Lenire — Bimodal Stimulation Treatment by Neuromod

[Lucifer]

Authors of Bimodal Stimulation encoded the truth about it into its name. Yes, it's BS!

I do see Bimodal Stimulation being useful once regeneration drugs come out in the market.

 

[OptimusPrimed]

Having had bad unilateral tinnitus for 13 years now, I would love to try something like Lenire. I hope that it works.

 

[VeryUnfortunate]

Anyone have any idea of when Lenire may be available in the USA?

 

[AfroSnowman]

After putting Lenire down for the better part of a year I'm giving it a go again.

I've sort or started and stopped (a half hour here or there) a couple of times over the last two weeks and seem to have had a subtle but meaningful reduction of symptoms in pretty short order. I wonder if after having done it for half a year previously whether my neurological system recognizes the stimulation pattern quickly and responds to it.

The other thing I am doing differently is cranking up the volume. I've recently had an extended audiogram and it is definitely in my 10-16 kHz where I have significantly more hearing loss than measured by Neuromod when I got fit for the device. This is also where my tinnitus lives.

I wonder if by increasing the volume the wide frequency sounds will stimulate that portion of my auditory system and maybe I'll get better results.

 

[OptimusPrimed]

I do see Bimodal Stimulation being useful once regeneration drugs come out in the market.

Yes, you would think that stimulating new hair cells and the general auditory pathway may encourage new connections.

But what if there are hair cells that are broken but not destroyed? Broken from noise damage and firing synaptic signals.

 

[Lucifer]

Yes, you would think that stimulating new hair cells and the general auditory pathway may encourage new connections.

But what if there are hair cells that are broken but not destroyed? Broken from noise damage and firing synaptic signals.

Not sure but I'm assuming FX-322 can fix that. We had a discussion awhile ago if broken hair cells can still regrow if they are not destroyed and in the end we were not sure what happens in that instance. I still believe that broken or damage hair cells can regrow/be replaced using FX-322.

 

[OptimusPrimed]

Not sure but I'm assuming FX-322 can fix that. We had a discussion awhile ago if broken hair cells can still regrow if they are not destroyed and in the end we were not sure what happens in that instance. I still believe that broken or damage hair cells can regrow/be replaced using FX-322.

I wonder if the brain's recruitment behaviour would be reversed if this worked...

 

[Lucifer]

I wonder if the brain's recruitment behaviour would be reversed if this worked...

I don't think FX-322 will be a quick fix of reducing tinnitus. It might take months to notice improvements and you may need Lenire as well to get rid of it completely.

 

[SenseiD]

First post on Tinnitus Talk. I woke up in May of 2020 with tinnitus, and have had a difficult 13 months since. It's an 11,000 Hz tone that sits kind of in my left ear but when loud, is in my whole head. I suspect TMD/jaw tension/neck pain/jaw clenching brought it on, but I was also taking a course of antibiotics for a skin condition plus Effexor plus occasional Ibuprofen, could have been any of those.

In the year since it arrived, some days I can't figure out how to survive and some days I can barely hear it. Right now, I'm vacillating between my normal annoying but tolerable level and just coming down off a month long spike that left me wanting to jump off a bridge.

I've tried acupuncture, chiropractic, 6 weeks of a candida diet (no alcohol, sugar, gluten, corn, caffeine, etc), and am now working with a periodontist to re-align my jaw. None of these things has really helped. I paid Joey Remenyi $1500 for her program - didn't get anything out of it and dropped out (but may try again).

I've begun to think, as my sound is somatosensory (I can alter it by moving my jaw, pressing on my head), that either Lenire or Susan Shore's bimodal treatment holds promise. Dr. Shore is taking new people for her study in 2021 (was halted in 2020) but you have to live in Michigan/Ohio for 6 months (I'm in LA). I considered moving there for 6 months out of desperation but can't really see that as an option.

So I called Neuromod and talked to the Clinic Manager who answered the phone. At first, she said they do remote treatments, even for Americans, despite not being FDA approved - I just had to go to Dublin (or Germany). So I arranged an assessment, which was promptly cancelled and then the Clinic Manager got all weird and said she had wrong information and that they were no longer treating Americans even if they come to Dublin (which is in quarantine right now), and that there was nothing they could do. I offered to fly to Europe, but she claims they can only treat actual EU residents right now. It was a shocking turnaround, given that I know for sure Americans were being treated prior to COVID-19 - she admitted that until being 'corrected' and of course, your stories are here on this board.

I suspect someone came down on them for treating Americans, even those who travel to the EU, since they are not FDA approved. Has anyone experienced this or heard this from them? They literally will not treat people who aren't EU citizens, even if they pay out of pocket to travel to Dublin. And they won't discuss it - they just won't explain things and the Clinic Manager before hanging up suggested I even try changing my diet to help my tinnitus. I was pretty floored and am deeply unhappy with this situation.

I wonder if I can get a used Lenire and a new tongue tip. Anyone want to sell me their used one? I literally don't know what to do.

 

[annV]

Dr. Shore is taking new people for her study in 2021 (was halted in 2020) but you have to live in Michigan/Ohio for 6 months (I'm in LA). I considered moving there for 6 months out of desperation but can't really see that as an option.

If you fulfill the criteria for Dr. Shore's clinical trial, I'd go for it, unless it's not possible for you. If you are working from home, maybe it could work?

I wonder if I can get a used Lenire and a new tongue tip. Anyone want to sell me their used one?

Someone recently sold their Lenire here, so it's possible.

I paid Joey Remenyi $1500 for her program - didn't get anything out of it and dropped out (but may try again).

You should have donated that money to @Hazel and @Markku who run this site. This site is much more useful than that scammer Joey Remenyi.

 

[MadsWithT]

First post on Tinnitus Talk. I woke up in May of 2020 with tinnitus, and have had a difficult 13 months since. It's an 11,000 Hz tone that sits kind of in my left ear but when loud, is in my whole head. I suspect TMD/jaw tension/neck pain/jaw clenching brought it on, but I was also taking a course of antibiotics for a skin condition plus Effexor plus occasional Ibuprofen, could have been any of those.

In the year since it arrived, some days I can't figure out how to survive and some days I can barely hear it. Right now, I'm vacillating between my normal annoying but tolerable level and just coming down off a month long spike that left me wanting to jump off a bridge.

I've tried acupuncture, chiropractic, 6 weeks of a candida diet (no alcohol, sugar, gluten, corn, caffeine, etc), and am now working with a periodontist to re-align my jaw. None of these things has really helped. I paid Joey Remenyi $1500 for her program - didn't get anything out of it and dropped out (but may try again).

I've begun to think, as my sound is somatosensory (I can alter it by moving my jaw, pressing on my head), that either Lenire or Susan Shore's bimodal treatment holds promise. Dr. Shore is taking new people for her study in 2021 (was halted in 2020) but you have to live in Michigan/Ohio for 6 months (I'm in LA). I considered moving there for 6 months out of desperation but can't really see that as an option.

So I called Neuromod and talked to the Clinic Manager who answered the phone. At first, she said they do remote treatments, even for Americans, despite not being FDA approved - I just had to go to Dublin (or Germany). So I arranged an assessment, which was promptly cancelled and then the Clinic Manager got all weird and said she had wrong information and that they were no longer treating Americans even if they come to Dublin (which is in quarantine right now), and that there was nothing they could do. I offered to fly to Europe, but she claims they can only treat actual EU residents right now. It was a shocking turnaround, given that I know for sure Americans were being treated prior to COVID-19 - she admitted that until being 'corrected' and of course, your stories are here on this board.

I suspect someone came down on them for treating Americans, even those who travel to the EU, since they are not FDA approved. Has anyone experienced this or heard this from them? They literally will not treat people who aren't EU citizens, even if they pay out of pocket to travel to Dublin. And they won't discuss it - they just won't explain things and the Clinic Manager before hanging up suggested I even try changing my diet to help my tinnitus. I was pretty floored and am deeply unhappy with this situation.

I wonder if I can get a used Lenire and a new tongue tip. Anyone want to sell me their used one? I literally don't know what to do.

You should consider yourself lucky.

Neuromod has gotten cold feet by now due to several adverse outcomes of their treatment.

There are no trustworthy stories of people being cured from tinnitus by using Lenire. Most doesn't see any change at all.

The reason why they will not treat Americans is probably fear of being sued.

I don't think FX-322 will be a quick fix of reducing tinnitus. It might take months to notice improvements and you may need Lenire as well to get rid of it completely.

This statement shows the reason why one shouldn't trust anything posted on the internet. FX-322 should be considered, as of now, a failed treatment.

Lenire has shown absolutely no effect on tinnitus. Postulating that those two treatments combined is the answer to cure tinnitus is unfounded speculation.

 

[Gee82]

I wonder if I can get a used Lenire and a new tongue tip. Anyone want to sell me their used one? I literally don't know what to do.

I am willing to sell my device. I would not personally recommend Lenire as it was a money/time waste for me, however as a tinnitus sufferer I understand and respect that you may want to leave no stone unturned.

 

[GlennS]

Kinda sucks that Susan Shore is in Michigan considering that's the #1 hotspot for the variant wave in the US at present.

 

[Toby1972]

I talked to my psychologist about the Lenire study.

He says he is very skeptical about the study results without a placebo group.

It is in the nature of things that a before / after questionnaire gives you a slightly better rating after the study has ended, because you don't want to disappoint the interviewer / provider.

I think the same happened to the Tinnitus Hub study.

So my skepticism grows more and more.

I just found two verifiable profiles who had benefited from Lenire. But maybe they got naturally better in that time of using Lenire, and not because of Lenire.

 

[T Toledo OH]

Dr. Shore is taking new people for her study in 2021 (was halted in 2020) but you have to live in Michigan/Ohio for 6 months (I'm in LA). I considered moving there for 6 months out of desperation but can't really see that as an option.

I am in Toledo, Ohio. How do I apply for Dr. Shore's clinical trial?

 

[SenseiD]

I am in Toledo, Ohio. How do I apply for Dr. Shore's clinical trial?

You can email the study coordinator, Gerilyn Jones, at gerjones@med.umich.edu or email the study team at tinn.trial@umich.edu and tell them you'd like to sign up for the study.

I lived 3 years in Toledo as a kid - great place to grow up. Wish I was there now to do Dr. Shore's study.

 

[SenseiD]

I am willing to sell my device. I would not personally recommend Lenire as it was a money/time waste for me, however as a tinnitus sufferer I understand and respect that you may want to leave no stone unturned.

I might be open to that - does the device have to be altered to match your sound? My sound is left ear, 11,000 Hz. I don't think I would be able to pay full price that you paid, but maybe a "used price" that we agree on? Yes, willing to try anything and leave no stone unturned.

Does your tongue tip still work?

 

[UHPTS]

You can email the study coordinator, Gerilyn Jones, at gerjones@med.umich.edu or email the study team at tinn.trial@umich.edu and tell them you'd like to sign up for the study.

Another study? I thought we were supposed to get the results of the current study mid this year and then she would start looking for a company to produce and market the device.

 

[SenseiD]

Another study? I thought we were supposed to get the results of the current study mid this year and then she would start looking for a company to produce and market the device.

They had to shut down the study last year because of COVID-19 so this one right now is the 2nd study that should lead to the device. They are still taking participants until June, then should finish by end of 2021 and do data analysis starting 2022.

Then it's just doing the work to get it to market.

 

[Gee82]

I might be open to that - does the device have to be altered to match your sound? My sound is left ear, 11,000 Hz. I don't think I would be able to pay full price that you paid, but maybe a "used price" that we agree on? Yes, willing to try anything and leave no stone unturned.

Does your tongue tip still work?

On a second thought: I remember someone here who reported some serious adverse effect using Lenire. There is a small chance that this could happen to you too. I am sorry to take my offer back but I am not comfortable selling something that could cause serious health troubles. Lenire is still a medical device (with quite unpredictable outcomes) that should be used under medical guidance.

I know of other clinics in Europe that offer Lenire and they may be not so strict in terms of treating only European citizens; maybe you can contact them and ask? Brai3n in Belgium and Tinnitus Clinic in Milan.

 

[UHPTS]

I might be open to that - does the device have to be altered to match your sound? My sound is left ear, 11,000 Hz. I don't think I would be able to pay full price that you paid, but maybe a "used price" that we agree on? Yes, willing to try anything and leave no stone unturned.

Does your tongue tip still work?

I would sell you mine but they did a very clever thing with the tongue tip. It only lasts for 180 hours I think. Well, it lasts way longer but they implemented a timer into it to shut it down if you go over that limit. I'm not sure if they would sell you a tongue tip if you haven't bought the device from them. That small piece of plastic with couple of electrodes on it is a rip off at 250 euros. I stopped using Lenire as I was not willing to pay another 250 euros + postage for something that has no effect.

The sound is the same for all, they might adjust some bands according to your hearing profile. They have 2 different timings though. Mine is on PS4, which introduces delay between sound and electric shock.

The device has no negative effect on tinnitus or anything else. What others write here about worsening is just a typical internet exaggeration without any proof. If you can handle sound from any tinnitus app than you are good to go with Lenire. But it also has no positive effect. If you want to waste your money, be my guest.

 

[Toby1972]

I would sell you mine but they did a very clever thing with the tongue tip. It only lasts for 180 hours I think. Well, it lasts way longer but they implemented a timer into it to shut it down if you go over that limit. I'm not sure if they would sell you a tongue tip if you haven't bought the device from them. That small piece of plastic with couple of electrodes on it is a rip off at 250 euros. I stopped using Lenire as I was not willing to pay another 250 euros + postage for something that has no effect.

The sound is the same for all, they might adjust some bands according to your hearing profile. They have 2 different timings though. Mine is on PS4, which introduces delay between sound and electric shock.

The device has no negative effect on tinnitus or anything else. What others write here about worsening is just a typical internet exaggeration without any proof. If you can handle sound from any tinnitus app than you are good to go with Lenire. But it also has no positive effect. If you want to waste your money, be my guest.

I think your post is the best evaluation of Lenire ever posted here. Of course it's a shame.

 

[MadsWithT]

The device has no negative effect on tinnitus or anything else. What others write here about worsening is just a typical internet exaggeration without any proof. If you can handle sound from any tinnitus app than you are good to go with Lenire. But it also has no positive effect. If you want to waste your money be my guest.

Tinnitus is a condition that is impossible to measure objectively. At least for the time being. Hence, in the context of the Lenire experiment, you have to trust what others are reporting on the effect of the treatment. What you write here with the confidence of an all knowing scholar is why reading and taking anything seriously on this, or any, online forum is so dangerous. It is absolutely impossible for you to know if other Lenire users have had positive or negative effect from using it. The only thing you can rely on, a little bit at least, is taking various reports on the Lenire User Experiences thread at face value.

Your statement concerning "typical internet exaggeration" is therefore a textbook example of bullshit - namely postulating something without caring whether if it is true or false.

 

[Toby1972]

Not so good news from Munich.

The latest edition of the independent German Tinnitus League magazine issue writes about the Lenire study:

- The study is criticized that it does not list what counseling was carried out in addition to the diagnosis, whether information about tinnitus was provided, etc. Providing information itself often has a high therapeutic effect.

- The study did not disclose why the third group, which was actually unspecific in terms of acoustic stimulation, improved in the same way as the other groups, which at least suggests a placebo effect.

- It is noteworthy and actually the main point of criticism of the study that 8 of the total of 13 authors are directly employed by Neuromod that sells Lenire. Another three authors receive consultancy fees from Neuromod. Therefore it is not an independent study.

- It is also criticized that it is very easy in Germany to bring a device on the market that can be used for therapeutic purposes. All that is required is a so-called CE classification or a CE mark...

I personally thought I could try Lenire as I have nothing to lose. But now I won't try it.

 

[DaveFromChicago]

Thanks very much, Toby1972:

If you tried it, you just might have $3,000.00 to lose.

As far as I am concerned, the utter uselessness of this is indicated by 11 out of the 13 authors having a blatant conflict-of-interest bias. Did they really think they could get away with no one noticing this?

Who wants to make a gentlemen's (or gentlewoman's) bet that this never receives FDA approval in the USA?

 

[F-u-T]

Who wants to make a gentlemen's (or gentlewoman's) bet that this never receives FDA approval in the USA?

I'll take that bet. I say Lenire is approved for use in the USA by May 4, 2023.

 

[UHPTS]

I'll take that bet. I say Lenire is approved for use in the USA by May 4, 2023.

My bet is Lenire will never get approved.

But never is not good for bet validation so let's make it clearer: they won't get approved in the USA before May 4th, 2023.

I bet my Lenire device with expired tongue tip.

 

[FGG]

Devices have a very, very low bar compared to drugs. I think Lenire is crap but I bet it gets approved.

 

[DaveFromChicago]

To FGG:

I revise my prior comment.

You are entirely correct; in retrospect this is why the now defunct (and for me, useless) Desyncra received FDA approval.

Perhaps Neuromod's argument may be that since there is currently nothing else available, a device that theoretically helps only a small fraction of tinnitus sufferers is better than no device at all.

The serious difference between Desyncra and Lenire is that Desyncra, although useless, did not receive reports of anyone being harmed by its usage. Lenire, however, had several reports of its usage resulting in worsening. The FDA should be notified of this.

 

[Chinmoku]

The reason why FDA could approve Lenire is that Neuromod has a study claiming results that are better than anything else. At a quick look this study seems to be a proper, academic paper. Now, the study has a number of flaws, partly highlighted by @Toby1972 three or four posts above, and we know from the survey done here that results are probably not as good as they present them in the paper, and we know that there have been cases of worsening, and we know that the study had a large dropout ratio, but this might not deter the FDA to give approval if they don't look at the paper carefully. Desyncra is a clear example of the bar being very low, if it hasn't change since then. What about the equally useless Levo? Was it FDA approved?

It's crazy that devices can be approved so quickly and superficially by the FDA, while medications that are deemed safe because they passed Phase 1 take years and years and years to come to the market.