Lenire — Bimodal Stimulation Treatment by Neuromod

[jmasterj]

Thanks @Autumnly, @PeterPan, @Markku, and @Hazel for all your hard work on this. I hope my data was helpful!

I was wondering if I could possibly see my TFI scores? I guess I would just be curious for myself where those scores were at at each milestone even though Lenire thus far hasn't really done anything for me.

Again, thank you all for the hard work that was put into this.

 

[dayma]

I just wanted to say thanks to all involved for producing this report. Much appreciated.

 

[Hazel]

So actually the average TFI reduction is somewhat out of proportion as the people who worsened dropped out of the treatment?

Correct. But just to be clear, this was not a deliberate skewing. We had no choice in the matter, because the dropouts did not provide TFI data.

The full story, including dropouts, is presented in this part of our infographic:

 

[PeterPan]

I was wondering if I could possibly see my TFI scores? I guess I would just be curious for myself where those scores were at at each milestone even though Lenire thus far hasn't really done anything for me.

Yes, sure. I will PM you.

 

[PeterPan]

So actually the average TFI reduction is somewhat out of proportion as the people who worsened dropped out of the treatment?

Just to elaborate a bit on Hazel's response. We had 43 patients.

7 of these were lost to the study because:

• The patient didn't provide the data at all the milestones (mostly because they didn't respond to reminder emails etc but in one case it was because the device broke).
  
• The patient didn't tell us that they were quitting due to adverse outcomes.

That left 36. Of these 36, 6 told us they were quitting due to adverse outcomes. That left 30. Of these 30, 29 provided TFI and 1 did not (TFI was optional in the study).

The infographic pertains to the 36 patients. These are the patients who provided information on the results of the treatment either to the 12 weeks, or to the point at which they stopped due to adverse outcomes. That is, these 36 patients are the ones for which we had complete information about the course of the treatment.

The percentages in the infographic come from this chart in the summary report:

An explanation of this chart is in the detailed report. People are classified as getting better if their self-assessed severity rating improved (and similar for no change and got worse).

Ostensibly a more scientific method of determining if someone got better is to use a patient's change in TFI at 12 weeks (a TFI improvement of 13 or more points represents a minimally important clinical difference). If we use this method, we get similar results. 48% of patients who provided TFI improved. If we added in dropouts to adverse outcomes, we see 40% improving, 43% staying the same, and 17% worsening.

One thing however is that the study showed that some groups had much better improvements than others. If you are not in the "No Hyperacusis with Hearing Loss" group, for example, then your chances improve.

Instead of 40% improving, 43% staying the same, 17% worsening, they become 48% improving, 31% staying the same, 21% worsening. If you are in the "No Hyperacusis with Hearing Loss" group it looks like this treatment is probably not for you (6 out of 6 had no improvement).

Of course all these results have the huge caveat that we had no control arm!

 

[PeterPan]

Instead of 40% improving, 43% staying the same, 17% worsening, they become 48% improving, 31% staying the same, 21% worsening. If you are in the "No Hyperacusis with Hearing Loss" group it looks like this treatment is probably not for you (6 out of 6 had no improvement).

Actually a little bit better than this because some of the people who dropped out due to adverse results were "No Hyperacusis with Hearing Loss" people.

The actual results for patients not in this group are 52% got better, 33% stayed the same and 15% got worse (or about 1/2 got better, 1/3 stayed the same and 1/6 got worse).

 

[Mathew Gould]

People who filled in reports at 13 weeks averaged a 13.9 TFI reduction (29 people). Some people dropped out and were lost to the study, and some people dropped out because of adverse outcomes. These dropouts were not included as they didn't provide TFI data at 12 weeks.

What is TFI? I thought THI was the 40 question test to give you a score out of 100?

 

[hans799]

If you are a patient in the US who already has Lenire, you are very much on your own. I emailed asking about the possibility of remote appointments and they said they cannot help me until 2021, despite having already paid for my six week and 12 week appointment, neither of which have I been able attend due to COVID-19.

Why is that? Are they booked full, or are they having a hiatus?

By the way the only thing that matters during the 6 week appointment is a switch to another timing, and based on several people's experiences in this thread, including mine, you're better off on the first one. So if you already have the device you are not really missing out.

 

[Bartoli]

Just to elaborate a bit on Hazel's response. We had 43 patients.

7 of these were lost to the study because:

• The patient didn't provide the data at all the milestones (mostly because they didn't respond to reminder emails etc but in one case it was because the device broke).
  
• The patient didn't tell us that they were quitting due to adverse outcomes.

That left 36. Of these 36, 6 told us they were quitting due to adverse outcomes. That left 30. Of these 30, 29 provided TFI and 1 did not (TFI was optional in the study).

The infographic pertains to the 36 patients. These are the patients who provided information on the results of the treatment either to the 12 weeks, or to the point at which they stopped due to adverse outcomes. That is, these 36 patients are the ones for which we had complete information about the course of the treatment.

The percentages in the infographic come from this chart in the summary report:

View attachment 39110​

An explanation of this chart is in the detailed report. People are classified as getting better if their self-assessed severity rating improved (and similar for no change and got worse).

Ostensibly a more scientific method of determining if someone got better is to use a patient's change in TFI at 12 weeks (a TFI improvement of 13 or more points represents a minimally important clinical difference). If we use this method, we get similar results. 48% of patients who provided TFI improved. If we added in dropouts to adverse outcomes, we see 40% improving, 43% staying the same, and 17% worsening.

One thing however is that the study showed that some groups had much better improvements than others. If you are not in the "No Hyperacusis with Hearing Loss" group, for example, then your chances improve.

Instead of 40% improving, 43% staying the same, 17% worsening, they become 48% improving, 31% staying the same, 21% worsening. If you are in the "No Hyperacusis with Hearing Loss" group it looks like this treatment is probably not for you (6 out of 6 had no improvement).

View attachment 39111​

Of course all these results have the huge caveat that we had no control arm!

Ok, that is definitely the sound way of handling the information and something over which you obviously had no control.

There was no control arm, but neither was there with Neuromod's own trials. Still your numbers are less promising than Neuromod's.
Of course that could be due to the small sample size, but until Neuromod's peer review is published, I think it's everyone's guess.

Definitely good and useful work you've done!

Thanks for all the work and responding to questions. You're a champ!

 

[Alex0o_o0]

What I also see in these numbers is that neuromodulation has influenced (good and bad) the tinnitus of 64% of the participants. So it actually does something for the majority of people.

The problem is that, as usual, there is almost no objective way to determine the characteristics of each group. Imagine that this would be possible, you'd have an actual safe and effective treatment for at least 1 subgroup of tinnitus sufferers! I really hope this is why it's taking Susan Shore this long to develop her thingy.

 

[GlennS]

Ostensibly a more scientific method of determining if someone got better is to use a patient's change in TFI at 12 weeks (a TFI improvement of 13 or more points represents a minimally important clinical difference).

And that dividing line is crucial as far as differentiating between actual improvement vs. potential placebo effect or improvement too marginal to be deemed worth it. I think that's where most of the arguments in this thread revolved as it's highly subjective, both in the case of users being able to determine whether improvement actually occurred and those interpreting their reports. I suppose me bringing this up again will touch off another round of back and forths but I've already said my piece on it.

 

[Hazel]

What is TFI? I thought THI was the 40 question test to give you a score out of 100?

TFI = Tinnitus Functional Index

THI = Tinnitus Handicap Inventory

Both are essentially questionnaires on things like how tinnitus affects your sleep, work, relationships and general quality of life. Both yield some kind of score that indicates 'severity.' Both are frequently used in academia and clinical trials as "outcome measures" to determine the effectiveness of treatment.

At the advice of some of our research contacts, we went for the TFI. Personally, I like it better because it explicitly asks about tinnitus loudness. But of course, in the end, both are super subjective. There's currently no good way of objectively measuring tinnitus, which is one of the major obstacles to finding a cure

 

[Emgee]

What I also see in these numbers is that neuromodulation has influenced (good and bad) the tinnitus of 64% of the participants. So it actually does something for the majority of people.

The problem is that, as usual, there is almost no objective way to determine the characteristics of each group. Imagine that this would be possible, you'd have an actual safe and effective treatment for at least 1 subgroup of tinnitus sufferers! I really hope this is why it's taking Susan Shore this long to develop her thingy.

Agreed. Though it is certainly disappointing that some users experienced adverse effects, it is at least assuring to see that neuromodulation does indeed have an impact on tinnitus to some degree. Hopefully, this form of treatment can be modified over time to remove these negative effects - or as you mentioned, it would be extremely helpful to determine the subset group of which these products can provide efficacy for.

I would expect Susan Shore/UMich, U of Minnesota, and other neuromodulation research teams to be keeping a close watch on the reported results of Lenire. I am optimistic that future devices can yield stronger results after they account for the good and bad that resulted from Lenire.

 

[Chinmoku]

Agreed. Though it is certainly disappointing that some users experienced adverse effects, it is at least assuring to see that neuromodulation does indeed have an impact on tinnitus to some degree. Hopefully, this form of treatment can be modified over time to remove these negative effects - or as you mentioned, it would be extremely helpful to determine the subset group of which these products can provide efficacy for.

I would expect Susan Shore/UMich, U of Minnesota, and other neuromodulation research teams to be keeping a close watch on the reported results of Lenire. I am optimistic that future devices can yield stronger results after they account for the good and bad that resulted from Lenire.

From what @kelpiemsp mentioned Minnesota would do a brain scan to decide the setting for the neuromodulation. Susan Shore asks you about your somatic points and type of tinnitus sound. Lenire only uses a crude audiogram to configure the treatment. So it's the least specialised of the approaches.

 

[danielbp85]

So people with a measurable hearing loss but no hyperacusis can't expect to benefit from neuromodulation, like Lenire, at all?

What makes hearing loss so special that makes this technique ineffective?

 

[Emgee]

From what @kelpiemsp mentioned Minnesota would do a brain scan to decide the setting for the neuromodulation. Susan Shore asks you about your somatic points and type of tinnitus sound. Lenire only uses a crude audiogram to configure the treatment. So it's the least specialised of the approaches.

Does anyone know how far along the Minnesota device is?

I spoke with Dr. Shore and she said she expects the 2nd trial to be done by early fall. She is unsure when commercialization will occur. She said it is likely that their treatment will have a positive effect if you can modulate your tinnitus.

Unfortunately, I can't modulate mine. Then again, mine is reactive so I'm part of a smaller subset of tinnitus sufferers.

 

[lucy_snow]

So people with a measurable hearing loss but no hyperacusis can't expect to benefit from neuromodulation, like Lenire, at all?

What makes hearing loss so special that makes this technique ineffective?

Or the other way round. What makes hyperacusis so special that makes this technique effective?

 

[Chinmoku]

Does anyone know how far along the Minnesota device is?

I spoke with Dr. Shore and she said she expects the 2nd trial to be done by early fall. She is unsure when commercialization will occur. She said it is likely that their treatment will have a positive effect if you can modulate your tinnitus.

Unfortunately, I can't modulate mine. Then again, mine is reactive so I'm part of a smaller subset of tinnitus sufferers.

We don't know and that is particularly frustrating because personally I feel Minnesota is the best of the three. If you have reactive tinnitus Lenire _might_ work for you.

Susan Shore is a great researcher but in terms of final delivery she moves with the speed of a sloth under anesthesia.

 

[Chinmoku]

Or the other way round. What makes hyperacusis so special that makes this technique effective?

Hyperacusis makes you more sensitive to sound. Perhaps that gives more impact to the sound part of the modulation. But who knows...

 

[PeterPan]

So people with a measurable hearing loss but no hyperacusis can't expect to benefit from neuromodulation, like Lenire, at all?

When looking at the patients who provided complete data (36 patients), 8 of them had no hyperacusis and some hearing loss. Of these, 2 dropped out due to adverse outcomes. All 6 of the remainder had no significant improvement. In fact, the average TFI of these 6 increased rather than reduced (despite the fact that the average across all patients was -13.9). So it looks like if you don't have hyperacusis and do have some hearing loss, you won't do well. More data would be nice of course, but there is a significant statistical difference between these patients and the patients with hyperacusis and with no hearing loss. Maybe the Michigan or Minnesota devices may work for tinnitus with these characteristics.

What I also see in these numbers is that neuromodulation has influenced (good and bad) the tinnitus of 64% of the participants. So it actually does something for the majority of people.

Yes, this is the case. But we need to be mindful of the caveat that we had no control arm. All the changes we observed could be due to the placebo effect (and even the fact that patients with hyperacusis did better than others could also be due to this effect, as this relationship was known prior to the study commencing). The way to counter the possibility of a placebo effect is to execute a randomized controlled trial. In the Neuromod trials they stated they could not run a trial with a dummy arm because patients would know that they are in that arm (e.g. if they turned off the electrical stimulation, patients would be able to tell they are in the placebo arm as they would not feel the electrical stimulation). Instead Neuromod ran a trial with three different treatment arms. There were some differential effects in the outcomes of these arms, but they were not (at least to me) especially convincing. All 3 arms had a similar drop in THI on average.

Interestingly in the UofM trials they came across this issue as well. However, according to @linearb, who participated in the trials, they were able to tone down the electrical stimulation so that it was not detectable in either the placebo or the treatment phases (and yet still be effective). They DID see differences in the average TFI reduction between placebo and treatment arms (albeit with a very small sample size).

The problem is that, as usual, there is almost no objective way to determine the characteristics of each group. Imagine that this would be possible, you'd have an actual safe and effective treatment for at least 1 subgroup of tinnitus sufferers! I really hope this is why it's taking Susan Shore this long to develop her thingy.

We did actually see some groups get better results than others (and discovering these relationships was, in fact, one of the objectives of the study). We saw positive results for people with hyperacusis and lack of hearing loss. We also saw a lack of relationship on a whole range of other factors.

 

[hans799]

So people with a measurable hearing loss but no hyperacusis can't expect to benefit from neuromodulation, like Lenire, at all?

What makes hearing loss so special that makes this technique ineffective?

Nah, that's not true. I have measurable hearing loss (though not much), no hyperacusis, and yet Lenire seems to be working for me. Actually visited the forum today to say that today's the 3rd day in a row when my tinnitus has been unusually quiet. Still afraid of jinxing it but the magic appears to be starting again

@alanisnotadj how are you doing?

 

[UKBloke]

8 of them had no hyperacusis and some hearing loss.

This sums up my tinnitus to a T (pardon the pun).

the average TFI of these 6 increased rather than reduced (despite the fact that the average across all patients was -13.9). So it looks like if you don't have hyperacusis and do have some hearing loss, you won't do well.

It seems then that for people like me, Lenire is less a placebo machine and more a dis-improvement device.

I have to say that I suspected there would be an element of this from the beginning because there was something about the data that came out of Neuromod that left me feeling perplexed. Add to this the anecdotal reviews that began to appear in this thread and the data crunched, my own personal fears are confirmed despite the small sample size.

For the record I would have paid for a placebo machine because I think the nature of tinnitus means the body naturally tries to capitalise on any improvement, real or perceived. Having said that, I began to lose faith when Allan's and Alice's reports filtered through.

It's been a long road watching this thread and waiting, but I've now reached the end of it. For what it's worth, having done much more reading and research of my own both of this very valuable forum and wider, I now believe more than ever that the solution to chronic tinnitus in a sufferer like myself where it can be pretty certainly said that the tinnitus is noise-induced must include some kind of regenerative medicine. There is simply something else going on with our auditory systems/organs that in my opinion Lenire, Shore, Minnesota et al are just not going to be able to address in their own current treatment configuration.

I'm waiting for the day when the regenerative disciplines work together with the ion-channel disciplines (ala Thanos) and the Shore's/O'Neill's of this world to organise themselves into a full 360 degree consortium. Until that day comes when we have reliable sub-typing I think the various processes of treating tinnitus, particularly given the very real dangers of patient worsening, is going to be too hit and miss.

Cheers all

 

[DaveFromChicago]

To the UKBloke:

Your assessment is precisely what I have been led to conclude given how similar my lifelong experience in finding a real pain-eliminating solution for migraines has been.
Before the introduction of the drug Maxalt, I could just tell that all of the other suggested treatments such as acupuncture, massage therapy, herb supplements, barbiturate based drugs, etc. never quite reached the core of the pain-creating condition. It was as if this core condition was a target and all of the other previous methods were either near misses or just glancing blows. With Maxalt I can actually feel my head's internal structure changing with the dissolution of the pain.

More than this electrical/auditory stimulation will be required; there will also have to be a drug that acts in its own way as directly as Maxalt has.

 

[david c]

The Lenire users results compiled by @PeterPan are extremely useful and certainly very different from the results that Neuromod have been providing. The main summary points seem to be that:

Around two in five users had no change from using Lenire.
Around two in five users had some improvement from using Lenire
But around one in five users had some worsening from using Lenire.

The main takeaway is that using Lenire seems like a complete gamble. If you have a lot of time and money it might be worth a go but absolutely not if you are at all worried about your tinnitus worsening - as this seems to be a major risk from Lenire use. Personally, I will definitely not be using Lenire in the future.

 

[danielbp85]

Nah, that's not true. I have measurable hearing loss (though not much), no hyperacusis, and yet Lenire seems to be working for me. Actually visited the forum today to say that today's the 3rd day in a row when my tinnitus has been unusually quiet. Still afraid of jinxing it but the magic appears to be starting again

@alanisnotadj how are you doing?

Nah, that's not true. I have measurable hearing loss (though not much), no hyperacusis, and yet Lenire seems to be working for me. Actually visited the forum today to say that today's the 3rd day in a row when my tinnitus has been unusually quiet. Still afraid of jinxing it but the magic appears to be starting again

@alanisnotadj how are you doing?

@hans799 How is your hearing loss in a bit more detail? Is it mild? Is it in the higher frequencies or across all?

Btw, are you Hungarian or an expat living in Budapest? Thanks!

 

[pinklights98]

What is measurable hearing loss defined as?

 

[alanisnotadj]

@alanisnotadj how are you doing?

I am doing fine actually thank you

The tinnitus is much lower than my normal average.
About the report, first of all congratulations to all those involved with it. It is really a first class piece of work.

When I filled in the questionnaire, at the end of the 12 week mark, I might have been rather negative compared to how I felt when I started the treatment. The second settings really did not work for me and it felt like all the good progress I had made while on the first settings had been cancelled. But now that I am back on the first settings I can totally see the difference and they definitely work for me. I once again managed to fall asleep last night without sound enrichment (or alcohol)!

Lenire will probably not eliminate my tinnitus, but it will definitely make the waiting game for the regenerative & ion-channel therapies a lot easier.

I honestly can't imagine coping without it now.

 

[UKBloke]

I am doing fine actually thank you

The tinnitus is much lower than my normal average.
About the report, first of all congratulations to all those involved with it. It is really a first class piece of work.

When I filled in the questionnaire, at the end of the 12 week mark, I might have been rather negative compared to how I felt when I started the treatment. The second settings really did not work for me and it felt like all the good progress I had made while on the first settings had been cancelled. But now that I am back on the first settings I can totally see the difference and they definitely work for me. I once again managed to fall asleep last night without sound enrichment (or alcohol)!

Lenire will probably not eliminate my tinnitus, but it will definitely make the waiting game for the regenerative & ion-channel therapies a lot easier.

I honestly can't imagine coping without it now.

Alan, do you have measurable hearing loss and no hyperacusis or is/was there some hyperacusis there?

 

[alanisnotadj]

Alan, do you have measurable hearing loss and no hyperacusis or is/was there some hyperacusis there?

Here is my latest hearing test. I would add that I don't seem to hear much above 9kHz. Remember I have had 3 acoustic traumas (as well as too many nights spent in Berghain) so my ears are pretty messed up.

I have mild hyperacusis/noxacusis in my left ear. Like a dull pain that never really goes away. I don't really know how to qualify it. The pain is so random sometimes. Gabapentin seems to help but to I have to say a good pint of beer always seems to make the pain go away

 

[UKBloke]

Nah, that's not true. I have measurable hearing loss (though not much), no hyperacusis, and yet Lenire seems to be working for me.

Hans, are you one of the six in this part of the data PeterPan mentions?

8 of them had no hyperacusis and some hearing loss. Of these, 2 dropped out due to adverse outcomes. All 6 of the remainder had no significant improvement. In fact, the average TFI of these 6 increased rather than reduced (despite the fact that the average across all patients was -13.9). So it looks like if you don't have hyperacusis and do have some hearing loss, you won't do well.

This is becoming confusing.