MuteButton

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#2,671
Paulmanlike said:
Well nothing else is in development and if it was, there are no large scale clinical trials to back it up.

Only other thing I see in the next 3-5 years is Shore's device.
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I've participated in trials where the device is more palatable and seems more effective.
 
#2,674
kelpiemsp said:
It was pulled because they hadn't done the full scale study required for med device approval, as well as limited resources at the time. No one wants to invest in something that isn't proven.
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In the US or EU? You do not need a full scale study for device approval in the EU til they apply the new rules in 2020 and even then it's only a requirement sometimes.
 
#2,675
Agrajag364 said:
In the US or EU? You do not need a full scale study for device approval in the EU til they apply the new rules in 2020 and even then it's only a requirement sometimes.
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I think it was so they could enter the US market. Would be impossible to redo study once it's already out in the EU.
 
#2,676
TimmyC said:
Well, that's kind of debatable though isn't it? If this device proves to be a big push forward for tinnitus, then I can imagine many other biotech companies wanting a piece of the pie. So who knows, maybe in the next 5 years we will have a plethora of tinnitus devices. So many companies are investing in medical tech, it's insane.
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...or someone just buys Neuromod. It's a pretty small company financially.
 
#2,679
Encountered one guy who didn't get relief from Neuromod on Facebook just now. He said he developed tinnitus from chemotherapy 8 years ago, apparently the Cisplatin in the chemo caused it.

He did say that it worked for some of the others he encountered and that it lowered or even stopped the ringing, but alas it didn't work for him. He did say he's pretty hard of hearing and has hearing aids.
 
#2,680
Drone Draper said:
Encountered one guy who didn't get relief from Neuromod on Facebook just now. He said he developed tinnitus from chemotherapy 8 years ago, apparently the Cisplatin in the chemo caused it.

He did say that it worked for some of the others he encountered and that it lowered or even stopped the ringing, but alas it didn't work for him. He did say he's pretty hard of hearing and has hearing aids.
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He could have been in the "control" group. We don't know.

Also the more hearing loss you have the less it works based on what they said. It was an exclusion factor.
 
#2,682
Drone Draper said:
Encountered one guy who didn't get relief from Neuromod on Facebook just now. He said he developed tinnitus from chemotherapy 8 years ago, apparently the Cisplatin in the chemo caused it.

He did say that it worked for some of the others he encountered and that it lowered or even stopped the ringing, but alas it didn't work for him. He did say he's pretty hard of hearing and has hearing aids.
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BAM placed that guy there to test our faith in false gods.
 
#2,688
Neuromod have updated their Twitter. It says they have presented their 326-patient trial and also confirmatory efficacy data in TENT-A2 (192 patients).

What we can assume here is they've had similar success with the TENT-A2 study.

What we don't know is if they've learned anything new from TENT-A2. One of their objectives for TENT-A2 was to explore different parameters for further improving efficacy.

I hope they've learned something new because as far as I know there are no further trials that I'm aware of, once the product is available, I guess we will be using the setting that has showed the most promise so far.
 
#2,689
Jack Straw said:
He could have been in the "control" group. We don't know.

Also the more hearing loss you have the less it works based on what they said. It was an exclusion factor.
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There was no control group for the Neuromod trials, all three arms were theorised to have a clinical effect, but he could've been one of the arms that had a smaller effect.
 
#2,690
TimmyC said:
Let's hope Johnson & Johnson buys them lol.
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Johnson and Johnson have repeatedly demonstrated that they don't give a tiny shit if any of their devices cause mass harm. They know the costs of litigating around that harm or the fines they might receive for doing things like shredding documentation relating to their knowledge of excessive harm are going to be dwarfed by the profits they make. If a large company like Medtronic or Johnson and Johnson made MuteButton I would be running a mile. I am encouraged by the fact that it is a small start-up.
 
#2,691
I halfway would like Apple to buy it, because then it'd be available everywhere, and maybe even integrated with one of their phones eventually. Hell, their products were probably the tool that many of us gave ourselves tinnitus with, it'd be good to offer a solution, lol. But then it'd end up with a higher markup, I'm sure.
 
#2,692
Agrajag364 said:
There was no control group for the Neuromod trials, all three arms were theorised to have a clinical effect, but he could've been one of the arms that had a smaller effect.
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That's what I meant by "control" group.
 
#2,693
Drone Draper said:
Encountered one guy who didn't get relief from Neuromod on Facebook just now. He said he developed tinnitus from chemotherapy 8 years ago, apparently the Cisplatin in the chemo caused it.

He did say that it worked for some of the others he encountered and that it lowered or even stopped the ringing, but alas it didn't work for him. He did say he's pretty hard of hearing and has hearing aids.
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The other two people that Clare B ran into were also older and much more hard of hearing. I'm seeing a trend here. I have a feeling that your hearing ability plays a big part.

People with hyperacusis (like myself) have almost super sonic hearing (exaggerating of course lol), I can hear things that most people cannot now, so it makes sense that the hyperacusis group had huge success. People who are older and naturally are much more hard of hearing are less likely to be affected. Again, this is just my speculation, but it makes sense.
 
#2,694
Agrajag364 said:
Johnson and Johnson have repeatedly demonstrated that they don't give a tiny shit if any of their devices cause mass harm. They know the costs of litigating around that harm or the fines they might receive for doing things like shredding documentation relating to their knowledge of excessive harm are going to be dwarfed by the profits they make. If a large company like Medtronic or Johnson and Johnson made MuteButton I would be running a mile. I am encouraged by the fact that it is a small start-up.
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The Johnson and Johnson was more of a joke lol, I forgot joking can be tough here. Sometimes laughing helps me cover up the pain.
 
#2,696
Jack Straw said:
He could have been in the "control" group. We don't know.

Also the more hearing loss you have the less it works based on what they said. It was an exclusion factor.
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I thought that it's only the profoundly deaf people who it doesn't work for?

My right ear which has t has a couple of mild dips i hope it will get rid of my tinnitus. My t is mild but it would be great if i could get rid of it.
 
#2,697
TimmyC said:
The other two people that Clare B ran into were also older and much more hard of hearing. I'm seeing a trend here. I have a feeling that your hearing ability plays a big part.
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They've already said the level of hearing loss is important. I wonder how large of a (measurable) hearing loss you can have and still get the benefits of Neuromod. Hopefully they will make that clear before the product launches with the second study. The guy I spoke to said he can understand people 1 on 1 ok, but struggles with speech in crowds. In his words "a disaster". I don't quite know how large his hearing loss is, I did ask. It's a shame it didn't work for him. Nobody should have to struggle with this nonsense.
 
#2,698
The exclusion criteria was no more than 40 dB loss up to 2 kHz (or might have been 1) and no more than 80 db loss between 2-8 kHz.

So they included people with quite a bit of loss in there...

Also, if this happens to be the case, where the more hard of hearing you are, the worse the efficacy is, who knows, integrating it with a hearing aid may be a solution.

It makes sense though, how can you stimulate all the frequencies if you have lots of loss in those particular frequencies.
 
#2,699
Paulmanlike said:
The exclusion criteria was no more than 40 dB loss up to 2 kHz (or might have been 1) and no more than 80 db loss between 2-8 kHz.

So they included people with quite a bit of loss in there...

Also, if this happens to be the case, where the more hard of hearing you are, the worse the efficacy is, who knows, integrating it with a hearing aid may be a solution.

It makes sense though, how can you stimulate all the frequencies if you have lots of loss in those particular frequencies.
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I agree. I'm very curious why the hyperacusis people had such a good rate of success (90% I believe) and the hearing ability makes the most sense. Even if Neuromod isn't a grand slam (although I think this kind of tech will be), their research is going to shed a ton of light on tinnitus and hyperacusis. So here's hoping.
 
#2,700
TimmyC said:
The Johnson and Johnson was more of a joke lol, I forgot joking can be tough here. Sometimes laughing helps me cover up the pain.
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Were you making the joke because of Johnson and Johnson's bad reputation? If so good day for exposure of bad practice by device companies.
 
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