MemberAgree, unfortunately too many medicines fail efficacy trials. I need to wait and see what the data says, then if the data says it works then shout from the rooftops.
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- Thread starter threefirefour
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This is a very tricky subject regarding NIHL and tinnitus.
I think @Contrast is right in this sense.
There has also been some talk from researchers who say that not everyone gets tinnitus with NIHL because the brain has its a mechanism to block these phantom sounds on its own. People like us who's brains for whatever reason don't block these phantom sounds, get tinnitus. My dad has NIHL, but doesn't have tinnitus. I have NIHL and have tinnitus and so did my grandfather. I believe it to be a genetic predisposition for the brain, for whatever reason, to just not block these phantom sounds when noise induced hearing loss happens. This is similar to people who has phantom pain or feeling in phantom limbs. Not everyone gets this sensation, but there are those who do. I truly believe that it is due to the lack of input to the brain, so the brain creates it itself, but for whatever reason the brain also doesn't block it out for some like others. If we restore the input, the brain won't create the sound and it won't matter if it can block the phantom sounds.
Please remember I am an idiot so take what I say with skepticism. I am trying to find the video I watched where the researchers were discussing the brain's natural ability to block phantom sounds and how it is missing with people who have tinnitus. Ill post it here when I find it.
I think @Contrast is right in this sense.
There has also been some talk from researchers who say that not everyone gets tinnitus with NIHL because the brain has its a mechanism to block these phantom sounds on its own. People like us who's brains for whatever reason don't block these phantom sounds, get tinnitus. My dad has NIHL, but doesn't have tinnitus. I have NIHL and have tinnitus and so did my grandfather. I believe it to be a genetic predisposition for the brain, for whatever reason, to just not block these phantom sounds when noise induced hearing loss happens. This is similar to people who has phantom pain or feeling in phantom limbs. Not everyone gets this sensation, but there are those who do. I truly believe that it is due to the lack of input to the brain, so the brain creates it itself, but for whatever reason the brain also doesn't block it out for some like others. If we restore the input, the brain won't create the sound and it won't matter if it can block the phantom sounds.
Please remember I am an idiot so take what I say with skepticism. I am trying to find the video I watched where the researchers were discussing the brain's natural ability to block phantom sounds and how it is missing with people who have tinnitus. Ill post it here when I find it.
Occam's razor is what lead me to the conclusion that treating sensori-neural hearing loss should treat tinnitus.
Look at this guys.
The device is ready to be sold in Europe, but they are awaiting for their results to be peer reviewed before they release it so it can legitimize it. They said they want peer review to end by mid 2019, so that could mean end of 2019 this thing goes to market.
The device is ready to be sold in Europe, but they are awaiting for their results to be peer reviewed before they release it so it can legitimize it. They said they want peer review to end by mid 2019, so that could mean end of 2019 this thing goes to market.
Not sure Occam's Razor should always apply in biology, cause we previously know that there are so many factors that could very reasonably affect organic state.
But I think I still agree with it in this case.
And either way T reduction with HA use evidences the point here.
Is there an error in the penultimate sentence in the middle paragraph? Shouldn't it read "...but most people with tinnitus have hearing loss." - ?
- May 29, 2018
- 1,161
- Tinnitus Since
- 10/2017
- Cause of Tinnitus
- Neck/stress
No mention though of how it's 'sold'. Be great if it just comes from them to us. But no doubt you have to go through approved audiologist dealers and they'll want to see you 3 or 4 times as part of the 'golden care package' and that will cost an additional 3k.
FounderA few years back, before they pulled the device from market, the consultation was €300:
https://www.tinnitustalk.com/posts/380601/
With the trial they've now done and the costs it's obviously incurred, I wouldn't be surprised either if it was more expensive. My estimate (for total cost incl. the consultation fee) is €3000 - 4000.
We'll see. We'll be sure to ask about pricing for the Q&A - hopefully they can by then say an approximate number... @Steve
Do you guys ever notice how much conflicting info is on here from posters?
I have been looking at threads about headphones and there is just shit all over the place. Majority of it is mainly using anecdotal evidence since there is no scientific information on it, but still.
Anyone else have thoughts on over-ear open-back headphones?
I have been looking at threads about headphones and there is just shit all over the place. Majority of it is mainly using anecdotal evidence since there is no scientific information on it, but still.
Anyone else have thoughts on over-ear open-back headphones?
Why can't the human cochlea be regenerative it's so unfair, I wish we regenerated cochleas like fish. Why do fish need to hear anyways smh
I dont see how keyzilen(am101) is in anyway comparable to fx322 in any way shape or form. Plus my point is that this current trial for fx322 is only officially measuring safety. They will have efficacy data. I'm just saying that people are
SUFFERING HORRIFICALLY
They are prisoners in their homes
They have lost their relationships
They have lost their jobs
They want to die
They really want to live
There are some arbitrary aspects of government regulations that make sense in some situations but not others.
We have the American Tinnitus Association
We have Captain Kirk.
I'm saying that the ATA could easily reach out to the FDA with a phone call or an email and plead for them to cut some of the red tape for this drug. And at the end of the day FrequencyTx may not even want to go any faster and we are at square one. I'm not even saying we should push right now. the data will be there by December. Seriously why not? I cannot understand one good reason why we cant ask the ATA to send Captain Kirk to the FDA and FrequencyTX and ask them to work out a deal to go ahead and test this on tinnitus sufferers, so long as the December data points point towards success.
- May 29, 2018
- 1,161
- Tinnitus Since
- 10/2017
- Cause of Tinnitus
- Neck/stress
I really agree with John. I am probably the worst example of what tinnitus can do to someone in the prime to their life who was previously very productive and happy. The BTA and ATA should be all about fast tracking potential treatments with the utmost urgency.
I would say DannyBoy is a prime example. May God give his soul rest.
You're still alive brother.
Just give the ATA a call.
1-800-634-8978.
Be very professional, even if they make ignorant statements or disagree. Professionalism is key here. Besides we don't hate these people. Just explain to them that they ought to be ready to call Jeff Karp or Will Mclean either now or in December and ask them how the trial went. They can easily sign NDAs and keep everything legal. If things point towards success then they can contact the FDA and advocate for the poor souls suffering horrifically from tinnitus. We can also write our Congressional representatives. We can do this. We should at least try. How much money have we all collectively spent on supplements? How much effort have we all put into just trying to sleep? Start threads about this short of professional activism, spread it on facebook, tell your friends. E-mail the Wounded Warrior Project. Reach out to the leaders of this site and the BTA.
I am interested in one good reason as to why we shouldn't. Ver interested.
- May 29, 2018
- 1,161
- Tinnitus Since
- 10/2017
- Cause of Tinnitus
- Neck/stress
I think we do need some sort of nod from someone that they can actually 'cure' to a greater or lesser extent T before we push hard to get hold of whatever it is.
It's a shame that all these drugs - I signed up for a trail for one today - seems so focused on hearing loss when as far as I'm aware being moderately deaf never turned anyone's life in to a living hell. It's as if T is just an insignificant side effect.
We won't get the nod. The trials are very expensive and they are primarily focused on hearing loss. This is my whole point. They will know soon, but won't release that info as it is not part of their trial endpoints. I am saying we need to get the FDA to cut the red tape and let them hurry up and find out if it can cure tinnitus without having to go through the normal, prolonged process because this is a hidden national health crisis. Besides, it is safe. There is not one good reason for them not to be allowed to do a sub trial for tinnitus starting early next year. Not one good reason. It's this easy, take someone, like you, with bad T and let them inject both your ears with it. Wait months, and then you say whether or not it worked. No control group needed. Then try it again on another T sufferer and ask if it works.
If you were born deaf then you don't have a mapping for that input. When you could hear your whole life then lose your hearing, your brain wants that input and cannot get it.
- May 29, 2018
- 1,161
- Tinnitus Since
- 10/2017
- Cause of Tinnitus
- Neck/stress
Well I will push - and lie- to get in this trial next year and if it works I will make sure everyone gets it ASAP.
Kain
Member
- Aug 25, 2018
- 365
- 26
- Tinnitus Since
- March, 2018
- Cause of Tinnitus
- excessive loud music through earbuds
I sincerely believe that if it restores lost brain input it will bring everything back into balance.
Kain
Member
- Aug 25, 2018
- 365
- 26
- Tinnitus Since
- March, 2018
- Cause of Tinnitus
- excessive loud music through earbuds
They are all drugs? I'm referring to their efficacy, not their mechanisms. All I'm saying is to not get carried away during the safety phase; remember, they are only testing 24 people.
The real test starts at phase IIa when they will look at its efficacy over a larger number of people. I remember reading that only 30% of drugs that are tested pass this phase, and this is averaged over many years. Some years have been as low as 18%.
You need to hold off lobbying governments until we know more about it. Frequency Therapeutics themselves don't even know if it's any good at this stage as it's far too early to tell. I understand where your enthusiasm is coming from, but you need to put it all into perspective. If the data is great then you can start lobbying. However, I'm not entirely sure what can be done to fast track it. The pharmaceutical world moves very slowly.
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