Lenire — Bimodal Stimulation Treatment by Neuromod

Thanks for getting him to post his story. More data is good data.

 

@hans799 thanks very much for posting your first update in the user experience thread.

With all the bleeps, chirps etc, and the time you've had tinnitus, the characteristics sound very similar to my own.

Am paying a lot of attention to your journey with Lenire. Good luck with it, I hope things go well.

 

The assertion that someone with a lower initial level of tinnitus receives more benefit from a set reduction amount is misleading. We already know that there are thresholds that tinnitus can drop below and go relatively unnoticed by many people. If you're at a level where it isn't that disruptive and you receive a reduction by x amount the benefit is arguably less noticeable than it would be for someone with a screeching unbearable tinnitus that is reduced by x and brought down a level that is still relatively high but at least more tolerable. I'm in a agreement with Glenn on this. If my "bad"ear went down by 15 points it would still be very noticeable and probably more beneficial than the same reduction in my better ear. If these people aren't reporting positive results it's probably because the treatment is ineffective.

 

Lenire's effectiveness in the trials was primarily measured in THI. Tinnitus Handicap Inventory.
You're viewing this as though THI is a measure of loudness. It isn't.
It's about percentages. You can't really dispute it from that point of view. 10 THI points is a 10% improvement for someone at 100 points but 33.3% for someone at 30. So if Lenire only gives out static numbers and doesn't scale to the base THI level then it is factually better for mild/moderate sufferers.

Again I'd say you've misunderstood how THI works. THI asks questions like: How often does tinnitus bother you? How does tinnitus affect your sleep? etc... So unless you can explain how a person might get better sleep in their left ear? Then what you're saying makes no sense I'm afraid.

 

Exactly. And the THI, it IS linked to loudness--indirectly. Dr. Ross O'Neill said that more or less in the interview. This is because impairment is largely a function of masking level. The louder it is, the harder to mask, the more it impairs you. Common sense, really.

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And to Jay, as far as who gets to decide what is placebo, the testimonials are their own subjectivity, not mine. When they're wishy-washy, they're telling the outside world the results are so mild to almost not even detect, hence placebo.

Now, Neuromod claiming the results are statistically significant, that is THEIR metric, not the outside world. So the disconnect is not due to pessimists setting too high of a bar, but perhaps Neuromod setting too low a bar. Wishy washy testimonials don't come across as "statistically significant" results. That was true in the videos they shot AND for the few "positive" user reports we have to go on, which are, IMHO, more akin to neutral or only fleeting benefits.

I do get the sense, Jay, that you've already dug your heels in and you're gonna fight this tooth and nail. Suggesting that severe tinnitus sufferers are basically a lost cause is part of it, but it won't be the last rationalization you conjure up. I think you're on the losing end of this argument based on the data presented.

Objectively speaking, there IS a genuine disconnect between field reports and Neuromod's claims. The interview has done nothing to clear that disconnect up. They merely punted when asked how people are actually doing post-release, and added insult to injury by saying what data they ARE gathering will not be released anytime soon. So for better or worse, the data being gathered here is all that will be available to independently verify the efficacy of Lenire. If you'd rather disregard that data and trust Neuromod, be my guest, but that seems rather foolhardy considering their track-record with MuteButton.

 

Thanks man. I have a gut feeling that this will work. Just had my morning session and again the noise is on its best behavior.

By the way I asked Neuromod on Tuesday about what results they've been seeing in the wild. They say that the real-world distribution of outcomes is matching the studies: a majority of patients responds well with a subset of them being hyper-responders; a significant minority doesn't respond; there have been no permanent adverse outcomes; some temporary worsening is often observed but eventually goes away.

Also, they reaffirmed that they're very much continuing the development of Lenire with the additional data that's flowing in, so I think we can expect steadily better results as the months and years go by.

It'll be interesting to see how the later devices (e.g. Shore's) will fare against Lenire. Even if they start from a better baseline for some reason, Lenire will have a few years' worth of real-world refinement behind it and will probably be even better than what it is now.

 

Isn't this part of the problem we tinnitus sufferers face though? Perhaps not a discussion for this thread but I can't help thinking that THI muddies the waters somewhat by introducing psychological variables that are semi-related to the condition but evidently lie within different disciplines. For example, some people are fine sleeping in apartments that are in close proximity to train tracks, whereas for others, the passing trains will be a constant distraction.

Evidently an individual's reaction to a noise isn't the measure of volume the noise is making. And yet we tinnitus sufferers find ourselves in this strange situation where a company like Neuromod (and I don't blame them for this, they can only use the various metrics available to them at this time) focus on trying to reduce the physical presence of tinnitus but then rely heavily on what seems to essentially be a psychological tool to measure the results.

I wonder whether or not there needs to be a complete separation of the disciplines with Neuromod et al eventually dispensing with THI altogether and focusing solely on measuring and trying to reduce the loudness of tinnitus. If it transpires that patients with similar hearing profiles and loudness reduction outcomes have varying perceptive results then maybe that would be the time to introduce something like THI and a more cognitive approach. I just feel that the current scenario where treatments are moving into a more physical arena and yet measurement of perception remains largely rooted in a psychological arena are creating something of a medical paradox.

 

From a mathematical point of view, yes.
From a perceived reduction point of view, no.
I think the latter matters most to sufferers.

 

Just to make you aware Neuromod did measure MML (Minimum Masking Level) for all the trials and TLM (Tinnitus Loudness Matching) for some of the earlier trials.

Unfortunately measuring the volume of tinnitus will never be reliable nor accurate, hence why the community considers THI or TFI a must for clinical trials.

You have to consider that some patients' tinnitus fluctuates, residual inhibition interferes when trying to match frequency and level (such as in TLM measurement), and that some patients may experience decreased volume in some tones but not others etc.

 

Neuromod confirmed that they are developing a method of updating the device settings remotely.

 

This is most certainly not the case. THI is not linked to loudness. It's a very personal metric. You can see examples of it in real life and on these boards. My friend whose tinnitus is self reportedly louder than the ambience in a nightclub isn't bothered by his tinnitus at all and thinks I (mild/moderate easily maskable tinnitus) would be wasting my €2,000 on Lenire if I go for it. "You could buy a 60's Standard Les Paul for that" he says to me often. No prize for guessing how he ended up with tinnitus.

This is really the crux of it. If you don't feel like Neuromod's bar was set high enough then don't do the treatment.
But they had to set a bar somewhere. 10 THI points would be a solid investment of €2,000 for me. Possibly not for others. Assuming I'd respond.

Again don't assume on my behalf thanks. You said you quoted my earlier remark for posterity right? Go look at it again. You don't just get to use it as a stick to beat me with if Lenire flops and I go against my own words. I've said what i said about several 10's of reports with the majority being non responders and I meant it.
I don't happen to think severe sufferers are a lost cause. I just think that relatively speaking they have less percentage improvement to gain. And they need to tailor their expectations a bit. Don't expect to be an outlier.
Arbitrary example: Someone with severe tinnitus and spikes vs mild tinnitus and spikes. Remove the spikes. Who feels the most gain?

The rest of your post about our data vs Neuromod's can easily be addressed as before. Small sample sizes rounds it up nicely.

 

Dr. Susan Shore has not even completed phase 2, it will take at least 2 years before her device is commercialized.

 

This is basically it I feel. But the key point to make is that Neuromod only ever claimed their results based on THI. Not on loudness reduction. Sure enough that will be the reason for many peoples THI reduction. But not all.

It seems however the general negative vibe here is that unless Lenire significantly reduces most peoples tinnitus loudness that they aren't making good on their claim. And that simply isn't the case.

 

THI is a measure of perceived reduction/improvement though. That people on here expect that to be in loudness levels and not THI is not Neuromod's failing.

Don't get me wrong. I'm with you. If I use Lenire and my THI improves, I'd obviously prefer that to be expressed in loudness levels. As for me (and many others/even most others) loudness is a big factor. But if it doesn't mean that then I don't have anything to blame but my own expectations.

 

Agree. However I think Neuromod has been on record stating it will reduce loudness levels as well (expressed in MML).

Also, while the example of your friend with loud tinnitus is a well-known example, it's also just one person's account. I'd say that loudness and annoyance are definitely related, if not correlated. I'd love to have the coping skills of your friend though!

 

What, apart from @Allan1967? Still hoping his worsening goes, but Neuromod have not been told it hasn't? I hope this product doesn't end up like a surgery I had that made a condition worse, with the proponents and even published papers saying it's great and no one got worse, with a ton of patients eventually emerging on social media with problems.

 

And you believe that?

 

I'll give you my own example.

The difference in suffering for me is wrapped up in whether normal everyday background noise just happens to mask tinnitus without me having to really think about it, because the more I think about it, the more distraction, the more suffering. The more I have to seek out more and more aggressive "sound enrichment" as a masking source, the more intrusive tinnitus is. This is not a linear gradient. This is more of a binary phase change. What I mean is that when tinnitus is just low enough to blend in with ambience, the brain will do its magic to pretend it's not there. But... when it's just high enough in volume to not be maskable, then it makes my life a living hell. That is pretty much WHY I'm here, Jay, because in my normal day to day I was getting by all these years with "organic" masking from everyday things, rain, birds chirping, computer fans, TV, etc... Now I can hear the tinnitus in my left ear even while watching a baseball game with audience noise. If my left ear tinnitus level were to drop just a little, it would probably fall down below the masking threshold and my life would be SIGNIFICANTLY better despite the fact the volume difference would be slight.

This is all because of the average actual dB that "normal" every day background noise tends to fall into. Most people do not live under a waterfall and most people don't like the prospect of having to wear masking hearing aids or constantly be pumping white noise through a speaker and calling attention to themselves. So the easiest way to get by and pass as a normie is to rely on these everyday sounds.

For those with what I would consider "mild" tinnitus, normal everyday ambience would probably mask it completely and they normally only suffer in complete silence like when trying to sleep or read in a silent room. So for them, it's already far more manageable and the improvement in quality of life is that much milder since they already have a host of coping mechanisms to lean on. Therefore I really see things in a completely opposite way to you. I think severe tinnitus sufferers have far more to gain than mild ones because of how much tinnitus sufferers are riding on that razor's edge between habituation (i.e. maskable) and distraction/anxiety.

 

While it's only 5% or so, the product will remain in the market. It happens with many medications and with other things, for example concerts. It is known that a percentage of people end up with hearing damage. But most will be OK, so nothing changes.

 

Mate you're such a legend for doing all this. Cheers.

 

Yes. Thanks for your concern.

I do understand what you're saying Glenn. And to a degree I'm in the same boat. In the same vein my mild/moderate comes from my good/bad days. Where a good day is a notch below ambient and a bad one a notch above, with regular random spikes thrown in to boot. But as you say a very moderate volume reduction would give you a very large THI reduction. I'd presume many people are in the same boat.
But Lenire's results are parsed in THI reduction. Not as volume reduction necessarily. It may mean a removal of spikes. It might mean one of your noises disappears or changes to something a bit less annoying.

Again I understand what you mean. I've often used the carrying of weight analogy when it comes to this.

A man who's had to walk with 100 kilos on his back his whole life is going to feel very light if someone suddenly relieves him of 20 kilos.
Maybe he'll feel so good that he basically doesn't care about his load anymore.
But Lenire isn't removing 20 kilos. It's making him feel 20% better. And it may be that it only removes 5 kilos to do that. Or makes his back feel a bit stronger or the road a bit smoother. It's a subtle difference but it's important.

This is the severe sufferer to my mind.

 

Wow, so would that eliminate the need for the follow-up appointments? I'd hate to have to do 4 trips from Indonesia just to recalibrate the device.

 

Oh yeah I'd definitely do that. My THI isn't that high (probably in the teens nowadays) currently so it would be awesome to go down 10 points.

 

As it seems that one of the commonly purported benefits attributed to Lenire is the reduction or elimination of spikes, what exactly are we talking about with these 'spikes'?

I think (I'm still in cautious experimentation mode) my tinnitus is not reactive at all so I don't spike due to any external input, but I have a high level of day to day or during-the-day variation of intensity. To be fair the actual difference is probably relatively subtle, but it is all the difference between me being able to go about my life normally and being from significantly to profoundly challenged.

Is this what people mean by spikes?

 

No – I didn’t mean the issue is people getting worse. The issue is Neuromod not having a record of it or acknowledging it.

It indicates they may not warn future patients of the true risks which is a problem when there is no published data yet and when people are spending a lot of money.

 

Yes the information which Neuromod is supplying we know is contradicted by the group of Tinnitus Talk members who have been using Lenire. That makes me really doubt the information which Neuromod are putting out - we know they have a vested interest in playing up positive outcomes and playing down negative outcomes.

Anyone looking to find out the efficacy of Lenire would do much better to read the User Experience and Reviews thread which are the honest experiences of those who have put their own time and money into trying out Lenire and are an unbiased source - unlike Neuromod.

 

But what was said upstream is that Tinnitus Talk members are biased on the basis that only more severe sufferers come here looking for support. But then you can counter that by saying early adopters willing to try an under-tested device would also probably self-select for more severe cases (maybe not in the trials where the selection criteria was chosen by Neuromod, but with the product in release, yes). So for those who don't buy the data one way or another, it's an inkblot test.

 

Has @Allan1967 been the only one with reactive tinnitus to try Lenire so far? I’m extremely disheartened that his experience was not successful in the least, as someone who just developed reactive tinnitus (along with some sound distortion)...

 

But if your THI is in the teens... Why are you here? Based on that, your tinnitus has very little effect on you, so why bother?