Lenire — Bimodal Stimulation Treatment by Neuromod

After an appointment with Neuromod to see whether the device is suitable or not, how long does it take for people to receive the actual device?

 

Whether or not Neuromod offers more statistics, the moderators here trying to gather data is the best way to go.

Once you have the data you can sort and group things based on all sorts of different criteria, just as Neuromod themselves did in their PowerPoint presentation. It's only when you have just a handful of anecdotes does it seem completely random.

Given enough responses, patterns should start to emerge (hopefully for my sake the link between hyperacusis and greater amount of benefit). But these patterns should make it easier to predict how much benefit you're likely to get.

I don't think it should have to be seen a total crapshoot other than for those brave first-adopters.

 

@FGG

Yes, seems like that would be a good way to suss it out. I heard/read over the last year or so of a tribe (I think it was in South America) who whispers to preserve their hearing for hunting in the jungle but I can't find anything with a quick search.

 

Where did you get that?

 

Lenire Homepage

 

They have done clinical trials and published research. So has the Shore and UMich team.

You think random anecdotes from the internet are a better data set, as long as we have enough of them?

 

I do, because of the sheer volume. Trials in the realm of hundreds of participants with some fairly restrictive exclusion criteria aren't going to be as good as thousands or tens of thousands of real-life participants. Of course, out of those thousands not all will report their results here, but that's where getting the word out matters. I found this forum because it's right at the top of google searches for tinnitus forums. Anyone who wants to share is probably going to do likewise and wind up here.

 

From trusted members here that we know suffer... yes.

You have to remember that ACRN and all that bullshit had good 'trial' data too.

But both are equally important to me.

 

@linearb am I correct in saying you tried Shore's device for 2 weeks? What is the story?

 

Yes I was in the phase-I and if you dig through the UMich thread back to ~4 years ago when the trial was ongoing I had a lot to say.

The tl;dr of my experience is that I found it significantly helpful and look forward to this tech becoming accessible. That said it was not a cure and I definitely still had tinnitus during the peak effect (which was weeks 3 & 4 of the trial for me, it takes a couple weeks for the effect to start to become noticeable)

 

I see this the other way around; exclusion criteria exist exactly to not confound data by including people who can't possibly be helped for one reason or another, and health forums across the board tend to self-select for the most severe cases, which often include underlaying psychiatric problems of one kind or another.

Also, the person I was replying to was saying they didn't want to spend €2500 without "evidence" from this forum; that's funny to me because it's easy to find dozens or hundreds of cases on here where people have spent ~hundreds of dollars on supplements and other random things that are not likely to be helpful based on the say-so of a couple people.

 

HEY- if Tinnitus Talk analyses their outcomes properly, that IS data. I think you've mentioned before you've worked in academic research? You must know of the reproducibility crisis in bench science; medical science may be still worse. You may have read this famous paper- https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.0020124

Lenire's data might be fabulous, with wonderful well controlled published studies coming soon, and success rates in clinic might be just as good as whatever is quoted in their papers, once they're published. They have studied 100s of patients after all. Or the data might be interesting, but flawed. Or it might be like ACRN. Either way I look forward to reading Lenire's papers, and to hearing about the data gathered by Tinnitus Talk over time.

 

You still had tinnitus, but it was reduced to mild?

If I got mild tinnitus, I would consider myself cured to be honest.

 

And that's all well and good as long as Neuromod doesn't turn around and let those people who were excluded buy a unit.

And that's exactly what they're going to do if you look at just one exclusion criteria: length of tinnitus < 5 years. There's no way they will limit their market to such an extent.

So the trial participants are not going to match 1:1 with those buying units, hence early adopters will be taking a leap of faith.

I'm not talking about cherry-picking individual testimonials. I'm talking about looking at aggregate data. Of course, self-reporting will incur a bias, as only those motivated to talk about their experience will report, but that's all we've got to go on.

And for the most part, this strategy of crowd-sourced reputation works. Think about Amazon, Newegg, TripAdvisor, AirBnB, etc... Rotten Tomatoes might be a bad example thanks to brigading, but the others, sans sock-puppets, works wonders.

 

No, this is completely incorrect.

What Neuromod is doing is following the same model that every clinical trial for every drug or device does: identify the cohorts most likely to benefit, exclude cohorts with confounding conditions, and then do an RCT to look for demonstrable efficiency.

This does not mean that people who are excluded definitely won't benefit; it means that the data set built is based on the people who serve as the best lab rats, nothing more, nothing less.

I think patients should have a right to try all approved therapies, even if they know for a fact they have comorbidities that make them unlikely to benefit, do you disagree?

I don't think these are good data sets, in fact, the way Amazon reviews are cooked have been written about and is subject to ongoing regulatory pressure.

It's not, though?
https://www.ncbi.nlm.nih.gov/pubmed/29298868 etc etc etc.

 

It was four years ago and so I am very hesitant to quantify what I remember of my experience with words like "mild".

 

Are you suggesting that the actual population will not experience the same results as the trials because of a loosening of the exclusion criteria?

I don’t think time period having tinnitus will affect the treatment. I can see things like TMJ having an effect.

 

Sure, the exclusion doesn't say they won't benefit, but it doesn't say they will either. And dealing with a condition as stubborn as tinnitus, I'm going to look at the treatment as not working until proven otherwise, so I want to see data from those who have had it longer than 5 years.

I've said multiple times that there should have been a broader TENT-A3 trial that is more representative of those they're going to let actually use this thing upon release. In lieu of that Neuromod is asking people to make a leap of faith.

If there's anything I view as fishy about Neuromod, it's that. There is a missing trial here that they are skipping over in order to rush this out the door.

But part of their decision to try it should be the trial data, of which we have none from Neuromod for patients that have had tinnitus longer than 5 years.

Speak for yourself. I know how to spot statistical outliers and shill reviews when I see them. I also trust that the moderators will do a better job of verifying the testimonials here than sites that just sort of passively crunch the data like Amazon.

So I don't really know what you're arguing for or against here. More data gathering is better than less as far as deciding whether or not to gamble with your money.

I'm saying Neuromod's exclusion criteria left uncertainty about that, which bothers me. If Neuromod felt the length of having T was completely irrelevant they would not have excluded people. My opinion is they cordoned off the trial subjects to a subset they thought would yield the most promising results. But to then expand availability to everyone is, well, it's a little fishy. If they're that confident in the device they should be able to point to trial data that doesn't have these exclusions, otherwise it gives the impression of cooking the books. There are far far more T sufferers out there who have had it longer than 5 years than fewer than 5 years and they have to know this.

And this is nothing new. It was discussed vigorously months ago here and it remains an open question. It will remain so until we begin to see testimonials from actual users in the field who have had it longer than 5 years.

 

This I 100% agree with; having worked in the VC-backed venture world I am inherently very skeptical of claims such companies make.

I'd absolutely be more heavily on the skepticism claim if we didn't have parallel efforts from research-based universities. Also, I'm biased by the fact that I used one of the damned things, I realize my own anecdote is not "data" by my own logic, so, just throwing that out there.

I think that's very reasonable. FWIW that was not an exclusion criteria for UMich, and I'd had tinnitus for 15 years when I did that trial, and I know there were other long-term people in that group of 20.

 

All very interesting debate chaps. I've had tinnitus for a lot longer than 5 years, but I've only struggled with troublesome / problem / intrusive tinnitus since late 2016. That's when I went from mild / slight to severe.

My take on Lenire is that when the independent evidence base builds, which it will in time, there are going be to some people who've seen a huge improvement, some who've seen a bit of an improvement and some who've seen no change. Going by their data - a dangerous game, I concede - most people will fall in the 'bit of an improvement' category. So you'll be looking at this thread in a year's time thinking 'well, I might be one of the ones who sees a huge improvement' - but there's only one way to find out.

I'm waiting for my appointment and I'm signed up for the Tinnitus Talk User Experience Group, so you'll get the unvarnished truth from me, one way or another.

 

Yes, which is why I'm still hopeful (in addition to the hyperacusis aspect). But Neuromod played it safe in the trials which results in a suspicious gap in the resulting dataset. I would like to see a lot of success stories from people like you instead of just your isolated testimonial from a similar (but not quite identical) treatment. Because of how they structured the trials, we're going to have to lean on actual patients who are gambling with their money, which is unfortunate.

 

I have an appointment next week. Like I said I'm from Ireland but mine is very mild, sometimes unnoticeable during the day. Most people here would probably consider themselves cured with mine and my heart goes out to you all. It just annoys me at night, mostly when I wake up and has a strange pattern of going up and down depending on stress and diet. I would like to be rid of it though. It will be interesting whether this is more suited to take severe tinnitus down a few notches or whether it can eliminate mild tinnitus.

What I don't like is I went to an ENT recently who operates out of that building and he said the usual how there is no cure. A bit strange he didn't mention it since I quizzed him on various forms of relief and even cures.

Everyone has to remember that tinnitus has lots of causes and just as many ways of relieving or even curing it. For some it's just a B12 or Magnesium deficiency, high blood pressure, their current medication, TMJ, ear infections, ear wax build ups. If you signed up to this treatment with those being your cause it's safe to say you might not find relief with Lenire. That's why there can't be a single magic cure for tinnitus.

 

I hope you are able to get rid of it. I will be curious how your appointment goes. Let us know and best of luck to you!

 

Neuromod responded to you already?

Anyone else got a response from Neuromod regarding appointment scheduling?

 

"It seems to be better"

"I think it's helping"

You're right. That's incredibly pessimistic.

 

Splendidly selective quoting there.

You don't give the impression that you're convinced by this new possibility, so people are going to naturally assume you're not optimistic regarding the chances of success.

 

So you choose two, not even negative, reviews about bimodal stimulation and completely negate the other positive reviews we have gotten here.

Yes this is pessimistic because you're only addressing the negative aspects and ignoring the positive ones.

 

They can see my number is Irish so I would assume that would have helped in getting an early appointment. They didn't say much on the phone other than it would take about 90 minutes. It's a little expensive but it's also a comprehensive exam of your ears with a hearing test, neither of which I've had.

I feel like I'm getting better anyway and I'm having many more good days so like I said I'm not overly confident I'll be a suitable candidate. My tinnitus is weird, I once turned it off for the night by doing yoga. I'll report back on Tuesday anyway. If I am a candidate you can expect reports for me here along with a full honest review of it.

Remember this is the first public trial I believe so some tweaking and refining may happen.

 

@ThomasW Could you share what they asked you on the phone, please? For me it's very important. I do not know English very well, so I have to prepare answers in advance.