this superhuman! She's not only one of the kindest persons on earth, but always goes above and beyond with her transcription work.
  
• I again spent several long nights editing & tinkering, hopefully producing somewhat of a good end experience for all of you.

Later next week, we'll publish the episode to everyone; now we wanted to give this exclusive pre-release as a gesture to our Patreons. We want to make all the content free for everyone to enjoy, so stay tuned for the public release.

Have a great weekend everyone!

Thank you for your hard work for the tinnitus community. You are all true heroes.

Just listened to the Tinnitus Talk Podcast interview with Neuromod, and wanted to give the Tinnitus Talk staff and volunteers a shout out. You are angels. Thank you so much for everything you do.

 

[UKBloke]

But I'm a mere amateur, so how it comes across in the end I can't say.

For an "amateur" you did a sterling job and came across really well. Every question about this treatment I have at this point in time was broached in great detail and this is what we as a community need right now.

Thanks also to @Autumnly, @Liz Windsor and @Markku for making this podcast happen. Your work is very much appreciated.

 

[Hazel]

The "12 week thing" refers to the situation where those patients who've reached the end of their 12 week treatment period and haven't seen any improvement are being urged by Neuromod to continue treatment on the basis (although there doesn't seem to be any scientific grounding for it at the moment) that their tinnitus may get better.

Ah, I see. To be honest, I don't recall whether that was covered, but I guess you found out by now after listening

Thanks everyone for the nice comments!!!

 

[Agrajag364]

Self-reported anecdotes are not data, and a sample size of 9 is useless anyway.

Much medical data is ultimately self-reported. Obviously! Scoring systems just mean this is measurable. Many scoring systems e.g. THI are themselves just as flawed as asking a series of patients whether they felt a treatment improved the condition it was intended to. It's best to use a range of outcome measures and ask patients directly whether they felt the intervention improved their condition.

Anyone who thought this would work amazingly well or be a cure for all / the significant majority of tinnitus patients hasn't been following the data. I am sorry if that sounds harsh but I believe it's accurate.

Agree.

 

[linearb]

Much medical data is ultimately self-reported. Obviously! Scoring systems just mean this is measurable.
Agree.

Er, I don't think we disagree, this wasn't my point.

THI scores in RCTs are not the same as patients reporting their own THI scores outside of a controlled setting, and even further removed from people on a health forum which inherantly self-selects for worse cases, reporting a handful of subjective experiences with no clinical guidelines at all or clinicians present.

I doubt if you'd disagree?

 

[JohnAdams]

Fine if you didn't say it. But then to the data. The data isn't encouraging, in the same way that a failure in a sample size of 1 isn't encouraging either. But you can't use it to draw any conclusions.

Don't assume on my behalf thanks. I said it in my previous post on this. If we get into the 30/40/50 patients and the majority are like @Cojackb and @ruud1boy then you won't find me leaping to Neuromod's defense.

Are you afraid to cast scrutiny on Lenire or something?

 

[Agrajag364]

Er, I don't think we disagree, this wasn't my point.

THI scores in RCTs are not the same as patients reporting their own THI scores outside of a controlled setting, and even further removed from people on a health forum which inherantly self-selects for worse cases, reporting a handful of subjective experiences with no clinical guidelines at all or clinicians present.

I doubt if you'd disagree?

Yes it is possible there is inherent self-selection for the worse cases on internet forums. But RCTs can sometimes be selective in a way that might be argued to bias the data too! E.g. TENT-A1 excluded people whose tinnitus can't be masked during MML assessment, people who've had tinnitus for more than 5 years, people "the site Principal Investigator does not deem the candidate to be suitable for the study for other reasons not listed above", people with a high depression score.

You could argue the Tinnitus Talk users might represent a more realistic tinnitus population than that lot. Sometimes people talk about RCTs as if they're the Delphic Oracle or inherently well desgined just because they're RCTs.

I'm not saying RCTs are not the highest form of evidence in theory! I am just saying that I, for one, have learnt through bitter experience to place a value on the outcomes you see reported online outwith clinical trials, as well as clinical trial data. It just that people talk about "anecdotes" as if they're next to worthless; given the flaws in many trials, they aren't.

I had surgery for another condition I have, some years ago. It was quite a new surgery, but the published data looked very impressive. There were few accounts online, as this was years ago. My surgeon claimed to have operated on 100s of people and that the surgery did not worsen the condition. I had the surgery, and it did worsen my condition. To cut a long story short, years later, after the advent of social media, it could be seen that there are many more people with problems as result of that form of surgery than were reported on in the clinical trials. Boy do I wish I'd had social media around at the time of my surgery with all its worthless anecdotes.

https://clinicaltrials.gov/ct2/show/NCT02669069

 

[GlennS]

Self-reported anecdotes are not data

I'm sure people here who have had little to no improvement or "disimprovement" will be happy to know that their experiences simply don't matter.

 

[JayBowson]

Are you afraid to cast scrutiny on Lenire or something?

No. Anything else I can help with? I'm here for you.

 

[linearb]

I'm sure people here who have had little to no improvement or "disimprovement" will be happy to know that their experiences simply don't matter.

View attachment 32679

I never said this, nor would I. Whether or not something "matters" has nothing to do with whether it's a solid basis to make extrapolations from, in this specific case where we have maybe a dozen people messing with something that's brand new.

Beyond that, again -- we had to expect that in the best case there would be a lot of Lenire failures based on their own data, so while it's regrettable and unfortunate and I know (from experience) it burns to spend thousands of dollars on something that ends up being useless, that's just the reality on the ground here. And, these people are all being tracked by Neuromod, so to the extent they remain compliant with protocols and do not get relief, their experiences very much "matter" even in the sense of rigorous scientific data, because it goes directly to failure rates and/or adverse incident reports.

You're substantially accusing me of taking a position I never have, nor would.

To cut a long story short, years later, after the advent of social media, it could be seen that there are many more people with problems as result of that form of surgery than were reported on in the clinical trials. Boy do I wish I'd had social media around at the time of my surgery with all its worthless anecdotes.

I am sorry you went through that and obviously (given my post count) I'm not disputing the important of patient interaction and social media. We're pretty far off the rails here; I was critical of people being emphatically strong-minded in either direction about Lenire based on a handful of self-reported cases here. I could tell you stories about my own experiences with other health conditions, which are relatable to your own, but that wasn't the point I was making at all.

 

[GlennS]

we had to expect that in the best case there would be a lot of Lenire failures

Not as many as we've seen to date. I guess arguing over the statistical math will be the order of the day for the foreseeable future, but that's where the divide lies.

And I will restate that if Neuromod had a bunch of Allan situations where they simply didn't include cases where the tinnitus got worse to the point where they dropped out, that would be a serious flaw in their methodology. Don't put Neuromod's methodology on a pedestal when it still hasn't even been peer-reviewed.

 

[Emma33]

Thanks to @Hazel and everyone involved in producing the podcast. I thought you did a great job of covering the main issues.

I was especially interested in the part about the Bluetooth and his theory on why the treatment can make the tinnitus temporarily worse. (I did have to Google "Benelux" at the end though, couldn't work out what country he was talking about!!)

 

[linearb]

Not as many as we've seen to date. I guess arguing over the statistical math will be the order of the day for the foreseeable future, but that's where the divide lies.

And I will restate that if Neuromod had a bunch of Allan situations where they simply didn't include cases where the tinnitus got worse to the point where they dropped out, that would be a serious flaw in their methodology.

Why would it be a serious flaw to not include people who were resistant to the study protocol and had an additional trauma very shortly after beginning treatment? That's not going to be the statistical norm.

Don't put Neuromod's methodology on a pedestal when it still hasn't even been peer-reviewed.

Completely agree, and if you look at all my posts in this thread you will see that mostly I have expressed a deep, deep skepticism of Neuromod as a VC-backed firm whose own, non-peer-reviewed representation of their data makes their tech appear to be much more effective than UMich -- who is doing much more in terms of valid, normal "research".

I am not putting anything on a pedestal, I am rolling my eyes at people who want to argue this too hard one way or another based on the very limited information we have.

 

[DaveFromChicago]

To linearb:

If I'm inexcusably naive for anticipating that this would work "amazingly well", then precisely what sort of a return can I expect from a $2,500.00 outlay (and perhaps more if you wish to have additional visits after 12 weeks).
(And given Chicago prices, I dread what local audiologists will charge).

Also, should I be expected to so blithely assume the risk that (as was the case with Allan1967) it could exacerbate this, even permanently?

I must say that I am very concerned about the rearguard actions defenders of Lenire are resorting to when we continue to receive more and more disappointing reports.
The plain fact of the matter is that as a potential customer, I am unfortunately not sold.
My wife would go totally ape if I admitted that I was buying this after she read most of these user comments.

 

[GlennS]

I am not putting anything on a pedestal, I am rolling my eyes at people who want to argue this too hard one way or another based on the very limited information we have.

Well, there comes a point when this devolves into a puddle of sarcasm and caricature. Maybe we should try to reign it back in so we know where everyone really stands.

 

[DaveFromChicago]

To GlennS:

If we receive, for example, 20 additional reports that this worked markedly well (beyond mere placebo affect), then I would be converted as an enthusiastic customer.

My wife comes from Czech ancestry, and their peasant acumen would thus far conclude that "this don't go by me."

My next hope consists in looking forward to seeing if Dr. Shore's device is technically superior.
My ENT Doctor already mentioned that it showed real potential.