Not sure if they will be doing clinical trials in Japan or anywhere else in the world.Doesn't Japan have some expedited drug approval process?
They definitely will be doing clinical trials outside the US as Europe trials result in Frequency Therapeutics getting their payment from Astellas.Not sure if they will be doing clinical trials in Japan or anywhere else in the world.
Maybe they could just use USA clinical trials data instead of having to conduct their own clinical trials to get FX-322 approved in those countries. I hope this is the case.
I understand what you're saying but multiple times here people have said this won't be the end all be all for tinnitus sufferers.I think some people here should be more humble.
I have tinnitus and no acoustic trauma, and no hearing loss in the frequency of my tinnitus.
One of my tinnitus sound is moving from 600 Hz to 800 Hz like a wind whistling.
So what, my hearing loss is moving now too? What's your explanation on that?
And how come my tinnitus wasn't brought on by any acoustic trauma?
It's not as simple as having hearing loss.
Some people experience pain even though they have nothing hurting them, so to paraphrase you "I don't know why it's such a difficult concept to understand"
Oh and what about visual snow? Is it because people have eye trauma?
Tinnitus doesn't always come from outside sources, it can come from within the brain.
Be humble when you speak please.
The cure will be out soon. I have a good feeling that FX-322 will pass their clinical trials and should be able to help most of us. There has never been a drug before that regrows hair cells and synapses before FX-322.I understand what you're saying but multiple times here people have said this won't be the end all be all for tinnitus sufferers.
There are over 400 pages of us having discussions, doing research, interviewing researchers, etc. I think it's a little tone deaf to assume that people here aren't humble. I was here when there was little to no hope, then progressively we've received more and more good news. There are people here who have put in countless hours doing their due diligence and never lying to people about what could happen as a result.
You're welcome to look through the hundreds of pages where we've discussed this time and time again. People here just have a little more hope or at least they're trying their best too and for good reason. We should be receiving more information progressively and hopefully it'll be good news.
I hope this answer helps
No one is saying all tinnitus is from cochlear damage/hearing loss but rather anything that interferes with hearing can cause tinnitus.I think some people here should be more humble.
I have tinnitus and no acoustic trauma, and no hearing loss in the frequency of my tinnitus.
One of my tinnitus sound is moving from 600 Hz to 800 Hz like a wind whistling.
So what, my hearing loss is moving now too? What's your explanation on that?
And how come my tinnitus wasn't brought on by any acoustic trauma?
It's not as simple as having hearing loss.
Some people experience pain even though they have nothing hurting them, so to paraphrase you "I don't know why it's such a difficult concept to understand"
Oh and what about visual snow? Is it because people have eye trauma?
Tinnitus doesn't always come from outside sources, it can come from within the brain.
Be humble when you speak please.
We're dealing with conditions that are highly complex, variable, and just beginning to be understood (by experts). People try to make things less scary by simplifying the issues in their own minds. Theories become facts, the most obvious possible etiology becomes the only possibly etiology. That may come across as arrogance. It's probably not. Keep that in mind when you browse the forums. Maintain a bit of healthy separation from the daily grind of it. Take away what makes sense to you. Remember that there are people out there with very big brains who progress the science on this stuff every day. There is definitely reason for hope for all of us.Be humble when you speak please.
You're in my head, I was thinking just that.On average, how many people with SNHL have tinnitus?
There was no official reporting on tinnitus because it wasn't even an element of the Phase 1/2 trial. There were anecdotal accounts about tinnitus however from participants which indicated they experienced an improvement in it.How many people noticed a change in their tinnitus during the last clinical trial phase? On average, how many people with SNHL have tinnitus?
What if 4/15 noticed substantial improvements in their hearing, while only 10 of them actually had tinnitus. Wouldn't that be important to think about? Maybe you've already talked about this. I'm just a little too far gone to go back 40+ pages.
EDIT: I randomly looked it up. The first thing I saw said only around 30% of people with hearing loss have tinnitus.
Thank you! I can understand why people on this thread are excited for the results.There was no official reporting on tinnitus because it wasn't even an element of the Phase 1/2 trial. There were anecdotal accounts about tinnitus however from participants which indicated they experienced an improvement in it.
Tinnitus will be discussed in the outcomes maybe as part of the 90 day read-out or as full results are released in July.
You can also have no hearing loss, but still have tinnitus caused by other factors. From what I can observe this doesn't mean that this then is something more complicated necessarily but rather it is possibly caused by something other than just sudden hearing loss for example.You're in my head, I was thinking just that.
Does everyone with sudden hearing loss have tinnitus? You already know that you can have hearing loss and not have tinnitus, that suggests that it is something more complicated.
I think that the other thing that should be mentioned is that it is only for the group that was deemed statistically significant.Thank you! I can understand why people on this thread are excited for the results.
30% is a solid percentage of any group and if they found it important enough to mention, then there's a good reason to push optimism through March/July.
Yeah this should be explored. If they can get approval in Japan quicker than in the US I'm sure many of us will gladly travel overseas and pay quite a bit of money for the therapy.Not sure if they will be doing clinical trials in Japan or anywhere else in the world.
Maybe they could just use USA clinical trials data instead of having to conduct their own clinical trials to get FX-322 approved in those countries. I hope this is the case.
I actually recall a study from a while ago, I'm trying to find it, but it must be on my old computer. It showed audiograms (normal + HF) of various age groups, 18-29, 30-39, 40-49, up to 80s. And it also identified a YES/NO for folks who complained of tinnitus. They provided an average audiogram + HF for the YES/NO tinnitus group. Just for fun, I graphed the points to better understand the data, which I did save:You can also have no hearing loss, but still have tinnitus caused by other factors. From what I can observe this doesn't mean that this then is something more complicated necessarily but rather it is possibly caused by something other than just sudden hearing loss for example.
Examples include the fact that people have tinnitus possibly due to synaptic issues for example.
If Japan got it before the U.S. did, I'd be there faster than the flash, Usain Bolt, Superman, and Nightcrawler combined.Yeah this should be explored. If they can get approval in Japan quicker than in the US I'm sure many of us will gladly travel overseas and pay quite a bit of money for the therapy.
Not sure how that would affect their business model though, unfortunately this isn't a charity.
Yes, near the end of May for up to Day 210 results. We get results up to Day 90 at the beginning of April.The full readout is in May, not July. Right?
If FX-322 caused a worsening in hyperacusis or noxacusis, they would have certainly suspended one of the trials by now. That type of outcome would certainly fall into an adverse event category.Has there been any deeper discussion whether the restoring of hair cells and synapses could potentially worsen hyperacusis/noxacusis? What are the arguments for/against?
Noxacusis involves different synapses (type 2 afferent neurons, which are pain fibers, and their synapses on the OHC). I don't see how this drug would make that worse, personally.Has there been any deeper discussion whether the restoring of hair cells and synapses could potentially worsen hyperacusis/noxacusis? What are the arguments for/against?
I love "just for fun" graphs. Subscribe.I actually recall a study from a while ago, I'm trying to find it, but it must be on my old computer. It showed audiograms (normal + HF) of various age groups, 18-29, 30-39, 40-49, up to 80s. And it also identified a YES/NO for folks who complained of tinnitus. They provided an average audiogram + HF for the YES/NO tinnitus group. Just for fun, I graphed the points to better understand the data, which I did save:
View attachment 42284
Vertical axis = Average threshold for the entire group. Horizontal = Audiogram tone tested.
One take-away I had was that it was obvious that the group that had reported having tinnitus had a steeper negative slope as their hearing was tested along the audiogram, and at least 10 dB more loss than the non-tinnitus group.
This is why I think that FX-322 restoring even partial signal for those experiencing tinnitus, just to get them up maybe 10-20 dB on the audiogram per frequency band might be enough to start resolving it. We know from the Phase 1/2, that at the edge of the testing scale, a few patients saw a 10-15 dB improvement at 8 kHz. If their audiograms looked anything like the one above, from 8 kHz + where they saw a 10-15 dB improvement, it might put them into a non-tinnitus range.
How would it work for other countries outside the USA? Would Astellas Pharma contact countries outside USA once their trials are done and apply to get FX-322 approved in those countries?If Japan got it before the U.S. did, I'd be there faster than the flash, Usain Bolt, Superman, and Nightcrawler combined.
Yes. It varies a bit by country, but generally there is a "Drug Approval" process for each region or country. Most, if not all, at this point accept US-FDA Approved trial data for their applications. Some countries' drug-regulating entities require at least part of the trial be conducted on their soil; so Astellas may have to strategically position some Phase 3 trials within specific countries. It also seems like US-FDA trial data and approvals are acceptable to apply to setup Phase 3 trial sites in those countries.How would it work for other countries outside the USA? Would Astellas Pharma contact countries outside USA once their trials are done and apply to get FX-322 approved in those countries?
I'm just wondering how the process normally works.
I just hope when the pivotal phase is done or during the phase, Astellas Pharma will apply for approval of FX-322 in all countries. Is it possible for them to apply for approval in advance during the pivotal phase if they start noticing the results are positive?Yes. It varies a bit by country, but generally there is a "Drug Approval" process for each region or country. Most, if not all, at this point accept US-FDA Approved trial data for their applications. Some countries' drug-regulating entities require at least part of the trial be conducted on their soil; so Astellas may have to strategically position some Phase 3 trials within specific countries. It also seems like US-FDA trial data and approvals are acceptable to apply to setup Phase 3 trial sites in those countries.
I don't think it will make hyperacusis/noxacusis worse. There's a better chance for it to improve hyperacusis/noxacusis. I have a good feeling once we restore hearing input then it should stop both loudness and pain hyperacusis.Has there been any deeper discussion whether the restoring of hair cells and synapses could potentially worsen hyperacusis/noxacusis? What are the arguments for/against?
This theory of yours seems entirely plausible. Prior to November 2020, for the last 6 years or so, I had what I would call a "quiet" high pitched tinnitus on my left side where I would not notice it unless I was specifically listening for it and the room was VERY quiet. I could increase the tinnitus just by clenching my teeth together. That's how I could gauge how bad it was - I would compare clenching teeth to no clenching of teeth, and would always be satisfied that the tinnitus was still the same "quiet" volume in my head. Entirely manageable and not intrusive at all.I actually recall a study from a while ago, I'm trying to find it, but it must be on my old computer. It showed audiograms (normal + HF) of various age groups, 18-29, 30-39, 40-49, up to 80s. And it also identified a YES/NO for folks who complained of tinnitus. They provided an average audiogram + HF for the YES/NO tinnitus group. Just for fun, I graphed the points to better understand the data, which I did save:
[their hearing was tested along the audiogram, and at least 10 dB more loss than the non-tinnitus group.
This is why I think that FX-322 restoring even partial signal for those experiencing tinnitus, just to get them up maybe 10-20 dB on the audiogram per frequency band might be enough to start resolving it. We know from the Phase 1/2, that at the edge of the testing scale, a few patients saw a 10-15 dB improvement at 8 kHz. If their audiograms looked anything like the one above, from 8 kHz + where they saw a 10-15 dB improvement, it might put them into a non-tinnitus range.
I'm inclined to agree - although noxacusis is a bit of an unknown generally-one thing we do know is that noxacusis/hyperacusis arises as a consequence of peripheral damage and hearing loss. So restoring input via FX-322 shouldn't worsen it at all IMO even if, for example, it doesn't necessarily improve it either.I don't think it will make hyperacusis/noxacusis worse. There's a better chance for it to improve hyperacusis/noxacusis. I have a good feeling once we restore hearing input then it should stop both loudness and pain hyperacusis.
I think when we loss hair cells due to loud noise it caused hyperacusis to happen and once we restore it should be gone.
I still believe both loudness and pain hyperacusis are happening in the same area.
I suffer from both pain and loudness hyperacusis and I have hope that FX-322 will cure it.