Lenire — Bimodal Stimulation Treatment by Neuromod

[Jazzer]

I have read nothing whatsoever that convinces me that this thing works.
I have read plenty that makes me skeptical.

Presumably this gadget is a box of tricks consisting of some wires, batteries, and an impressive box, with knobs and buttons, and a scientifically written instruction leaflet.

How could such a thing justify such a price?
Oh yea - the research that went into it.

(My wife believes that most men keep their brains in their 'Dicks.'
Perhaps they are stimulating the wrong appendage?)

Just a few random thoughts from
Mr Skeptical
U.K.

 

[Jazzer]

Time will put this device in its place.

"ZAKLY !!"

 

[ruud1boy]

I'm hoping they will start the process of getting the device approved by NICE as soon as possible, after which one could get it on the NHS.

I wouldn't hold your breath on that one. The NHS don't consider tinnitus to be a serious problem, as most people manage with it fairly well. It's just us poor saps that struggle. They frequently don't / can't pay for treatments that have been proven to save lives, so there's no chance they'll fund this IMHO. Maybe in 10yrs time, when it's been refined, proven to work and Ross O'Neill's paid off the yacht.

 

[Skinjob]

My God so much money, if it's true then I don't know how to afford this.

I'm surprised that people are surprised by this. Neuromonics cost me about $4800 in 2007 (and revealed to me how capable I was of producing an amazing placebo effect for the first two weeks.) A desensitization protocol, nothing more. An equalized iPod with counseling and follow-ups.

Essentially the same money for fewer (and lesser) results. Tinnitus treatment has never been cheap.

 

[Candy]

It might depend, NICE would assess case by case.

Does anyone know the difference between the trial results of Lenire and the Acoustic CR Neuromodulation at the Tinnitus Clinic. Was it just a larger trial?

At one point the Acoustic CR Neuromodulation had made the Independent Paper, what happened after that? Did subsequent trials not yield such good results? After all these years they should have gathered tons of evidence on its efficacy? Why not apply for another trial? Always surprised that no one ever reported on using it apart from one person, even on TrustPilot the reviews are mostly on the clinic's service.

Is Neuromonics the same machine?

https://www.independent.co.uk/life-.../new-hope-for-tinnitus-sufferers-7576977.html

 

[Skinjob]

Bimodal stimulation sounds like TRT without the CBT, and an added mouth vibrator?

No. Read the threads.

https://www.tinnitustalk.com/thread...rch-with-acoustic-and-body-stimulation.28022/

https://www.tinnitustalk.com/threads/mutebutton.124/

Go back to the beginning of this one, too.

 

[Skinjob]

Is Neuromonics the same machine?

Different treatment. Neuromonics was a little purple (later silver) iPod (with fancy Bang & Olufsen earbuds) with classical and new age music (and an underlying "shower sound") equalized based on your audiogram that you listened to for +/- four to six hours a day.

I used it religiously (in mostly Phase One mode, I tried Phase Two for a while and asked to be put back on Phase One) for far longer than it was prescribed. Two years.

 

[jmasterj]

I have read nothing whatsoever that convinces me that this thing works.
I have read plenty that makes me skeptical.

Presumably this gadget is a box of tricks consisting of some wires, batteries, and an impressive box, with knobs and buttons, and a scientifically written instruction leaflet.

How could such a thing justify such a price?
Oh yea - the research that went into it.

(My wife believes that most men keep their brains in their 'Dicks.'
Perhaps they are stimulating the wrong appendage?)

Just a few random thoughts from
Mr Skeptical
U.K.

So @Clare B with Neuromod and @kelpiemsp with a similar device having had great success means nothing? This may not work for everyone, but bimodal stimulation has shown success from multiple different studies. I guess you can still keep denying this over and over all you want.

 

[Candy]

OK got it, thanks.

Can someone summarise the trial result differences between the Tinnitus Clinic's Acoustic CR Neuromodulation and Lenire in a nutshell?

The Tinnitus Clinic's Acoustic CR Neuromodulation also had promising results in the beginning? I've never gone down that route because no one on here seemed to have tried it (as it was believed to ineffective), the BTA didn't seem to support it, the NHS didn't support it.

I'm sure I would have had an easier journey of it with someone holding my hand but not for £5k...

 

[Skinjob]

For @Ken219,

If you would like a better understanding of what the "tongue vibrator" does, read this article about neuromodulation.

"Patients may also balk at the invasiveness of the treatments. Even minor surgeries for implantable devices come with risks of infection, not to mention pain and inconvenience during the recovery."

The "tongue vibrator" is a USB port to the trigeminal nerve, thus making a surgically-implanted shunt unnecessary. Implants would also drive up the cost of such a treatment. This is why the Lenire treatment is so cheap for what it does.

 

[Jazzer]

So @Clare B with Neuromod and @kelpiemsp with a similar device having had great success means nothing? This may not work for everyone, but bimodal stimulation has shown success from multiple different studies. I guess you can still keep denying this over and over all you want.

Just a couple of reviews and I remain skeptical - yes.
But that doesn't matter does it.
Either it works or it doesn't?
A bit like a pain killer.

As @Alex Matyjasek has said,
'Time will Tell."

Life has made me skeptical up to a point.

 

[Skinjob]

As @Alex Matyjasek has said,
'Time will Tell."

Life has made me skeptical up to a point.

I should be as skeptical as you after my Neuromonics experience 12 years ago. I followed @kelpiemsp's posts daily in 2018. He is a researcher himself (in another field) and knows what he is talking about. His experience is why I have hope.

 

[Jazzer]

I should be as skeptical as you after my Neuromonics experience 12 years ago. I followed @kelpiemsp's posts daily in 2018. He is a researcher himself (in another field) and knows what he is talking about. His experience is why I have hope.

Quite simply - there is not enough evidence to go on - IMHO.

(To be fair - I don't even believe in the tooth fairy.
When I was a nipper I lost 36 teeth.
On just one occasion I got two shillings
- and I bet that was me mum!)

 

[Jack Straw]

That's almost $4,500 USD. Yikes, that is a dent in the bank.

Where are we getting this number from? Last time we heard it was somewhere closer to $3,000.

 

[Ruse]

I will be waiting for the TENT-A1 & TENT-A2 studies to be published, and the testimonials to come out before even thinking about spending €4000!

At €2500ish I may have been willing to give it a go sooner.

I'm very interested in how the hearing loss cohort did in the trials, i.e. the average reduction in THI, TFI etc. without the super-responders (hyperacusis sufferers) taken into consideration.

Some of the data behind the questions in the TFI questionnaire like 'how strong or loud was your tinnitus?' may also shed some light on the effectiveness of the device, in addition to the tinnitus loudness matching level data.

I also wonder whether they will charge existing customers full price for any future treatments if the device is further developed? Assuming they do have plans for future iterations.

 

[Drone Draper]

Sup, playas.

Just caught this on Ross O'Neill's LinkedIn profile.

Ross liked the comment, so at least for the UK based tinnitus crew, you know of one place that will offer the system eventually.

 

[Paulmanlike]

Jason Levy is a tinnitus sufferer himself.

 

[KMc24]

If and when this becomes available in the U.S. what kind of channels will I have to go through to purchase it, and get the settings customized to my needs?

 

[SignalExec]

4000 euro is absurd. And I'll tell you why.

I've looked at the data for TENT-A2, arm 1. These are the most impressive results so far. For the people who were able to look at Humbert Lim's presentation: right graph, slide 26.

I digitized the data points and looked at the effect of the device as a function of the baseline THI. In other words, I wanted to know how much improvement in THI can one expect for a given baseline THI.

The result (see graph below) is that the effect in terms of THI points is about constant. Irrespective of the THI score at the start of the trial, people on average reported a decrease in THI of nearly 20 points. That's not nothing! But it's especially good news for those with mild tinnitus. For example, someone with a score of 30 can expect a 60% drop in his/her score yielding a score of 10, which is probably clinically significant. On the other end of the scale, someone with a score of 90 ends up with a score of 70 (a 20% drop). In fact, two people with a THI of about 90 ended up with a score of 80 in the trial (10% drop). That's still very invasive tinnitus.

The bottom line is that the relative effect of Lenire seems to be more significant for milder tinnitus. Or differently: the people craving this the most will derive relatively the least relief. The more desperate you are for the device, the less relative effect it will have for you - that's what *their* data tells me.

On top of that: notice the huge spread in the data. I've added a histogram of the effect sizes. Yes, there are people with a 50 point decrease in THI. But there are more people with 0-10 points decrease. In their data, 40% of people had a decrease in THI less than 15 points.

To me, these results seem not a good base to go and charge people 4000 euro. Especially if those people are the most desperate among us. I don't want to discourage people, but I think it best to look at the data and try to be objective and evaluate the expected results before forking over 4000 euro.

And I think this cautioning message should come from Neuromod and not someone on a forum.

P.S. I'll be happy to look more at the data if people think this is helpful.

 

[Fmykoul]

Thanks for the information.

 

[GlennS]

the people craving this the most will derive relatively the least relief....notice the huge spread in the data.

Ah, but you're omitting one salient point: the hyperacusis super-responders!

These may be the lion's share of those who experienced the biggest improvement. Like in my case, I can't quantify my tinnitus but subjectively I would call it severe, at least in my left ear... but I also have hyperacusis so it's reasonable to assume that I will experience greater improvement than the statistical average. So perhaps not a waste of money after all...

There wasn't a chart that broke it down by hyperacusis sufferers, right? That would put the above theory to the test.

 

[jmasterj]

Great work and analysis @SignalExec. These is the type of useful information we need in this thread. I am curious if they kept the same parameters for all twelve weeks with TENT-A2, arm 1? I know Hubert Lim mentioned that they had the best results when they changed up the timing/sounds (?) after six weeks.

 

[Skinjob]

4000 euro is absurd.
[...]
To me, these results seem not a good base to go and charge people 4000 euro. Especially if those people are the most desperate among us. I don't want to discourage people, but I think it best to look at the data and try to be objective and evaluate the expected results before forking over 4000 euro.

And I think this cautioning message should come from Neuromod and not someone on a forum.

P.S. I'll be happy to look more at the data if people think this is helpful.

View attachment 29793
View attachment 29792

I do think your analysis is helpful. But I'm still going to get the treatment as soon as possible. My condition keeps worsening. One trial subject, Ken, spoke of tinnitus spikes no longer happening to him. Lightning struck nearby a few nights ago and my earmuffs were next to my pillow but I was too late. As a consequence, I've been dealing with a massive spike for a couple of days. My ears actually feel raw, exposed and wounded on the inside. This isn't just a source of annoyance. It is life-altering. If your tinnitus is stable and remains the same over time and you don't have hyperacusis, count your lucky stars.

A treatment that helps even a little will buy me some time. Another, better treatment may be available in five years. I will pay the €4000. There is not really another choice.

 

[Jab4]

4000 euro is absurd. And I'll tell you why.

I've looked at the data for TENT-A2, arm 1. These are the most impressive results so far. For the people who were able to look at Humbert Lim's presentation: right graph, slide 26.

I digitized the data points and looked at the effect of the device as a function of the baseline THI. In other words, I wanted to know how much improvement in THI can one expect for a given baseline THI.

The result (see graph below) is that the effect in terms of THI points is about constant. Irrespective of the THI score at the start of the trial, people on average reported a decrease in THI of nearly 20 points. That's not nothing! But it's especially good news for those with mild tinnitus. For example, someone with a score of 30 can expect a 60% drop in his/her score yielding a score of 10, which is probably clinically significant. On the other end of the scale, someone with a score of 90 ends up with a score of 70 (a 20% drop). In fact, two people with a THI of about 90 ended up with a score of 80 in the trial (10% drop). That's still very invasive tinnitus.

The bottom line is that the relative effect of Lenire seems to be more significant for milder tinnitus. Or differently: the people craving this the most will derive relatively the least relief. The more desperate you are for the device, the less relative effect it will have for you - that's what *their* data tells me.

On top of that: notice the huge spread in the data. I've added a histogram of the effect sizes. Yes, there are people with a 50 point decrease in THI. But there are more people with 0-10 points decrease. In their data, 40% of people had a decrease in THI less than 15 points.

To me, these results seem not a good base to go and charge people 4000 euro. Especially if those people are the most desperate among us. I don't want to discourage people, but I think it best to look at the data and try to be objective and evaluate the expected results before forking over 4000 euro.

And I think this cautioning message should come from Neuromod and not someone on a forum.

P.S. I'll be happy to look more at the data if people think this is helpful.

View attachment 29793
View attachment 29792

Thanks for taking the time to do that. Very well done.

 

[cjbhab]

This is a lot of cash for something that has little chance of working.

If someone guaranteed me silence while wearing 32 dB earplugs in a silent room - i'd pay $100,000 though - and I'm serious.

 

[Mathew Gould]

4000 euro is absurd. And I'll tell you why.

I've looked at the data for TENT-A2, arm 1. These are the most impressive results so far. For the people who were able to look at Humbert Lim's presentation: right graph, slide 26.

I digitized the data points and looked at the effect of the device as a function of the baseline THI. In other words, I wanted to know how much improvement in THI can one expect for a given baseline THI.

The result (see graph below) is that the effect in terms of THI points is about constant. Irrespective of the THI score at the start of the trial, people on average reported a decrease in THI of nearly 20 points. That's not nothing! But it's especially good news for those with mild tinnitus. For example, someone with a score of 30 can expect a 60% drop in his/her score yielding a score of 10, which is probably clinically significant. On the other end of the scale, someone with a score of 90 ends up with a score of 70 (a 20% drop). In fact, two people with a THI of about 90 ended up with a score of 80 in the trial (10% drop). That's still very invasive tinnitus.

The bottom line is that the relative effect of Lenire seems to be more significant for milder tinnitus. Or differently: the people craving this the most will derive relatively the least relief. The more desperate you are for the device, the less relative effect it will have for you - that's what *their* data tells me.

On top of that: notice the huge spread in the data. I've added a histogram of the effect sizes. Yes, there are people with a 50 point decrease in THI. But there are more people with 0-10 points decrease. In their data, 40% of people had a decrease in THI less than 15 points.

To me, these results seem not a good base to go and charge people 4000 euro. Especially if those people are the most desperate among us. I don't want to discourage people, but I think it best to look at the data and try to be objective and evaluate the expected results before forking over 4000 euro.

And I think this cautioning message should come from Neuromod and not someone on a forum.

P.S. I'll be happy to look more at the data if people think this is helpful.

View attachment 29793
View attachment 29792

Could someone explain THI baseline please?

Also is your THI score taken when your tinnitus is at its lowest (assuming you have fluctuating tinnitus)?

 

[PDodge]

@SignalExec That's awesome of you to extrapolate that data. Maybe some real world testing (us) will show something different? This is the first iteration of something that's proven to work, it's pretty rad and hopefully they will build on this and narrow down and laser this beast in the face BZZZZZZzzzzzz.... POW!

 

[Martin69]

High hope - and finally failing? We have seen this several times in the past. Never ever will I spend that much money on a device which could MAYBE help. Trust me, I would spend much more than €4000 for something that will kill my severe tinnitus. Even if it is available in Ireland and Germany (where I am located) first, insurance won't pay for it until it is proven to be working.

Also we need to be careful to not see any "fake" positive results from people owning the device - once it is released.

@Neuromod: Don't get me wrong. We all would love to buy your product and get silence again (or a big drop in volume). But €4000 would simply be too much - even though it would be for me personally no problem to pay that. But many others out there cannot afford it.

It smells a little bit like trying to sell as many devices as possible in the beginning to collect enough money until anyone understands it does not work. Or to convince clinics and insurance companies that there are some patients who have an improvement and perhaps it can also work for the next patient. Sounds similar to what happened with the ACRN device.

Sorry for being a downer here. But I am not that optimistic.

 

[Allan1967]

If it's likely to be better for people whose tinnitus isn't severe, logically would that mean people who have multiple noises would benefit?

For example, I have a predominant high pitched whine, but behind that I have other noises that are quieter and not always there or immediately audible. Therefore from what's being said here I could possibly expect those noises to be either eliminated or reduced and the predominant noise reduced possibly from top end moderate to mild?

 

[Ruse]

Could someone explain THI baseline please?

Also is your THI score taken when your tinnitus is at its lowest (assuming you have fluctuating tinnitus)?

I would assume that the THI baseline is the score on day 0 of the treatment as opposed to having any reference to the patient's tinnitus baseline.

For anyone who is interested please see a link to the THI questionnaire below.

https://www.ata.org/sites/default/files/Tinnitus_Handicap_Inventory.pdf

As has already been discussed THI score attempts to measure how tinnitus affects someone emotionally rather than to measure any perceptions of loudness / intrusiveness.