Lenire — Bimodal Stimulation Treatment by Neuromod

[Redknight]

I have it on good authority from a person who was enrolled in the trial and knows people at Neuromod that they are launching it in Ireland in June!

Just a month to go!!!

It sounds like they have got enough local audiologists trained in how to administer the device that they are ready to start selling in Ireland. I wonder if they've got any in Northern Ireland where I am or if I'll have to drive to Dublin.

I think I'll email them and maybe get queued with an audiologist.

 

[ruud1boy]

I have it on good authority from a person who was enrolled in the trial and knows people at Neuromod that they are launching it in Ireland in June!

Just a month to go!!!

I remember the Irish fella - @RCP something? - saying in December that it was 'weeks away'. I'll believe it when we see it. My determination to wait it out and watch the real world testimonials build up is wavering however. It's like my money just wants to leap into Neuromod's pocket.

 

[Tanni]

I have it on good authority from a person who was enrolled in the trial and knows people at Neuromod that they are launching it in Ireland in June!

Just a month to go!!!

Awesome . How did the person on the trial get on? Any improvement for them?

 

[Paulmanlike]

Oh no, good point!

Maybe they felt that the THI is the most accurate way of judging this subjective condition? If your tinnitus is louder or quieter each day due to your perception, the actual volume wouldn't make for very accurate data I suppose?

Overall, do you feel more positive after these results, or less positive?

Tough question. I was a bit disappointed that the results didn't improve more on a THI/TFI scale compared to CBT therapy, but I have always kept my expectations realistic. Still it would have paved the way to being NICE-approved if it did and possibly even one day being available on the NHS/insurance. If this device costs less than CBT therapy then it may make its way to being covered by NHS/insurance. Also, I recall for something to be NICE-approved it has to be proven it's better than current methods of treatment. Whilst they haven't been able to achieve greater results than CBT, they've achieved it quicker rather than months of therapy - which is good but not earth shattering.

I was also a little disappointed we didn't learn much more than we already know. It was informative to the first time listener however, but not new to me.

I am also concerned about not presenting the MML/TLM scores and just the TFI/THI scores. Going from the same results that CBT claims - CBT would do nothing to reduce the actual loudness of your tinnitus, but would rather help you to learn to live with it in a more positive manner that would improve the symptoms of tinnitus; anxiety, depression, insomnia, lack of concentration.

Put it this way, if Neuromod was available today just based on the information presented, I would certainly not pay thousands for it - yet.

There was also concerns from members about the testimonials making it sound like a habituation device - a very real concern. These results just going off this slide, suggests nothing about the actual volume going down. TFI and THI are just psychological measures of tinnitus distress.

I would be interested in another Q&A with Ross O'Neill or Hubert Lim to clear questions up because going from this and their lack of PR it hasn't given me the will to buy it.

There are reasons to be positive of course but I would reiterate what an above poster stated about the placebo effect being very high and given that tinnitus is a very subjective condition, it's bound to show improvements when you think you're hooked to a device that claims to reduce the tinnitus. If you research placebo effects, you'll find lots of information how strong it actually is. That's why there are usually rigorous trials with drugs for example, you're almost always going to find improvers under sham treatments.

I don't want to kill the positivity so I would suggest to read the positives people have highlighted as well as take on board the concerns; however a critical eye is crucial in any tinnitus treatment to the tinnitus sufferer given its history.

 

[Heinrich_S7]

I agree with every word.
We do not have a cure (yet.)
Mocking positive attitudes and coping methods is not only ridiculous but highly dangerous to our own psyche, let alone the reader's.
Anything that helps - relaxation, meditation, hypnotherapy, autosuggestion etc... has to be in, and not ruled out.
They are helping many of us to survive and maintain our optimism.

Even then, we do know some people that have had theirs entirely disappear. That one lady in the testimonials also comes to mind. So some do have their *symptom temporarily cured*.

All in all, I think most of us are going to be using this until gene therapy or FX-322 arrive to fix the cause and not the symptom. This just fixes or significantly reduces the symptom.

I do know this, @kelpiemsp claimed he had his tinnitus at 85 dB, if he can only hear his when plugging up his ears, then I'm confident this can knock a lot of ours out entirely.

That is, of course, assuming this device is as effective as Shore's or Lim's personal device.

 

[Amv]

I literally cried this morning. This may oy may not work, but at least for me it represents the beginning of finding a cure for tinnitus, and it is nice to live this scenario. It is nice to know there is something happening for us. Just knowing this is going to be released and then trying the device is nice.

This attacks parts of the brain supposed to help our tinnitus, the difference between this and CBT is that Neuromod is a more focused tool, which in case your argument is about CBT, discards many factors (how good your therapist is, how well you come along with him/her... etc).

At this point in my life, any type of relief is a gain for me. Even if this only made habituation faster but not reduce the noise, it would make it much easier to live with it. If this helps with the tinnitus spikes as some people have suggested then that is a really big win for me, because this means I can recover much of my life activity (with precaution) and get rid of the fear of something bad happening.

So, let's see how this works, let's be optimistic people!!

 

[Paulmanlike]

Just had another good look at the PowerPoint. What's interesting is that the most therapeutic effects occur in the first 6 weeks - that was already known - but here we can see it in the data. This is good news because once this device is released, hopefully a flood of testimonials will come and it should be obvious to the user that the device is doing something. On the other hand, people were hoping that continued usage will further drive the tinnitus down. However changing the stimulation setting at 6 weeks shows a slight further optimisation of keeping getting results.

I would reiterate again, it is shown on the graphs that post-treatment there are still scores - indicating that tinnitus still exists. There are a few where that score is zero - this could mean that tinnitus is gone or simply it's just not a problem for them anymore (we don't know this because it's measured with TFI/THI). So for those thinking it's a cure - it isn't.

What is interesting however, is that they have got results and they have got results fast. Now who knows where this may lead. Bimodal neuromodulation is still in its infant stage. It may be possible that further changes every 6 weeks could be used until one day the tinnitus is gone completely. However that's pure speculation and data for that does not exist - yet.

Very encouraging - I am happy for us all.

 

[GlennS]

I don't want to kill the positivity so I would suggest to read the positives people have highlighted as well as take on board the concerns; however a critical eye is crucial in any tinnitus treatment to the tinnitus sufferer given its history.

I agree with your concerns and I would not want to be one of the very first early adopters. But there WILL be plenty of early adopters and their word of mouth will matter a lot more than any followup Q&A or PowerPoint presentation. I'll be on board as a second-wave adopter if there are enough positive testimonials.

So I am... cautiously optimistic.

 

[Paulmanlike]

I agree with your concerns and I would not want to be one of the very first early adopters. But there WILL be plenty of early adopters and their word of mouth will matter a lot more than any followup Q&A or PowerPoint presentation. I'll be on board as a second-wave adopter if there are enough positive testimonials.

So I am... cautiously optimistic.

Same here Glenn, I'm a long term sufferer myself now and have seen lots of treatments come and go and there isn't even 1 treatment that has an 80-90% improvers rate. Sure, a lot of them claim to have these figures but that isn't the reality of it. Only time will tell if Neuromod delivers!!

If these guys can turn clinical trials into 'real life' figures demonstrating 80-90% improvers rate, then they'll be the first and they'll be swamped in cash.

After this, I just hope that Otonomy, Frequency Therapeutics and Audion Therapeutics will be able to completely eliminate tinnitus for everyone with their regeneration programmes. Again with that, even if they can regenerate hearing - that's not a guarantee to cure tinnitus so I am always open to any company figuring out new ways of treating tinnitus.

 

[Tanni]

Tough question. I was a bit disappointed that the results didn't improve more on a THI/TFI scale compared to CBT therapy, but I have always kept my expectations realistic. Still it would have paved the way to being NICE-approved if it did and possibly even one day being available on the NHS/insurance. If this device costs less than CBT therapy then it may make its way to being covered by NHS/insurance. Also, I recall for something to be NICE-approved it has to be proven it's better than current methods of treatment. Whilst they haven't been able to achieve greater results than CBT, they've achieved it quicker rather than months of therapy - which is good but not earth shattering.

I was also a little disappointed we didn't learn much more than we already know. It was informative to the first time listener however, but not new to me.

I am also concerned about not presenting the MML/TLM scores and just the TFI/THI scores. Going from the same results that CBT claims - CBT would do nothing to reduce the actual loudness of your tinnitus, but would rather help you to learn to live with it in a more positive manner that would improve the symptoms of tinnitus; anxiety, depression, insomnia, lack of concentration.

Put it this way, if Neuromod was available today just based on the information presented, I would certainly not pay thousands for it - yet.

There was also concerns from members about the testimonials making it sound like a habituation device - a very real concern. These results just going off this slide, suggests nothing about the actual volume going down. TFI and THI are just psychological measures of tinnitus distress.

I would be interested in another Q&A with Ross O'Neill or Hubert Lim to clear questions up because going from this and their lack of PR it hasn't given me the will to buy it.

There are reasons to be positive of course but I would reiterate what an above poster stated about the placebo effect being very high and given that tinnitus is a very subjective condition, it's bound to show improvements when you think you're hooked to a device that claims to reduce the tinnitus. If you research placebo effects, you'll find lots of information how strong it actually is. That's why there are usually rigorous trials with drugs for example, you're almost always going to find improvers under sham treatments.

I don't want to kill the positivity so I would suggest to read the positives people have highlighted as well as take on board the concerns; however a critical eye is crucial in any tinnitus treatment to the tinnitus sufferer given its history.

Thanks for this detailed answer. I would also like a follow up interview with all our new questions, but I suppose if @annV is right and it's coming out next month, we may as well just wait.

I don't think the NHS will be picking it up for many years unfortunately. Are you going to get involved in the new NICE guidelines for the treatment of tinnitus in the UK?

Tinnitus Hub are now a stakeholder, as is the BTA and Neuromod themselves. Think you would be amazing at it:

https://www.tinnitustalk.com/thread...anagement-guideline-feedback-committee.34717/

 

[Watasha]

Same here Glenn, I'm a long term sufferer myself now and have seen lots of treatments come and go and there isn't even 1 treatment that has an 80-90% improvers rate. Sure, a lot of them claim to have these figures but that isn't the reality of it. Only time will tell if Neuromod delivers!!

If these guys can turn clinical trials into 'real life' figures demonstrating 80-90% improvers rate, then they'll be the first and they'll be swamped in cash.

After this, I just hope that Otonomy, Frequency Therapeutics and Audion Therapeutics will be able to completely eliminate tinnitus for everyone with their regeneration programmes. Again with that, even if they can regenerate hearing - that's not a guarantee to cure tinnitus so I am always open to any company figuring out new ways of treating tinnitus.

This is why I am a big proponent of Dr. Rauschecker's research. I feel like he is on the hunt for what actually is occurring in the brain for those who have the experience and is attempting to build a model in primates that have the higher brain structures similar to humans. This could greatly accelerate advancements in research by having test subjects similar to humans.

 

[Allan1967]

It sounds like they have got enough local audiologists trained in how to administer the device that they are ready to start selling in Ireland. I wonder if they've got any in Northern Ireland where I am or if I'll have to drive to Dublin.

I think I'll email them and maybe get queued with an audiologist.

You'll get an email if you registered. It's going to be a mass email based on who registered their interest.

 

[KotaDomowa]

I sent a question about the improvement of MML. Worst case, they won't answer.

 

[Paulmanlike]

I sent a question about the improvement of MML. Worst case, they won't answer.

Please let us know if and what they reply.

You could also ask them about the Tinnitus Loudness Matching (TLM) that they also recorded?

What would be bizarre is if there wasn't much change or any, with a corresponding decreases in TFI/THI over a relatively short amount of time. What would that mean for how it works? You can understand it with a long course of CBT, but not within 6 weeks of using a device.

Anyway, I would assume or hope that these scores have also come down.

There is a paper in the research section under Emerging Drugs for Tinnitus that is an interesting read. Apart from the drugs that many of us have followed over the years - there is talk of Susan Shore, Neuromod, VNS Therapy, Bimodal Neuromodulation in there as well if anybody likes to keep up to date with what's going on.

 

[Heinrich_S7]

How does everyone think Lenire is going to stack up to the devices from University of Minnesota and University of Michigan?

On par? Superior? Inferior?

All three seem to use bimodal stimulation. They just target different areas and use different locations for delivery of the electric pulses, correct?

 

[GlennS]

This is why I am a big proponent of Dr. Rauschecker's research.

While I don't think his work is useless, I think he's focusing too much on the perception of tinnitus and not the source (the fusiform cells). I don't know if that's because he's convinced these downstream brain structures are the source instead or he feels there's no way to intervene at the fusiform level (hence his lack of knowledge of Neuromod).

 

[JohnAdams]

How does everyone think Lenire is going to stack up to the devices from University of Minnesota and University of Michigan?

They have a device?

 

[Heinrich_S7]

They have a device?

I believe so. I don't think it's anything commercial though. Or going to resemble their final product when they do actually come to market.

I'm actually not far from the state of Minnesota. If Neuromod doesn't release the Lenire in North America (really crossing my fingers we can get it in 2019) until next year, I might try to get in contact with Lim's team, I'd love to be their guinea pig until I can buy one of these.

 

[Watasha]

While I don't think his work is useless, I think he's focusing too much on the perception of tinnitus and not the source (the fusiform cells). I don't know if that's because he's convinced these downstream brain structures are the source instead or he feels there's no way to intervene at the fusiform level (hence his lack of knowledge of Neuromod).

I wasn't aware we had solidified the source in hard science? Otherwise all of our efforts would and should be aimed at directly addressing the source. Also, could not a source also be the mechanism that allows us to perceive the sound? His theory makes sense, there is an insult to the auditory system and then something else occurs that allows the manifestation of the sound into perception.

If he can figure out a way to block the perception of the signal, I'm all on board for that too. IMO, he's trying to build a working model of what is actually happening in the brain from start to finish. I think this is the type of thing that can lead to the most holistic cure/understanding.

This is why I support his research. If we get lucky and back into a cure without understanding what is actually happening (Neuromod, regeneration, etc) that's awesome, but I do want people studying what is actually going on as well.

 

[Alex Matyjasek]

I wonder if people who started having visual snow after the onset of their tinnitus might have a chance in seeing improvements in their visual snow from using Lenire?

I had to get something even more rare than tinnitus!

 

[KotaDomowa]

In answer to my question about MML Neuromod said:

Thank you for your enquiry. I have passed your email on to the relevant department and someone will be in touch in due course. Please do bear in mind that due to a high volume of queries, it may take longer to get a response.
Thank you for your interest

@Paulmanlike OK, but first I will wait for the answer to this question. Later I will also ask about the Tinnitus Loudness Matching (TLM). I do not want to impose myself on them.

 

[Allan1967]

There's a post in the support section here with a chap saying 'have you read the latest about Lenire... it doesn't help severe tinnitus'.

Has anything formally been said along these lines by Neuromod? I would class myself as severe, but I'm under no illusion that Lenire isn't touted as a cure and might help eliminate a person who has mild tinnitus, but best I could hope for is a reduction in tinnitus, not an elimination.

Have I missed something?

 

[Autumnly]

There's a post in the support section here with a chap saying 'have you read the latest about Lenire... it doesn't help severe tinnitus'.

Has anything formally been said along these lines by Neuromod? I would class myself as severe, but I'm under no illusion that Lenire isn't touted as a cure and might help eliminate a person who has mild tinnitus, but best I could hope for is a reduction in tinnitus, not an elimination.

Have I missed something?

Neuromod didn't say anything in the interview about the device not working for severe sufferers and I don't remember them having said anything along the lines of that. The report function exists for a reason. Being skeptical of the device is completely fair, spreading misinformation like that isn't. They excluded very severe sufferers but that doesn't mean the device can't work for them.

From the interview on why they excluded severe sufferers with very high THI/TFI scores:
Ross: Also, the really top patients, the patients who were scoring really, really high on the THI and TFI tend to have a lot of complex comorbidities. And they tend to be intertwined, so they can suffer from depression, anxiety, a lot of issues. A lot of them tend to be medicated or are using some levels of medication. So how do you tell that it's your intervention having the effect and not some change in their medication? That is the reason you exclude both of those groups.

 

[Allan1967]

Neuromod didn't say anything in the interview about the device not working for severe sufferers and I don't remember them having said anything along the lines of that. The report function exists for a reason. Being skeptical of the device is completely fair, spreading misinformation like that isn't. They excluded very severe sufferers but that doesn't mean the device can't work for them.

From the interview on why they excluded severe sufferers with very high THI/TFI scores:
Ross: Also, the really top patients, the patients who were scoring really, really high on the THI and TFI tend to have a lot of complex comorbidities. And they tend to be intertwined, so they can suffer from depression, anxiety, a lot of issues. A lot of them tend to be medicated or are using some levels of medication. So how do you tell that it's your intervention having the effect and not some change in their medication? That is the reason you exclude both of those groups.

I thought as much. Whats THI and TFI?

 

[KotaDomowa]

THI - > https://starkeypro.com/pdfs/THI_Questionnaire.pdf
TFI -> http://www.ata.org/sites/default/files/TFI.pdf

 

[Paulmanlike]

Clear answer from @Autumnly.

Also, @Allan1967, looking at the graphs, it would appear most people got the same sort of reduction. So if you're a severe sufferer you can bring it down to a moderate level, a moderate level to a mild level, a mild level to a lower than that level. There was one though that had a TFI of about 80 (severe) and was less than 20 at the end of treatment.

@kelpiemsp had TF/THI over 80 I recall and achieved about 14 post treatment - but it's not happening a lot looking at the graphs, but occasionally.

Nevertheless a reduction to moderate is pretty exciting and hopefully this is just the start of bimodal neuromodulation.

 

[Allan1967]

Clear answer from @Autumnly.

Also, @Allan1967, looking at the graphs, it would appear most people got the same sort of reduction. So if you're a severe sufferer you can bring it down to a moderate level, a moderate level to a mild level, a mild level to a lower than that level. There was one though that had a TFI of about 80 (severe) and was less than 20 at the end of treatment.

@kelpiemsp had TF/THI over 80 I recall and achieved about 14 post treatment - but it's not happening a lot looking at the graphs, but occasionally.

Nevertheless a reduction to moderate is pretty exciting and hopefully this is just the start of bimodal neuromodulation.

That's what I thought @Paulmanlike. I did the questionnaire and I came out top of the moderate score, so if I could reach 'mild' or top end of 'mild' it would be a welcome improvement.

 

[Shelly75]

That's what I thought @Paulmanlike. I did the questionnaire and I came out top of the moderate score, so if I could reach 'mild' or top end of 'mild' it would be a welcome improvement.

Yes - I wonder if getting down to top end of mild would then make it easier to habituate? Maybe the continued reduction in THI scores after treatment has ended shows some natural habituation kicking in to the new lower level?

 

[Paulmanlike]

That's what I thought @Paulmanlike. I did the questionnaire and I came out top of the moderate score, so if I could reach 'mild' or top end of 'mild' it would be a welcome improvement.

I hope it works for you Allan and for all of us. The results are showing that pretty much you are likely to respond and would have to be quite unlucky to be a non-responder.

 

[Allan1967]

I hope it works for you Allan and for all of us. The results are showing that pretty much you are likely to respond and would have to be quite unlucky to be a non-responder.

Fingers crossed @Paulmanlike. I'm already scoping out flight schedules and checking my email well... every 30 seconds.

Thank you for your insightful thoughts incidentally.