Frequency Therapeutics — Hearing Loss Regeneration

[Aleksa Uzunovic]

Yeah, if something should be granted a special status, this should. This is one of the greatest urgent medical needs in the WORLD TODAY! I mean just how many of my peers like me for example aren't protecting their ears and go out to clubs and other places and BOOM, you got your hearing damaged with no return. Than you will have problems interacting with other people for the rest of your life because of that? While there are treatments out there to reverse blindness and whatnot else, do the same bloody thing with ears for Christ's sake. Hearing aids don't even work properly, they just amplify the sound, they don't help with speech recognition.

 

[Fabrikat]

Fast Track Status would be nice.

 

[Ray552]

Fast Track Status would be nice.

How quick would fast track be anyways?

 

[JohnAdams]

How quick would fast track be anyways?

Depends on several factors.

 

[GSC]

Depends on several factors.

What difference statuses can there be in FDA approval?

 

[GSC]

Oh. Could this get breakthrough status... though, I doubt it...

 

[JohnAdams]

What difference statuses can there be in FDA approval?

I think it just means that they get priority review. The drug company does all the testing and submits their papers to the FDA for review, from what I understand they just review it as they get to it.

Oh. Could this get breakthrough status... though, I doubt it...

It definitely could get breakthrough/fastrack status.

 

[Paulmanlike]

Fast track will speed things up by months and not by years just to note.

 

[Bndsmheowqhe]

Fast track will speed things up by months and not by years just to note.

That's my understanding. I thought it was something like 6-8 months roughly.

 

[TeslaGuy]

Fast track will speed things up by months and not by years just to note.

That is the case but it is better than nothing. The good news is that it works in humans. We'll just have to wait for the results and see how well it worked and the possibility of extending the effect with multiple doses.

 

[Paulmanlike]

That is the case but it is better than nothing. The good news is that it works in humans. We'll just have to wait for the results and see how well it worked and the possibility of extending the effect with multiple doses.

There's also the question if it will help fix tinnitus, they said it showed some effect on hearing and that was it. There's also lots more hurdles for them to jump to get it on market.

As far as I understand, Frequency Therapeutics turn progenitor cells into hair cells. But what if tinnitus is caused by synaptic damage that occurs before hair cell death?

For example I have a normal standard audiogram and yet tinnitus. I figure I have synapse damage but my hair cells are intact - but at this moment in time nobody can determine this.

 

[TeslaGuy]

As far as I understand, Frequency Therapeutics turn progenitor cells into hair cells. But what if tinnitus is caused by synaptic damage that occurs before hair cell death?

For example I have a normal standard audiogram and yet tinnitus. I figure I have synapse damage but my hair cells are intact - but at this moment in time nobody can determine this.

Hopefully the others can tackle this problem. Would be great to be able to handle both hearing losses.

 

[Chad Lawton]

For example I have a normal standard audiogram and yet tinnitus. I figure I have synapse damage but my hair cells are intact - but at this moment in time nobody can determine this.

Standard audiogram only goes to 8 kHz. Your hearing range is more than double that and most likely extends up to 16 kHz. They only test to 8 kHz because that is the sound range that impacts speech and day to day life the most. So you very likely have hearing damage in the 50% of hearing range that they didn't test.

 

[JohnAdams]

Standard audiogram only goes to 8 kHz. Your hearing range is more than double that and most likely extends up to 16 kHz. They only test to 8 kHz because that is the sound range that impacts speech and day to day life the most. So you very likely have hearing damage in the 50% of hearing range that they didn't test.

Goes to show that the priorities of the medical industry are majorly confined within their ability.

 

[ee9892]

Just wanted to pop in and say I'm so happy knowing things are finally moving forward. Between this and bimodal stimulation, I'm excited to see how things turn out for us sufferers.

 

[dmorg]

My understanding is that Regain set the timeline right from the start. The phase 1 study was always going to take a year. The phase 2 study (it it happened) was always going to take a year. That doesn't sound that fast to me.

I recently emailed them expressing my interest in their work and that I have been following it for some time in hope of getting some type of update that is not available on their website (knowing I am from the US and not eligible). Wishful thinking, I know. They essentially replied... what country are you from, we'll send you forms to register for phase 2. So... they are still recruiting I guess?

Does anyone know if a study does not move forward until all slots are filled/recruited? Frequency Therapeutics's 1b study, though much smaller, filled up quickly.

 

[Flamingo1]

I recently emailed [Fx] expressing my interest in their work and that I have been following it for some time in hope of getting some type of update that is not available on their website (knowing I am from the US and not eligible). Wishful thinking, I know.

Why can't US citizens participate?

 

[Strife_84]

Standard audiogram only goes to 8 kHz. Your hearing range is more than double that and most likely extends up to 16 kHz. They only test to 8 kHz because that is the sound range that impacts speech and day to day life the most. So you very likely have hearing damage in the 50% of hearing range that they didn't test.

Even healthy person of my age cannot probably hear to 16 kHz or at least takes someone with really golden ears. So I understand why they don't test over 8 kHz, as sounds over that area is pretty much useless to us humans.

But I would still like them to test at least to 12 kHz.

 

[d'Wooluf]

I recently emailed them expressing my interest in their work.

They seemed to be accepting applications for phase 1 all through last year. I posted a question to them. I asked 'Has anyone's hearing changed?' They replied 'We can't tell you.' Well, more words, same effect. The reason they stipulate UK citizens is some bureaucratic requirement of the NHS. There are two other countries participating in phase 2 though I think. I have no idea what's happening there.

 

[trc]

Even healthy person of my age cannot probably hear to 16 kHz or at least takes someone with really golden ears. So I understand why they don't test over 8 kHz, as sounds over that area is pretty much useless to us humans.

But I would still like them to test at least to 12 kHz.

How old are you man?

 

[Strife_84]

How old are you man?

I'm 35. Even my girlfriend cannot hear over 15 kHz and she has healthy ears.

 

[TeslaGuy]

They are planning to present the results in a conference and it would be the one that is in July.

 

[Paulmanlike]

I know that hearing can go up to 16 kHz and they don't measure hearing loss over 8 kHz.

The question then remains, if you have a normal audiogram up to 8 kHz would this exclude you from FX-322 treatment as you don't really have a measurable hearing loss to get on through life? Or would it be that if you have tinnitus then you get this treatment with a normal audiogram in the hope damaged cells wherever they are will be corrected to solve tinnitus? After all, this is a hearing loss treatment and not a tinnitus treatment?

You know where I'm coming from? There are sufferers out there with noise induced tinnitus or whatever that have normal audiograms and are somewhat excited about FX-322 even though it is not a tinnitus treatment.

 

[parsky]

Even healthy person of my age cannot probably hear to 16 kHz or at least takes someone with really golden ears. So I understand why they don't test over 8 kHz, as sounds over that area is pretty much useless to us humans.

But I would still like them to test at least to 12 kHz.

Yes, but premature loss of those frequencies (8-16 kHz) would be an indicator of hearing loss and could warn people to start making lifestyle changes before it gets to the important frequencies.

 

[Ray552]

Yes, but premature loss of those frequencies (8-16 kHz) would be an indicator of hearing loss and could warn people to start making lifestyle changes before it gets to the important frequencies.

Isn't music in frequencies past 8 kHz or only till 8 kHz?

 

[Strife_84]

Yes, but premature loss of those frequencies (8-16 kHz) would be an indicator of hearing loss and could warn people to start making lifestyle changes before it gets to the important frequencies.

Normal people usually don't take hearing tests, only after damage has happened = feeling something is wrong. So it's too late then. Only reason I would like to test my hearing above 8 kHz is because music is a hobby of mine and I would like to see if I have a notch somewhere. Online tests are not reliable. As when you perform the test at home and know when the sound is playing, you are already psychologically biased. Also high frequencies usually can contain artifacts on some audio systems, people claiming they can hear over 20 kHz, but don't understand it's probably just some artifacts you hear.

So high frequencies should be tested only with proper, calibrated gear.

My hearing was last tested when I was 18 (military inspection). Now I am 35 and would have gone without test for years probably if I had not damaged mine. Our hearing deteriorates on it' own as we age. It's unavoidable. But of course you should take care of your ears so they last longer.

And after someone gets tinnitus, I think they will become more cautious in the future.

 

[dmorg]

$322??? That's what that number means right?

If only that were the case. You're probably missing 2 zeros.

 

[Pero1234]

There are sufferers out there with noise induced tinnitus or whatever that have normal audiograms and are somewhat excited about FX-322 even though it is not a tinnitus treatment.

I'm one of them... and if the risks / side effects are limited, I regain (part of) my hearing above 13 kHz and it helps for tinnitus... I will push very hard to get this! Even if strictly speaking I do not qualify from a health insurance perspective.

 

[PeteJ]

I don't want to rain on the parade but I am not as optimistic as I used to be.
I think scientists need to figure out what's going on with tinnitus.
Restoring hearing loss is great for those who have less than normal audiograms but I suspect most want the tinnitus (and hyperacusis) to stop permanently. To become their normal self again. If hearing is restored, too, that is a welcome bonus.

I know people with bad hearing but no or little tinnitus. There are people on here with normal or good hearing but have tinnitus.

I'm just afraid that the achievements will be limited and we will wait for such a long time only to see limited improvement or not much at all.

Can they offer 'cures' without having more insight on tinnitus and NIHL?

 

[Pero1234]

@kelpiemsp mentioned he felt less sensitive to noise after neuromodulation, see the Minnesota thread.

Perhaps we can only be helped by restoring hearing in a damaged area AND by stopping the brain from becoming hyperactive and turning the volume up.

There is still a lot to be learned...

I personally think hearing regeneration and neuromodulation are both part of the tinnitus puzzle. We may even need both to make a lasting cure.