Lenire — Bimodal Stimulation Treatment by Neuromod

Exactly. Trials/results without controls are fairly meaningless...

 

Looks like they are doing a new study TENT-A3 looking at PS6. Maybe they are finally testing an upgrade?

Treatment Evaluation of Neuromodulation for Tinnitus - Stage A3 (TENT-A3)

 

I think they want to test sound stimulation only in comparison to bimodal stimulation (with electricity on tongue).

 

TENT-A3 trial criteria looks like they want to test 6 weeks of sound only, followed by 6 weeks of bi-modal, sound + electrical stimulation.

I find it difficult to make sense of this. If Neuromod are now heading down the route of sound only stimulation for a significant portion of the entire treatment period then hasn't that already been done before by Peter Tass back in 2012 with what actually looked like amazing results?

This study concluded; CR therapy significantly lowered tinnitus frequency and reversed the tinnitus related EEG alterations.

Moreover, The Tinnitus Clinic in London went on to provide a therapy utilising the Tass method (and to the best of my knowledge were still doing so even a couple of years ago) but then all of a sudden discontinued it. I've never been able to get to the bottom of why.

Today, The Tinnitus Clinic provides Lenire. So unless I've missed something here, Neuromod are about to embark on a trial utilising a method that will have them not only take a step back, but one which will also put them into the footprint of a competitor whose product one of our main independent providers of tinnitus treatment here in the UK no long uses.

Wall. Head. Bang against.

 

Sound stimulation from Peter Tass (CR Neurostimulator) failed in the "real world".

Therefore it is not offered anymore at German ENTs or audiological clinics.

 

Do we have any information/documentation as to why and how that happened? Even as a layperson, when I put Tass's trial protocol next to Neuromod's, well... at least Tass's controlled for placebo.

I don't know if we agree or not that Neuromod's single moded stimulation using sound only is a re-run of the Tass protocol, but it seems mighty weird that Neuromod are re-visiting old territory with their new product.

 

Well also the PS6 is different. I thought everyone got PS1 followed by PS4.

 

God only knows

 

Guys, please. Take it to the Favourite Video Games thread, yeah?

 

Yea, you're right. See you over there, though I must warn you, you may need to lower your expectations.

 

Hype for Lenire seems to be down. Clearly it doesn’t do anything for tinnitus.

Wondering why Neuromod spent so much money in this device. It doesn’t help at all. All the responders are placebo responders in my view.

In 2 -3 years it will be taken from the market. Pretty sure about that. It is such a fake treatment.

 

I joined the Lenire webinar today (or Otologie as the clinic is called now). I'll give an overview below:

• Gave overview of the Lenire device (nothing new), their new hearing aid offering and also TRT / CBT
• They mention the lack of a standard practice by GPs / specialists when patients first present with Tinnitus and they end up getting passed around between the medical system (they are correct and I have experienced this)
• Mentioned the TENT-A1 study when asked how successful the Lenire device was - didn't mention TENT-A2 or success from their clinic
• They have an offer for tinnitus week where the consultation is free (normally €100 or £85)
• Outlined that there are studies to suggest tinnitus can be caused by COVID-19 (new tinnitus) and people with existing tinnitus can be exacerbated by COVID-19 - they also said that people without COVID-19 have seen an increase during the pandemic due to stress etc - so all in all the pandemic has been bad for tinnitus
• Webinar was held by three Otologie Audiologists
• They refer to Lenire as a treatment and habituation device a number of times that reduces the perception of tinnitus
• Mentioned it is possible to use Lenire and Hearing aids but not to start them at the same time - recommend starting hearing aids for 90 days before Lenire
• They mentioned there is no time limit on the Lenire device except that you have to had tinnitus at least 3 months to qualify for the device but there is no upper time limit

I asked how many people they have treated in a clinical setting and when will TENT-A2 results be out and both these questions were not answered.

Overall, fairly benign and didn't give too much away. They spent quite a bit of time on the Q&A but there wasn't any hard questions. The webinar will be emailed to attendees afterwards.

 

Yes, some of us were extremely sceptical about the Lenire device from the very beginning and questioned whether Tinnitus Talk giving it such prominence (pinned threads etc) was really a good idea. To be fair to Tinnitus Talk, most of the pushing of this was from a Director who's since left.

Now that the device has been around for a couple of years there is ample evidence on the user reviews thread to suggest that:

1. For the majority it has had little impact
2. For a minority it has actually made things worse (in some cases disastrously so)
3. For a minority who did notice some improvement most of these were relatively recent tinnitus onset and the impact was probably little more than placebo.

 

Can you provide substantial proof for any of this? I don't like just taking someone's word for this sort of thing.

Thanks!

 

Because it hasn't helped you?

I'f they get FDA approval, it would be hard to say it is a fake treatment. A clinic in Spain and Italy now offer the treatment.

I agree the hype on Tinnitus Talk has died down but that doesn't indicate anything to me. I don't trust Tinnitus Talk members as a barometer of whether there will be an effective treatment. No treatment will be 100 percent effective. Too many variations and causes.

 

The clue really is in my previous post which said:

So if you wish to enquire further I would read through the user reviews thread (now many pages long) in which people who bought Lenire give their feedback. It's particularly worth focusing on the later sections of that thread as several users who initially posted positive feedback after buying Lenire then report that after a few months it stopped being effective, suggesting that the earlier impact had been little more than placebo.

 

Well this sucks. I wonder if who they rebranded as operates the same?

 

Hey @AfroSnowman, I know this is old news but your posts are so informative. For those of us who aren’t habituated and seeking it, I’m wondering if Lenire would be worth the shot? Does it somewhat shift the tinnitus to the background? Curious what the habituation effect is, no matter how slight.

As far as Dr. Shore’s device’s effect on ultra high frequency tinnitus, hopefully it does help. The researcher I contacted said the pitch matching goes up to 12 kHz and that they did not differentiate I believe on tonal vs non-tonal for the trials. @linearb, as widely known here, had results and my tinnitus closely matches his (14 kHz oscillating hissing that’s centralized). So I am more hopeful about her device in that regard now.

 

Hence the nightmarish hell I live in with unmaskable high frequency reactive tinnitus that’s in the center of my head and physically hurts.

 

I take issue with your statement "a majority."

You could be saying a "majority of people who reported on Tinnitus Talk."

You could even add to that "...of which I chose to read about."

Or perhaps "on a messaging board called Tinnitus Talk."

Or how about "of the people that chose to report what they experienced on Tinnitus Talk, sometimes repeatedly."

In fact, here you go:
https://www.tinnitushub.com/heres-why-the-jurys-still-out-on-lenire/#does-lenire-work

This is one thing I base my comments on. We have the Lenire study, and we have a Tinnitus Talk "study." Both have flaws. There are questions about results. Questions about using THI as a measure.

From my perspective there are many people who claim it has worked. They don't have to go to Tinnitus Talk to report that. I don't know if this is news, but not everyone with tinnitus that have used this product are on Tinnitus Talk.

 

So you said:

But here's some (apparent) news for you. Tinnitus is a subjective condition which means there is no objective measure of whether a patient's tinnitus has got better or worse, the only way you know is by asking the patient how they feel and believing what they say.

There is no large scale independent clinical trial of Lenire out there so to decide whether it is effective or not you either have to rely on what the Tinnitus Talk Lenire user reviews thread say and the Tinnitus Talk study - people with no axe to grind, who spent their own money on Lenire and was hopeful that it would work. Or you have to believe what Lenire's own study says, produced by a company which obviously has its own axe to grind. I know who I would rather believe.

 

@david c, in my learned opinion, everyone who wants to try Lenire should first take your assessment and hang it on the wall. Those three types of outcomes is what we have seen and experienced.

My experience on this website is that there is a certain type of tinnitus sufferer or a phase some go through that make them not only extremely biased, but also angry towards other people's experience in regards to any type of “tinnitus cure”. It will namely work them. Period.

It is fruitless to argue with these individuals, the belligerent believer. It just becomes more and more of this nonsense in this thread, as it revolves another round in the desperate merry-go-round of Tinnitus Talk.

 

And this is why I believe both, and why I won't say things like "a majority," or "it's a sham."

And if your statement is true, that there is nothing to go by except anecdotes, exactly what are you going to use to decide if you are going to try a product? A company that doesn't have an axe to grind? Which Tinnitus Talk user are you going to believe? Do you have specific users you believe?

I am serious, I want to know who I can trust so that when a product comes out, I believe they don't have an ax to grind? Is it the person I responded to about saying blanket statements? Did that person even try the product?

 

Look at it this way - in terms of deciding whether to try Lenire you are in a much better position than the people three years ago who had to decide whether to spend a lot of money and effort on the device based on no data at all.

You now have a large number of reviews in the User Reviews threads to look through. Each of the people posting has been verified by Tinnitus Talk as having bought Lenire. There's no reason to disbelieve any of them - it's to be expected that people will have different reactions to a treatment. What's clear looking through the User Reviews is that the balance of the reviews tilts to people who either derived no benefit from the device or who derived some benefit in the early stages but that this benefit didn't last.

In this respect the Tinnitus Talk User Reviews threads has provided a helpful service to you.

 

Hype:
German study confirms efficacy of Irish tinnitus therapy (irishtimes.com)

Reality:

 

Both studies are simply useless, reasons:

- Purely psychological effects:

a) Study participants who know that they are using an expensive device think that it must have a use. And if you don't see any improvement, just enter 10 THI points better.

b) Study participants tend to mark better values at the end of the study because they believe strongly that someone wants to help them. In order not to disappoint them, they choose better values at the end of the study.

- Study participants are not monitored =>
I estimate at least 50% of the participants do not use the device as regularly as prescribed, or give it up quickly after it has no effect. Out of a guilty conscience, they give better values at the end of the study.

- There is no placebo control group

- 3/4 of the authors of the 1st study were paid by Lenire.

I think everything has been said about Lenire. The thing is like a high quality looking iPod that plays some random sounds and provides some EMS stimulation. Production cost < $49 if made cheaply. Without any significant benefit.

 

Glad to hear of your improvements! How long did you end up using Lenire? And are you still using it?

 

Glad to hear that @ChrisBoyMonkey is doing better.

 

@ChrisBoyMonkey said he had improvement. Waiting for the great @Toby1972 to come in and say it’s all a sham.

 

This occurred to me when the first series of reports about Lenire were posted:

"The brand new treatment Lenire,
Was supposed to silence the Ear;
It was great in Theory,
But we became Leery,
When failures were posted on Here."