Audiologists' main concern is with understanding conversation. I don't think they really care about anything aside from 250 Hz-8 kHz. The national standard is obviously a joke but it's understandable that testing frequent intervals is somewhat infeasible. The test I took was 35-40 minutes long as it was.
No worries, maybe I can help. FX-322 has shown in their animal models that they regenerate IHC and OHCs both. They generated fewer IHC than OHC but in the same proportion. This is probably because noise does not usually take out a large amount of IHC before completely depleting OHC. So for ex. if they started with 5 IHC they doubled that to 10, and doubled 30 OHC to 60 (hope that makes sense).
I think it's both by the paper they published. Also, they mentioned in the Q and A it would treat cochlear synaptopathy only where hair cell growth occurred because the new hair cell would grow new synapses. This statement would make no sense imo if they were talking about OHC because that's not where "cochlear synaptopathy" is.
Thanks so much! You've enlightened me for sure.
It's never been tested in animal models for tinnitus. The Hough pill has however and was able to reduce/eliminate tinnitus. But the Hough pill and FX-322 do different things - however after the most recent presentation we are concluding that FX-322 will also benefit synaptopathy if you need to generate IHC. So far this seems to be the case as their speech in noise scores improved.
Not so much going in different direction, but acting as compliments to each other. Some drugs like PIPE-505 do both synapses and OHC (don't ask me how, I still don't know lol) I firmly believe that most of us will need both to fully repair our cochleas. It's hard to package all of cochlear repair into a single drug but I think the fact that we can get pretty close with only 2-3 is absolutely incredible imo.
Yep, yep. That is one possible way we can rectify pain hyperacusis (noxacusis). By replacing the damaged OHC, the newly formed cells will not be leaking ATP onto the type 2 nerve fibers causing the pain. I regrettably know a lot less about noxacusis than I do loudness hyperacusis and tinnitus but from the little I've read (and from what user member Lab has told me) I think it stands a very good chance at being correct.
My guess is that since hyperacusis is more of a 'niche' condition than tinnitus it's perhaps not really been on their radar so much but hopefully once the trials advance further we will get an even more comprehensive picture of outcomes/secondary outcomes. I'm probably just biased because my hyperacusis bothers me more than my tinnitus lmao and I don't want to get my hopes up but yeah it's exciting.
You know what? Now I'm not so sure. They referred to speech in noise as a measure of clarity and then said clarity improved but I, just now, found another slide calling *both* word scores and speech in noise measures of clarity. From their Q and A it sounds like they found some measure of synaptopathy improvement but I am failing to find the actual numbers. Anyone have this?
I had no idea drugs could be released to the market during Phase 3. I thought we would have to wait after the trial has finished. Is this true?
That's what I was told by a doctor when I did a phase 3 study for a cholesterol drug ~10 years ago. I can't find any info online about it though, so now I'm not so sure.
One of the links that were posted a while back about the under-appreciated role that extended high frequencies may play in speech comprehension specifically mentioned improved speech-in-noise understanding as a benefit. Synaptic repair may not be what's causing the improved scores.
I hope so too. I'm a bit worried that there will be a bit of a delay releasing the drugs worldwide since Astellas have international rights and Frequency Therapeutics have US rights.
Yeah, fixing the OHCs seems like the logical solution.
Probably a stupid question, but can you have hair cell loss with a normal/'perfect' audiogram? Since an audiogram only tests up to 8 kHz? It's been established that cochlear synaptopathy can hide behind an audiogram and that they are better at detecting HC loss but can higher-frequency HC loss still be present for someone with a normal audiogram?
True but they also said in the Q and A that synapses would be repaired in places where the new hair cells had to connect when someone directly asked them about cochlear synaptopathy.
You can get an extended audiogram and test for OHC loss up to 16000 Hz. High frequency OHC damage especially can completely hide behind a normal "standard" audiogram up to 8000 Hz.
I think that's been accepted for a long time. I read a paper from 2004 which said that hair cells attract synaptic connections as they develop. Do synapses die along with their connected hair cells and re-appear when hair cells are regenerated? Is this synaptopathy then? I thought synaptopathy was the loss of synaptic connections independent of hair cells.
"Synaptopathy" is the loss of the synapse connections whether or not you have also lost hair cells. What Frequency was saying in their Q and A was that, if you happen to have synaptopathy where you also have hair cell loss, the drug should address both problems. And in that sense, FX-322 could be a treatment for some cases of "cochlear synaptopathy". Seems implied they are talking about regenerating *IHC's* here in that instance because that is the synapse connection that is lost in "cochlear synaptopathy", which is pretty exciting! Obviously, if you don't have any IHC hair cell loss, this drug wouldn't help, though.
Well if it's a one-time cure, I guess most of us are ready to spend $10,000 or maybe even more to get rid of tinnitus for the rest of our lives. We buy $400,000 houses, we could spend 10% of that to get rid of what may represent the greatest pain point in our lives.
Maybe around October this year. Could be a possibility that after the Phase 2a trials have finished they could go directly to Phase 3 instead of Phase 2b.
Unfortunately most insurance doesn't cover hearing health at all. At least here in the US. They consider it "cosmetic," whatever the F that means...
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