Frequency Therapeutics — Hearing Loss Regeneration

[tommyd87]

Well, basically completely restoring an inner ear function, be it in a lab, is more than "hope to hold on to", it's a fact.

And I personally would be satisfied with a 25% alleviation, not necessarily a cure.

It is exactly more than a hope.

Having a look at it, only two things can happen.

Firstly, Frequency Therapeutics cannot replicate this complete regrowth in a real ear.

Secondly, there is something stopping Frequency Therapeutics from replicating this in a real ear which we don't know about.

At this stage I am going to suggest if it is either of these then it is the latter, although Frequency Therapeutics has demonstrated on multiple occasions that they tend to be able to get FX-322 to work in a real ear.

 

[GBB]

I plan on starting the Stamets NPLS stack in the next few weeks if my source is legit. I may have missed it, but I have yet to see anyone on this forum mention that they tried it. There are prior users of Psilocybin, Lion's Mane, and Niacin, but no one has tried the stack. I'm already a big fan of Lion's Mane. Niacin has given me bad spikes before, but it usually happens after prolonged use. It will be the first time for me taking Psilocybin, so it will be a micro-dose for sure. I have zero interest in using it for recreational purposes.

A user named Little Lamb tried it, who I cannot link to for some reason. She seemed to have success but never came back to discuss. Please let me know your results as I have been debating doing the same, but it's lower on my list than other ideas presently.

The post is here: https://www.tinnitustalk.com/posts/441980/

 

[Philip83]

It is not proven that restoring hearing will suppress tinnitus. We are only making speculations.

I do agree that we are missing conclusive hard data on this, but there is a large amount of people with anecdotal evidence that has reported reduction in tinnitus while using hearing aids. Myself included here.

I tried an in-ear hearing aid about a year ago and the reduction in my tinnitus was more substantial then I had guessed it would be. The fact that I had to stop using it after about a week because of my hyperacusis going through the roof was unfortunate, but it luckily settled again shortly after.

In general though, I don't disagree with you, we need more hard data, which we will hopefully have come end of Q1, 2021!

 

[Aaron91]

I plan on starting the Stamets NPLS stack in the next few weeks if my source is legit. I may have missed it, but I have yet to see anyone on this forum mention that they tried it. There are prior users of Psilocybin, Lion's Mane, and Niacin, but no one has tried the stack. I'm already a big fan of Lion's Mane. Niacin has given me bad spikes before, but it usually happens after prolonged use. It will be the first time for me taking Psilocybin, so it will be a micro-dose for sure. I have zero interest in using it for recreational purposes.

I've done a lot of research on shroom supplements (currently taking Lion's Mane) and the one thing I can tell you is to stay away from Stamets. Yes, I know he was on Joe Rogan etc. but what matters is quality control and none of his stuff is verified by a third party lab as far as I know. His and many other products are based on myceliated grains/rice instead of mushrooms and are not extracted. The percentage of active ingredients such as beta-glucan is extremely low. See more here.

 

[Rb86]

I'm not talking about inner ear function. I've followed the evolution of the company, I know what they can do with hearing.

I'm talking about tinnitus itself and it's pretty clear now that tinnitus is not only a matter of hearing. A lot is happening in the brain, if not most of it, no matter the source of the problem.

It is not proven that restoring hearing will suppress tinnitus. We are only making speculations.

The available data isn't pointing to suppression of tinnitus. It shows that it helped some people's tinnitus.

OK, that's good, but other medications do that already, and again, they are psych meds.

There is not yet any formal diagnosis for tinnitus. Until we don't know precisely why tinnitus arises and stays for some people while it remains temporary for others, we won't have a cure for everybody.

But I'll admit it's a great step to treat hearing loss. Hearing better is always good when it comes to tinnitus anyway.

And guys, that's fine, be happy, be faithful, that's cool

I'm just worried you'll face big disappointments when the treatment is out.

Again, I'm an optimistic as well, I'm just waiting for actual proof. We're in the clinical study still.

You could be right but I mean hell, here's a good example...

I work with power tools often, be it in the garage or mowing lawns. I now protect my ears religiously. By the time I'm done mowing, with my ear muffs on or foam ear plugs in, my ears are screaming. The second I take my ear plugs out, that reduces substantially, and after an hour, it returns to baseline. Every time.

 

[serendipity1996]

Now I'm wondering if FX-322 will do anything to help noxacusis after reading that study with the mice cochlea. Hyperacusis sufferers will probably need it regardless since most of us have tinnitus and distortions.

I think it may well benefit us (along with a synapse drug) because ultimately noxacusis is a consequence of peripheral damage - noise-induced hearing loss. NIHL is the underlying cause here IMO.

 

[tommyd87]

I'm not talking about inner ear function. I've followed the evolution of the company, I know what they can do with hearing.

I'm talking about tinnitus itself and it's pretty clear now that tinnitus is not only a matter of hearing. A lot is happening in the brain, if not most of it, no matter the source of the problem.

It is not proven that restoring hearing will suppress tinnitus. We are only making speculations.

The available data isn't pointing to suppression of tinnitus. It shows that it helped some people's tinnitus.

OK, that's good, but other medications do that already, and again, they are psych meds.

There is not yet any formal diagnosis for tinnitus. Until we don't know precisely why tinnitus arises and stays for some people while it remains temporary for others, we won't have a cure for everybody.

But I'll admit it's a great step to treat hearing loss. Hearing better is always good when it comes to tinnitus anyway.

And guys, that's fine, be happy, be faithful, that's cool

I'm just worried you'll face big disappointments when the treatment is out.

Again, I'm an optimistic as well, I'm just waiting for actual proof. We're in the clinical study still.

There are a lot of examples though which demonstrate tinnitus increases have been correlated with increased hearing loss and that using an auditory input device like a hearing aid will reduce this.

 

[serendipity1996]

There are a lot of examples though which demonstrate tinnitus increases have been correlated with increased hearing loss and that using an auditory input device like a hearing aid will reduce this.

This source from the Hearing Health Foundation states that tackling tinnitus means restoring hearing.

"In conclusion, all indications are that tinnitus, when not caused directly by a central nervous system issue (e.g., stroke), is always associated with one or more forms of hearing loss. As a result, although a treatment of most forms of tinnitus will likely emerge in the years to come, curing tinnitus will first require curing hearing loss. It also points to tinnitus potentially being an early symptom of an underlying auditory injury before measurable audiometric changes."

https://hearinghealthfoundation.org/blogs/tinnitus-and-noise-trauma-to-the-inner-ear

 

[GBB]

This source from the Hearing Health Foundation states that tackling tinnitus means restoring hearing.

"In conclusion, all indications are that tinnitus, when not caused directly by a central nervous system issue (e.g., stroke), is always associated with one or more forms of hearing loss. As a result, although a treatment of most forms of tinnitus will likely emerge in the years to come, curing tinnitus will first require curing hearing loss. It also points to tinnitus potentially being an early symptom of an underlying auditory injury before measurable audiometric changes."

https://hearinghealthfoundation.org/blogs/tinnitus-and-noise-trauma-to-the-inner-ear

I think we are on the right track with restoring hearing, I just want to see data before I believe - both that FX-322 works as well as everyone here posits for restoring hearing, and that the restoration of hearing will lead to the reduction or elimination of tinnitus.

One thing that makes me cautious, is there are many stories of people having ear wax removed or getting hearing aids, and that leads to a *reduction* in tinnitus, but it is much rarer to hear about it being outright gone. Of course a reduction would be great, but I have several rapidly pulsing tones in each ear, so real silence is infinitely more valuable to me... a quieter version of something inherently intrusive won't be worth much

Some part of me feels that given my lack of measurable hearing loss, even with a restoration of hair cells and synapses, my brain has ingrained the tinnitus signal already, but I suppose that is as speculative as those betting on an outright cure.

What keeps me going is a hope that between hair cell restoration, synapse restoration, neuromodulation and a refined pharmaceutical, I can one day approach normalcy again.

 

[weab00]

I think it may well benefit us (along with a synapse drug) because ultimately noxacusis is a consequence of peripheral damage - noise-induced hearing loss. NIHL is the underlying cause here IMO.

I agree it will benefit, but I kind of have a problem with dropping $10k on something to the effect of "eh, it might help a bit."

 

[serendipity1996]

I agree it will benefit, but I kind of have a problem with dropping $10k on something to the effect of "eh, it might help a bit."

Well, hopefully we will have data on that before any of us have to make a decision.

 

[Gb3]

I agree it will benefit, but I kind of have a problem with dropping $10k on something to the effect of "eh, it might help a bit."

It's going to be covered by insurance. You won't have to pay that. That's ridiculous.

 

[tommyd87]

It's going to be covered by insurance. You won't have to pay that. That's ridiculous.

I think that Frequency Therapeutics would be dumb to not get this covered by insurance and would be doing all they can to make sure that this actually happens.

 

[Lucifer]

I think that Frequency Therapeutics would be dumb to not get this covered by insurance and would be doing all they can to make sure that this actually happens.

They need to make it affordable for all people.

 

[GlennS]

It's going to be covered by insurance.

Well, given the makeup of the Supreme Court and the tussle over preexisting conditions, I'd say wait and see.

 

[tommyd87]

They need to make it affordable for all people.

I think Frequency Therapeutics are aware of this and will work to do so. They know how lucrative markets are in US, UK, Germany etc but where they can make the most money will be in countries like India which do not have the income levels or medical assistance that the other countries have. Hence why I think that they will set the price at an affordable level and also actually eliminate the propensity people might have to travel to a third world country which offers FX-322 because it is cheaper there.

 

[Shizune]

Apologies for posting, but anyone have an idea of the chances that FX-322, or any other medicine in development, will be able to reverse neurological symptoms, coming from tinnitus and hyperacusis? Or even those caused by them? Would that only be the case if these symptoms were purely cochlear based (ex: vertigo due to vestibular dysfunction) rather than any changes in the brain resulting from it? Stuff like visual snow, for example?

I know I probably sound like an idiot since I'm lesser than a layman here and don't quite understand the science behind it all or where to begin since all the threads are quite long at this point. I'm just trying to pinpoint which medication to hold out for, if there are even any. Sorry again.

 

[Filip]

I just came back after 4 years to see discussion for FX-322 after I saw it mentioned because my God they to need find a cure for hearing loss. I have been hearing about (pun not intended) that hearing loss is associated with cognitive decline. Ugh I hope it is not too late, especially with how 2020 turned out. I also heard COVID-19 has been causing hearing loss.

 

[tbuzz89]

It's going to be covered by insurance.

I think that Frequency Therapeutics would be dumb to not get this covered by insurance and would be doing all they can to make sure that this actually happens.

Speaking for US patients only, for those who have moderate to severe and traditionally measurable hearing loss via the standard audiogram, it may be fully or partially covered by some insurance plans to start. I'd venture a guess to say that mild hearing loss would not fall within insurance companies' coverage guidelines, at least not for a few years until they have enough tangible data on the drug's efficacy over a large population set. Insurance carriers may look at mild hearing loss as "not substantial enough to warrant treatment" and thus deny a claim in the instance of mild audiograms. Insurers only look at data and rarely take subjective suffering into account. Depends on the coverage and or company, and how much effort your doctor is willing to put in to justify the usage and argue on your behalf.

Tinnitus may be a completely different story and will largely depend on the subjective tinnitus results of the clinical trials and how the drug is marketed upon release. Let's say the final drug is only marketed as treating "hearing loss" with no mention of a first-line treatment for tinnitus. Some insurance companies may view the treatment of tinnitus as an off-label use of FX-322 and thus try to deny coverage on the basis of off-label or experimental use. Again, this depends on the information obtained from the clinical trials regarding the efficacy on tinnitus and how Frequency Therapeutics decides to present the drug to insurers. However, I have full faith in Frequency Therapeutics to present FX-322 as both a hearing loss drug AND a tinnitus drug if both show favorable results after trials.

I would also like to add that if FX-322 is truly a home run with significant efficacy for both hearing loss and tinnitus, then I can see many of the major US health insurance companies jumping on agreements with Frequency Therapeutics to work on price setting in order to make covering the drug profitable for the insurer. However, this is only if FX-322 knocks it out of the park.

Source: I'm an underwriter for a large US insurance company and have spent years brokering, underwriting, and writing policy coverage forms for specialty commercial lines.

 

[Billy_Shears]

I think that Frequency Therapeutics would be dumb to not get this covered by insurance and would be doing all they can to make sure that this actually happens.

At least in the United States, pharmaceutical companies have little influence on the private health insurance industry in relation to what they specifically cover. One way or another, the patient will pay whether directly or through high insurance premiums.

I'm speculating that the cost for FX-322 treatment will, in fact, be much lower than many of us would have previously thought. Relative to Lasik surgery which now has a cost of approximately $2500 per eye, FX-322 requires no surgery and, therefore, probably not as expensive if the supply is readily available. ENT physicians in the United States will work with individuals in providing this treatment through affordable credit sources if need be.

 

[patorjk]

I just came back after 4 years to see discussion for FX-322 after I saw it mentioned because my God they to need find a cure for hearing loss. I have been hearing about (pun not intended) that hearing loss is associated with cognitive decline. Ugh I hope it is not too late, especially with how 2020 turned out. I also heard COVID-19 has been causing hearing loss.

Correlation doesn't equal causation. A lot of people who have hearing loss / tinnitus are older, so they have cognitive decline too. Unless someone posts something showing younger people suffering cognitive decline due to hearing loss I wouldn't be concerned.

As an aside, a few years ago I read that there was a correlation between tinnitus and having fewer teeth than normal. I think this is probably also due to age (i.e. older people have poorer dental health). Otherwise it would mean tinnitus is somehow causing people to lose their teeth.

 

[weab00]

Correlation doesn't equal causation. A lot of people who have hearing loss / tinnitus are older, so they have cognitive decline too. Unless someone posts something showing younger people suffering cognitive decline due to hearing loss I wouldn't be concerned.

As an aside, a few years ago I read that there was a correlation between tinnitus and having fewer teeth than normal. I think this is probably also due to age (i.e. older people have poorer dental health). Otherwise it would mean tinnitus is somehow causing people to lose their teeth.

Tinnitus increases your risk of wasting time on this forum ten fold.

 

[Cernuto]

I see the protein prestin is mentioned. I wonder if there is a correlation between tinnitus and prestin levels?

 

[antonio77]

Many people have tinnitus and do not perceive hearing loss, others - like me now, but not before for years - yes, but hearing aids have no effect on the tinnitus.

I would be surprised if FX-322 worked for tinnitus, but I wish it did.

 

[Lucifer]

Many people have tinnitus and do not perceive hearing loss, others - like me now, but not before for years - yes, but hearing aids have no effect on the tinnitus.

I would be surprised if FX-322 worked for tinnitus, but I wish it did.

It does work for tinnitus. Carl LeBel stated in the Tinnitus Talk Podcast that some patients who came back to be reviewed mentioned that their tinnitus improved.

 

[TrevorSanders]

Many people have tinnitus and do not perceive hearing loss, others - like me now, but not before for years - yes, but hearing aids have no effect on the tinnitus.

I would be surprised if FX-322 worked for tinnitus, but I wish it did.

Your hearing loss is probably in the ultra-high frequencies (8000+ Hz range).

 

[tommyd87]

Many people have tinnitus and do not perceive hearing loss, others - like me now, but not before for years - yes, but hearing aids have no effect on the tinnitus.

I would be surprised if FX-322 worked for tinnitus, but I wish it did.

The issue is hearing aids will only help tinnitus when they are being used to provide additional auditory stimulation for hair cell loss.

If you have synapse damage then hearing aids are useless at helping with this as they cannot provide the replacement stimulation for this in the same way a hearing aid is able to for hair cell loss.

Looking at it, this is probably why groups like Hough Ear Institute tend to believe that synapses shall seem to play a significant role in tinnitus. This appears to be why Hough Ear Institute are targeting the regrowth of synapses with their pill.

This tends to be why research suggests people who have tinnitus but have a regular audiogram reading is because their synapses are broken but their hair cells are intact. This tends to be why Hough Ear Institute is measuring and working on this as a key part of their pill treatment.

 

[tommyd87]

Your hearing loss is probably in the ultra-high frequencies (8000+ Hz range).

This is probably plausible since most hearing aids are not able to treat the very high frequencies. The promising thing is that there tends to be a good prospect that treatments for all the various aspects of hearing loss (outer and inner hair cells) and synapses could be available soon.

 

[Koz]

Apologies for posting, but anyone have an idea of the chances that FX-322, or any other medicine in development, will be able to reverse neurological symptoms, coming from tinnitus and hyperacusis? Or even those caused by them? Would that only be the case if these symptoms were purely cochlear based (ex: vertigo due to vestibular dysfunction) rather than any changes in the brain resulting from it? Stuff like visual snow, for example?

I know I probably sound like an idiot since I'm lesser than a layman here and don't quite understand the science behind it all or where to begin since all the threads are quite long at this point. I'm just trying to pinpoint which medication to hold out for, if there are even any. Sorry again.

My two cents: It's hard, almost impossible to tell right now until these treatments come out because a lot of these things aren't primary outcome measures as much as hearing restoration is. I too have visual snow / tinnitus / hearing loss.

 

[weab00]

My two cents: It's hard, almost impossible to tell right now until these treatments come out because a lot of these things aren't primary outcome measures as much as hearing restoration is. I too have visual snow / tinnitus / hearing loss.

I definitely hope this can reverse tinnitus induced visual snow syndrome. It seems to make sense to me, that curing tinnitus would calm the random neuron firing which would cure the visual symptoms as well. But who cares about speculation, let's see the real thing first.