Lenire — Bimodal Stimulation Treatment by Neuromod

I really don't get this attack against people who want to wait for more than 3 reviews to get a good sample size.

Do some people not have a basic grasp of statistics?

Get a grip. It's pathetic.
 
I really don't get this attack against people who want to wait for more than 3 reviews to get a good sample size.

Do some people not have a basic grasp of statistics?

Get a grip. It's pathetic.
I am not a mathematician, but if the probability of not seeing clinical improvement is 1/3, then the probability that all three people would see no improvement would be (1/3)*(1/3)*/(1/3). That is around 4%. Not a good start and maybe my understanding of probabilities is wrong as well. I personally still believe there is promise in this technology.
 
Judging by that response, it looks like you haven't.

I'm not rooting or booing for this. I'm waiting and seeing. Chill out. Resorting to call me some sort of "deniar" so quickly. Pitiful.
There's statistics and then there's common sense. This wouldn't be the first time that this company has rushed an underperforming product to market. That combined with the lackluster "testimonials" and the fact that Dr. Lim was likely brought in out of desperation puts the existing user experiences into perspective. At the end of the day you can take all the passive aggressive swipes you want and it isn't going to change the fact that the device is preforming at a level that is inconsistent with the company's claims of efficacy.
 
I really don't get this attack against people who want to wait for more than 3 reviews to get a good sample size.

Do some people not have a basic grasp of statistics?

Get a grip. It's pathetic.
Here's a statistic for you:

Up to this point the company has had a 100% failure rate with previous commercially available versions of this device.
 
Personally I feel pessimistic about the whole thing. Sure, too soon to tell and sure it's a small sample size but we have a dozen or so confirmed users on Tinnitus Talk. With 80% (66% according to other sources) it shouldn't be too hard to find a genuine account of someone having a proper improvement.

Now show me one person who experienced this. Not like: "I think I have an improvement, on some days" story, but a "no doubt it's better" story.

As I said, this is how I'm starting to feel about Lenire.
 
Even if you take the small sample size into account, the results aren't encouraging at present.

If an uptick in testimonials is to happen either due to the device taking longer to have an effect or seeing more people participate in the user reports, I don't think it should take much longer to manifest. If we're in this same exact position in another 3-6 months it's just going to be literally impossible to reconcile against Neuromod's statistics. And if we get to that point then...

View attachment 32635

They've already recorded a recent interview for Tinnitus Talk, right? We need to see that interview, STAT.

Ditto. I got a tip that Reddit has some chatter. I see you and some other Tinnitus Talk members have been there too. I checked it out and found only one person not on Tinnitus Talk who reported mild improvement (of which I classify as in range of placebo).
I mostly agree with what you say here. We're just not at the point where we can call it.

I don't really agree with the placebo thing, I think if there was a change or none whatsoever we would probably know, as demonstrated in how we have drastically different reportings so far.

But I love that meme, it's hilarious!

Hopefully it doesn't come to that but who knows. I spoke to a very wise audiologist and professor at USC today and all she said about it for now is that it's best to wait to see if the FDA approves it because the European system is pretty lenient.
 
I am not a mathematician, but if the probability of not seeing clinical improvement is 1/3, then the probability that all three people would see no improvement would be (1/3)*(1/3)*/(1/3). That is around 4%. Not a good start and maybe my understanding of probabilities is wrong as well. I personally still believe there is promise in this technology.
By that logic the probability of getting two responders and one non responder would be:

(2/3) x (2/3) x (1/3) = 14%.

Totally agree that this still had promise however! Very early stages.
 
There's statistics and then there's common sense. This wouldn't be the first time that this company has rushed an underperforming product to market. That combined with the lackluster "testimonials" and the fact that Dr. Lim was likely brought in out of desperation puts the existing user experiences into perspective. At the end of the day you can take all the passive aggressive swipes you want and it isn't going to change the fact that the device is preforming at a level that is inconsistent with the company's claims of efficacy.
Dude, you're the only one taking swipes. I'm just stating facts. We can't call it yet, our sample size is too small and unreliable. I agree it's a little underwhelming, but then again it's still early.

So far, we don't have enough to work with. Maybe it'll prove you wrong and this device works. Maybe I'll be agreeing with you that this is a dud.

But I can say neither right now.
 
It's very interesting. Keep in mind that these neuroplastic changes are going to be very slow and might need at least 6 months. Most people who got a real improvement from this device seemed to get better in the months after the treatment. That's why I might consider taking at least a 3 month break from the treatment after the initial 12 weeks.
 
Dude, you're the only one taking swipes. I'm just stating facts. We can't call it yet, our sample size is too small and unreliable. I agree it's a little underwhelming, but then again it's still early.

So far, we don't have enough to work with. Maybe it'll prove you wrong and this device works. Maybe I'll be agreeing with you that this is a dud.

But I can say neither right now.
Any reasonable person would have to admit that at this point Lenire has failed to live up to the hype. You can spout all of the statistical jargon you want and it doesn't change that. If the device was consistently producing positive results you wouldn't resort to being openly dismissive of other points of view simply because you "took a class". It's the kind of tactic that people resort to when they sense they're losing an argument.
 
By that logic the probability of getting two responders and one non responder would be:

(2/3) x (2/3) x (1/3) = 14%.

Totally agree that this still had promise however! Very early stages.
No, it's not. You forgot to add to that (2/3)x(1/3)x(2/3) + (1/3)x(2/3)x(2/3) which sums up to the right probability of around 44%. Sorry for being a nerd, just thought that false information should be corrected. :D

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?
 
Any reasonable person would have to admit that at this point Lenire has failed to live up to the hype.
Depends on what the hype was and who was creating it. It wasn't Neuromod. They've only ever gone by their statistics.
It is too early to tell whether the real world cases bear them out.
You can spout all of the statistical jargon you want and it doesn't change that.
LOL. Is it really that hard to understand? The sample size so far is negligent. This is exactly why trials tend to be done on hundreds and thousands of people. Not 4. You can come up with all sorts of wild statistics with small sample sizes.
It's the kind of tactic that people resort to when they sense they're losing an argument.
Again, depends. There hasn't actually been an argument given. Especially not by you.
Is there a good argument to be had? That Lenire is a total flop that doesn't work with less than 5 reviews available?
I've yet to see it.
 
To ruud1boy:

What concerns me is your comment that "any future visits would be chargeable."

In that case, if you elected to have these future visits, what could be the cumulative total cost?
I recall that after I finished with Desyncra I was told that future visits for recalibration would also
be in addition to the $5,269.00 original charge.

Inwardly, I exploded - "What?" I said to myself - You already charged me this amount when it had no effect and you have the gall to have it cost more?"
"What do you expect me to end up doing? Sell my house and live in a Single Room Occupancy Flophouse, so I can pay for all of this?"
 
I get the feeling no argument will ever be deemed good in your eyes.
Rather than presuming what my reaction would be you could try actually make a case?
One good case for why we should write something off despite the minuscule sample size.
I'm all ears.
 
I make it two better — RedKnight and drcross, both with fairly new tinnitus.

Three unsure — Big Nick, TinMan, jacob21

No improval, or no improval as yet — ruud1boy, Cojackb, Liz Windsor

One worse, probably due to Lenire — Allan1967.

I agree with those who say a sample size of 9 is rarely wildly unreflective of a bigger sample of 500 (though it's not impossible), i.e. if 2/3 of the 500 in the trial truly got better, it's odd only 2 of 9 have reported that here.

I was more uncertain a few weeks back when a few people thought they might have improvals they are now unsure about. But not everyone has completed their sessions.

So it's still uncertain but it's not looking good.

Peter Pan's more rigorous analysis of a larger number of Tinnitus Talk users should be much more telling though. I bet we get to hear about that before Neuromod's TENT-A1 trial comes out.

People sometimes don't realise how bad a proportion of the medical literature is. Even really commonly used products like antidepressants - the evidence supporting their use in mild or moderate depression, evidence for their effectiveness above placebo, is quite poor. This was in contrast to early papers on the subject. I still had a small amount of hope for this product though during the discussions early this year. They did a really big trial.

I'd still like to see the TENT-A1 results published.
 
No, it's not. You forgot to add to that (2/3)x(1/3)x(2/3) + (1/3)x(2/3)x(2/3) which sums up to the right probability of around 44%. Sorry for being a nerd, just thought that false information should be corrected. :D

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?
Yes I know, I was giving an example of why the quoted logic was wrong.

I.e. how could the most likely outcome only be 14%.

Perhaps I wasn't clear enough / also couldn't be bothered to type out any more fractions on my phone!
 
Someone posted a graph (wish I could find it again) of patient results/response on the trial that was an angled line across a chart with an x/y axis. It had a load of dots pasted about the graph, and essentially, each dot represented a patient with those dots below the line indicating an improvement in tinnitus since using the Lenire device in trial.

Shouldn't we be seeing some kind of reflection of that in the real-world reports? If the current sample size is too low, what sample size do we need to see in the User Experience thread before we can say the results are statistically valid?
 
Rather than presuming what my reaction would be you could try actually make a case?
One good case for why we should write something off despite the minuscule sample size.
I'm all ears.
Did I say we should write it off? You're strawmanning. I said the data is not encouraging, and objectively speaking, it's not. You can spin it anyway you like, but those are the facts.

what sample size do we need to see in the User Experience thread before we can say the results are statistically valid?

That's just it. Those crying out the most for a larger sample size will never feel it's large enough as long as the results aren't looking good. Unless they actually commit to a figure then it's just a rhetorical gimmick and holds no weight.
 
I make it two better — RedKnight and drcross, both with fairly new tinnitus.

Three unsure — Big Nick, TinMan, jacob21

No improval, or no improval as yet — ruud1boy, Cojackb, Liz Windsor

One worse, probably due to Lenire — Allan1967.

I agree with those who say a sample size of 9 is rarely wildly unreflective of a bigger sample of 500 (though it's not impossible), i.e. if 2/3 of the 500 in the trial truly got better, it's odd only 2 of 9 have reported that here.

I was more uncertain a few weeks back when a few people thought they might have improvals they are now unsure about. But not everyone has completed their sessions.

So it's still uncertain but it's not looking good.

Peter Pan's more rigorous analysis of a larger number of Tinnitus Talk users should be much more telling though. I bet we get to hear about that before Neuromod's TENT-A1 trial comes out.

People sometimes don't realise how bad a proportion of the medical literature is. Even really commonly used products like antidepressants - the evidence supporting their use in mild or moderate depression, evidence for their effectiveness above placebo, is quite poor. This was in contrast to early papers on the subject. I still had a small amount of hope for this product though during the discussions early this year. They did a really big trial.

I'd still like to see the TENT-A1 results published.
Well, it's only 2/3 who have completed the 12 week treatment. We don't have 9 complete reviews by any means.

Worth noting that this it was only 2/3 of compliant patients that clinically improved.

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

Wouldn't surprise me if most of those who were non compliant in the trials did not finish the treatment due to temporary worsening or lack of progress.

BigNick is an interesting one as the device had an effect although he remained unchanged in THI.

All it takes is a couple of improvers out of those 'unsure' names and everything swings back towards the clinical trial results.
 
Yes I know, I was giving an example of why the quoted logic was wrong.

I.e. how could the most likely outcome only be 14%.

Perhaps I wasn't clear enough / also couldn't be bothered to type out any more fractions on my phone!
I don't believe my logic was wrong. Please explain. According to Neuromod's statistics, 2 out of 3 should see clinically significant improvement and 1 out of 3 should not. So the probability that "three rolls of the dice" would all be non-responders I believe should be 1/3*1/3*1.3.

@Demigod Thoughts?
 
Yes I know, I was giving an example of why the quoted logic was wrong.

I.e. how could the most likely outcome only be 14%.

Perhaps I wasn't clear enough / also couldn't be bothered to type out any more fractions on my phone!
And that's why I quoted you because you tried to show that Watasha's logic was wrong by quoting a wrong number/calculation. The quoted logic is unfortunately right and 3 of course is no sample size, but 9 people is, albeit a tiny one. 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, but I agree with everybody who is becoming skeptical because of the experiences reported so far. That doesn't mean that I have written it off of course (and here I agree with you), we must all wait for the sample size to increase and that's why I feel that it was great for Tinnitus Talk staff to organise this parallel user experience survey group (and I thank them of course for that), to the results of which I am now looking forward more than before.
 
I don't believe my logic was wrong. Please explain. According to Neuromod's statistics, 2 out of 3 should see clinically significant improvement and 1 out of 3 should not. So the probability that "three rolls of the dice" would all be non-responders I believe should be 1/3*1/3*1.3.

@Demigod Thoughts?
My apologies, I misread and thought you were calculating 2 non responders and 1 responder i.e. 1/3*1/3*2/3.

edit: that's what you get for writing replies when you're at dinner!
 
Did I say we should write it off? You're strawmanning. I said the data is not encouraging, and objectively speaking, it's not. You can spin it anyway you like, but those are the facts.
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.
That's just it. Those crying out the most for a larger sample size will never feel it's large enough as long as the results aren't looking good.
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.
 
Depends on what the hype was and who was creating it.
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.
It wasn't Neuromod. They've only ever gone by their statistics.
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.
It is too early to tell whether the real world cases bear them out.
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.
LOL. Is it really that hard to understand? The sample size so far is negligent. This is exactly why trials tend to be done on hundreds and thousands of people. Not 4. You can come up with all sorts of wild statistics with small sample sizes.
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.
There hasn't actually been an argument given.
There have been literally dozens.
Especially not by you.
I suggest you go back and read this entire thread.
 

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