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For the record, I have bilateral neurotinnitus, the infamous high pitch EEEE that is in the head but that is not the type of tinnitus I am having issues with at the moment. For about the last year, I started to develop hyperacusis and reactive tinnitus in my left ear. This type of tinnitus is...

Just recently found out about the results from FX-322's Phase 2a clinical trial. I'm quite disheartened but I can't say I'm surprised as I previously had serious doubt and critical view of the FX-322 model. If we all just disconnect from our bias and look at it from an engineering and...

That is good evidence. I like this support to the arguments. I'm glad this is true.

See, the point that I was trying to make is not to say "this doesn't work" but to give a plausible explanation that's different from just a dosage issue for the phase 1 results. It's quite reasonable not to discount actual possibilities that can seriously affect the success of Frequency...

I am not throwing skepticism out there but discussing possibilities that there can be issues. I think my thought processing is logical and plausible. Identify possible issues and see if there can be solutions.

If there's no molecular guide, then I assume it's random. If it's not random, what mechanism will cause them to correctly grow toward the nerve? I refuse to just hope it works. What is the explanation that they just magically grow correctly? Also, there can be a guide but we don't know. They...

I did post the alternative explanation in post #10981. I'll paste it here since there seems to be people not reading completely. Whether you agree or disagree is another matter. But it is an explanation. From post #10981: -- So the basis for my concern is that the new hair cells and the spiral...

I think you are missing an important aspect I'm trying to make. It's not just a matter of a drug plopping down a new neural cell. It's the fact that the new cell need to know where to connect to and connect correctly. There needs to be molecular signals for the cells to guide them to grow...

Again, like @FGG stated, the in vitro study can not confirm if these hair cells are functional. They tell us the new hair cells are proliferating from new progenitor cells, but (as @FGG says in the in vitro tests) can not confirm. They need to confirm it in a histology exam (and I think they...

Yeah, the fact that they did not have significant improvements may show a possibility that not all hair cells are functional. You and I disagree on the term significant. You interpret 10 dB improvement as significant (it certainly is an improvement) but they still nonetheless rely heavily on...

Also, if you think about this logically, if you wasted all your space on faulty new hair cells, then you're permanently screwed. Carl LeBel says there is no overpopulation issue, which means at some point when you reach a population saturation, hair cells will no longer regenerate, either...

I disagree with you on that basis. If there's no evidence shown (in a properly documented scientific paper), I'm not fully convinced. NO assumptions should be made. If I were an investor, then I'm not willing to put thousands of dollars into a company when I have these doubts, which they can...

I don't have evidence. Hence it's my hypothesis for a possible explanation for their phase 1 results. In my opinion, it's a valid and logical hypothesis. You can disregard this if you don't want to discuss all possibilities. And the reason I brought this up is because I have not seen anywhere in...

I'm not saying that they're lying. Have you even read my logic? I'm saying that their conclusion is based on the assumption that new hair cells directly relate to restored hearing. Conclusions are subjective. Why? Because they haven't tested if the new hair cells are all functionally correct...

That is one of my fears. The second is that we should identify all possibilities. I think the data from clinical phase 1 fits more in line with this possibility than not. The fact that there is a majority of people not improving, or statistically improving, or even if there is improvements, it...

They have NOT demonstrated that ALL the new hair cells are functional. Where did you get that? Please cite to support your claims. Slides are just slides. They are not research papers. Please cite a proper research paper and explain how they concluded it. [Note: conclusions are also up for...

Again, my point is that we can not discount the fact that perhaps some, many, or most regenerated hair cells are non-functional And currently, we can not discount this because there is NO hard evidence to confirm this. As investors, you should seriously consider this. Making the assumption that...

I think that's contradictory logic. As an investor, I would want hard proof and the least amount of ambiguities (i.e. show me proof from your preclinical studies confirmed functional hair cells, not just regenerating lots of hair cells). If they're spending thousands or millions into a company...

I'm saying not all of them are dysfunctional. Some of them are connected correctly by chance. Because we don't know if there's any molecular marker that directs where the synapses grow to the correct place. It's not lego blocks that fits perfectly. The cell needs direction on where it should...

Yes, thank you for pointing out I'm not a medical student. I am not. Then are you implying the PR slides are geared towards investors that have medical student knowledge? As PR, would you not try to be convincing as possible to include all relevant data? That's a great assumption there and...

Like I said, personally, I need hard evidence. All these he says, she says, could have done, should have done, and etc are just that. Edit: What is definitively enough evidence for me is that they should have done similar case study on measuring the animal's brain activity for baseline, induce...

Exactly, you cannot test that and so, they did not conclusively provide evidence of it directly restoring auditory function. Assuming and guessing that Frequency Therapeutics should have or could have is quite hopeful. Companies aren't perfect and there's many examples of failed companies...

Okay, so the whole point I want to bring this up is because: 1) I want to provide an plausible explanation why the majority of the patients did not improve. 2) It would be silly to jump into early, and if possible, compassionate treatments because those new hair cells maybe dysfunctional...

So the basis for my concern is that the new hair cells and the spiral ganglions are not connected to the receiving end of the cochlear nerve. The spiral ganglions need a signal to know the direction to grow toward the cochlear nerve. The issue is that we currently do not know if these drugs...

That is my point, which they obviously of course can not test auditory function based on their experimental procedures. Scientifically, if there isn't hard evidence to establish renewed cochlear hair cells are fully functional, i.e. that the synaptic structures connect or connect correctly back...

You are confusing the Frequency Therapeutics' investor slides with research studies. Those investor slide claims it restores hearing in all frequencies (based on the assumption that newly restored hair cells are neurologically active for the animal studies and improved word scores for the human...

I think there's some misconceptions that everyone who hasn't carefully read their actual animal studies here: Clonal Expansion of Lgr5-Positive Cells from Mammalian Cochlea and High-Purity Generation of Sensory Hair Cells First, their animal studies directly and surgically removed inner ear...

Hey guys, I've originally only have pure tone tinnitus on my right ear due to ear infections two years ago. My symptoms have gotten worse. Left ear has both pure tone tinnitus and reactive TTTS popping noises since middle of August. Right ear has developed an additional electrical hiss since...

@Hazel I've been busy lately and haven't been checking on many posts. My primary concern for ENTs is: 1) Ear symptoms are not just an "annoyance" but much more serious. It drives me nuts how ignorant they are to our symptom's severity. At the least, it is extremely disruptive to our everyday...

So with Frequency Therapeutics' recent press release, this related article popped up in my news feed: https://www.wbur.org/commonhealth/2020/09/13/frequency-therapeutics-regenerate-hearing-drug And from the article's quotes regarding pure tone testing: An improvement of 10 decibels at 8000...

@Martinf Did you get your dental fillings (mercury ones) removed? If so, how did it go?

I don't think it will help with TTTS as that is caused by the tensor tympani muscle spasm or some disorder. The tensor tympani muscle has nothing to do with the inner ear or cochlear hair cells and since FX-322 is addressing hearing issues at the inner ear, TTTS is unlikely to be affected...

Previously good ear can hear up to 15khz clearly. Now that tinnitus appeared, can no longer hear 15khz but only up to 14khz...

You can do an advance search on ClinicalTrials.gov and search by Sponsor with Hough or Oblato or Auditus (the latter two are partners with Hough). So far, I have found no clinical trials regarding hearing loss or tinnitus by any of them. It would be really nice if Hough could post an update on...

I've accidentally stumbled upon this on the ClinicalTrials.gov website. On PubMed, there was a pilot study, which found out that Oxytocin nasal spray reduced Tinnitus Functional Index by ~20 points in 10 subjects. Link is here. There's an ongoing clinical study pilot by NYU Langone Health...

Ah. Nevermind, I forgot that FX's animal studies used gentamicin (aminoglycosides) to induce hair cell death for their in situ cochlear explant studies. So FX-322 should still work with aminoglycosides antibiotics.

I don't suppose you know if it will also trigger support cell apoptosis too?

@FGG, Do you perhaps know how aminoglycosides damage the cochlea? Is it neuronal or hair cell damage, or both? Have there been proposed theories on the ototoxicity mechanism of action for this type of antibiotic? It's been kind of hard searching it. I was wondering if FX-322 will help in this...

I stopped taking NAC after getting stomach ache and tinnitus spikes afterwards. It did not help my tinnitus.

What was your experience with this treatment? How does it feel to have the implant in your chest? Does the implant need a battery? And most importantly, did it help your tinnitus? If so, to what degree? Thanks.

Damn. I have tinnitus in both ears now. Good ear is no longer good.

@Christiaan Can you explain how this works exactly? Is it implanting a device into the neck and if so, what's the detail for this surgery? Does it put wires into the spinal core? In other words, how will it stimulate the vagus nerve? Directly putting some wires into it or near it? I feel this...

I have either a hair or some needle like thing stuck in the ear drum. I have a lot of mosquitoes lately biting me and was wondering if anyone knows if the mosquito needle point can come off? I've tried using some very fine eye brow trimmer to pull it out but I keep missing. I can hear the...

That's very discouraging...

It's not 10 years. It's frustrating that many either don't listen correctly or just join the bandwagon train from a fellow Tinnitus Talk member's post. The video never said 10 years. It said the most conservative estimate - the worst case - is 5 years for phase 3 but Carl says FX-322's phase 3...

Please discuss Hough Pill in the Hough Ear Institute thread. @Justin De Moss I have made a post in the Hough's thread regarding @ajc and @tommyd87's interpretation at this post: https://www.tinnitustalk.com/posts/543199/

@Justin De Moss, @ajc and @tommyd87 did misinterpret the answer regarding the off label use. Post #966 and specifically at the quoted answer at part 6, which was talking about off-label use not covered by insurance and that it would put "medical license in jeopardy": 6) If prescribed off...

Recently, my good ear is acting up. A few days ago I noticed certain sounds would make me a crackling noise afterwards. This cracking noise sounds like when you open your jaw and your eustachian tube opens. Certain sounds, like clicking on the light switch, pen dropping on the desk, microwave...

I'm sorry to say there isn't a cure or even an effective treatment to reduce tinnitus because most people, including medical professionals, do not view tinnitus as a serious issue to solve. However, there is currently research into repairing hearing loss in the hope that it can reduce tinnitus...

Is this invasive? Sorry, I haven't kept up with the vagus stimulation treatment research.

Not just FREQ but EARS, OTIC are also dropping.

The fundamental concept to your idea is, at our current understanding, is not entirely correct. The assumption is that "damaged" out hair cell removal will eliminate tinnitus. In other words, these "damaged" out hair cells are continuously activated to send auditory signals and so removing them...

It looks connected. You have really clean ear canals btw. When I used my otoscope my ear canal has so much junk. Best wishes when you see the ENT.

I'm not a doctor nor have experience but... it looks like cholesteatoma. It usually takes a while for it to build up. Have you looked at your ear drum recently? When was the last time that looked normal? It's described as skin growth that looks like a cyst or pouch. From that picture, it looks...

Developed a really loud unmaskable static hiss after the hour long fleeting tinnitus. The unmaskable nature is driving me nuts!

Me neither but if it truly eliminates tinnitus... and FX-322 doesn't work... this is the only route left. Then again, I don't think it's worth if it only reduces tinnitus. It would be similar to just masking devices for many but would be a life saver for unmaskable tinnitus. Too bad severing...

Seems like your tinnitus spikes during sleep. Do you have some kind of TMJ issues? Do you grind your teeth at night that can aggravate your tinnitus? Have you tried different sleeping positions, such as sleeping upright in a lounge chair instead of a bed? Just throwing out some thoughts...

Out of curiosity, wouldn't something like canalostomy (which drills a hole through the canal into the endolymph) introduce risks for symptoms to cochlear hydrops? From what I understood of the hypothesized cause of cochlear hydrops is that the endolymph-perilymph membrane is broken that results...