MuteButton

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#3,361
Paulmanlike said:
The info that has come out so far is that 80% or 2/3's reported clinically statistical improvement on subjective tinnitus and the pitch/tonality/atonality/centrality/laterality has not shown to influence results.
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This is one of the things that's really nagging at me about this thing. Mr. O'Neill trotted this line out several times in the Q&A without actually defining 'clinically significant'. I've read the pre-study paper on Neuromod's website and as far as I can gather they define 'clinical significance' as an improvement of 7 or more in your THI score. An improvement of 7, or 10 even, doesn't feel that significant to me - the natural fluctuation of the condition will move your THI score up & down by 10-15 points regularly.

Let's hope the actual improvement seen leans more towards the 'or more' bit.
 
#3,362
upload_2019-4-3_11-16-54.jpeg
 
#3,363
ruud1boy said:
This is one of the things that's really nagging at me about this thing. Mr. O'Neill trotted this line out several times in the Q&A without actually defining 'clinically significant'. I've read the pre-study paper on Neuromod's website and as far as I can gather they define 'clinical significance' as an improvement of 7 or more in your THI score. An improvement of 7, or 10 even, doesn't feel that significant to me - the natural fluctuation of the condition will move your THI score up & down by 10-15 points regularly.

Let's hope the actual improvement seen leans more towards the 'or more' bit.
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I'll get back to you later with my thoughts on this.
 
#3,364
I feel excited about this launch. Have you realized that at LEAST one thing with strong scientific support, vast trials will hit the market? Well, something is something! Will see if this helps or not, but at least then an ENT can tell you, "well based on x and y this treatment has scientific support and it may help you."

Let's keep supporting each other until Neuromod hits the market. I am saving money for it and at least will try it.
 
#3,366
Just keeping my fingers crossed it's not a Levo or Desyncra and becomes recognised as the 'gold standard' treatment for tinnitus. May be a bit far fetched but that's what I'm hoping for.
 
#3,367
It's been almost ten years in the pipeline. I mean are they not keen to generate revenue ASAP if they are ready?! Patience is not my virtue.
 
#3,368
ruud1boy said:
This is one of the things that's really nagging at me about this thing. Mr. O'Neill trotted this line out several times in the Q&A without actually defining 'clinically significant'. I've read the pre-study paper on Neuromod's website and as far as I can gather they define 'clinical significance' as an improvement of 7 or more in your THI score. An improvement of 7, or 10 even, doesn't feel that significant to me - the natural fluctuation of the condition will move your THI score up & down by 10-15 points regularly.

Let's hope the actual improvement seen leans more towards the 'or more' bit.
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I read that clinically significant improvement simply means that it has a beneficial effect on the patient's life. That's why so many of the testimonials are about the subjective quality of life benefits and not specific numbers going up or down.
 
#3,369
Please see my previous post. A highly regarded ENT doctor I recently saw said that Dr. Susan Shore's results were (so far) very encouraging. This could also apply to treatments with similar methodology.

We know that electrical Vagus Nerve Stimulation has been markedly beneficial for Epilepsy.

If the brain is a two billion cell electrical transmission device, perhaps this will be like providing a jump with cables (or at least rerouting the pathway of a habitual signal).
 
#3,370
Ger W said:
It's been almost ten years in the pipeline. I mean are they not keen to generate revenue ASAP if they are ready?! Patience is not my virtue.
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The product is ready, not necessarily the best method though, or the launch of it. Going off all data from TENT-A1 it is something that has shown promise for tinnitus. One out of 3 arms has shown the efficacy lasting up to 12 months that outperformed the others. The data from the TENT-A2 should all be collected and analysed in the next few months that has 9 arms. This will hopefully confirm the efficacy of TENT-A1. It may also give the researchers a better understanding of improving efficacy with it having 9 arms.

There is also waiting on the peer review to take place, that hopefully will confirm the quality of the studies and hopefully give reassurance to the doubters.

Then there is the whole partnership thing as it can't just be sold via the internet. An audiologist needs to configure the device based on your hearing profile.


Also - I might contact THE TINNITUS CLINIC in the U.K. They specialise in treating tinnitus with the latest gadgets and no doubt they have their eye on Neuromod. I bet they have been in touch with Neuromod to help sell the device.
 
#3,371
Ger W said:
It's been almost ten years in the pipeline. I mean are they not keen to generate revenue ASAP if they are ready?! Patience is not my virtue.
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I've been waiting for a viable treatment for over 25 years. Not making any assumptions here, but ever since I joined here I have encountered people who come across as if they are ticking suicide time-bombs with a short-fuse. Lack of patience and tinnitus are a poor combination. I know tinnitus can feel like trying to keep your head above water in choppy seas. It's not easy, but you can soldier on, especially if we're talking about the limited time horizon required to know whether Neuromod is our salvation or not.
 
#3,372
GlennS said:
I've been waiting for a viable treatment for over 25 years. Not making any assumptions here, but ever since I joined here I have encountered people who come across as if they are ticking suicide time-bombs with a short-fuse. Lack of patience and tinnitus are a poor combination. I know tinnitus can feel like trying to keep your head above water in choppy seas. It's not easy, but you can soldier on, especially if we're talking about the limited time horizon required to know whether Neuromod is our salvation or not.
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This limited time horizon is taking forever.
 
#3,373
As I said before, it feels as if the glaciers formed the Great Lakes at a faster rate than it is taking Medical Science to develop and release anything for this condition.
 
#3,375
I have a question about the Q&A. I could post it in the thread about that but I've got the feeling that attention has shifted to this thread.

Here goes.

The first question asked in the Q&A is why the device was pulled in 2015. The answer is 'because we wanted to focus resources on running more trials'.

Is that a satisfactory answer or is that just a way of avoiding having to say 'because it didn't work'? What do you guys think?
 
#3,376
SignalExec said:
I have a question about the Q&A. I could post it in the thread about that but I've got the feeling that attention has shifted to this thread.

Here goes.

The first question asked in the Q&A is why the device was pulled in 2015. The answer is 'because we wanted to focus resources on running more trials'.

Is that a satisfactory answer or is that just a way of avoiding having to say 'because it didn't work'? What do you guys think?
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There are many ways to read into that statement. I'm at the point where I don't care if the other device worked in 2015. I only care if the device from 2019 works.
 
#3,377
SignalExec said:
The first question asked in the Q&A is why the device was pulled in 2015. The answer is 'because we wanted to focus resources on running more trials'.
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It's an equivocation. They overpromised and the results were not all that, forcing them to go back to the drawing board. This is why the test results are key. There are only so many swings they can take at this before their credibility is shot.
 
#3,378
Bob Marley, I don't want to wait in vain for my love.

Oh my lovely MuteButton, your sensuous curves and seductive electronic pulses,
I yearn for you, to caress your your plastic and warm metal to my lips, to lick you, to lavish you as a lover should be seduced, letting go, losing control.

Quivering and quaking as you make sweet love to my ears.
Oh MuteButton, where art thou.

Please come... I yearn for you... my lovely, sweet, angelic, MuteButton.
 
#3,379
Is there any indication that the answer to this question was:

"Within this four year period here are a list of real innovative discoveries and improvements we have made that makes this truly much more effective than the original." (?)

And, can we see and review that enumerated list? Can it be posted on this site?
 
#3,380
Daniel Lion said:
Bob Marley, I don't want to wait in vain for my love.

Oh my lovely MuteButton, your sensuous curves and seductive electronic pulses,
I yearn for you, to caress your your plastic and warm metal to my lips, to lick you, to lavish you as a lover should be seduced, letting go, losing control.

Quivering and quaking as you make sweet love to my ears.
Oh MuteButton, where art thou.

Please come... I yearn for you... my lovely, sweet, angelic, MuteButton.
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:D

I fear strongly this lover will betray us though :/
 
#3,381
TheDanishGirl said:
:D

I fear strongly this lover will betray us though :/
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Yes... unrequited love... a mad teenage crush, or just an over the top romantic love... I share your feellings @TheDanishGirl.

When you've been around the" block", there are too many red flags to dismiss.

We will wait, we will see.

Stay strong, we have no choice.
Love to all.
 
#3,382
ruud1boy said:
This is one of the things that's really nagging at me about this thing. Mr. O'Neill trotted this line out several times in the Q&A without actually defining 'clinically significant'. I've read the pre-study paper on Neuromod's website and as far as I can gather they define 'clinical significance' as an improvement of 7 or more in your THI score. An improvement of 7, or 10 even, doesn't feel that significant to me - the natural fluctuation of the condition will move your THI score up & down by 10-15 points regularly.

Let's hope the actual improvement seen leans more towards the 'or more' bit.
Click to expand...
Significant is a measure of statistical reliability. That is all it is.
 
#3,383
Just a reminder. May 8, 2019 is the end of the opposition period for the trademark of the new device (MuteButton) or Lenire patent.

Hopefully relief is on the way.
 
#3,385
The device needs a patent so Neuromod can reap the profits. Only makes sense that they will not market the device till they have the exclusive rights.
 
#3,388
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