MuteButton

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Apologies to all for being slow - a day off work means more to come back to, and it's our year end so I have been busy tidying up invoicing (and being shouted at for being the last one :))

Markku will likely have access to the raw footage tomorrow morning, my fault. Sorry again... I'm out all day tomorrow at a conference so I won't be able to address any questions in a hurry - although if anyone wants to volunteer to boil subsequent posts and key things you want to know down into an easy to digest set of questions I'll happily answer them.

I haven't read everything but I wanted to say a few things based on some of the things I have read.

This isn't a cure, and they aren't promoting it as one. The most improved of the participants have reported a large effect on their tinnitus, to the point they can barely hear it. The numbers we discussed are better than those I've seen from other treatments, though we do have to wait for the peer reviewed paper to confirm everything. They are reporting based on 12 weeks of treatment then following up at 12 months to measure the lasting effect. There is another trial just completing that will be reported in time, they have to get the 12 month follow up date for this so it will take a while.

The hypothesis is based around lack of auditory input - hearing loss and associated processing in the brain. The tinnitus tone or pitch does not affect the eligibility. The device is calibrated to your audiogram, which needs to be performed by the audiologist. After this you have the device at home and use as required. Because it's to your hearing it's highly unlikely to ever need recalibration. They recommend being in the same country so you have access to the audiologist. If you have profound hearing loss you currently wouldn't be able to use the device.

They have recruited some of the best people in tinnitus research to conduct their trials - Berthold Langguth, Deborah Hall, Hubert Lim, Richard Tyler. I'm confident that the conducting of the research is legit and the results can be trusted. I'm not a fan of getting sued so I won't explicitly point out a different product that enlisted the help of some top people and then (allegedly) suppressed the results - which were not flattering. What we have here to date is an open process, with some of the largest numbers of patients seen in tinnitus trials, ready to be peer reviewed and reported.

I am personally all for any company that enters the tinnitus space and tries to do things properly. One of the things we talked about off camera was the difficulty in getting investment for tinnitus treatments. Investors aren't big on new fields, they like to know there is a proven market (and of course the lack of an objective measure is a sticking point). If this device works then, from a selfish point of view, it makes the tinnitus space something an investor will be more likely to become involved with and increases competition. All good for us patients.

Disclosure: I accepted a sandwich and some hot beverages from Neuromod, which don't bias my views :)

Where can I invest?

Holy shit man... made my day!

Can't wait for the Q&A!

The only question I have it... what kind of sandwich? If it was PPJ, then I would agree that you aren't being biased. But if it was a steak sandwich with the works, then I think we may have a conflict of interest here!
 
Nobody would be happier than I if this device is even half as successful as some of the claims about it. But so many "wonder" audiology devices have been released with all sorts of claims about their efficacy for tinnitus (some apparently backed by research trials), desperate sufferers' have paid large amounts of money for them and have been left bitterly disappointed when they didn't do anything for their tinnitus.

A large degree of skepticism is required - I was concerned by the amount of free publicity this was getting at the recent BTA tinnitus conference - accompanied by some claims that NICE in the UK were thinking about it, which is extremely doubtful.
This is the first "audio" device of its kinda. No other device has used bimodal stimulation as a means of changing neuroplasticity.
 
This is the first "audio" device of its kinda. No other device has used bimodal stimulation as a means of changing neuroplasticity.
To be honest every audio device which has been released promises to do something new. Again, I'd be delighted if this product really does live up to the hype about it. I just wouldn't want to be one of the people parting with large amounts of money only to discover that was all it was - hype.
 
To be honest every audio device which has been released promises to do something new. Again, I'd be delighted if this product really does live up to the hype about it. I just wouldn't want to be one of the people parting with large amounts of money only to discover that was all it was - hype.
Fair play to Steve for coming to Dublin and trying out the device. Markku as well. It is a difficult balance being armchair commenters and showing lack of respect to the people who are actively making things happen. We are all in awe of Markku and Steve.

Fair play guys.

I for one will be making a monthly contribution to Tinnitus Talk - For those who are also indebted to these gentlemen - As well as posting comments here a donation would also be in order to help the running of things.

Tiocfaidh ar Lá (Our day will come - In Irish)
 
accompanied by some claims that NICE in the UK were thinking about it, which is extremely doubtful.
I didn't hear that and I was there. NICE are not looking at it as far as I'm aware, nor do Neuromod claim they are. For every new treatment there is always a healthy rumour mill.

Saying that we did discuss healthcare and insurance yesterday. They confirmed that they are going to be looking at this (and have begun the process in one country) but of course they need complete, robust data. Likewise the process of FDA approval is in motion.

I understand the skepticism, years of being involved in this space have given me a healthy dose of it. I am also an optimist for the future, wanting to encourage as much investment as possible into treatments. One thing we discussed was that they have some good data on who the device will work for, but that they also need to explore the data and figure out who the device won't work for. It's not a panacea and it isn't good business sense to give false expectations, better to be able to advise a patient up front if they are not likely to benefit. For example, one of the exclusion criteria for the trial was somatic that required a surgical type of intervention. If the tinnitus is related to something like TMJ then the hypothesis doesn't stand up.

I do wonder if there is possibility of dual treatment, addressing the somatic along with using the device. The problem of that is that the more elements you introduce to a clinical trial, the more participants you need and the more complexity you introduce.
The only question I have it... what kind of sandwich? If it was PPJ, then I would agree that you aren't being biased. But if it was a steak sandwich with the works, then I think we may have a conflict of interest here!
It was a chicken club. Maybe I should re-assess my statement of bias.
 
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Fair play to Neuromod not wanting any of Susan Shore's somatic market!
I find that interesting too. Seems like they won't be competing with each other.
 
Whoa. That just turned what I thought I knew exactly on its head. Just goes to show.
Susan Shore seems to be working on a device that is tested on somatic ONLY tinnitus. @kelpiemsp is also in a trial that is similar.

If I understand correctly, Neuromod targets the cells that are misfiring the signal to stop them, while Susan Shore's device targets a specific part of the brain?

I could be very wrong here so anyone who could clarify would help out.
 
I didn't hear that and I was there. NICE are not looking at it as far as I'm aware, nor do Neuromod claim they are. For every new treatment there is always a healthy rumour mill.
So this is based on what one of the Tinnitus Talk volunteers at the BTA conference said:
@Jack Straw, @Steve,

I had a good chat with the lady who was hosting the Neuromod stand and she explained she was very keen approaching NICE which would be the first step in eventually making the device available through the NHS (UK). Am not sure what her role in the organisation was hence with what authority she was talking but her words were encouraging.
So I'm not making that up @Steve.

Again I've expressed skepticism about whether NICE would be interested before but this is clearly part of MuteButton's strategy to increase the hype and their sales.
 
For example, one of the exclusion criteria for the trial was somatic.

This one sentence just crushed me. I've put months of faith in a device that won't even help me.
 
For example, one of the exclusion criteria for the trial was somatic. If the tinnitus is related to something like TMJ then the hypothesis doesn't stand up. I do wonder if there is possibility of dual treatment, addressing the somatic along with using the device.
So it won't work for at least two-thirds of people with tinnitus?
 
For example, one of the exclusion criteria for the trial was somatic.

This one sentence just crushed me. I've put months of faith in a device that won't even help me.
Many of us were in the opposite situation. I read about this device but I was not sure if it was designed for my "non somatic" case. Anyway, if I were in your place, I would not lose hope, surely your tinnitus is not 100% somatic.
 
For example, one of the exclusion criteria for the trial was somatic.

This one sentence just crushed me. I've put months of faith in a device that won't even help me.
Signal timing/neuromodulation is more effective on somatic tinnitus because signal timing relies on somatic pathways. They are just being conservative with their study design. If results are significant with non somatic they will be even more when somatic is added.

Also, we've been through this a million times but somatic vs non somatic isn't a true distinction. I've posted the diagram many times. Long story short there is an 80% probability this device will work on you regardless. (The numbers fudge a bit when you go into the dependencies)
 
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I think the word "somatic" is used to mean two distinct things, causing some confusion here.

Meaning 1 is the sense in which Neuromod is using it, that is: "of the body", tinnitus that is caused not by hearing loss, but by TMJ issues etc (whether or not it can be modulated by bodily movements).
Meaning 2 is the sense in which Susan Shore's team is using it, that is: tinnitus that can be modulated by jaw movements etc (whether or not it was caused by hearing loss, TMJ or whatever).

Which means that whether you can modulate your tinnitus by jaw movements etc (Meaning 2) has nothing to do with whether the Neuromod device will work for you.

Unfortunate that there's just 1 word for these 2 things.

So if you suspect that your tinnitus cause is hearing loss, it doesn't matter whether you can modulate it via movements or not: you're in the target group for Neuromod. This actually expands the target group, people, and is to be seen as good news!
 
Or imagine that you live in Argentina and you do not know how you will be able to do the treatment. LOL.
Does Argentina have their own form of FDA to approve devices? Do you have a tinnitus organization in Argentina that could help let politicians be aware of this form of treatment?
 
i wonder how this device will work with multiple tones tinnitus. Do you have to treat one tone at a time?
 
i wonder how this device will work with multiple tones tinnitus. Do you have to treat one tone at a time?

Apparently no. They consider all tones just a "tinnitus".
 
Signal timing/neuromodulation is more effective on somatic tinnitus because signal timing relies on somatic pathways. They are just being conservative with their study design. If results are significant with non somatic they will be even more when somatic is added.

Also, we've been through this a million times but somatic vs non somatic isn't a true distinction. I've posted the diagram many times. Long story short there is an 80% probability this device will work on you regardless. (The numbers fudge a bit when you go into the dependencies)

Is yours still reduced by the parallel trial? Did it work significantly for you?
 
I think the word "somatic" is used to mean two distinct things, causing some confusion here.

Meaning 1 is the sense in which Neuromod is using it, that is: "of the body", tinnitus that is caused not by hearing loss, but by TMJ issues etc (whether or not it can be modulated by bodily movements).
Meaning 2 is the sense in which Susan Shore's team is using it, that is: tinnitus that can be modulated by jaw movements etc (whether or not it was caused by hearing loss, TMJ or whatever).

Which means that whether you can modulate your tinnitus by jaw movements etc (Meaning 2) has nothing to do with whether the Neuromod device will work for you.

Unfortunate that there's just 1 word for these 2 things.

So if you suspect that your tinnitus cause is hearing loss, it doesn't matter whether you can modulate it via movements or not: you're in the target group for Neuromod. This actually expands the target group, people, and is to be seen as good news!
Sorry but this is just not correct. It is purely for a study design perspective. Again this is a false distinction. And hearing loss is an exclusion criteria (large hearing loss).
 
Does Argentina have their own form of FDA to approve devices? Do you have a tinnitus organization in Argentina that could help let politicians be aware of this form of treatment?

I really dont know. I guess I'll have to find out. There is no association of people affected by tinnitus. There is a tinnitus clinic in Buenos Aires, which I suppose will be interested in providing this treatment, if Neuromod wants to sell it worldwide.
In the worst case I will have to consider the possibility of traveling.
 
I really dont know. I guess I'll have to find out. There is no association of people affected by tinnitus. There is a tinnitus clinic in Buenos Aires, which I suppose will be interested in providing this treatment, if Neuromod wants to sell it worldwide.
In the worst case I will have to consider the possibility of traveling.
You should definitely contact them and notify them of this treatment. I'm sure they will jump on the ability to be the sole provider of the device in Argentina. It means more money for them and as we all know, money is what make the world go round. lol
 
Sorry but this is just not correct. It is purely for a study design perspective. Again this is a false distinction. And hearing loss is an exclusion criteria (large hearing loss).

About interpretations of "somatic": Well, you know more about this than I do, as you're a participant in Dr Shore's trials :) At the end of the day all that matters is that somatic people (however we interpret the word) are not left behind by Neuromod.

As for hearing loss: yes, profound hearing loss is an exclusion factor, but if you exclude all people with hearing loss from your tinnitus treatment, it's not going to find a very big audience... :)

Steve wrote: "The hypothesis is based around lack of auditory input - hearing loss and associated processing in the brain. The tinnitus tone or pitch does not affect the eligibility. The device is calibrated to your audiogram, which needs to be performed by the audiologist."

To me this sentence implies that it is actually a prerequisite in Neuromod's working hypothesis is that you have some degree of hearing loss.
 
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