MuteButton

[Jack Straw]

Been catching up on posts just now and I thought I'll reflect. Sad still no news on this device, but thought I'll have some input as I'm not short of offering my views.

Firstly, the small study by Susan Shore was good, not but not amazeballs in terms of efficacy.

Second, you can see the results of efficacy through the Neuromod website of a small study of 60 people dating back before the first MuteButton came out. A lot of them were non-compliant so the results were even smaller. Like Susan Shore's study, the results were good, but not earth shattering.

Third, the poster who asked about anybody who used MuteButton (the original one) - There was an Irish lad who was on the trial. Again, he said it was good, but later said it was a 5/10 (comprehend that how you want). None of his posts reported particularly ground breaking results.

Fourth, Neuromod have already disclosed that they are testing different arms (parameters). One thing Dr. Ross O'Neill did disclose was people responded better to high frequency than low frequency stimulation and then went on that people had longer term effects of it.

Fifth, absolutely nobody here knows the results of efficacy from TENT-A1 or A2. We have a couple of very positive feedback, and I personally have seen more negative feedback of it doing nothing (not by lots but these comments have been made by people who were on the trial).

Sixth, Neuromod have appointed prominent tinnitus researchers on their board. Hubert Lim - is indeed from the University of Michigan where this research has stemmed from although I recall it was originally from another university from somewhere else. Richard Tyler is also very good, he has published and been cited a lot of times. The others are also well known in the field. Neuromod are not just merely a commercial company looking to sell tack, by the looks of it they have the minds and passion behind it to actually sell a product based on evidence.

I also checked out the patent page and what was interesting was the inventors of the MuteButton or Lenire or whatever it's called. Dr. Ross O'Neill was one of them and several other people including Caroline Hamilton, but none of the other prominent researchers we talk about. Some unknown names on there that I plan to look into.

What would be interesting is if this treatment goes mainstream and becomes accepted (something that will be difficult to do and may take some years), who will then be known as the person who 'cured' tinnitus?

Dr. Ross O'Neill said that the majority of investors in the beginning were wealthy businessmen who were frustrated with the lack of tinnitus treatments.

 

[gorzakus]

Just read the tonguetip has to be replaced every 90 hours (twice a year) ... that's weird. it costs 150€ !

I hope with a new name comes a device with a free extra tongue tip this time

 

[linearb]

500 people, in their eyes, is not enough proof for it to be adopted, especially when there isn't a 100% reporting significant improvement.

The sad reality is that bad studies abound. The large sample size helps, but NHS more or less by charter has to put resources into the most proven thing for the most people, even if the treatment it provides is potentially weaker than the less proven or more expensive thing.

It'll either be a big success, or will slowly die and become less of an interest just like ACRN. That's what I think anyway.

I agree, and think that largely hinges on if it works, and if so, for how many people. I could only find one clinician in the US here who had worked people through ACRN, she had only done three, two were compliant with the protocol, and it worked to some significant degree for one of them. Hardly conclusive, and their exclusion criteria reads like a laundry list of "really common comorbid problems that tinnitus patients have". In my case, the three reasons their literature suggested ACRN (Desynchra in US) wouldn't work, are "tinnitus over 10 kHz", "multiple tones" and "TMJ".

Something that often gets overlooked in all the discussion of the bimodal tech: if any of this stuff works, it means we're at a place technologically where can can create and observe measurable changes in brain structure and function by giving targeted nerve groups specific, synchronous stimulation to drive particular neuroplastic processes. This sounds like science fiction. If this is real, then it seems likely to lead to other things some of which may be profoundly bizarre or interesting.

 

[Fabrikat]

I hope with a new name comes a device with a free extra tongue tip this time

I remember being surprised when I saw that years ago too! A piece of wire with a plastic tongue paddle costing 150€ and which was an ongoing consumable. You don't get the feeling Neuromod are going to go gentle on you and your wallet.

 

[Jazzer]

It's fine to ask. My tinnitus isn't really a part of my daily life. I'm here for the habit and friendship. I think about it maybe 5 minutes a day.

Oh? - I remember you saying that you were suffering severe tinnitus at over 85 dB....??
Please correct me if you think I imagined it...?

 

[Paulmanlike]

Just to slightly fact check you here. Hubert Lim is from the University of Minnesota which pioneered the bimodal stimulation method. Susan Shore is from the University of Michigan who picked up on this study and has been working with the results and research from Minnesota. Hubert Lim has stepped away from his PI role at Minnesota and is working with Neuromod. @kelpiemsp was part of the University of Minnesota study. I am not trying to nickel and dime you here, but there has been so much misinformation I think it is important to keep the facts around this device.

I actually meant Lim is from Minnesota, not Michigan.

I did know that but thanks for the correction.

 

[Bob den Hartog]

He used to - and then he went into the neuromodulation Michigan trials, is what I understood .

 

[kelpiemsp]

Oh? - I remember you saying that you were suffering severe tinnitus at over 85 dB....??
Please correct me if you think I imagined it...?

Yup the days before I was part of the bimodal stimulation trial. T'was no fun. No fun at all.

And by days I mean years. And by years I mean decades.

 

[GamesB2]

Dr. Ross O'Neill said that the majority of investors in the beginning were wealthy businessmen who were frustrated with the lack of tinnitus treatments.

This always gives me hope as well.

If I was wealthy enough to invest in tinnitus treatments you can be sure I'd be dead set on seeing results. They'd get sick of answering the phone to me.

But who knows how much sway the investors really have over the scientific process?

 

[Jazzer]

Yup the days before I was part of the bimodal stimulation trial. T'was no fun. No fun at all.

And by days I mean years. And by years I mean decades.

'Yea right.......'

 

[GamesB2]

Yup the days before I was part of the bimodal stimulation trial. T'was no fun. No fun at all.

And by days I mean years. And by years I mean decades.

I'm happy to hear this. I'm glad it's helped you so much.

Hopefully we can all join you soon enough.

 

[Agrajag364]

Yup the days before I was part of the bimodal stimulation trial. T'was no fun. No fun at all.

And by days I mean years. And by years I mean decades.

Well I think this little post wins not just the thread but the whole forum.

 

[Tanni]

Yup the days before I was part of the bimodal stimulation trial. T'was no fun. No fun at all.

And by days I mean years. And by years I mean decades.

That is so comforting to know. Thank you for sharing this.

Just think, if it works for some people now, it should keep getting refined with higher and higher success rates. Fingers crossed anyway.

 

[GlennS]

Yup the days before I was part of the bimodal stimulation trial. T'was no fun. No fun at all.
And by days I mean years. And by years I mean decades.

Wow. I know sometimes text doesn't convey emotion but it's funny how people who have seen their tinnitus go down or go away completely (like Clare B) don't come across as if they're in a constant state of euphoria over it. If I experienced that sort of improvement I'd be laying rose petals in front of those responsible for the rest of my life and then proceed to climb Mt. Everest and go chasing after rainbow unicorns.

 

[dayma]

Yup the days before I was part of the bimodal stimulation trial. T'was no fun. No fun at all.

And by days I mean years. And by years I mean decades.

Awesome to hear!

 

[Aklara319]

Podium description from Neuromod's next presentation. Accidentally "published" and postdated to March 3.

 

[Aklara319]

Podium description from Neuromod's next presentation. Accidentally "published" and postdated to March 3.

View attachment 26941

What can be taken from this:
(1) An 84% compliance rate suggests ease of use and (perhaps) at least some degree of efficacy, considering that the device must be used daily over 12 weeks.
(2) The greatest therapeutic effects were observed within the first 6 weeks.
(3) Most importantly, the therapeutic effects of PS1 (synchronous auditory and trigeminal stimulation) repeated in TENT A-2.

What I still hope to see:
(1) A randomized blind placebo in TENT A-2 using the marketed treatment modality.
(2) Whether the device is purchased or rented.
(3) A release date!

 

[GregCA]

What can be taken from this:
(1) An 84% compliance rate suggests ease of use and (perhaps) at least some degree of efficacy, considering that the device must be used daily over 12 weeks.
(2) The greatest therapeutic effects were observed within the first 6 weeks.
(3) Most importantly, the therapeutic effects of PS1 (synchronous auditory and trigeminal stimulation) repeated in TENT A-2.

What I still hope to see:
(1) A randomized blind placebo in TENT A-2 using the marketed treatment modality.
(2) Whether the device is purchased or rented.
(3) A release date!

What I find interesting is that the outcome measures listed are both of psychological nature (THI & TFI). For some reason I had the impression that they collected actual volume as outcome measure, and that it showed a decrease in volume. Perhaps I'm confused with other trials.

 

[Aklara319]

What I find interesting is that the outcome measures listed are both of psychological nature (THI & TFI). For some reason I had the impression that they collected actual volume as outcome measure, and that it showed a decrease in volume. Perhaps I'm confused with other trials.

Their primary outcome measures were THI & TFI and they also measured MML (an exploratory measure). Dr. Ross O'Neill said in the Q&A that they saw clinically significant improvements in all outcome measures.

 

[Drone Draper]

I believe Susan Shore's measured volume.

 

[Deamon22]

What I find interesting is that the outcome measures listed are both of psychological nature (THI & TFI). For some reason I had the impression that they collected actual volume as outcome measure, and that it showed a decrease in volume. Perhaps I'm confused with other trials.

They mentioned in the Q&A that they also measured the MML, not sure why that is not mentioned in the results.

Edit: I see they write "outcome measures INCLUDED the THI and TFI" so maybe there are still more measured values to be released in the future.

 

[Bob den Hartog]

Let's not forget that's only a podium description of the presentation, a teaser for what is to be expected to present at the presentation, and not meant to stand on its own. So let's not try to read too much into it for what's not there, and just focus on what it is.

 

[Paulmanlike]

According to that chart they have included MML, TLM, VAS. Let's hope these also achieved clinically statistical improvement as well as TFI & THI that has continued to the 12 month mark! This question remains unanswered.

But the only thing I have learnt from it is that there was a 84% compliance rate (those 16% should be slapped as they've taken away the opportunity for someone else to try it) and the greatest benefit is seen in the first 6 weeks.

What we don't know did the '80% reporting improvement' include the non-compliant rate, so if 16% didn't comply were they deemed as non-responders or were they taken out of the results? Probably the former but if they included it that means only 4% never responded? I would imagine though they would be taken out of the results?

Also the greatest level of efficacy being in the first 6 weeks is good news = higher compliance if it works. That means less time to wait before 'real life' results build up on Tinnitus Talk!

Comments?

 

[Ricardo1991]

I can say with certainty that they are not releasing it before June. We have more months to wait...

View attachment 26865

I never thought I'd be saying, "oh just a few more months? Okay, cool I can wait." The reason why I'm so nonchalant about it is that although I suffer severely (more so recently). I think I have realized I have no other option than to wait and be patient. Thank you for the update, I was starting to lose hope about the legitimacy about this device until I read your post.

Thanks.

 

[Agrajag364]

Podium description from Neuromod's next presentation. Accidentally "published" and postdated to March 3.

View attachment 26941

Does anyone know whether any of these three arms in the TENT-A2 trial (this one they're presenting now) represented a "sham" placebo? In their 2016 study, which I think didn't have a "control" group, they said in they would go on to do a randomised controlled trial with a sham arm, and their reviewer comments at end of the paper - "I hope to see a randomized placebo controlled study soon". https://onlinelibrary.wiley.com/doi/pdf/10.1111/ner.12452

But in the study protocol describing what they plan to do (and have now done) in the TENT-A2 - they do not describe any of the three "arms" as a sham control arm. I see from the above poster outline that all three arms were considered to have clinical effects... I wonder why they did not use a sham proper placebo type arm, but I could be missing something...

@Paulmanlike can you speculate as to why they did not use a sham as planned? https://www.neuromoddevices.com/content/1-company/2-clinical-advancement/e018465.full.pdf

 

[Drone Draper]

I'm wondering if they'll be able to meet demand for this device once released. I guess the price will prohibit a lot of people from being early adopters, but still, the demand will be substantial.

 

[Paulmanlike]

Does anyone know whether any of these three arms in the TENT-A2 trial (this one they're presenting now) represented a "sham" placebo? In their 2016 study, which I think didn't have a "control" group, they said in they would go on to do a randomised controlled trial with a sham arm, and their reviewer comments at end of the paper - "I hope to see a randomized placebo controlled study soon". https://onlinelibrary.wiley.com/doi/pdf/10.1111/ner.12452

But in the study protocol describing what they plan to do (and have now done) in the TENT-A2 - they do not describe any of the three "arms" as a sham control arm. I see from the above poster outline that all three arms were considered to have clinical effects... I wonder why they did not use a sham proper placebo type arm, but I could be missing something...

@Paulmanlike can you speculate as to why they did not use a sham as planned? https://www.neuromoddevices.com/content/1-company/2-clinical-advancement/e018465.full.pdf

You're confusing the trials. The first link you posted was neither TENT-A1 (326 patients) or TENT-A2 (192 patients). That was a small pilot study done just before the original MuteButton was launched.

There were 3 arms in TENT-A1 (326 patients) that was divided 80% being trialled in Ireland and 20% in Germany. This study has been completed and is in the process of being peer reviewed. We have yet to see the papers.

The TENT-A2 study (192 patients) is still ongoing and should finish the 12 month follow up soon. This study has 4 arms divided by 80:80:16:16.

Here is a link to the recruitment of the study
https://clinicaltrials.gov/ct2/show/NCT03530306

What I found curious is that part of the inclusion criteria for the TENT-A2 is 'tonal' tinnitus, yet Dr. Ross O'Neill stated the tonality/intonality doesn't matter. But atonal tinnitus is not part of the exclusion criteria. However the PI can exclude patients on any other grounds they seem appropriate. This concerns me when studies are made by the developers of the device; how do we know they want to get in as many people with tonal tinnitus and not specifically exclude atonal; just to sell more devices?

Also @Agrajag364, I don't know what these 4 arms consist of or why; but I presume they are confirming the results of the TENT-A1 study and the smaller arms (16) confirming they are the least effective maybe.

 

[Paulmanlike]

Okay so I checked the inclusion and exclusion criteria for both the TENT-A1 and the TENT-A2 study so I'll give you some speculation that I find a little concerning.

Recruitment for TENT-A1.

- neither in the inclusion or exclusion criteria does it mention having to have tonal or atonal tinnitus.

Q&A with Dr. Ross O'Neill clearly stated that the tonality/atonality does not matter.

- recruitment for TENT-A2 states part of the inclusion criteria is having to have tonal tinnitus. The good news is that atonality is not part of the exclusion criteria, however the PI can exclude patients based on what they seem not appropriate.

The reason this concerns me is that how do we know that tonal patients have not reported better results than atonal patients - is the whole point of including tonal patients to make their results seem better??

 

[Bob den Hartog]

I'm wondering if they'll be able to meet demand for this device once released. I guess the price will prohibit a lot of people from being early adopters, but still, the demand will be substantial.

Me too. Wondering if there'll be waiting lists.

 

[TimmyC]

You're confusing the trials. The first link you posted was neither TENT-A1 (326 patients) or TENT-A2 (192 patients). That was a small pilot study done just before the original MuteButton was launched.

There were 3 arms in TENT-A1 (326 patients) that was divided 80% being trialled in Ireland and 20% in Germany. This study has been completed and is in the process of being peer reviewed. We have yet to see the papers.

The TENT-A2 study (192 patients) is still ongoing and should finish the 12 month follow up soon. This study has 4 arms divided by 80:80:16:16.

Here is a link to the recruitment of the study
https://clinicaltrials.gov/ct2/show/NCT03530306

What I found curious is that part of the inclusion criteria for the TENT-A2 is 'tonal' tinnitus, yet Dr. Ross O'Neill stated the tonality/intonality doesn't matter. But atonal tinnitus is not part of the exclusion criteria. However the PI can exclude patients on any other grounds they seem appropriate. This concerns me when studies are made by the developers of the device; how do we know they want to get in as many people with tonal tinnitus and not specifically exclude atonal; just to sell more devices?

Also @Agrajag364, I don't know what these 4 arms consist of or why; but I presume they are confirming the results of the TENT-A1 study and the smaller arms (16) confirming they are the least effective maybe.

From my understanding the separate arms are to determine best outcome measures, right? I can only assume the they added the inclusion criteria so they can have more evidence of it working on multiple parameters. From a basic science level, if all we are doing is breaking up the synchronized neural activity, then the tone you hear shouldn't matter. However, if they can claim that it helps "all types of tones" then that's a better marketing term.

A side question @Paulmanlike, I take into account a lot of what you say (I value your opinion), but I would still like to know why you compare this to the ACRN device so often. Is it just because of the hype? I wasn't around for that launch, but would you say this device has way more clinical trial patients, and way more clinical evidence (even though we have not seen it yet) to back it up? The papers I have read about ACRN do not have nearly as much university and clinical study behind it, and even though it has worked for some, it doesn't seem nearly as promising as bimodal stimulation.

Just wondering what your thoughts are. Thanks!