MuteButton

I know there is a lot of logistics to something like this, but it would be awesome if Tinnitus Talk could help make something like this a reality. I know there is like a million moving parts to this and a lot harder to implement than we think, but it is a good idea.

I would be happy to help fellow Tinnitus Talk members who are not able to afford the devices financially.

 

No dude, Decibel Therapeutics. Not Susan Shore.

 

@JohnAdams the peer review and publishing system is a complete joke unfortunately.

It can often take a year at least to get published. The system is slow.

It’s an academia problem rather than a Neuromod problem. It really holds research back because we don’t get to see things until a way after they are ready to be shared.

 

My wife works in "academia" and processes library loans and manages database subscriptions. She has shown me that one of the biggest obsessions in academic research right now involves gender studies and sexuality.

Because believing you have the wrong organ between your legs has a higher research priority than debilitating diseases.

Also many professors sit around on Facebook all day and complain about politics.

 

No option then but to purchase it in advance - Which works for the Company - But they'll be getting a lot of the machines back if it doesn't work - They will sell very few if it doesn't work to be honest...

It's a good idea and the head guy old Ross is a good man as is the Consultant from the Hermitage - They have to be genuine as they will lose their shirts if it does nothing. They are selling to one of the most informed and skeptical BS hating sections of society. It's no easy sell even though folk are desperate...

 

I have access, because of my wife, to a medical college's online subscription based databases. I'll look and see if I cant get my hands on this research myself. Just knowing if it works will give many of us what we very clearly deserve, hope. There are people on this site daily contemplating suicide and they need and deserve assurance. Especially considering that there will be profits made off of their horrible suffering. Idgaf I havent signed anything and I utterly despise secrets.

 

That's right - The Andromeda Galaxy is heading our way - The threat of Radical Extremism and a senseless 3rd world war have never been closer and we're worried about our feelings and how we can avoid being offended...

To quote Jimmy Carr

"My First wife Died...
Yes she was from Thailand...
It's not a laughing matter
She died...
Of testicular cancer"

Anyone offended

Right I'm off to bed. Meeting Ross O'Neill for a few pints tomorrow and trying out the new MuteButton so need to be fresh as a daisy

 

Well, if it doesn't work they have bankruptcy laws and they will surely be able to find other lucrative opportunities. The emphasis should be on helping people first.

 

I personally see very positive outcomes from the peer review research process. What we don’t see is that during the peer review process the authors are given input into the paper and a chance to explain things in a more clear manner before it gets pushed out worldwide. Having another set of eyes review your work and give positive or negative feedback makes for a much stronger paper.

For what it’s worth, I don’t think the sales channel and FDA (or whatever the Irish equivalent is) has to wait for these results to be published.

 

Fell for this for about 10 seconds. lol

 

Looks like I am headed to Ireland if this is released there first. It was on my list of places to go anyhow. WIN WIN.

 

On what point do you disagree?

Being a tinnitus sufferer now, AND being in the medical device world for a long time, I don't care for long waits and peer review either. However, data validation needs to occur before submission for approval depending on the avenue you are pursuing.

In the implantable device world, you needed that peer review to get the IDE (Investigational Device Exemption) from the FDA to proceed with writing the trial and submitting the protocol for approval. I'm not sure where they are in that process, and I am not familiar with how CE mark is granted.

I'm also not familiar with how their field of medicine works in the submission process. They all generally follow a similar protocol, but yes, resources ($) could come into play. Respected journals do expect their authors to be compensated, but honestly, in my experience it wasn't that much. I had clients do peer review on journal submissions to JACC for as little as $5K. Certainly won't break the bank of even a small biotech company. Again, I can only speculate and not speak from any experience in this particular field.

The reason you need data validation, whether you are in the Western hemisphere or anywhere else, is to avoid the very thing that plagues tinnitus sufferers right now; un-validated, sham, gimmicks, and treatments. I don't see the fault in that.

Some of the difficulty here is the subjective nature of the disease. The more subjective the measure, the more difficulty in quantifying your primary endpoints. How is volume of tinnitus quantified from something that really isn't a sound? This, I'm sure, plagues study authors and researchers. So, they are left with, again, subjective surveys and questionnaires. They are getting better, but they are very analogous to QOL surveys with cardiac patients. Sometimes they were helpful in attaining the primary endpoints, sometimes they were not.

Anyway, we all want the same thing; a valid device, drug, therapy, etc. that will help us suffer less, and hopefully stop us from suffering entirely.

 

Save me a seat. I'm with you on that one. Bucket list to taste some great whiskey there too.

 

+1, Exactly...

 

There's better things than the Whiskey over here now. The whole craft beer industry has taken off and it's bloody awesome!

 

Beer!? Where?

 

This is very old news bruh.

 

They don't stop presenting positive data, but we don't know anything for now.

 

Tell them to stop talking and get moving.

Yeah half joking, I know how these things work.

 

What data?

 

I'll have something hopefully on Monday as an update. They are going to look at what information they are able to share without compromising the peer review process and also look to program in a date for a Q&A.

 

You have made my day!!!!!

 

Exactly, there could be new updated information about tinnitus, hyperacusis by researchers and it won't be published until another 2-3 years.

 

Super excited

 

The only question is what is different with the apparatus in this phase compared to the previous one.

The previous one to my knowledge did not have even 1 positive anecdote.

As time is moving on I am afraid I am waning on this one.

I started out optimistic as the results seemed positive but as time moves on it is phase I all over again.

Also how come Susan Shore needs to jump through all these hoops and MuteButton has already released a device to market... It doesn't make sense.

 

I have a question for anyone who has read more than I have about this stuff. I’m sorry if this has already been covered in this forum.

What are the differences/similarities between the University of Michigan device and the Neuromod device.

It seems to me that the Neuromod device is closer to market than the University of Michigan device.

I’ve read that the Neuromod device could enter European market within the year.

Medtech Strategist from September 14, 2018 has a decent article.

 

When I was working in the implantable device world, we always got our latest/greatest tech approved in the European markets (CE Mark and Approval) first because the process was far less stringent than the FDA's PMA approval. The FDA is so underfunded and understaffed that I'm amazed they get any drug or device to market. I was never directly involved in a CE mark device, but I think the bar is just not set as high because they are more realistic about what they can and cannot do given budget constraints... If the device was basically safe, you'd get the go ahead. If it did what it was alleged to do in the trials??? Maybe not so much...

It's hard not to get excited about something that brings one hope. Maybe something good will come of it, even if it's just another stepping stone to a valid treatment.

 

I think this is the difference between an academic project and a commercial project. The former gets funding and a budget so it inevitably will last for the length of the funding period - they wouldn't normally cut short a student's PhD or forgo department funding to launch a device. Obviously with commercial they are looking to go to market as soon as they can, for the ROI.

That is something for us to ask in a Q&A.

 

If that is seriously a consideration to delay helping people in very serious need that are suffering then these are some truly evil people.