MuteButton

[jmasterj]

I just really don't get it. We have had one person on here who had their tinnitus eliminated @Clare B and @kelpiemsp who has had great results from a similar device. You guys sit here and question every small detail. Face it this is the best prospect we have available to us. It probably won't work for everyone. 1 out of 5 people aren't going to get relief from this based on their numbers. From my understanding the Minnesota trial didn't use a sham either. You have to have inclusion and exclusion criteria so you can measure effectiveness.

I just really wish Neuromod would release and put this to bed.

 

[kelpiemsp]

I just really don't get it. We have had one person on here who had their tinnitus eliminated @Clare B and @kelpiemsp who has had great results from a similar device. You guys sit here and question every small detail. Face it this is the best prospect we have available to us. It probably won't work for everyone. 1 out of 5 people aren't going to get relief from this based on their numbers. From my understanding the Minnesota trial didn't use a sham either. You have to have inclusion and exclusion criteria so you can measure effectiveness.

I just really wish Neuromod would release and put this to bed.

Hey! We actually did have a sham. Dr. Shore did not. During a session we had as many as 6 different trials of 8 minutes I believe. After every 8 minute interval MML was measured. It's very possible sham effects were here. I.E. run a false timing and measure MML. Also there was sham throughout the intro period of the study before the final month actual study. Which I'm told included a sham.

 

[Markku]

IMHO, there should be a 2nd Tinnitus Talk Q&A session with Neuromod where these sorts of questions can be put to them.

Last Q&A must have been a lot of work for the few Tinnitus Talk volunteers!

It definitely was a lot of work:

- @Steve took time out of his busy schedule to travel to Dublin to meet Neuromod;
- @Hazel spent 8h curating and structuring the interview questions, another few hours advising on video production;
- 30h went into subtitling the video, work shared between @Manny, @hans799, @Deamon22, @JLP - and a couple of hours by @Hazel making final adjustments for the subtitles;
- I myself spent about 30h on video editing and production. It's definitely the biggest video project we ever did!
- @Ed209, @Jack Straw and @TuxedoCat functioned as our review panel, providing valuable feedback.

I'm of course willing to give Neuromod a little nudge and suggest another Q&A, possibly in the form of text (or maybe they could join our Tinnitus Talk Podcast), however we would first need to assess the number of questions people have, and the feasibility of Neuromod being able to, or wanting to, answer them - considering the previously stated limitations on talking about the trials before the peer review has finished and been published.

 

[Paulmanlike]

Neuromod did NOT say they will use a placebo. It was commented on the paper (by a third party) saying they hoped a further paper will have a placebo. Just something positive to think about; although 80% reported improvement; 67% reported clinically significant improvement. That would be pretty hard for such a high number of a placebo.

I would say though basing things like 1/5 aren't going to get relief is depending on too much of the results that would represent the whole population. How can 500 people be representative of the millions of us with subjective tinnitus worldwide? It just isn't.

I am more concerned why a tonal tinnitus tone had to be part of the inclusion criteria for the TENT-A2 if it demonstrated effectiveness for (tonal/intonal) etc.

To comment on the trials, if you haven't already looked, TENT-A1 had 3 arms (P1, P2, P3).

It looks as if TENT-A2 has 9 arms (P1, P2, P3 ,P4,...P9).

They are swooping arms after 6 weeks. Again, we still don't know if they have learnt anymore from the latest TENT-A2 trial - such as if they have further got indication they can improve efficacy/if it was a fluke in terms of longer lasting efficacy/who it may not work for etc etc.

As far as I'm aware, during the interview, Dr. Ross O'Neill has only commented on the data from the TENT-A1. Remember the TENT-A2 has a further 192 patients divided between 80:80:16:16. Even though the study is entirely finished they should have data coming in.

 

[Agrajag364]

I just really don't get it. We have had one person on here who had their tinnitus eliminated @Clare B and @kelpiemsp who has had great results from a similar device. You guys sit here and question every small detail. Face it this is the best prospect we have available to us. It probably won't work for everyone. 1 out of 5 people aren't going to get relief from this based on their numbers. From my understanding the Minnesota trial didn't use a sham either. You have to have inclusion and exclusion criteria so you can measure effectiveness.

I just really wish Neuromod would release and put this to bed.

I am not questioning the fact this worked for several users here, or saying that it won't work for many! It might! It's very exciting. But analysing the quality of clinical trial data is what patients could and should do these days.

 

[Jack Straw]

Neuromod did NOT say they will use a placebo. It was commented on the paper (by a third party) saying they hoped a further paper will have a placebo. Just something positive to think about; although 80% reported improvement; 67% reported clinically significant improvement. That would be pretty hard for such a high number of a placebo.

I would say though basing things like 1/5 aren't going to get relief is depending on too much of the results that would represent the whole population. How can 500 people be representative of the millions of us with subjective tinnitus worldwide? It just isn't.

I am more concerned why a tonal tinnitus tone had to be part of the inclusion criteria for the TENT-A2 if it demonstrated effectiveness for (tonal/intonal) etc.

To comment on the trials, if you haven't already looked, TENT-A1 had 3 arms (P1, P2, P3).

It looks as if TENT-A2 has 9 arms (P1, P2, P3 ,P4,...P9).

They are swooping arms after 6 weeks. Again, we still don't know if they have learnt anymore from the latest TENT-A2 trial - such as if they have further got indication they can improve efficacy/if it was a fluke in terms of longer lasting efficacy/who it may not work for etc etc.

As far as I'm aware, during the interview, Dr. Ross O'Neill has only commented on the data from the TENT-A1. Remember the TENT-A2 has a further 192 patients divided between 80:80:16:16. Even though the study is entirely finished they should have data coming in.

500 sample is a huge number for a clinical device trial. This is as good as it is ever going to get for tinnitus treatments. I am not sure why you don't think this is a good representative group.

Also they aren't targeting specific types of tinnitus in that original trial. They are not trying to treat the specific causes of tinnitus either. They are throwing a blanket over all tinnitus and targeting the part of the brain that deals with tinnitus in everyone and changing or inflicting neuroplasticity to change how the brain deals with it.

I can see why you would be very pessimistic regarding tinnitus treatments because like you, I have had it for over 20 years and have seen stuff come and go. This is the first time I am actually excited because this isn't a pharma drug or and sound treatment. This is bypassing all mechanisms in the ear that may cause the tinnitus and just going to the brain to "turn it off".

 

[_Patrick_]

Guys I don't understand the need to be negative about this. My tinnitus was kind of manageable until a couple of months. Since then it became very loud, and I'm totally freaking out. Didn't know this could happen. I was looking forward for this Neuromod device, and am following this forum every day, but it continuously blows hot and cold to the point where I'm not sure what to think anymore. Which is ridiculous because in the end, we can't know anything for sure until we try it for ourselves, so what's the point in making so many assumptions? It's only making things worse for all of us longing for some peace of mind.

Please give factual information if you have any, but keep any assumptions to yourself, especially if they are negative.

 

[Arseny]

@kelpiemsp,
There's a very important question for you that I'm sure many are interested in.

After the treatment did you stop getting the spikes in your tinnitus?
Are you able to be around loud noises (traffic, trains, airplanes) without tinnitus reacting/spiking?
Does anything now affects your tinnitus or it stays at stable low level?
Do you experience hyperacusis?

Thank you.

 

[Paulmanlike]

@Jack Straw (Love your accent by the way), I am optimistic, I do at times may come across as pessimistic and this isn't my intention to appear like this amongst the members here, especially the regulars, we all have good discussions. It is optimism, believe it or not, that keeps me going and so far, I am impressed with Neuromod, bimodal neuromodulation, Hubert Lim etc.

I do however (with great reason) ask a lot of questions especially to myself, that has stemmed from years of upcoming tinnitus treatments. It's true that 500+ patients demonstrating a medical device is a big deal, but being realistic I don't believe how anybody can demonstrate the alleged efficacy being a 4/5. If it was in the thousands like a medicine going through a phase 3 trial, I'd be a little more convinced. I believe it is our job as sufferers and as forum members who actively discuss tinnitus research and treatments to dissect information presented to us. We tinnitus sufferers have for many years been the target for quackery. I don't believe Neuromod is quackery by the way but questions need to be asked and debates made.

 

[Agrajag364]

Neuromod did NOT say they will use a placebo. It was commented on the paper (by a third party) saying they hoped a further paper will have a placebo. Just something positive to think about; although 80% reported improvement; 67% reported clinically significant improvement. That would be pretty hard for such a high number of a placebo.

I would say though basing things like 1/5 aren't going to get relief is depending on too much of the results that would represent the whole population. How can 500 people be representative of the millions of us with subjective tinnitus worldwide? It just isn't.

In the 2016 pilot study paper, the authors (i.e. Neuromod and not their reviewer) said:

"The present study demonstrates the feasibly of this device and provides evidence of improvements in tinnitus symptoms. The results of this study support the continued evaluation of this inter- vention as a treatment for tinnitus. The next step is a series of clinical trials to disassociate the specific and unspecific effects of this thera- peutic intervention. Parameter optimization studies will investigate the association of the bi-modal stimuli to determine the optimal stimulation settings. These studies will be followed by a Randomised Control Trial to compare this intervention to a sham treatment"

https://onlinelibrary.wiley.com/doi/pdf/10.1111/ner.12452​

As I understand it, a sham treatment is effectively a placebo in these types of device trials.

The fact that they chose to use active comparators in all arms in the end rather than having sham arms in the two trials doesn't mean they were just trying to make the end results look better, though that's certainly a possibility. It could indeed be that after testing shams they decided it was too obvious they were shams, so had no choice but to design the trial this way.

Comparing a series of active comparators all expected to have a therapeutic effect is still scientifically valid and ok, just from my understanding of this field having a sham arm would have made the evidence better quality under conventional standards.

500 people is a good sample size for a trial.

 

[Paulmanlike]

What are people's thoughts why "tonal tinnitus" is an inclusion criteria in the TENT-A2 trial? I'm just worried they have found this treatment works only on tonal tinnitus like ACRN? I know Dr. Ross O'Neill said tonality/intonality doesn't matter, but I know many tinnitus sufferers have different sounds every day. I have hissing, hoovering, ringing, air escaping, sirens.

 

[GregCA]

500 sample is a huge number for a clinical device trial. This is as good as it is ever going to get for tinnitus treatments. I am not sure why you don't think this is a good representative group.

500 is definitely statistically significant. I thought the concerns were more along the lines of the bias due to the selection criteria.

In other words, it is representative, of the people who match the selection criteria.

 

[TuxedoCat]

Comparing a series of active comparators all expected to have a therapeutic effect is still scientifically valid and ok, just from my understanding of this field having a sham arm would have made the evidence better quality under conventional standards.

Having a sham treatment would certainly strengthen the conclusions that could be made based on the trial. But it's often difficult to find a sham treatment for a device trial that either doesn't unblind the study or introduce bias.

Neuromod must have given it some thought if they mention a sham treatment in an early study report, however they may not be willing to discuss details on a public forum and unblind the future study. It would still be helpful to know if they continue to plan for such a trial.

 

[hopeful4future]

What are people's thoughts why "tonal tinnitus" is an inclusion criteria in the TENT-A2 trial? I'm just worried they have found this treatment works only on tonal tinnitus like ACRN? I know Dr. Ross O'Neill said tonality/intonality doesn't matter, but I know many tinnitus sufferers have different sounds every day. I have hissing, hoovering, ringing, air escaping, sirens.

Is tonal tinnitus one sound?

 

[GregCA]

Is tonal tinnitus one sound?

One tone. A tone is a type of sound (a pure sine wave, to be exact).

 

[GlennS]

BTW, I'm only speaking for myself but I don't think if I were on a placebo trial of this sort of treatment that I would report improvement, or if I did, it would sure as hell be classified as mild improvement if it were just me imagining improvement that isn't there. And I think that goes for most people's tinnitus if it's in any way severe.

So I think it's possible to look at the results closer and determine whether placebo is or would have been a factor.

 

[Bob den Hartog]

What are people's thoughts why "tonal tinnitus" is an inclusion criteria in the TENT-A2 trial? I'm just worried they have found this treatment works only on tonal tinnitus like ACRN? I know Dr. Ross O'Neill said tonality/intonality doesn't matter, but I know many tinnitus sufferers have different sounds every day. I have hissing, hoovering, ringing, air escaping, sirens.

Just guessing here, but maybe because it's easier to put a loudness measurement on tonal tinnitus, whereas it's a lot more difficult to measure improvement without such a version?

 

[Arseny]

One tone. A tone is a type of sound (a pure sine wave, to be exact).

Like eeeeeeeeee?
Or can it be just one hissing sound or ringing?

So they included only people with eeeeeeeeee sound or people with any sound, but it had to be one sound?

 

[GregCA]

Like eeeeeeeeee?
Or can it be just one hissing sound or ringing?

So they included only people with eeeeeeeeee sound or people with any sound, but it had to be one sound?

This is a pure tone: http://www.szynalski.com/tone-generator/

 

[grate_biff]

And that's probably why they allowed those with tinnitus for less than a year into the trial. To make the results look better. And they don't have placebo group... this smells!

You really are the sunshine of this forum!

 

[Tanni]

The problem with this treatment is that any suggestion of a cure sounds too good to be true, so of course people will be doubting it. All we've ever been told about tinnitus is that you have to 'live with it', and our best outcome is that we'll stop being bothered by it.

Even if this treatment isn't yet effective for everyone it looks like a real big step in the right direction, and I really believe that in years to come people will look back and be shocked that we used to have to live with tinnitus.

 

[spedgas]

I've read several times that during their last round of fundraising they thought they would be profitable in the first quarter of 2019. We are a week away from March already. It's impossible to be profitable if you aren't selling anything.

 

[Paulmanlike]

The problem with this treatment is that any suggestion of a cure sounds too good to be true, so of course people will be doubting it. All we've ever been told about tinnitus is that you have to 'live with it', and our best outcome is that we'll stop being bothered by it.

Even if this treatment isn't yet effective for everyone it looks like a real big step in the right direction, and I really believe that in years to come people will look back and be shocked that we used to have to live with tinnitus.

What I don't understand, is that out of all the incurable medical conditions, with tinnitus being probably the most common one, is the lack of media attention or knowledge about 'Neuromod' or 'bimodal neuromodulation'.

For example, go onto any of the tinnitus support groups like on Facebook and talk about Neuromod, nobody really knows anything about it. Also given that Tinnitus Talk has 27k members, I doubt even 100 know about Neuromod.

For a company that has 500 followers on Twitter, you don't expect a breakthrough from them, that if it does help 67/80 people achieve significant reduction in noise, then it would be a breakthrough.

Also, there is very little media coverage on a supposedly promising new treatment for a very common condition.

I would have thought it would have gained a lot more attention even at this stage pre-release.

Also, ask a ENT or audiologist about Neuromod..... do you think they've heard about it? Mine didn't. But another one I contacted did.

 

[Markku]

Also, there is very little media coverage on a supposedly promising new treatment for a very common condition.

Indeed. But then again, tinnitus is generally very little written or talked about in the media. I wonder if most health journos are even aware of Neuromod's existence yet. It's interesting to see how much press they will get if the treatment gets established with a good success rate.

In the past year, here is what BuzzSumo reports when you search for "tinnitus" - with regards to social engagement levels for content on the internet:

 

[spedgas]

What I don't understand, is that out of all the incurable medical conditions, with tinnitus being probably the most common one, is the lack of media attention or knowledge about 'Neuromod' or 'bimodal neuromodulation'.

For example, go onto any of the tinnitus support groups like on Facebook and talk about Neuromod, nobody really knows anything about it. Also given that Tinnitus Talk has 27k members, I doubt even 100 know about Neuromod.

For a company that has 500 followers on Twitter, you don't expect a breakthrough from them, that if it does help 67/80 people achieve significant reduction in noise, then it would be a breakthrough.

Also, there is very little media coverage on a supposedly promising new treatment for a very common condition.

I would have thought it would have gained a lot more attention even at this stage pre-release.

Also, ask a ENT or audiologist about Neuromod..... do you think they've heard about it? Mine didn't. But another one I contacted did.

I cringe as I write this. I have no idea if I'm correct about this or not. We know that tinnitus is experienced by millions and millions. I agree that for what we are being presented with that it would seem that more people would know about it. It makes me think there are significant numbers of people with tinnitus that just don't actively seek out information about cures/treatments. I can't imagine ever reaching that point. I can barely avoid checking this website every 30 minutes daily. Habituation or not, there are people that clearly don't feel the drive to seek this stuff out. Success will be the best advertising possible.

 

[dayma]

What I don't understand, is that out of all the incurable medical conditions, with tinnitus being probably the most common one, is the lack of media attention or knowledge about 'Neuromod' or 'bimodal neuromodulation'.

For example, go onto any of the tinnitus support groups like on Facebook and talk about Neuromod, nobody really knows anything about it. Also given that Tinnitus Talk has 27k members, I doubt even 100 know about Neuromod.

For a company that has 500 followers on Twitter, you don't expect a breakthrough from them, that if it does help 67/80 people achieve significant reduction in noise, then it would be a breakthrough.

Also, there is very little media coverage on a supposedly promising new treatment for a very common condition.

I would have thought it would have gained a lot more attention even at this stage pre-release.

Also, ask a ENT or audiologist about Neuromod..... do you think they've heard about it? Mine didn't. But another one I contacted did.

Agreed. Amazing how the groups on Facebook have very little knowledge of Neuromod.

This can all change with success. As long as I know about it I am happy

 

[GamesB2]

I'm not too surprised with the lack of attention, I know a few people with tinnitus who all have it mild or only occasionally flares up.

Most of these people have habituated or aren't bothered by it, they don't research cures because it doesn't bother them daily.

When mine was mild for around 7 years, I never looked into it, sometimes I'd come across an article stating 'New Tinnnitus Cure in Development!' and be like 'oh cool it'd be nice to get rid of my noise someday' but I wasn't bothered enough to keep checking.

I only started browsing here daily and paying attention to new treatments when it suddenly spiked up to moderate/severe a year ago.

Also going to ENTs/aduiologists and hearing, there's nothing we can do just live with it must be very off putting for a lot of people, so they don't continue research because, how could a doctor be wrong?

Just my rambling thoughts on it.

 

[Tanni]

What I don't understand, is that out of all the incurable medical conditions, with tinnitus being probably the most common one, is the lack of media attention or knowledge about 'Neuromod' or 'bimodal neuromodulation'.

For example, go onto any of the tinnitus support groups like on Facebook and talk about Neuromod, nobody really knows anything about it. Also given that Tinnitus Talk has 27k members, I doubt even 100 know about Neuromod.

For a company that has 500 followers on Twitter, you don't expect a breakthrough from them, that if it does help 67/80 people achieve significant reduction in noise, then it would be a breakthrough.

Also, there is very little media coverage on a supposedly promising new treatment for a very common condition.

I would have thought it would have gained a lot more attention even at this stage pre-release.

Also, ask a ENT or audiologist about Neuromod..... do you think they've heard about it? Mine didn't. But another one I contacted did.

I think because tinnitus it not a very 'media friendly' condition. Non-sufferers can't see it, so they can't measure how debilitating it is. Everyone can see the limitations of someone being in physical pain/unable to see/unable to walk, but not the limitations of tinnitus.

Also, a lot of people have it quite mildly and it doesn't really affect their everyday life, so that sort of skews public perception against the more severe cases.

Also, when new technology comes out there's always a 5% group of early adopters. They try the new technology as soon as they can, regardless of whether it might work or not. The rest of us are more results-driven - we wait to see how the early adopters got on before we purchase also. And this is the time when something will get media attention.

Just my opinion anyway; before I got tinnitus, I'd barely even heard of it.

 

[Bob den Hartog]

Also, I can imagine Neuromod to wait seeking media attention until it's been presented within medical circles first, maybe wait for the peer reviews to come out.

Once the media attention breaks, that will be the first impression to the world, and you want it to be as good as possible. So including all the new data, of all the trials.

 

[Tanni]

because, how could a doctor be wrong?

So true! I can now confidently say that I don't trust a thing a GP tells me. Their lack of knowledge when it comes to tinnitus is shocking!