Lenire — Bimodal Stimulation Treatment by Neuromod

[ThomasC]

So the results are not permanent? Dr. Ross O'Neill said the opposite, he stated the benefits could last at least 12 months after the end of the treatment.

 

[UKBloke]

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

What you describe is remarkably similar to my own experience with tinnitus although I never actually went and got a proper hearing test, only a head X-Ray (presumably to look for a neuroma) when first diagnosed back in '91.

And I agree, a good pint of beer always helps!

 

[alanisnotadj]

So the results are not permanent? Dr. Ross O'Neill said the opposite, he stated the benefits could last at least 12 months after the end of the treatment.

I think they are, providing you don't "dis-improve" them with the wrong settings!

 

[Darktale]

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

For me you have no hearing loss up to 8 kHz since till 20 dB is considered as normal...
And you have not been tested above 8khz that's why there is no figure or curve there... which is quite common as most of « standard » hearing tests stop at 8 kHz.

To really know if you have (« hidden ») hearing loss above that frequency you must do a more complete hearing test involving high frequencies (possibly up to 20 kHz when you are young)

 

[GlennS]

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.

I'm not ready to draw conclusions about all of neuromodulation based solely on Lenire. That being said I wasn't particularly impressed with Susan Shore's improvement charts vs. Lenire although hers didn't (as I recall) feature any worsenings. Minnesota seems the most promising but they seem to be the least heralded and may languish in obscurity.

 

[PeterPan]

This is becoming confusing.

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).

The results above are correct given the data from the patient questionnaires. Note that an "improvement" here is defined as a reduction in TFI of 13 or more points.

As @Hazel mentioned earlier, part of the challenge in tinnitus research is coming up with an objective measure of the severity of tinnitus. Another challenge we have is the small sample size.

I think the take-away is that of the 8 patients who reported no hyperacusis and hearing loss, all 8 either reported no significant improvement as defined by a reduction of 13 or more points in TFI or dropped out due to adverse events.

Does that mean that the treatment will not work for you if you have no hyperacusis and hearing loss? No. But it does provide support for the proposition that it is less likely to work for you. If we had more data, we may be able to answer this question more definitively.

 

[hans799]

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

Hey Daniel,

According to Neuromod's audiogram, I have -25 dB hearing loss at 4 kHz on the right side. That's roughly where my 1990 tinnitus noise is - around that frequency and it leans towards the right.

My 2016 tinnitus noise is mainly on the left around 1800 Hz. Audiograms don't measure that frequency, of course, but have listened to these gradually ascending "hearing test" videos and I seem to have hearing loss around that frequency, too.

I can hear up to 15 kHz and don't seem to have hidden hearing loss according to "word comprehension in a noisy environment" tests.

So to sum up: hearing's fine except on specific frequencies and that's where my tinnitus is.

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

Hungarian, born and bred! I use an alias simply for privacy, I wouldn't want colleagues or HR googling my name and finding out about my issues with tinnitus. I believe we also have @Kriszti here, too!

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

Possibly. Since the 2nd timing lead to spikes my TFI at 12 weeks might have been worse than at 0 weeks. However this is a little bit misleading because the first timing did lead to improvements and now that I'm back on it, I'm doing better again.

Maybe the "no hyperacusis, yes hearing loss" people just have to stick to the first timing and avoid the second.

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.

This is exactly my experience. 1st timing works, 2nd actually disimproves.

@PeterPan would it be possible to compare the 6-week data with baseline for the 6 people who report hearing loss but no hyperacusis? I have a hunch that they might actually have had improvements at that point which were later spoiled by the 2nd timing.

 

[PeterPan]

@PeterPan would it be possible to compare the 6-week data with baseline for the 6 people who report hearing loss but no hyperacusis? I have a hunch that they might actually have had improvements at that point which were later spoiled by the 2nd timing.

Hi Hans,

We already have that data:

Average TFI change gets slightly worse from 6 weeks to 12 weeks.

At 6 weeks we had 8 people. 6 reported no change, and 2 a significant improvement. We had one dropout due to adverse events prior to the 6 weeks.
At 12 weeks we had another two dropouts (one to adverse results, one because the device broke). The patients who reported significant improvements at 6 weeks were still in the study at 12 weeks and they both reported that that change was no longer significant (as measured by change in TFI). This contrasts with the other arms where we had more improvements from 6 to 12 weeks.

BTW, there is a heap of other stuff in the report, not just the hyperacusis/hearing Loss finding (although this is probably the most significant). There are also some models developed which can help to predict the outcome of using the Lenire (although use at your caution as sample size is VERY small). This is the real geeky stats stuff! It would be great if we could have got some more data to make some of the results a bit more conclusive.

 

[UKBloke]

I'm not ready to draw conclusions about all of neuromodulation based solely on Lenire.

Me neither. I essentially still have faith in the science, and it looks like neuromodulation, at least in its current Lenire format, will help. But the main caveat (not withstanding hyperacusis) seems to be that one's basic hearing profile needs to be intact to get the most benefit. This is something I'm struggling with.

"Hidden hearing loss" aside, the primary contradiction for me is that much of the medical advice across the Internet tells us that tinnitus is often experienced as a result of some hearing loss. If that is mainly true then according to the small amount of data we have here, those whose symptoms fit the dictionary definition are the least likely to be helped by the device. It's a circle I'm finding difficult to square.

 

[jmasterj]

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.

I haven't heard much from the Minnesota team for some time. I am on their mailing list for a possible next phase study, but I haven't heard much of anything since Hubert Lim started working with Neuromod. Last update around here was that they were looking for engineers to create a wearable device for their treatment. I would say that was probably a year ago or so.

 

[hans799]

A discussion with @PeterPan has revealed that I've misunderstood the definition of hyperacusis and apparently I have it, too. I often find myself flinching and moving away from and feeling uncomfortable around sounds that don't bother others (e.g. cutlery dinging, weight plates dropped in the gym, etc). After such a sound, my ear often becomes temporarily clogged, like there's some kind of muscle which tightens to protect it (even if it doesn't affect my hearing or spike the tinnitus).

Because there's no physical pain I didn't think this was hyperacusis but I stand corrected. This means that I also fit the "has hyperacusis, but hearing profile is mostly intact" mold that Lenire seems to be most beneficial to.

I'm posting this to correct my earlier statements about not having hyperacusis.

 

[UKBloke]

A discussion with @PeterPan has revealed that I've misunderstood the definition of hyperacusis and apparently I have it, too. I often find myself flinching and moving away from and feeling uncomfortable around sounds that don't bother others (e.g. cutlery dinging, weight plates dropped in the gym, etc). After such a sound, my ear often becomes temporarily clogged, like there's some kind of muscle which tightens to protect it (even if it doesn't affect my hearing or spike the tinnitus).

Because there's no physical pain I didn't think this was hyperacusis but I stand corrected. This means that I also fit the "has hyperacusis, but hearing profile is mostly intact" mold that Lenire seems to be most beneficial to.

I'm posting this to correct my earlier statements about not having hyperacusis.

Thanks for clearing this up. If flinching from certain sounds means hyperacusis, or a mild form of it, then I guess I qualify too. The missus has a habit of dragging a metal griddle across the stove causing a brief squealing sound. It's bloody awful and makes me wince!

 

[hans799]

And now I'm getting spikes in the noise-induced 2016 noise. Damn it. I've done 1x30 minutes for 3 weeks and 2x30 minutes for 4 weeks, and I recently had 5 consecutive good days. However, for some reason the tinnitus decided to be a bitch and kept me up until the small hours for the second night in a row.

Gotta love how this thing fluctuates. I think I'll cut back to 1x30 minutes, that worked so well that I had 2 consecutive weeks of good days. Maybe 2x30 minutes is just too much stimulation for me. Neuromod says the same thing (in case of adverse events with 2x30 minutes, cut back immediately to 1x30 minutes to avoid overstimulation).

 

[SignalExec]

@PeterPan

The report is a great piece of work. It shows dedication to bring us the information we need but are not getting from Neuromod. I am truly grateful for your efforts. It is even difficult for me to express how much I appreciate what you are doing (and how sad it is this needs to be done by volunteers instead of by the people taking the money).

I was wondering, do you think it would be possible to share the data? If I understand correctly there were about 40 respondents. Therefore, people here might be able to scroll through the data themselves and might be able to pick out patterns not reported on? Just an idea.

 

[ruud1boy]

Hans, are you one of the six in this part of the data PeterPan mentions?
This is becoming confusing.

I have a hearing impairment, no hyperacusis, have been using Lenire for 10 months now and it's done jack all for me. The positives I'm taking from this are that at least I do know it doesn't work for me in it's current form and I was fortunate enough to avoid the 1 in 5 chance of worsening.

Now, where's Susan Shore's e-mail address...

 

[ruud1boy]

I'd just like to echo the praise for @PeterPan - it's clear there's an enormous amount of work gone into this and it is greatly appreciated. I get the impression he loves stats tho' ;-)

I have one completely unimportant question - one of the responders in the survey dropped out at 6 weeks because the device broke and couldn't be replaced? Why could it not be replaced? I'd be irked to say the least if a £2k box of tricks packed up after 6 weeks and the supplier refused to replace it.

 

[PeterPan]

I was wondering, do you think it would be possible to share the data? If I understand correctly there were about 40 respondents. Therefore, people here might be able to scroll through the data themselves and might be able to pick out patterns not reported on? Just an idea.

I think that's a question for @Markku and @Hazel. It would be great if Neuromod could share their data with Tinnitus Talk as well (e.g. under some form of non-disclosure).

I get the impression he loves stats tho' ;-)

Yeah, that's right. I'm a Maths Graduate with some statistics, and have been enjoying getting back into the stats!

The report is a great piece of work. It shows dedication to bring us the information we need but are not getting from Neuromod. I am truly grateful for your efforts.

I'd just like to echo the praise for @PeterPan - it's clear there's an enormous amount of work gone into this and it is greatly appreciated

Thanks for the compliments. I hope it has been useful.

 

[PeterPan]

I have one completely unimportant question - one of the responders in the survey dropped out at 6 weeks because the device broke and couldn't be replaced? Why could it not be replaced? I'd be irked to say the least if a £2k box of tricks packed up after 6 weeks and the supplier refused to replace it.

Hi ruud1boy,

It was reported "My tonguetip seems to have shorted out (far ahead of schedule) and so I haven't been able to do the treatment for about 3 weeks now".

I guess it would be covered by warranty but maybe the member who had the problem can elaborate (if they are reading!).

PeterPan

 

[pinklights98]

Hi ruud1boy,

It was reported "My tonguetip seems to have shorted out (far ahead of schedule) and so I haven't been able to do the treatment for about 3 weeks now".

I guess it would be covered by warranty but maybe the member who had the problem can elaborate (if they are reading!).

PeterPan

If they were a US resident then Neuromod doesn't cover replacement.

 

[LongWait]

Minnesota seems the most promising but they seem to be the least heralded and may languish in obscurity.

Absolutely. Why is something so promising the least developed for a potential relief from this hideous disorder.

 

[hans799]

My device developed a Bluetooth glitch. Which didn't even render it unusable, was just an annoyance. They replaced it, free of charge, even threw in a free tonguetip. They're cool with their warranty policy.

 

[UKBloke]

Now, where's Susan Shore's e-mail address...

Definitely. I think between this and something like FX-322 we're on the road to getting real treatment options.

 

[Amv]

IMO, Neuromod at least have taken accountability on timings and launched Lenire, while we may keep waiting for Susan Shore's for a bunch of years.

If Neuromod has a considerable quantity of patients, they can learn from them and adjust Lenire in future versions. They will have a capital advantage versus other devices that progress slowly, so don't underestimate Neuromod and their Lenire!

 

[Chinmoku]

Absolutely. Why is something so promising the least developed for a potential relief from this hideous disorder.

It's partly due to Neuromod distracting Lim from the Minnesota device, that looked much more interesting than Lenire from the little we know. I wonder if Lim has signed a clause for Neuromod about not working for a competing device for a given time.

It's a crime we have people contemplating and sometimes committing suicide while on some dusty shelves in Minnesota they have a device they can calibrate with a brain scan that completely eliminated tinnitus for @kelpiemsp.

 

[hans799]

It's a crime we have people contemplating and sometimes committing suicide while on some dusty shelves in Minnesota they have a device they can calibrate with a brain scan that completely eliminated tinnitus for @kelpiemsp.

Yes it is. Same goes for the Hough pill which has existed for what? 5 years? 10 years? Same for FX-322.

How many lives were lost while the cure has most probably been in existence all along? How much suffering, broken families, lost jobs? Why is there no legal way for us to accept personal responsibility, and pay whatever the companies ask for, but TRY these things if we want to? While at the same time there IS a legal way for us to pay for assisted suicide?

What twisted, diabolic lawmakers came up with this legal environment? I'd love to give them a good, strong, resounding slap right on the ear.

 

[Chinmoku]

One question on the type of sounds that are delivered with Lenire.

I spoke with one patient who told me he had no white noise sounds in PS1 but just piano music. However, other patients here with PS1 mentioned white noise.

Does this depend on hearing loss? Do patients without hearing loss only get the piano music and those with hearing loss the white noise too? Can anyone confirm? Thanks.

 

[alanisnotadj]

Another day of very low tinnitus.

Like @hans799 I don't want to jinx it but surely this reduction can only be attributed to Lenire.

 

[alanisnotadj]

One question on the type of sounds that are delivered with Lenire.

I spoke with one patient who told me he had no white noise sounds in PS1 but just piano music. However, other patients here with PS1 mentioned white noise.

Does this depend on hearing loss? Do patients without hearing loss only get the piano music and those with hearing loss the white noise too? Can anyone confirm? Thanks.

I have a bit of hearing loss and I am on PS1 (white noise & piano).

 

[Chinmoku]

One question on the type of sounds that are delivered with Lenire.

I spoke with one patient who told me he had no white noise sounds in PS1 but just piano music. However, other patients here with PS1 mentioned white noise.

Does this depend on hearing loss? Do patients without hearing loss only get the piano music and those with hearing loss the white noise too? Can anyone confirm? Thanks.

@hans799, @pinklights98, @ruud1boy, @alanisnotadj, @MadsWithT, @BigNick and other Lenire users, could you let me know if Lenire's sounds included white noise or not?

I have heard both versions. I'm sensitive to white noise so I was wondering. Thanks.

 

[alanisnotadj]

@hans799, @pinklights98, @ruud1boy, @alanisnotadj, @MadsWithT, @BigNick and other Lenire users, could you let me know if Lenire's sounds included white noise or not?

I have heard both versions. I'm sensitive to white noise so I was wondering. Thanks.

There is definitely some white noise in PS1.