MuteButton

How is that inconsistent?

@Steve reported "late this year OR early next year" and the news article said "next year."

The news article's "next year" is consistent with Steve's "early next year."

Obviously "next year" also covers "early next year." That's consistent enough for me.

 

That wasn't from Berthold, it was from the Neuromod team at the BTA Conference and Expo. There isn't a concrete date but this is what they are aiming for. I can only report what I hear (which in this case was direct from the team behind the product), and as @annV says it is consistent with the message so far.

The EU approval process may likely be the thing that brings uncertainty on an exact date.

 

For me this device is a possible “lifeline” for a somewhat back to a “normal” life if it works. Not just because of the tinnitus improvement but more so the possibility of improvement for us with hyperacusis.

I just don't want to feel pain from normal sounds.

 

The date is not important. It will not take a decade, we should just hope that it works.

 

I heard this from a medical assistant from Regensburg lab.

I do wonder how they now claim it does help.

Perhaps we have to wait for the results to be published.

Don't get me wrong, I would love to hear that the device works.

 

This is hearsay. It's not very helpful to anyone if things are presented as a fact when there is not any kind of verifiable basis, science isn't delivered in conversations over the garden fence.

I, and others who attended the BTA conference, have seen a presentation of the results direct from the lead at Regensburg, nothing has come out that suggests that it didn't work but they then changed their minds to say it does. There were three groups in the study so maybe this assistant was talking about one of the groups.

I agree that we need to wait for the results to be published, from this trial and also the US trial. This goes for all treatments - best to withhold judgement until the evidence is there and verifiable (even when the approach feels right).

 

https://www.neuromoddevices.com/con.../neuromod-mts-9-14-18-store-ul.pdf?1537955861

 

@Steve could you possibly go into a little more detail about this device and hyperacusis? And was it hyperacusis with pain?

 

I wish I could. The presentation unfortunately didn’t give any more detail other than hyperacusis.

 

The Neuromod device (MuteButton) is CE marked. For us in the EU this means that there is one less obstacle to get passed before it can come to market.

Our product is approved for sale within the European Union (CE marked) and is protected by a growing portfolio of issued and pending US, European and international patents.

 

326 patients participated in the trial and nobody came here to post their experience? I am wondering

 

If I understand this correctly,

There are 3 devices currently being worked on. There is this one, Minnesota and Susan Shore. What are the time line for the release of these devices? I remember reading, but cant confirm, that Susan Shore is shooting for 2024.

@Deamon22 I see that the results will be discussed on the 9th. That is exciting!

 

Yes, really exciting. I so hope this can help people who are struggling, and lower the actual volume to a more manageable level. But we‘ll see

 

From their Twitter:

 

I feel the hype train growing because they are insinuating that the device is a success AND they will be releasing the device at the end of this year or beginning of 2019. Seems too good to be true!

I am so optimistic, but nervous something will go wrong as usually does with these things....

 

Will this treatment ever come for trials in the U.S.? And if so, how can I become a part of it? I am located in Massachusetts.

 

There is a world of tinnitus sufferers but this doesn't mean that they all want to write about their experiences or suffering.

 

Previously trials did not really control people, however very recently they have been sure to tie people up with agreements so that they cannot go online and unblind the trial.

Unblinding from social media posting has been a big (and fairly recent) problem - placebo can find out they are placebo and treatment group can compare results of different methodologies. As you can imagine this has serious implications to the reliability of trial data.

 

Makes a lot of sense!

 

Aaah, I've just read the comments above more carefully and notice the MuteButton works on the Vagus Nerve. That's the main one that runs from the stomach up to the brain. I'll have to try this device once it gets to Australia.

 

The Susan Shore (University of Michigan) device, I thought, was aiming for 2020 production depending on how the late 2018 trial went. I could be wrong though...

 

I can't confirm this, but people on here have been discussing it being as late as 2024. @threefirefour knows more about the release dates than me.

 

One more day my friends... I can't stop thinking about this.

 

SAME, hopefully it's all a success.

 

I have such high hopes right now, but I am still trying to be reserved.

 

I feel the same way, I feel like it'll be a success! But let's try to be calm because if it's the opposite it'll be a major let down, so let's just go on about our day until tomorrow arrives!

 

I will try! I have been waiting for a proper treatment of tinnitus for so long it seems unreal that it may be in the near future.

 

Hi Steve,

Just back on here today after a long absence. Wow I am totally blown away that MuteButton II is on the horizon for launch soon and with bona fide double blind results as well.

When these guys launched MuteButton I it had zero evidence for efficacy and the science behind it was absolute rubbish.

In your opinion is this now in the realm of a genuine device? With actually confirmed efficacy?

I am in Ireland so excuse my excitement at the thoughts this could be released soon.

If it does indeed work there will be a big party in Dublin!

R

 

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