Lenire — Bimodal Stimulation Treatment by Neuromod

[nicole76]

Even if Lenire works best for new sufferers, is that not amazing news for future sufferers, even though it doesn't serve your own need?

Yes, it is amazing, but definitely a disappointment for us longer term sufferers. It's easy to become a bit jaded thinking "look at this person who didn't even have this affliction for 6 months and is now healed and I've been suffering for years". It's just hard and it wears on a person. And this is why people are feeling so impatient about treatment - because they feel like the longer they have to wait the less chance they have at making a significant recovery.

That being said, I am glad you're having silent days. No one should have to live with tinnitus!

 

[Redknight]

I'm really glad that Lenire is working out well for you @Redknight. However, I note from your profile that your tinnitus dates from March 2019. It is not at all unusual during the first months after tinnitus for it to decrease significantly and it is quite likely that this is what is happening here - Lenire simply assisting the habituation process. I'm going to have to see quite a lot more positive reviews and feedback from those who have had tinnitus for a longer period to be convinced that there is more to it than that. So far I haven't. It is as I said before "early days" but the reviews on the User Experience Thread suggest that your experience currently is more of an outlier.

I think I'm probably done with this thread for a while, it's not helping me and I'm not helping you, so there's little point updating.

 

[newbieT]

I'm curious how Lenire can work off signal timing based on the very precise millisecond timing between sounds and tongue zap...

...but then uses Bluetooth headphones? Which has a very high latency in hundreds of milliseconds and it's not a constant latency too. It fluctuates and very difficult (if not impossible) to compensate for on the tongue zapper end.

Why didn't they just use a wired headphone with no latency?

Not saying it doesn't work, but as an electrical engineer I'm a bit skeptical on this detail.

 

[Pawel1]

Please, don't hate on me too much, for this post, I'm just very curious about the topic, and even if I have very little knowledge, I can sometimes contribute to the topics on this forum.

Maybe different people react to the treatment in such varied ways, because we all have different bodies?

https://edition.cnn.com/2017/03/22/health/magnesium-tinnitus-ringing-ears-partner/index.html

I have read the above article, and it basically says that if your body is lacking Magnesium, that any of your temporary hearing loss could become permanent hearing loss. Is this, what could have happened with Alan's treatment experience, where he had his tinnitus increased for longer time? Maybe there are other nutritional deficits inside one's body, when the Lenire treatment is not working correctly.

Neuroplasticity, immune system and general health, seem to be playing a big role in recovering from tinnitus, is it not right? It looks like there are a few things that can silence tinnitus, for example Lidocaine or being in a vegetative state. So there must be a way out of this maze, no matter how bad your tinnitus is, or for how long you had it. As tinnitus, sufferers we seem to have quite fragile auditory systems, in general, which often alleviates more problems, like anxiety and concentration problems.

I think that bimodal stimulation has a great potential, assuming that the electrical stimulation is actually applied the right way. For example, stimulation the Vagus Nerve with electrical pulses, does not seem to work, when you connect the wires to just human ears.

May be it, that dead hair cells only cause permanent hearing loss, and the ability to hear certain sounds, but this does not necessarily have to result in tinnitus, as long as other parts of your auditory system, will regenerate well after the hearing loss which when the hair cells died. Also, maybe when scientists re-grow ear hair cells in clinical study patients, this process later stimulates the whole auditory system of the patients, and tinnitus disappears, as the whole 'phantom pain' or 'phantom sound' effect is just not needed anymore (?)

It seems that bimodal stimulation causes some hearing damage, which later should heal, and promote further healing, therefore your hearing and tinnitus should improve over the course of the treatment.

DCN is mentioned in my above post. Phantom sounds are being created by fusiform cells, which seem to come out from DCN.

Dr. Tzounopoulos is looking for a tinnitus treatment, that could be a modified version of Trobalt (Epilepsy drug.) This new drug would try to alter physiological reactions inside DCN.

On the below link you can find more information about the process.
https://elifesciences.org/articles/07242

I think that we are very near to discovering a cure drug for tinnitus and epilepsy, at the same time.

 

[GlennS]

It seems that bimodal stimulation causes some hearing damage

The damage was already done. The term they use is to "disrupt" the pattern of the misfiring nerves.

As for the rest, you might want to browse around because there are lots of other dedicated threads on those sorts of things.

The general consensus is that there are only two promising methods of treatment for tinnitus, neuromodulation (of which Lenire is one of three treatments in development) and hair-cell regeneration.

Prior to Lenire, nothing has ever been proven to work, which is why so many are willing to give it a shot, as there's really no alternative at present.

I'm curious how Lenire can work off signal timing based on the very precise millisecond timing between sounds and tongue zap... but then uses Bluetooth headphones?

This was raised in the forum right before the device came out and to date Neuromod hasn't addressed it (don't think they've ever been directly asked).

 

[ChrisBoyMonkey]

This is another thing, we know of course that not everyone is going to be a responder, I concede that, but the hyperacusis patients were said to have the best outcomes in the paper, so much so that they labeled them "super responders". It's generally accepted by Neuromod that this subgroup of tinnitus patients benefit the most from Lenire.

I'm sure a few of the people who got their Lenire in July who have hyperacusis would have reported back with at least some improvements by now, as I said, we're at 10 weeks as of October 2nd. Perhaps improvements will come after the initial treatment phase is over, but I'm going to be honest, it looks like something that can be chalked up to placebo.

It is pretty underwhelming for several thousand along with 2 months of worsening, which isn't uncommon in the slightest, I'm also curious as to why Neuromod never warned patients about this when commercialization began, they MUST have had this happen to SOME people in the TENT-A1 and A2 trials, I don't recall them mentioning this, which also concerns me. If anyone can correct me here, I don't recall the data they showed mentioning the increase in volume during the initial phase of treatment.

I'm not trying to be a downer here guys, I think bimodal stimulation works, it's just that we're in the "early days" right now. Improvements and refinements will be made later down the road, perhaps Lenire launched too early because of demand and that's why the results aren't too mind blowing yet.

But right now, I can't justify spending my money on this thing yet. Even the people who do have results seem do not notice all that much decrease. I wasn't expecting a "Miracle Cure", but I was expecting a moderate reduction in the responders group. Say 30-40% better post treatment. Right now, the improvements seem fairly insignificant.

I know this is going way back now, but the CEO disclosed the initial worsenings in the interview way before release.

 

[F-u-T]

I'm curious how Lenire can work off signal timing based on the very precise millisecond timing between sounds and tongue zap...

...but then uses Bluetooth headphones? Which has a very high latency in hundreds of milliseconds and it's not a constant latency too. It fluctuates and very difficult (if not impossible) to compensate for on the tongue zapper end.

Why didn't they just use a wired headphone with no latency?

Not saying it doesn't work, but as an electrical engineer I'm a bit skeptical on this detail.

Maybe that's why you see positive results for some people and worsening for others. The signal timing down to milliseconds is the key to success.

The Dr. Shore research shows -5ms sound preceeding shock calms the fusiform cells lowering tinnitus. On the flip side -5ms shock preceeding sound excited the fusiform cells worsening tinnitus.

The Dr. Shore research also said they used calibrated headphones in that trial.

Maybe the Bluetooth latency varies from unit to unit.

 

[ChrisBoyMonkey]

I think I'm probably done with this thread for a while, it's not helping me and I'm not helping you, so there's little point updating.

Maybe it's not helping the downers and maybe the longterm sufferers but for newer ones like me it's great news lol

 

[GlennS]

I know this is going way back now, but the CEO disclosed the initial worsenings in the interview way before release.

Yes, but he made it seem as though only a small percentage had this happen. Now it seems to be the majority--enough so that it's even in the manual. (disimproved is a euphemism if ever there was one. I'm not a fan of this sort of marketing-speak.)

IMHO, I think the Tinnitus Talk moderators should take the final 12-week results of the initial early adopters to a followup video interview with Neuromod and compare this against their internal claimed statistics.

 

[PeterPan]

Question for the mods, how many of those reporting in have hyperacusis? I've gotta imagine a few. So I'm not yet sold even on the above.

Here is the distribution of user responses to the hyperacusis question to date:

The question was:

"Do you have hyperacusis (reduced tolerance or increased sensitivity to everyday sounds)?"

and "No", "Mildly", "Moderately", "Severely" and "Don't Know" were the possible responses ("Don't know" omitted from the above chart.

 

[GregCA]

I'm curious how Lenire can work off signal timing based on the very precise millisecond timing between sounds and tongue zap...

...but then uses Bluetooth headphones? Which has a very high latency in hundreds of milliseconds and it's not a constant latency too. It fluctuates and very difficult (if not impossible) to compensate for on the tongue zapper end.

Why didn't they just use a wired headphone with no latency?

Not saying it doesn't work, but as an electrical engineer I'm a bit skeptical on this detail.

Indeed. I've asked the exact same question a few months ago. If the signal sync has to be millisecond accurate, I don't see how they can use Bluetooth. I would have expected wired.

 

[Mentos]

I'm really glad that Lenire is working out well for you @Redknight. However, I note from your profile that your tinnitus dates from March 2019. It is not at all unusual during the first months after tinnitus for it to decrease significantly and it is quite likely that this is what is happening here - Lenire simply assisting the habituation process. I'm going to have to see quite a lot more positive reviews and feedback from those who have had tinnitus for a longer period to be convinced that there is more to it than that. So far I haven't. It is as I said before "early days" but the reviews on the User Experience Thread suggest that your experience currently is more of an outlier.

I understand healthy skepticism but such opinion is far beyond it. On the one hand many people tend to complain about Lenire not being efficient, on the other hand when a real success story pops up you question it by claiming it's not thanks to Lenire but "habituation" even though @Redknight explained clearly habituation has nothing to do here.

Why not simply acknowledge that Lenire seems to work for some people?

 

[Cojackb]

I'm considerably lost with what some of the members here are expecting to see from this thread.

There's unfathomable amounts of skepticism and conspiracy theorizing here, yet when a member comes forward to report an improvement as a result of the treatment, the first thing you do is come up with theories as to why he's wrong.

If you've got nothing constructive to add to the discussion, I'd strongly advise taking your attention elsewhere before you alienate what's left of the Lenire user base.

 

[Ruse]

Have I imaged this or do I remember Dr. Hubert Lim saying in his TENT-A2 presentation that the hyperacusis findings from TENT-A1 were NOT replicated in TENT-A2?

Did anyone save the video presentation?

 

[Annpann]

I think I'm probably done with this thread for a while, it's not helping me and I'm not helping you, so there's little point updating.

I would like to say thank you for your posts. You have been helping me.

 

[Agrajag364]

I think I'm probably done with this thread for a while, it's not helping me and I'm not helping you, so there's little point updating.

Please don't leave the thread. You have posted very clearly that your reduction appeared to be down to Lenire and not spontaneous improval, and I value that account very much and I'm sure others do as well. People do know the behaviour of their own tinnitus. Clare B on the other hand was more uncertain whether the improval was definitely down to the treatment.

 

[Bartoli]

I'm curious how Lenire can work off signal timing based on the very precise millisecond timing between sounds and tongue zap...

...but then uses Bluetooth headphones? Which has a very high latency in hundreds of milliseconds and it's not a constant latency too. It fluctuates and very difficult (if not impossible) to compensate for on the tongue zapper end.

When you say they latency fluctuates, do you also mean between two similar units or even within a unit at any given moment? (Same model and brand). Otherwise it's possible they can account for the latency in their system as long as they don't change any components.

I suppose it can still be risky as companies are known to change component suppliers over the lifespan of a certain model of headphones. You wouldn't necessarily know if they changed anything inside the headphones like an electronical circuit.

 

[Heinrich_S7]

Indeed. I've asked the exact same question a few months ago. If the signal sync has to be millisecond accurate, I don't see how they can use Bluetooth. I would have expected wired.

Perhaps their design choice to use Bluetooth is messing with the signal timing and skewing results?

I agree they should have gone wired.

 

[GlennS]

Maybe that's why you see positive results for some people and worsening for others. The signal timing down to milliseconds is the key to success.

The Dr. Shore research shows -5ms sound preceeding shock calms the fusiform cells lowering tinnitus. On the flip side -5ms shock preceeding sound excited the fusiform cells worsening tinnitus.

The Dr. Shore research also said they used calibrated headphones in that trial.

Maybe the Bluetooth latency varies from unit to unit.

If so, that would be a recall/refund-grade oversight on Neuromod's part.

 

[david c]

I've already said how beneficial it is to hear the reviews and user experience of those using Lenire and would encourage those who are posting to continue doing so in the User Experience thread.

But we should also feel free to comment in this thread on the results we have seen so far. It is still early days but based on the reports and reviews I have seen so far around 50% of Lenire users have no significant change, 30 % have some improvement and around 20% have reported increased tinnitus. It's significant that the majority of those who are reporting an improvement have had tinnitus for a relatively short period of time (less than 18 months).

This kind of information is helpful for those choosing to make decisions about whether to use Lenire or not in the future. Of course as things progress the situation may change.

 

[GlennS]

There's unfathomable amounts of skepticism and conspiracy theorizing here

The burden is on Neuromod because of a) MuteButton and b) lack of peer review.

The Tinnitus Talk Lenire user survey is therefore extremely important as an independent verification of Neuromod's claims.

To draw any conclusions based on @Redknight's reports would be highly premature, especially considering that he's the only one with anything positive to report.

 

[TheDanishGirl]

I understand healthy skepticism but such opinion is far beyond it. On the one hand many people tend to complain about Lenire not being efficient, on the other hand when a real success story pops up you question it by claiming it's not thanks to Lenire but "habituation" even though @Redknight explained clearly habituation has nothing to do here.

Why not simply acknowledge that Lenire seems to work for some people?

Come on. If you read some stories of tinnitus sufferers, you can clearly see that many experience lowering of tinnitus in the first 3-12 months, so as long as @Redknight is in that potential natural healing period, it is ridiculous to state like a fact that it's Lenire that has made the difference. We can't know that. Could be... or not.

 

[Ruse]

IMHO, I think the Tinnitus Talk moderators should take the final 12-week results of the initial early adopters to a followup video interview with Neuromod and compare this against their internal claimed statistics.

Nonsense. I don't know why you would think that comparing initial data collected from 5-10 users in an uncontrolled environment against data from a controlled clinical trial involving over 500 participants would tell you anything reliable at all.

No doubt team skeptic will be waving the finger at Neuromod when they don't agree to this.

To draw any conclusions based on @Redknight's reports would be highly premature, especially considering that he's the only one with anything positive to report.

This is just not true at all.

The only positive report to come from Lenire?

Really?

 

[Agrajag364]

I've already said how beneficial it is to hear the reviews and user experience of those using Lenire and would encourage those who are posting to continue doing so in the User Experience thread.

But we should also feel free to comment in this thread on the results we have seen so far. It is still early days but based on the reports and reviews I have seen so far around 50% of Lenire users have no significant change, 30 % have some improvement and around 20% have reported increased tinnitus. It's significant that the majority of those who are reporting an improvement have had tinnitus for a relatively short period of time (less than 18 months).

This kind of information is helpful for those choosing to make decisions about whether to use Lenire or not in the future. Of course as things progress the situation may change.

I make it 50% reporting some improvement, 40% nothing or uncertain, and 10% worse after treatment. Almost everyone has reported a temporary worsening (before any subsequent improval or return to baseline).

Some reported improvement - BigNick, Redknight, drcross, jacob21, TinMan2019. Four still unsure or no change yet - ruud1boy, Cojackb, Liz Windsor, Mike T, and one presumably still worse overall - Allan1967.

EDIT- @Cojackb it's not clear to me from your post whether you are presently worse overall, what do you think?

I was extremely cynical before the release of this device, having being worsened by a "new" surgery for a different condition despite being assured that would not happen, and subsequently spending years researching just how much shit goes on in clinical research. Frankly the above results (very very early though they are) are better than I thought. I was never expecting them to be the 80% odd Neuromod might claim. The worsenings, temporary or otherwise, are also not a surprise - you can bet if they are talked about in a video before release, it's an issue. Tinnitus is a highly intractable condition with no real treatment options. If Lenire improves tinnitus for even 30% of users, it's still a huge advance.

It's super early though and the Tinnitus Talk analysis, when more people have used this thing, will be much more telling.

 

[Frédéric]

Well I just found this on the internet (about TENT-A2 if I understood correctly), I don't think it has been released.

Noninvasive Bimodal Neuromodulation for the Treatment of Tinnitus: Protocol for a Second Large-Scale Double-Blind Randomized Clinical Trial to Optimize Stimulation Parameters

ABSTRACT
Background: There is increasing evidence from animal and human studies that bimodal neuromodulation combining sound and electrical somatosensory stimulation of the tongue can induce extensive brain changes and treat tinnitus.

Objective: The main objectives of the proposed clinical study are to confirm the efficacy, safety, and tolerability of treatment demonstrated in a previous large-scale study of bimodal auditory and trigeminal nerve (tongue) stimulation (Treatment Evaluation of Neuromodulation for Tinnitus - Stage A1); evaluate the therapeutic effects of adjusting stimulation parameters over time; and determine the contribution of different features of bimodal stimulation in improving tinnitus outcomes.

Methods: This study will be a prospective, randomized, double-blind, parallel-arm, comparative clinical trial of a 12-week treatment for tinnitus using a Conformité Européenne (CE)–marked device with a pre-post and 12-month follow-up design. Four treatment arms will be investigated, in which each arm consists of two different stimulation settings, with the first setting presented during the first 6 weeks and the second setting presented during the next 6 weeks of treatment. The study will enroll 192 participants, split in a ratio of 80:80:16:16 across the four arms. Participants will be randomized to one of four arms and stratified to minimize baseline variability in four categories: two separate strata for sound level tolerance (using loudness discomfort level as indicators for hyperacusis severity), high tinnitus symptom severity based on the Tinnitus Handicap Inventory (THI), and tinnitus laterality. The primary efficacy endpoints are within-arm changes in THI and Tinnitus Functional Index as well as between-arm changes in THI after 6 weeks of treatment for the full cohort and two subgroups of tinnitus participants (ie, one hyperacusis subgroup and a high tinnitus symptom severity subgroup). Additional efficacy endpoints include within-arm or between-arm changes in THI after 6 or 12 weeks of treatment and in different subgroups of tinnitus participants as well as at posttreatment assessments at 6 weeks, 6 months, and 12 months. Treatment safety, attrition rates, and compliance rates will also be assessed and reported.

Results: This study protocol was approved by the Tallaght University Hospital/St. James's Hospital Joint Research Ethics Committee in Dublin, Ireland. The first participant was enrolled on March 20, 2018. The data collection and database lock are expected to be completed by February 2020, and the data analysis and manuscript submission are expected to be conducted in autumn of 2020.

Conclusions: The findings of this study will be disseminated to relevant research, clinical, and health services and patient communities through publications in peer-reviewed journals and presentations at scientific and clinical conferences.


Source and full text: https://www.researchprotocols.org/2019/9/e13176/

 

[JayBowson]

To draw any conclusions based on @Redknight's reports would be highly premature, especially

Draw some inspirations from your own words Glenn. It is too early to draw ANY conclusions. But half of this forum seems to have made their mind up already.

considering that he's the only one with anything positive to report.

Demonstrably untrue:

My tinnitus used to be 8/10 on bad days and it seems to have dropped to something around 6/10 when I'm having a bad day.

Overall, I have had some improvement, my tinnitus is softer and less intense

I felt I finally had some positive results early on in late week 5, where i had perhaps 5 solid days in a row of decent improvement. I was pretty happy about it, I don't think I'd ever had 5 days of improvement.

after about an hour it changes from it's usual high pitched screeching drilling sound to a soft hissing, fizzing sound, which is absolutely delightful by comparison.

this is the first time in 19 months I've had a pretty good week. Today especially I felt like my old self again. My tinnitus hasn't bothered me all day,

I mean these words are just a click away in the experience thread. And none of the above users have finished their treatment course. That doesn't even include the fact that they could continue to use Lenire beyond the 12 week period for more potential gain.

 

[john paul]

I'm slightly disappointed so far with the user experiences which is a shame but I still have hope. Time will tell, all those who are going through the treatment have my utmost respect and praise.

 

[Harley]

Perhaps their design choice to use Bluetooth is messing with the signal timing and skewing results?

I agree they should have gone wired.

I also thought it was rather strange to go with Bluetooth, when every millisecond could make a difference and one can never be sure that the Bluetooth is working as it should.
Good old fashioned wire would be so much more reliable.

It could well be, that Lenire is unnecessary wasting its effectiveness to signals being "lost in translation" or even unintentionally producing the wrong timing.

Now throw in the fact, that they are most likely dealing with the infamous lack of consistency the Chinese manufacturers are known for and you could easily go from a great device on paper, to something that does not work as intended.

 

[TheDanishGirl]

I personally haven't written off Lenire yet. Of course not.......that would be incredibly stupid as it's still early days, but as of now I am keeping my head cool and maintain my skeptic stance as I still haven't seen much to prove me otherwise.

But I still have hope in this. Make no mistake of this.

 

[GlennS]

I've read those threads too. My concept of what's a "positive" report is my own. Do you want me to go line by line and explain why it is those statements aren't as positive as they may seem in isolation? Do we really want to get that deep in the weeds? Nobody's going to be able to set the bar for me--or you. It's subjective. Likewise, if you want to set the bar lower, that's your prerogative too.

I don't know why you would think that comparing initial data collected from 5-10 users in an uncontrolled environment against data from a controlled clinical trial involving over 500 participants would tell you anything reliable at all.

OK, I'll explain my logic to you.

What are the odds of heads coming up 10 times in a row? Now what are the odds of heads coming up 500 times in a row? Either way, it's 50%, although variability being what it is, it's marginally more likely to get heads 10 times in a row, but still minuscule.

That means that we really shouldn't need a sample size of 500 to compare with Neuromod's data. The stats should fall roughly in line. At the very least, they shouldn't be wildly off. If it is, the only explanation would be if the majority of these early users shared some trait that could explain it.

Does that mean I'm drawing final conclusions? No, but that's why I said I have become more pessimistic, which I feel is reasonable. That tone IS still subject to change.