MuteButton
- Thread starter Jim
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Member- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
Drone Draper
Member
Think it'll be September in all European markets? Isn't September the confirmed Belgian date?
Why would they change their name after doing all the work under Neuromod or would it just be the device's name, like Apple has the iPod?
Drone Draper
Member
Well, didn't it use to be called MuteButton? Lenire is not as good of a name. I think MuteButton is better, but they probably want to distance themselves from it if they changed the first iteration.
If you are right - and you very well may be - I just don't understand why they can't just be straight with us. First they said January 2019 (see below), then they give a half-baked no-info statement to Markku (below). Delays can be understandable but can't they at least be straight with us? We're not waiting for a new flavor of ice cream - some of us are nearly dead!
(quoting Neuromod)
- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
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Yes. Because no doubt they will explore other indications with neuromodulation which they can sell under Neuromod. Fair play to them, for their first indication they targeted a highly complex condition with only theory to suggest why tinnitus happens.
Extremely risky business. But with that risk comes great reward if the treatment works for a vast majority as the trials have indicated so far.
I would state though as I have done previously tinnitus is highly subjective, so it's biased and there's no objective way of measuring it.
I remain cautiously optimistic but not holding my breath.
Drone Draper
Member
- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
As far as I understand it, a trademark is just that of a name (Lenire or whatever it is) and the opposition is those who don't want it labelled under that name for whatever reason. Perhaps somebody can clarify this?
Perhaps we can communicate with the company with the findings, and hopefully they can give us a bit more info for a timeline.
Without sounding pushy, this isn't a new game, it could very well stop somebody from committing suicide.
Drone Draper
Member
This is one of the most frustrating things about tinnitus. If you want to use THI to measure results, what's to say the person didn't just habituate to what they have and the tones have not in fact changed one iota?
Drone Draper
Member
Guys I am really in bad condition. Suicide has been an option for me for the past several months.
Therefore I see Neuromod as a life rescuer - if it works for me... and hopefully for you too.
It's so hard to stay positive and keep hope if you suffer so extremely each day. This is my last option...
Therefore I see Neuromod as a life rescuer - if it works for me... and hopefully for you too.
It's so hard to stay positive and keep hope if you suffer so extremely each day. This is my last option...
It might be sooner because they said they were actively looking for FDA approval in 2018.
- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
Exactly, I've been suicidal and I've at times been relaxed. I've had good days and I've had bad days. It's a bit like a depression or anxiety scale from 1 to 10. It is going to change throughout time.
The only measure I see as a true indicator is MML or some other measure that a patient can report an actual decrease in the volume and if it has been sustained. I am highly questionable of these trials that state 80% improvement. People need to know that this was the case few years ago with the Acoustic CR neuromodulation. They are very difficult studies to draw real conclusions from. Then there's the placebo effect. Of course we don't know much of the trials because they haven't been published yet, but hopefully those who want we can work to dissect all the information.
The sooner the thing is out, the quicker the real evidence base will (or won't) build up and I can make an informed decision whether to go through with it or not.
What people seem to forget is that in these trials there are different groups. They use the groups to test the efficacy of the product.
It is usually a placebo and drug group. We know that Neuromod didn't have a placebo group but a treatment group and a sort of placebo. These people posting that it didn't work for them very well may be in the false treatment group. The fact it didn't work for them literally means nothing. They could also have profound hearing loss or somatic tinnitus which Neuromod has already said can affect the treatment.
It is usually a placebo and drug group. We know that Neuromod didn't have a placebo group but a treatment group and a sort of placebo. These people posting that it didn't work for them very well may be in the false treatment group. The fact it didn't work for them literally means nothing. They could also have profound hearing loss or somatic tinnitus which Neuromod has already said can affect the treatment.
Drone Draper
Member
Is that right? Boy, I would be annoyed if I found out I was in the placebo device group after the fact.
"I listened to R2D2 frying bacon with a USB clip on my tongue for three months for nothing?"
"I listened to R2D2 frying bacon with a USB clip on my tongue for three months for nothing?"
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OK, I am confused. Neuromod submitted this in Nov 2018? Do we know for a fact this is the product?
The reason I ask is that the trademark timeline and gating would have put them way out to Q3 and Q4. So basically during the interview they would have known it was Q3 or Q4 and NOT Q1. Seems like this is a standard process where they would have known it was NOT Q1.
The reason I ask is that the trademark timeline and gating would have put them way out to Q3 and Q4. So basically during the interview they would have known it was Q3 or Q4 and NOT Q1. Seems like this is a standard process where they would have known it was NOT Q1.
- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
Jack if you looked at the criteria those with a hearing loss over a specific amount were excluded; as I think I recall somatic was excluded. There was no placebo, only different arms.
The fact is tinnitus has no focal point, it appears in different areas of the brain all contributing to it. Nobody can say this treatment will work for you even if you meet the criteria. That's the reality of it. The people who said it didn't work for them should not be ignored. We need to be realistic.
The different arms had different levels of efficacy. So this means they could have been in the less efficacious (placebo) group.
Also, people lie all the time to get into the experimental trials. If they told me they aren't accepting people who have 5+ years of tinnitus (I have had it all my life) I would lie and say it was for 3 years just to get in.
Lastly, this product doesn't work for 20% of people. The people who it helps most likely move on with their life. The people who don't stick around and post on forums. Same with other drugs that help with other illnesses.
You forget that we have had another forum member post here saying it worked for them.
There is a tried-and-tested way to measure the patient's perception of tinnitus in decibels (i.e. loudness). This is regularly done in many tinnitus treatment trials. Perception is reality: it's what matters to your body/brain/well being.
Hang in there, man. Even if the new info is correct and Lenire won't be released before June, that's still only a matter of months. Short enough to take benzos every single day if you have to - still much better than killing yourself. I deeply understand and sympathize with your pain, but with real hope on the horizon, please do everything you can to hang on just a bit longer.
The way I look at it: given the numbers, the testimonials, the forum members that stated success: it's impossible for this thing to do nothing. As per the Talmud says, save one life, save the world entire. And given the numbers, either they are lying, or a shitload of people have been helped immensely thus far. This thing is doing something well. It won't be 100%, but it most likely has already been a life saver. So I'm looking at the whole enterprise optimistically.
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- Apr 15, 2017
- 1,419
- Tinnitus Since
- 2008
- Cause of Tinnitus
- Noise
Just trying to stay positive Jack, it's hard when I've followed so many potential treatments that all ended in disappointment. I hope this one is the one and 2019 is the year we get relief.
Drone Draper
Member
Absolutely. I don't want to drink the Neuromod Kool-Aid, but if their initial trials didn't have the numbers behind them that they do, I don't think they would want to bring the product to market, but of course they already did bring out a previous iteration. I think a wait and see approach is right for most.
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