Lenire — Bimodal Stimulation Treatment by Neuromod

I didn't say there won't be any outcomes that are more dynamic. There will likely be a few lucky people that see complete remission. There will also be some people that experience no improvement. I suspect that most people will fall somewhere in between.

 

Three separate institutions are pursuing this approach so the technology clearly has potential. I happen to believe that the University of Minnesota and University of Michigan will be able to implement the technology with more robust results. That doesn't mean that the current device will be completely ineffective.

 

And in what century do you expect those to be released? I've been patient with Neuromod but at least they gave us a sign they were posturing to release, whereas those two are still stuck in the lab with no end in sight.

 

The 21st century.

 

Is Lenire supposed to work for those with noise-induced tinnitus or am I wrong?

 

Yes.

 

This question is interesting. It was not addressed by the Q&A.

My guess would be yes.

86% of the patients responded. Since noise-induced tinnitus makes up the majority of tinnitus' aetiology, noise-induced tinnitus patients would be expected to respond.

 

In the last few months there has been an exhausting amount of debate regarding the real efficacy of Neuromod (and much of it has been very insightful and thought provoking).

My ENT Doctor (who is very highly regarded) thought there was substantial legitimacy to this treatment method.

Please see my previous posts wherein I was duped into allocating $5,269.00 for Desyncra. I mentioned that I have probably spent about $12,500.00 on utterly useless treatments, drugs, etc.

This nonetheless still doesn't change the fact that when this is available in Chicago, as far as I am concerned there is only one choice available: to make the Kierkegarradian "Leap of Faith" and undergo it.

I just turned 65 and there has not been a day since I got this where I have not had to rigorously counsel and fortify myself against overwhelming panic, rage and catastrophizing.

I ask myself, "How many more decades do I have? What if the expenditure of about $3,000.00 brings me even the partial relief I have daily fantasized about?"

Even if I am being duped for a second time with placeboized nonsense, this would not be the worst mistake in the world for a person to make.

 

The only thing that doesn't make sense to me is:

If the treatment depends on noises and electrical pulses to the tongue in special timing with each other, why are they using Bluetooth headphones? Bluetooth has a latency of 200-600 ms! And what's one more cord to the headphones when you've already got a cord going to your tongue??

 

Automated latency compensation.

 

Perhaps they have accounted for that. They might have also considered that the wires might tangle and cause the tongue tip to shock the wrong places, damage the wires over time, or just be too messy.

 

Or maybe the timings don't actually matter that much, and we can just go listen to tone generators and lick 9 V batteries and save ourselves 2500 EUR

 

I can't wait to hear good news from Tinnitus Talk members who try this device and say it reduces not only their tinnitus but hyperacusis as well.

 

That's a really good question. I thought the headphones were wired.

 

@linearb Having tinnitus for more than five years (one of the exclusion criteria) isn’t a confounding condition.

In fact it would have been more scientific to include people who had it longer than five years, given that tinnitus annoyance scores often reduce a lot in the first two years and that the trial didn’t have a placebo arm.

 

Does Lenire also work for tinnitus that wasn't caused by noise exposure?

 

Yes, I think @Clare B's tinnitus wasn't caused by noise exposure.

 

In the TENT-A2 trial people with tinnitus up to 10 years were included. Source

 

That's better but would still exclude someone like me. They still should have done a TENT-A3 with no duration exclusion.

 

There are various theories about plasticity and things happening on a different timeline. My read on that exclusion criteria for this study is that they're a VC-backed for-profit company trying to maximize the efficiency they can demonstrate to make it easier to get to market.

I'd say I'm agnostic on the first issue, but agree that the second is a significant concern. Double blind RCTs are the gold standard; double blind RCTs are what UMich is doing, and this makes me a lot less suspicious of the UMich data despite smaller sample sizes. (I think UMich, so far, has shown somewhat less dramatic gains than what Neuromod is claiming? If so that all lines up neatly).

I'm agnostic on the first issue because we don't really know enough yet to say with any certainty at what point plastic changes happen in various brain regions, and I don't think it's impossible that bimodal stimulation could work better in general on people who have had tinnitus for X time frame or less. I am not privy to Neuromod's initial data, and they may have some reason to think so. On the other hand, UMich doesn't seem to care, because they're more interested in finding out as much as they can about how this stuff works and who it works on, than they are with the typical insane VC rush-to-market. So, we can say all the usual things about Neuromod that can be said about VC-backed capitalist endeavors, but I personally don't resent them for their existence; when it comes to capitalistic silliness, I hate the game a lot more than any specific player (excluding really dramatic examples of bad-faith actors like Dow Chemical or the petrochem industry).

 

Yes. The lack of a true placebo cohort in Neuromod's trials concerns me very much as well. I wonder why UMich was able to devise a convincing placebo, but Neuromod did not. Perhaps Neuromod's level of electrical simulation is strong enough to be detected; I believe I remember reading that Shore's was below the tactile sensory level.
We can only speculate...

 

Yeah, UMich set the stimulation slightly below tactile, and in the sham period there was no electrical stimulation. But, what was communicated to participants (and to blinded clinicians) was that the sham period would either be no stimulation OR randomly timed stimulation. I believe it was communicated that way to make it even harder to unblind oneself.

That said, it wasn't perfect; during the real protocol period, once I placed the electrode a bit too high and it made my eye twitch. So, I knew there was real electrical stimulation happening, but because of how it was communicated, that alone wasn't enough to unblind me.

That said, I was fairly unblinded by week 3 because I was thinking "gee it's quiet".

 

At Minnesota, the electrical stimulation was set to threshold pain, and then backed down just a bit. It hurt a bit. The sham was using offsets that were imperceptibly different.

 

Please read the background research. Variations as much as 5ms is the difference between increasing or decreasing tinnitus.

 

I can't understand how Neuromod has managed to do this with Bluetooth headphones. Even if they account for the Bluetooth lag, the lag isn't the same all the time, it varies.

 

Welp, that's probably why we aren't working for Neuromod

 

There is latency even with wired headphones just for everyone’s information (although of course Bluetooth will be longer).

The generation of Bluetooth will also have some bearing on whether the lag is meaningful.

With Bluetooth 2.0 for example the small bandwidth cannot always handle the high bit rate of an audio stream.

I suspect either automated latency / delay compensation software has been installed if the lag is variable OR there is just a set delay with the tongue tingler if the lag is not variable (i.e. a constant).

Automated latency / delay compensation software is the same feature which most modern DAWs use in music production.

It would be pretty easy for them to test for latency and I think it’s pretty unlikely that they haven’t considered this!

 

A few days ago I sent Neuromod an email asking about the availability in Latin America. I guess the answer is the same for all those outside of Europe.

Thank you for your e-mail. The Lenire® device is CE-marked in Europe, but has not been reviewed by any regulatory authority outside of Europe. Therefore, until the device is cleared for sale in Argentina, it will not be possible to access the treatment in your country.

We are working hard to bring our evidenced-based treatment for tinnitus (Lenire®) to as many regions as possible as quickly as we can, but at this time we cannot provide any accurate guidance on the timing of availability in additional countries.

 

I am curious if anyone in Europe outside of Ireland has set up an appointment yet. Between here and Reddit the only people that have appointments are in Ireland. It makes me wonder if traveling is an option at all.

I really wish they would do a follow up Q&A to answer some of these questions that people here have.