Lenire — Bimodal Stimulation Treatment by Neuromod

[PeterPan]

I fear that the sample size will be an issue. They had a trial with 500 people, the survey here - however admirable and high quality - is based on one tenth of that.

The other issue in our study is the lack of a control arm and the possibility of placebo results. The Neuromod study used three arms, however the contrast in results between the arms was, in my opinion, not especially convincing. I like the Michigan study design which clearly controls for placebo (although their sample size is even smaller than ours!).

What is key to me is to know if the people who experienced worsening while using the device finally went back to normal after a while... be it few weeks or be it even a few months.

Is there any way to track this with people who filled the Tinnitus Talk survey?

We'll see if we can follow up on the participants who dropped out. I think at least 2 (or about 5%) clearly got a lot worse.

 

[Niatoolit]

Hi, why have people stopped posting on the Lenire User Experiences and Reviews thread?

Anyone knows what percentage/number of Lenire users had their situation worsen?

 

[Darktale]

We'll see if we can follow up on the participants who dropped out. I think at least 2 (or about 5%) clearly got a lot worse.

Ok but maybe (hopefully!) these 2 will also be back to normal/baseline after a longer period... even few months... and this would change the overall picture and balance risk/benefits to me.

 

[uae96]

I honestly can't imagine coping without it now.

Same. When I have a bad day I can't wait until I start playing Lenire. Usually it eases things up. I went back to twice a day and it makes a bigger difference.

 

[raymilf]

Has anyone been in contact with the German facility? I have not heard back from them since they cancelled my appointment due to Coronavirus pandemic.

 

[Chinmoku]

...and herein lies the central issue with that. With our tiny survey number, one tenth of Neuromod's, we had at least two cases of very serious worsening, which is significant. I don't believe this was reflected in Neuromod's large trial data so the only conclusion I can reach is, it's either a statistical anomaly or something else is at play. I fear we'll never really know.

I think it's clear, actually, but let me all know if I am understanding this correctly.

Lenire had a very large dropout of people (20%?), who were labelled as non-compliant because they stopped before the end of the planned treatment.

That means they have been excluded from the final statistics.

But why have they dropped earlier? The main reason I can think of is worsening, and of such level as to force one to stop the treatment. I don't think anyone in the trial would have stopped the treatment lightly given it is the only hope to improve tinnitus at the moment.

So if someone has a temporary but tolerable worsening, one continues the treatment to the end, and perhaps by the end the worsening has resolved. However, if one has a terrible worsening, one stops, and does not make it to the end.

When Neuromod claims there have been no permanent worsening, are they including the people who were dropping out?

If not, and I believe they aren't, then that is where the permanent worsening would be hidden.

So it would be all consistent if this is what happened, and we would have that permanent worsening are within the 20% who dropped out.

If instead Neuromod checked on the dropped out patients to see that their worsening cleared up then indeed we have a mystery. Hopefully the paper, coming out in about 10 days apparently, clarifies that.

 

[JackJ]

Has anyone with antibiotics/medication induced tinnitus experienced positive results from Lenire?

Hi, yes my tinnitus was induced by medication and Lenire worked for me.
However, I don't know if cause of tinnitus as a subgroup is an indicator of effectiveness.

 

[Oceanick]

Hi, yes my tinnitus was induced by medication and Lenire worked for me.
However, I don't know if cause of tinnitus as a subgroup is an indicator of effectiveness.

Hey Jack, what medication caused your tinnitus? Mine was neomycin. Looking for hope.

 

[JackJ]

Hey Jack, what medication caused your tinnitus? Mine was neomycin. Looking for hope.

NSAID caused my tinnitus. I did have a bad tinnitus reaction to Doxycycline at one point as well.

You might find the attached useful as a reference. I'm very careful to avoid anything ototoxic now. The side effects can be worse than the condition!

 

[alanisnotadj]

This morning my tinnitus is at the lowest it has ever been since my worsening in October 2018.

The funny thing is I had a pretty bad day on Monday and I decided to skip my two Lenire sessions yesterday.

Is there a relation?
What is going on and how long is it going to last?

 

[DaveFromChicago]

To alanisnotadj:

I am taking into serious consideration the number of weeks you have used Lenire.
Given that length of exposure, when you report that 72 hours ago you still had a "pretty bad" day such that you had to discontinue its usage, I am closer to concluding that there is no point in paying over $3,000.00 for this.

For that kind of money I would require that such aggravated days be permanently eliminated or at least substantially reduced. Otherwise, what real benefit has accrued?

Is Lenire even affecting the usual fluctuations of your tinnitus?

What do they have to say when you report that even after all this time you still have severe episodes that make you unable to use this?

 

[alanisnotadj]

To alanisnotadj:

I am taking into serious consideration the number of weeks you have used Lenire.
Given that length of exposure, when you report that 72 hours ago you still had a "pretty bad" day such that you had to discontinue its usage, I am closer to concluding that there is no point in paying over $3,000.00 for this.

For that kind of money I would require that such aggravated days be permanently eliminated or at least substantially reduced. Otherwise, what real benefit has accrued?

Is Lenire even affecting the usual fluctuations of your tinnitus?

What do they have to say when you report that even after all this time you still have severe episodes that make you unable to use this?

Hi Dave,

To be clear, I did not use Lenire on Monday because I just wanted to head straight to bed after work and sleep the tinnitus off. I was not in the mood for 1 hour of Lenire, I was just too exhausted. I did not do a session on Tuesday either.

But to be honest I am very perplexed by my experience with Lenire. I have been in the tinnitus game long enough to know what is placebo and what is not and I am convinced that Lenire is having an impact beyond placebo levels.

I mean how could it be that I experienced a level of tinnitus so low that I had to look for it to hear it, if not for Lenire?

Like I said before, this has never happened in the 20 months since I had my terrible worsening.

What puzzles me is how can my tinnitus fluctuates so dramatically between near silence like this morning to so annoying on Monday. If Lenire is really having an impact then why aren't the effects permanent?

My tinnitus has always fluctuated wildly but rarely in the right direction. Moments of peace have never happened before Lenire. It was always bad or not so bad but still bad!

Sorry if all this sounds confusing but this is the reality of my experience with Lenire.

 

[DaveFromChicago]

Thanks very much for the report.

How many total weeks have you been trying Lenire?

Like any treatment, when will you decide that further application is really just a demonstration
of the Law of Diminishing Returns?

Did Lenire have any comment about the results you described?

 

[alanisnotadj]

Thanks very much for the report.

How many total weeks have you been trying Lenire?

Like any treatment, when will you decide that further application is really just a demonstration
of the Law of Diminishing Returns?

Did Lenire have any comment about the results you described?

I used it for 12 weeks from December to February. The second settings kind of undid the progress I made while on the first settings. Then I got really sick and was exposed to noise while in Egypt, then COVID-19 restrictions prevented me from going to Ireland, etc... so I did not use Lenire again until I had a Skype with them in April I believe. So my second run with Lenire must be in its 8th week now.

I have not been in touch with them since that Skype conference back in April.

 

[Emgee]

This morning my tinnitus is at the lowest it has ever been since my worsening in October 2018.

The funny thing is I had a pretty bad day on Monday and I decided to skip my two Lenire sessions yesterday.

Is there a relation?
What is going on and how long is it going to last?

Sorry if you already discussed this. How bad was your tinnitus on a 1-10 scale prior to beginning Lenire?

 

[ruud1boy]

Hi, why have people stopped posting on the Lenire User Experiences and Reviews thread? Anyone knows what percentage/number of Lenire users had their situation worsen?

I guess it's just 'cos there's not much to report. I'm still doing my twice daily Lenire sessions and it's not really affecting my tinnitus much - but - and I've said this before - I don't get anywhere near as distressed by my whistling friend as I did before.

I think this is just habituation - I'm nearly 4 years in with bad tinnitus - rather than anything that could be attributed to Neuromod's box of tricks, but I don't know this to be the case. I've been drinking like a mad fuppin' eedjit this last week, which would have previously sent my tinnitus crackers, but it's not causing any more difficulties than normal this week.

I'll know come August / September, when the tonguetip need replacing again. If I don't spaff another £200 and my tinnitus goes bananas, I'll know Lenire's being doing something.

 

[Darktale]

Hi Dave,

To be clear, I did not use Lenire on Monday because I just wanted to head straight to bed after work and sleep the tinnitus off. I was not in the mood for 1 hour of Lenire, I was just too exhausted. I did not do a session on Tuesday either.

But to be honest I am very perplexed by my experience with Lenire. I have been in the tinnitus game long enough to know what is placebo and what is not and I am convinced that Lenire is having an impact beyond placebo levels.

I mean how could it be that I experienced a level of tinnitus so low that I had to look for it to hear it, if not for Lenire?

Like I said before, this has never happened in the 20 months since I had my terrible worsening.

What puzzles me is how can my tinnitus fluctuates so dramatically between near silence like this morning to so annoying on Monday. If Lenire is really having an impact then why aren't the effects permanent?

My tinnitus has always fluctuated wildly but rarely in the right direction. Moments of peace have never happened before Lenire. It was always bad or not so bad but still bad!

Sorry if all this sounds confusing but this is the reality of my experience with Lenire.

Hi Alan,

Couldn't it be the Gabapentin you take in parallel which is affecting (positively) your tinnitus to a certain extent rather than Lenire?

 

[alanisnotadj]

Sorry if you already discussed this. How bad was your tinnitus on a 1-10 scale prior to beginning Lenire?

Prior to my worsening a 2 or 3. Now it can be as bad as 8 when I hear it everywhere.

 

[alanisnotadj]

Hi Alan,

Couldn't it be the Gabapentin you take in parallel which is affecting (positively) your tinnitus to a certain extent rather than Lenire?

That's a possibility but I am taking a rather low dose (200mg).

 

[Niatoolit]

I purchased Lenire and yesterday had my first session.

I have mild tinnitus but pretty bad hyperacusis. My hyperacusis spiked immediately because of the white noise in the treatment sound.

Has anyone with hyperacusis had problems using Lenire? The last thing I want is to mess up my hyperacusis.

 

[DaveFromChicago]

RE Niatoolit:

Here is another recipient reporting a worsening.

Perhaps some Regulatory Agency should notify Lenire of these cases and require an explanation and/or (if feasible) a correction in their unit's functioning. There have been far too many of these.

If this were drug testing, this would have been called off if even a fraction of these cases of worsening were reported.

 

[danielbp85]

Has anyone visited the Hannover Hearing Center to purchase Lenire? If so, what was your experience?

 

[alanisnotadj]

I purchased Lenire and yesterday had my first session.

I have mild tinnitus but pretty bad hyperacusis. My hyperacusis spiked immediately because of the white noise in the treatment sound.

Has anyone with hyperacusis had problems using Lenire? The last thing I want is to mess up my hyperacusis.

I have mild hyperacusis in my left ear and Lenire has not made it worse.

 

[Darktale]

That's a possibility but I am taking a rather low dose (200mg).

Well it is the exact same low dosage as used in France by Coopacou ENT association in its protocol to treat tinnitus...
And also similar dosage as in this not so old study (300mg):

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5380395/

Anyhow, what counts at the end is the result... no matter if it comes from Lenire or the drug.

 

[UHPTS]

That's a possibility but I am taking a rather low dose (200mg).

Isn't Gabapentin's possible side effect tinnitus?

 

[Chinmoku]

Isn't Gabapentin's possible side effect tinnitus?

Same story as with benzos, medications that treat it may also cause it, especially when trying to discontinue the drug/tapering, but also through tolerance. It works for some people though, everybody is different.

 

[Darktale]

Isn't Gabapentin's possible side effect tinnitus?

Indeed, tinnitus is quoted in possible side effects (rare though since listed in « frequency unknown ») but it is also one of the molecule used to treat tinnitus in some countries... for example in France with a low dosage of 200mg for the Coupacou protocol (which consists of you trying consecutively 5 different anti-epileptic drugs during 15 days at low dosage and then hearing aids if needed). They claim to have good results with this drug (and according to them no worsening which is always the most worrying thing)... but as was nicely said by Chinmoku, everybody is different though.

 

[Chinmoku]

Indeed, tinnitus is quoted in possible side effects (rare though since listed in « frequency unknown ») but it is also one of the molecule used to treat tinnitus in some countries... for example in France with a low dosage of 200mg for the Coupacou protocol (which consists of you trying consecutively 5 different anti-epileptic drugs during 15 days at low dosage and then hearing aids if needed). They claim to have good results with this drug (and according to them no worsening which is always the most worrying thing)... but as was nicely said by Chinmoku, everybody is different though.

Interesting, would you know the other medications in the Coupacou protocol?

Also, I came across these guys in Paris by chance, seeing a video on YouTube. They seem relatively competent, do you have experience with them?

We are going a little off topic here, but perhaps the topic could be how does Lenire work in combination with medication? I'm sure many people using it will be on AD or Benzos or gabapentinoids.

 

[Niatoolit]

RE Niatoolit:

Here is another recipient reporting a worsening.

Perhaps some Regulatory Agency should notify Lenire of these cases and require an explanation and/or (if feasible) a correction in their unit's functioning. There have been far too many of these.

If this were drug testing, this would have been called off if even a fraction of these cases of worsening were reported.

I'm not 100% my spike was from Lenire because other things went down as well the last few days, that's why I didn't post on User Reviews. Sorry if I wasn't clear. I'll wait for my spike to ease down and continue my treatment.

 

[W Hatch]

How can you register for the Lenire clinical trials, or to buy the unit?