Lenire — Bimodal Stimulation Treatment by Neuromod

Yes, very lucky not to be able to afford something just a hat's throw away.

 

I've been using Lenire for about 3 years and I'm pretty sure it does something more than YouYube.

It's just not constant, often after a session it spikes my tinnitus. But all in all it makes it lighter. Sometimes almost gone. But my tinnitus is still louder sometimes, so much that I doubt the impact. When I've had a break from Lenire for a while, I can feel the impact more. It's just a pity that it's not working better, but it gives me hope for better bimodal stimulation therapies.

 

Yes, some users are saying Lenire makes a difference. I know.

Just like there are people claiming tinnitus ear drops or tinnitus skin patches make their tinnitus better.

 

Have there been any studies or publications showing which types of tinnitus have better results from Lenire?

For example, when speaking to Prof. De Ridder on tDCS, he said those with unstable continuously changing tinnitus see better results than tinnitus which continuously stays the same. tDCS treatment though only helps about 30% of people. It seems similar to Lenire (perhaps a lesser %).

Does Lenire work better on somatic, non-somatic, changing or fixed tinnitus, acute or chronic (?)

It's been out 2 years or more and still no one the wiser.

I guess though it's not in Neuromod's interest to publish such data, as it would potentially limit their client base - but I'm surprised no independent studies have been carried out.

 

That’s not true. I think you are under the assumption that Lenire is a cure. It’s not. It’s a treatment. There has been people on here saying it helps but, as always, the negative reviews are focused on!

 

I think Lenire works to some extent. The fact that some people who have tried Lenire say their tinnitus doesn't bother them as much anymore, for me, means some amount of success.

Probably there are people for whom Lenire has worked but who are not here.

 

I know it is not a cure.

The question is - does it truly help at all in any other way than placebo?

There are no studies outside of those done by Neuromod which demonstrate that.

 

There is no unbiased research.

Neuromod claims 85% of users get significant improvement from Lenire.

Based on reports on Tinnitus Talk that is laughable - it is more like 30% who are a bit vague on how much it is helping.

I would be less negative if it was not so expensive or if Lenire would allow a try-before-you-buy scheme. I don't want to see people waste 3000 EUR on a tongue tickler white noise machine.

 

Look at the Low-Level Laser Therapy thread. Some people say it helped them, but no independent studies have been done, so just like Lenire.

You will never know if the treatment worked or if the tinnitus reduced over time by itself.

For me Lenire didn’t work, just like it hasn’t for most people on Tinnitus Talk.

I hope Dr. Shore’s approach will have more effect than Lenire.

Lenire isn’t worth the investment. But it’s everybody’s own decision.

 

This.

Given enough time someone usually chimes in on this thread to try to defend or root for Lenire a little bit but it doesn't change the underlying (at best) wishy washy testimonials.

The only device worth tracking of this sort is Susan Shore's and even there I'm not sure the testimonials will be that much better in the end.

But I've stopped hoping that Neuromod comes up with some big improvements to Lenire. Even if it gains US FDA approval, it probably won't be due to any fundamental improvements in the regimen.

 

Does Lenire work for those with pain hyperacusis + sound reactive tinnitus? Or is it not suitable?

 

Has anyone tried this with low dose ketamine?

 

From the Tinnitus UK (former British Tinnitus Association) website:

 

Neuromod got approval for Lenire in the US market:

Irish firm’s tinnitus treatment approved for US market

 

Sad goddamn day. Ross O'Neill and his piece of shit junk walkman didn't deserve the approval.

 

It clears the path for Dr. Shore (Auricle) to have a faster approval because it is not a De Novo technique/device anymore. This is good news in my opinion.

 

Tinnitus UK happily takes their money for sponsorship though.

 

Wow crazy news, I noted a few things about this approval, and excuse me if it’s already been discussed as I’ve not paid attention to Lenire for a while.

1) This is good news for approval of the Shore device; it will no longer be the first of its kind to seek approval, which should speed up the process.

2) It looks like the FDA made them do a TENT-3A trial.

3) They claim 0 negative effects in all 3 trials. This seems to be contradicted by the experience of Tinnitus Talk members.

4) They used PS6 in the TENT-3A trials. This is different, I believe, than what they used to do which was PS1 and PS4.

 

"Lenire is the first bimodal neuromodulation device to go through the rigours of the FDA’s De Novo process."

Rigours? What, like the lack of a placebo control? Riiiiiiiight.

 

@DeanD, did you have a consultation with Dr. De Ridder?

That's interesting about tDCS, although we have no data on this. Dr. De Ridder said Lenire does nothing to reduce the loudness, only distress.

And the 85% improvement is on what? Distress?

I've also seen Dr. De Ridder's recent lectures, and he has said that you should combine medication with electrical stimulation for better effect. Yes, I know some people have concerns with that, as I do, however this is what he said.

Maybe Auricle + medications would be better, if ONLY during the treatment phase.

Food for thought!

@Utdmad89, I actually approve of Tinnitus UK doing this because they still DO NOT recommend Lenire! Plus if they use the money for research, then even better.

@AfroSnowman, what's PS6?

 

Your blunt, succinct assessment of Lenire is all we need to know and carries more meaning than my orotund commentaries ever could.

However, I am convinced that within one year Lenire will go the way of SoundCure, Neuromonics, The Levo System and Desyncra (who have long since been out of business).

Like those, Lenire will be exorbitantly expensive and will do little or nothing. How many consumers will have in excess of $3,000.00 (which Medicare and any other Health Insurance provider will not cover) and the patience to wait for a result that never happens?

As with my experience with Desyncra, I really have to question the motives of the suppliers of Lenire:

"We fully know that the results are negligible, but advertise it as if it were a bona fide breakthrough treatment so that the level of widespread tinnitus desperation will induce enough clients to pay and (in the short term) make this profitable. These clients will eventually report on line that this was an unqualified dud so that fewer and fewer will be bamboozled into buying it until we no longer offer it, but at least we will have made enough to satisfy our investors."

 

They are some number of different electrical stimulation timings PS1-PSx, maybe with different sound component as well (I don't know about that). I think originally they did PS1 followed by a PS4 pattern. I wonder whether the PS6 was more effective.

 

If money was no object, would you try Lenire as soon as possible or wait for Dr. Shore's device?

 

Sure, if I had money to throw away.

I never went for Lenire. But I followed them from the start when it was called MuteButton. It was exciting but it wasn’t the great success it was speculated to be.

Personally, it makes much more sense to wait for Dr Shore’s device but, even then, I will be waiting for the experiences of long-term Tinnitus Talk members before deciding to go for it (and forking out the costs).

 

Did you listen to the Tinnitus Talk Podcast Episode 20 with Brian Fargo? To all intents and purposes, money is no object to him. So when he got tinnitus he spent shed loads of the stuff on a search for a cure that included flying to Ireland to pick up a Lenire device. It didn't work for him.

I'm sorry to say but my attitude towards Neuromod has hardened considerably these past 4 years. They never did the proper science. And they expect us "the consumer" to be OK with that.

The tortoise that is the Shore Lab in this bizarre hair and tortoise race, however, did do the proper science; in as much as they fulfilled the absolute bare minimum and controlled for placebo. I'm not a Shore fanboy per se but I do admire her for steering her ship the way she has. I've got far more interest in Auricle than I could ever have for Neuromod.

 

I mean if Dr. Shore releases data with hard statistics and the theories behind how the mechanisms work, then I will buy the device upon release. Which I would assume they will be doing, considering the device is coming from a public university which are usually public funded. After research papers are completed by any public university, you can pretty much get the data and publications through the Freedom of Information Act.

That was a pretty good podcast episode I thought.

 

No because apparently Lenire can make tinnitus worse.

 

How scary would that be. Spend all this money on a device and make your tinnitus worse lol.

 

It would be as scary as their creative new parlance to describe that outcome. They call it 'disimprovement'

 

Does anyone know when Neuromod applied for FDA approval? Did it take a year or so for Lenire to be approved?