Lenire — Bimodal Stimulation Treatment by Neuromod

[dayma]

Has anyone noticed that they have a volume for the headset and the tongue appliance? I never noticed this I guess.

I am curious if this was designed so that the user can change the stimulation? They mentioned in the presentation that changing the stimulation settings in 6 week periods gave a higher compliance rate.

This would mean you would not have to go back repeatedly to a supplier to change the stimulation. That's good for some of us who will be going to Ireland hopefully only once.

 

[KotaDomowa]

I do not understand English well. Did Hubert Lim mention anything about MML results? Why are not they the main measure?

 

[grate_biff]

This may hamper traveling to get this device if the parameters need to be changed at the halfway point. I doubt that will be possible for the user to do on their own.

Yes, this certainly complicates things. They really should try and make it more user friendly, i.e. that the user can have more ability to control things. We are not stupid.
Just provide an info sheet of the different input options from the device according to their findings and all is good to go.

 

[Tanni]

I'm not smart enough to understand everything in his presentation, but it seems that they have found even better parameters during the TENT-A2 trial, which is just brilliant news.

What do you think @Paulmanlike?

Ah, when I read this I had the strongest urge ever to hug you, whoever you are!

I was sure the results would be worse and there would be a ton of backpedalling going on.

 

[grate_biff]

Ah, when I read this I had the strongest urge ever to hug you, whoever you are!

I could use a hug too. In fact human contact (massage etc.) is the only thing that can calm me down. Not seen much of it these last few years though, due to isolation.

Hopefully Neuromod can change that

 

[urgentresearch]

ITT: FALSE HOPE VS. FALSE NOPE.

 

[kelpiemsp]

In regards to the video... it's nice to have Hubert Lim validate my experience

 

[Ray552]

Anyone think this can help hyperacusis to an extent?

 

[TimmyC]

I mean, how can you not have restored faith after that video. Even if it doesn't work for you, look at the care, time, and effort put into the science here. The tinnitus research field has exploded recently, and this device could usher in a slew of other companies wanting in on the pie. Hope is here my friends, stay strong no matter what!

 

[Jack Straw]

Can someone give me the bullet points of the video?!

I'm at work and can't watch but want to know what it says!

 

[Bndsmheowqhe]

I'm not smart enough to understand everything in his presentation, but it seems that they have found even better parameters during the TENT-A2 trial, which is just brilliant news.

What do you think @Paulmanlike?

My suspicion has long been that the results from the initial trial were not as strong as they would have liked so they brought in Hubert Lim to improve the situation. The problem is that they are stuck trying to use the mixed results from the first study to promote what they know is now an improved device. I think that's why some people have been skeptical of Neuromod over the past 6 months. It's obvious that they haven't been completely upfront about what's been happening even if they had a good reason for it.

 

[Agrajag364]

@annV you are a fking genius.

Mean THI improvement circa 14 for all three arms. Do any tinnitus research veterans know how that compares to other tinnitus interventions in clinical trial? In the presentation they cite a paper that shows 13 points improvement in THI with CBT, but then THI would improve whether a patient had an improvement in their reaction to tinnitus as might happen with CBT, or an improvement in the actual loudness.

The fact that THI improvement is so very similar for all three arms during the treatment phase makes it particularly unfortunate that they did not have a proper control arm. A marked difference between arms during treatment would have provided better evidence this was not a placebo/spontaneous tinnitus improvement. It may have been hard to create a convincing control due to the nature of the intervention.

There is a significant different between Arms 1 and 3 by 64 weeks, going beyond the treatment phase. That is exciting. But, I hope that they matched the patients in the different arms for duration of tinnitus. Because tinnitus has a spontaneous remission rate over time and particularly a large improvement in tinnitus distress in the first year, apparently it's important to match groups for time of onset. An ENT who specialises in tinnitus told me one of the other recent treatments, I think it was acoustic neuromodulation, had not done this this for treatment vs control and it messed up their data.

Finally, one area of concern to me is the chance of the tinnitus getting permanently worse. I'd try Lenire even if it had a 30% real life improvement rate as long as there was only a tiny risk of the tinnitus getting worse long term. The PowerPoint shows 32 cases got worse tinnitus. The speaker says in "the majority" it went back to baseline. Would have liked to known how many got permanently worse. I am not sure whether to take those 32 as a proportion of the 326 who started the trial (still 10%) or a as proportion of those who completed the trial (a number dropped out, and people who don't comply and drop out are more likely to have adverse effects) – this would make the worsening % higher still. Probably the former, circa 10% worse, but for the "majority" this was a temporary fluctuation.

@Paulmanlike, I'd be interested in your analysis of the PowerPoint. Also @PeteJ, @Drone Draper, @attheedgeofscience, @Aaron123, does anyone have a science background in this field and feel like giving us their thoughts?

Totally unscientific guess, I have a feeling that it's less than 70% odd who really do improve long term, but maybe there really is a small group of intense responders.

I'd still try this thing though I might wait a year or so post release.

 

[TimmyC]

My suspicion has long been that the results from the initial trial were not as strong as they would have liked so they brought in Hubert Lim to improve the situation. The problem is that they are stuck trying to use the mixed results from the first study to promote what they know is now an improved device. I think that's why some people have been skeptical of Neuromod over the past 6 months. It's obvious that they haven't been completely upfront about what's been happening even if they had a good reason for it.

Mixed results? The TENT-A2 trial is showing positive correlation from their initial arms. And what makes you think they have not been upfront?

My God, isn't the video enough evidence that they are showing positive results? Do you need Ross O'Neill to come to your house and tell you in person that they are working hard on solving this problem?

What is wrong with the skepticism of this place?

 

[Jazzer]

I (and my boobs) am kewl!

{{{{I love it when she talks dirty}}}}}

 

[Stakovic]

Does this device help us to reduce tinnitus volume or only to cope with it?

 

[Bndsmheowqhe]

Mixed results? The TENT-A2 trial is showing positive correlation from their initial arms. And what makes you think they have not been upfront?

My God, isn't the video enough evidence that they are showing positive results? Do you need Ross O'Neill to come to your house and tell you in person that they are working hard on solving this problem?

What is wrong with the skepticism of this place?

View attachment 29147

One failed launch under their belt from 2015.

Very poor PR management along with contradictory information on release dates.

Their measurements of improvement are vague.

Gave a competitor a financial stake in the company to help them "complete" the trials.

The testimonials were extremely lackluster.

 

[dayma]

Mixed results? The TENT-A2 trial is showing positive correlation from their initial arms. And what makes you think they have not been upfront?

My God, isn't the video enough evidence that they are showing positive results? Do you need Ross O'Neill to come to your house and tell you in person that they are working hard on solving this problem?

What is wrong with the skepticism of this place?

View attachment 29147

I honestly think there is just trolling going on.

Overall the video/presentation has given me hope that Neuromod is headed down the right path.

 

[Tanni]

I can't take credit for this one although I (and my boobs) am kewl!

I know the original context for this joke, but those who don't must have read it and wondered what the hell is going on

 

[GlennS]

Very poor PR management along with contradictory information on release dates.
Their measurements of improvement are vague.
Gave a competitor a financial stake in the company to help them "complete" the trials.
The testimonials were extremely lackluster.

I have the feeling even after thousands of people are posting positive testimonials you will still be mired in negativity. Enjoy. It's your loss.

As far as I'm concerned, Lim's presentation validated what I gleaned from the original Q&A video, that each time they run trials they find out what kind of parameters work. Then they take that knowledge into the next trial and try to continue to drive more and more improvement, which is working. This further validates this method of treatment.

What people will be getting out of the gate is sort of a version 1 or beta-test treatment. I suspect in another 3-5 years it will be refined to a point where results are more dramatic and predictable. There is something real going on and whether through Neuromod or elsewhere, it's going to make a positive impact on our lives. But please, don't let me disrupt you from drinking haterade.

 

[Bndsmheowqhe]

I have the feeling even after thousands of people are posting positive testimonials you will still be mired in negativity. Enjoy. It's your loss.

As far as I'm concerned, Lim's presentation validated what I gleaned from the original Q&A video, that each time they run trials they find out what kind of parameters work. Then they take that knowledge into the next trial and try to continue to drive more and more improvement, which is working. This further validates this method of treatment.

What people will be getting out of the gate is sort of a version 1 or beta-test treatment. I suspect in another 3-5 years it will be refined to a point where results are more dramatic and predictable. There is something real going on and whether through Neuromod or elsewhere, it's going to make a positive impact on our lives. But please, don't let me disrupt you from drinking haterade.

I've already acknowledged that they've probably made improvements. That was actually at the core of what I was saying. It would also explain the lackluster testimonials that were likely based on pre-updated programming.

 

[spedgas]

One failed launch under their belt from 2015.

Very poor PR management along with contradictory information on release dates.

Their measurements of improvement are vague.

Gave a competitor a financial stake in the company to help them "complete" the trials.

The testimonials were extremely lackluster.

They are trying to release a first of its kind product with huge demand to an impatient patient population that is underserved.

The device requires the training and distribution to clinicians to administer it. There are bound to be unforeseen obstacles.

The measurement of tinnitus in general is vague. It's called subjective for a reason.

Bringing on Hubert Lim only strengthens their knowledge base and experience. I work in medicine, collaboration in research is important so we can all understand things better and move it along faster.

Clearly your mind is made up. Don't use the device then. I'd hate for you to use it with all your concerns. Maybe you can get behind the next potential breakthrough, whenever that is. Enjoy your suffering in the meantime.

 

[Paulmanlike]

First of all - thank you @Meiro and @annV for finding this Information and sharing it with the forum! Thank you! @annV This isn't the first time you've brought useful links to the debate with a little bit of digging, much appreciated.

@grate_biff @Agrajag364 I am still to watch the video and go through the PowerPoint but I will of course offer my thoughts once I have.

Going from the comments (I haven't watched or read any of it yet) it would appear what I speculated - the reason TENT-A2 had 9 arms rather than the 3 arms they had in the TENT-A1 is that they were exploring ways of improving efficacy. Here's hoping that bimodal neuromodulation as a treatment for tinnitus will develop and be proved.

Also, on a cautionary note - this isn't the peer review of the trials and rather came from the developers of the device. However as they are submitting their papers for peer review it should indicate that they are feeling confident.

Anyway, I'll be back soon and look forward to watching the video/read the PowerPoint!

 

[GlennS]

I've already acknowledged that they've probably made improvements.

Probably? You see, even there you can't just concede a point. You'll walk back your negativity only as a last resort.

 

[TheDanishGirl]

I had a thought... Something I am now wondering about.

Why must the sound stimulus be heard through headphones? As I've said before, I am one of those who believe headphones carry a risk of worsening tinnitus. That some people in the trial experienced a worsening in their tinnitus, may be evidence of this and it really concerns me.

Couldn't one get the same effect by listening to the sounds through speakers? Or do they really have to be heard close to ear, through headphones, in order to have an effect on the brain?

 

[Bndsmheowqhe]

They are trying to release a first of its kind product with huge demand to an impatient patient population that is underserved.

The device requires the training and distribution to clinicians to administer it. There are bound to be unforeseen obstacles.

The measurement of tinnitus in general is vague. It's called subjective for a reason.

Bringing on Hubert Lim only strengthens their knowledge base and experience. I work in medicine, collaboration in research is important so we can all understand things better and move it along faster.

Clearly your mind is made up. Don't use the device then. I'd hate for you to use it with all your concerns. Maybe you can get behind the next potential breakthrough, whenever that is. Enjoy your suffering in the meantime.

What's with all the black and white thinking? I never said it won't work. I was asked what reasons I had to be skeptical. The first reason on that list is more than enough. Hopefully they've learned from their first failed rollout but the fact that they continue to make excuses for it is a concern.

 

[Agrajag364]

First of all - thank you @Meiro and @annV for finding this Information and sharing it with the forum! Thank you! @annV This isn't the first time you've brought useful links to the debate with a little bit of digging, much appreciated.

@grate_biff @Agrajag364 I am still to watch the video and go through the PowerPoint but I will of course offer my thoughts once I have.

Going from the comments (I haven't watched or read any of it yet) it would appear what I speculated - the reason TENT-A2 had 9 arms rather than the 3 arms they had in the TENT-A1 is that they were exploring ways of improving efficacy. Here's hoping that bimodal neuromodulation as a treatment for tinnitus will develop and be proved.

Also, on a cautionary note - this isn't the peer review of the trials and rather came from the developers of the device. However as they are submitting their papers for peer review it should indicate that they are feeling confident.

Anyway, I'll be back soon and look forward to watching the video/read the PowerPoint!

Look forward to hearing your opinion. I think they already submitted TENT-A1 for publication didn't they? Not sure about TENT-A2. I guess the data presented here will be similar to what is in the TENT-A1 paper when it's finally published, unless they get absolutely hammered in peer review. There will be more detail in the final published papers obviously.

 

[Piney]

Auditory sound with electronic stimuli, isn't this device mimicking a cochlear implant? Without of course the surgery and increased hearing ability. An electronic stimuli to suppress tinnitus. If it really does work, it should lead to better devices and knowledge in the near future I imagine.

 

[GregCA]

I had a thought... Something I am now wondering about.

Why must the sound stimulus be heard through headphones? As I've said before, I am one of those who believe headphones carry a risk of worsening tinnitus. That some people in the trial experienced a worsening in their tinnitus, may be evidence of this and it really concerns me.

Couldn't one get the same effect by listening to the sounds through speakers? Or do they really have to be heard close to ear, through headphones, in order to have an effect on the brain?

A few reasons I can think of, if I understood the research correctly:

1. the timing is critical (that's the secret sauce): adding a variable such as the distance between your speakers and your ear would most likely destroy the secret sauce. Sound propagates at about 1 foot per millisecond, and we do know from studies that getting the right timing requires millisecond accuracy. Using headphones reduces this variability greatly.
2. the volume is important (which is why it is corrected with regards to your PTA data) and would also be affected if you were using speakers
3. the PTA data can be different for left and right ears, which can be corrected with a different band equalizer for each ear in a headphone delivery mechanism, but not with speakers
4. it is not clear that the signal is the same for both ears: perhaps the left and right sound channels are different, which also requires headphones

 

[F-u-T]

 

[Jack Straw]

I have the feeling even after thousands of people are posting positive testimonials you will still be mired in negativity. Enjoy. It's your loss.

As far as I'm concerned, Lim's presentation validated what I gleaned from the original Q&A video, that each time they run trials they find out what kind of parameters work. Then they take that knowledge into the next trial and try to continue to drive more and more improvement, which is working. This further validates this method of treatment.

What people will be getting out of the gate is sort of a version 1 or beta-test treatment. I suspect in another 3-5 years it will be refined to a point where results are more dramatic and predictable. There is something real going on and whether through Neuromod or elsewhere, it's going to make a positive impact on our lives. But please, don't let me disrupt you from drinking haterade.

PREACH!