Frequency Therapeutics — Hearing Loss Regeneration

Discussion in 'Research News' started by RB2014, Dec 8, 2016.

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    1. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

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      The audiogram doesn’t measure whether or not a patient can hear a tone in the binary sense. It measures how much sound power in decibels are required at a specific frequency for a patient to hear a tone. For example, at 8 kHz, if a patient can hear the tone with 10 dB of power, it is considered within the normal range. If 50 dB are required, it is considered a moderate loss at that frequency.

      The challenge with the audiogram as a measurement tool is as follows:

      1. The tests produce a margin of error of up to +/- 10 dB at any given frequency. So, a patient could come in one day and detect 8 kHz at 20 dB one day, and 15 dB the next, and that’s considered normal.

      2. Decibels are a logarithmic measurement of sound power. A tone produced at 20 dB is 10x more powerful than the same tone produced at 10 dB. The same tone produced at 30 dB is 10x more powerful than one at 20 dB, which is 100x more powerful than the original produced at 10 dB. When looking at the audiogram, which measures from roughly 0 dB to 90 dB, it’s not sensitive enough to show changes on the low or high end of the power spectrum.

      3. The biology of the cochlea doesn’t match the output of the audiogram completely. To a human ear, each increase in tone by 10 dB, represents about 3x-4x improvement, not 10x as per the decibel scale. There’s also some level of redundancy in the cochlea hair cells, as up to 50% of outer hair cells need to be depleted before losses consistently show up in the audiogram. The human biology doesn’t take into account frequencies, those are man-made. So, the preset tones in the audiogram may not reflect the optimal biological ability of the cochlea.
       
    2. Eliot Martin

      Eliot Martin Member

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      Only 6 dB improvement and they call it "clinically meaningful". Who is going to pay hundreds of dollars for a slight yet not even noticeable improvement in hearing?
       
    3. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

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      Here's where we get into trouble with FX-322.

      If a patient is at / near a "normal" ceiling in terms of decibels, and regeneration takes place. Let's say 20 dB at 8 kHz. What is the likelihood that a regenerated cell or cells in that region are going to show an effect? There is an obvious ceiling effect and greater complication due to the margin of error with the audiogram as a measurement tool.

      If we consider that a range of patients with various hearing loss levels at 8 kHz were recruited into the program. Where there are normal (10-20 dB), all the way to as much as 70 dB needed to hear the tone. Then, consider the potential for a ceiling effect for those in the normal range. It makes it difficult to show a significant improvement vs placebo for a cohort that got drug.
       
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    4. Gb3

      Gb3 Member

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      Well if they said there was improvement in tinnitus, he wouldn’t be saying that. Listen, I was very hopeful about this drug too but I’m just following the outcomes of the latest trials. It doesn’t seem that promising.
       
    5. SD7
      Angry

      SD7 Member

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      I don't want to impute on @Diesel's character my understanding reading his past posts is that he's been pretty consistent. It's just hard to imagine that Frequency Therapeutics would read out the TFI even if they were good given the backdrop that these same members mislead to get into the trial.

      Their overall data is not bad. You can hold them accountable for originally misjudging the depth of the formulation. That being said we don't know if the drug is a failure yet based on drug delivery or amount of dosage contingencies.

      There are actually two bad outcomes here.

      1. If the drug is a failure.

      2. If the drug works but they can't get it to properly administer in the cochlea.

      They seem confident that the current issue is the latter.
       
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    6. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

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      A 6 dB improvement in a SIN test would definitely be noticeable in every day environments for someone with hearing-in-noise issues.

      Also, FX-322 is probably going to be in the thousands per dose.
       
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    7. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

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      SD7 is correct. FX-322 looks promising for a specific group of patients with acquired SNHL in the moderate range. That’s still 10-20 million in the US. Nice opportunity. This is probably the baseline for their PCA approach for hearing cells.

      FX-345 builds from the learnings of FX-322. It appears that they want to expand the market of patients with acquired SNHL that can be treated with FX-345. Plenty of opportunity.
       
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    8. Survivor234
      Hurting

      Survivor234 Member

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      Oh, so does this explain why I can hear up to 15 kHz if I raise the volume high enough but I can't hear it otherwise? Do volumes go by dBs? What is a ceiling effect?

      Hopefully the drug comes out so we can do some actual appropriate tests. I feel like a lot of what is established in audiology isn't appropriate for measuring hearing regeneration.
      So, at a certain level, you wouldn't be able to measure improvement in hearing higher frequencies at all? This means we wouldn't even know for certain whether ear hair cells have been completely regenerated?

      By the way, is it possible for cells to overgrow or regenerate beyond "top" capacity and why? I read the transcript for the Tinnitus Talk Podcast but I didn't really get an answer besides "we didn't find that there is".
      That sucks ass.

      Even after the drug comes out, it'll likely be unaffordable to most people.
       
    9. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

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      Yes. Volume is measured by dBs. Ceiling Effect = Something can only improve so much. In the case of hearing, it can only get so good. To be more scientific, the hearing hair cells being regenerated reach a point where hearing maxes out its sensitivity to sounds at low decibels. Which is what is really happening with hearing is restored.
      With the audiogram alone, correct.
      It doesn't appear that it is possible with the PCA approach Frequency is using for hearing hair cells. Apparently gene-therapy / stem-cell type methods might cause an overpopulation, but I am not as well versed in that area to answer in detail.
      This is the case for most drugs that are new treatments with no alternatives / no competitors. In fact, most drugs in general are priced that way without insurance. Frequency mentioned a while ago that they are working with insurers on reimbursement strategies, which is a signal that they make some headway in co-pays for treatment. Total speculation.
       
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    10. Survivor234
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      Survivor234 Member

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      Sorry. By that I mean like headphone volumes.
      What else can we use to measure the amount of hair cells regenerated?
      That is true. However, many people want to regenerate all their hair cells so as to avoid situations where a loud noise could possibly give them hearing loss again. 50% of your hair cells may need to be depleted before any hearing loss can be measured, but people don't want 40% of their hair cells. They want 100% so that they don't have to worry too much about it.
      Do you think it will be covered by Medicaid? I know that hearing aids aren't covered by Medicaid (although I think there was a bill that failed to pass a while back that was supposed to do that). If this works, this would be massive enough that I think it would be a human rights violation if it wasn't easily available.
       
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    11. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

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      Same applies. Decibels.
      To my knowledge, there isn't a good clinical test to determine if an individual patient's hair cells are regenerated. FX-322 only as recently as a few years ago demonstrated it is possible in humans. The tests have a long way to go to catch up with regenerative science. All clinical tests assume that human hearing degrades over time, therefore do not have a validated mechanism to measure regeneration. Some of the tests still in use today were developed as far back as the 1940s, and haven't changed too much (Standard Audiogram). In a lab, scientists can extract a cochlea and observe hair cell regeneration. But that isn't exactly practical for a living patient.
      Probably true for most anyone with some type of degenerative disorder. The reality is though, this is cutting-edge science being commercialized, and the baseline right now is low, but it won't be forever as long as the demand for a "higher regenerative %" exists.
      Depends on legislative branch and executive branch passing bills that allow it to be.
       
    12. SD7
      Angry

      SD7 Member

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      Headphone volume is also decibel measured. Moreover you should stop testing your hearing. It's easy to damage your ears that way.
      Word Scores or Speech in Noise.
      It will probably be impossible to know how much of the hair cells are regenerated but you for sure don't need anywhere near 100% of them back.
      Speculation here but I actually think it will be covered by Medicaid. You're mistaken, in the States Medicaid does cover hearing aids but it depends on the state that is distributing the funds. Some people in the past have tried to tie this kind of technology outcome to LASIK but with respect to inner hair cell function there is no equivalent like glasses to compensate so I think it will be near impossible to classify this as an elective option. But it remains to be seen if this is the way in the future.

      "Human rights violation," we have lots of those with respect to healthcare, sadly.
       
    13. Survivor234
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      Survivor234 Member

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      If I had known this, I would not have been as abusive towards my ears as I was. This should be far more well-known.
      There is allometric scaling which gives them something of an idea as to how much they can expect to regenerate (which is why they can say that they regenerated 40% of ear hair cells). However, it seems you're right that there is no way to observe hair cell regeneration. But, when you consider this:
      Wouldn't that make the entire conceit of hair cell regeneration moot? If you don't know how much hair cells you regenerated, then why would any "upgrades" matter to people at all? If you can't tell, then you wouldn't know whether you've been duped or if you've actually regenerated your hearing.

      Could 20,000 Hz be that new form of measurement? Only children can hear up to 20,000 Hz and it requires reaching to the end of the cochlea. Maybe that is what counts for "100% hearing"? That way you know for certain that you have all your hearing back (I would think).
      High frequency hearing is significantly better and actually reflects higher amounts of hair cells.
       
    14. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

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      I could hear 20,000 Hz at 28, and still had hearing in noise issues at that age. But, I digress.

      The problem is establishing a reliable baseline to specifically know that certain cells regenerated from previous dead areas of the cochlea.

      With the current testing, a baseline can be established with common clinical measures. Including: Audiogram (250 Hz - 8 kHz, Extended High-Frequency Audiogram (8 kHz - 16 kHz), Word-In-Quiet Score (50 Words), WIN/SIN tests (Words in varied noisy/multi-talk backgrounds). All of these figures can allow a clinician to conclude that a patient's hearing performance is normal, or some range below normal -> mild, moderate, severe in a number of categories: Pure Tone, Word Recognition, Words in Noise.

      However, NONE of these tests can truly tell the clinician that the outer hair cells on the 250th-500th rows on the cochlea from the base are damaged and need targeted for regeneration. Or that perhaps the cells are fine, but the synapses are what are no longer connected to the cells. Or, perhaps that there is a combination of cell loss and synapse loss throughout the cochlea, but the synapse loss is greater, so the patient will benefit from a synaptophathy repair first. Or, perhaps there is no dead cell damage at all, or synaptopathy damage, but the patient has some highly worn cells in a key location that need to be observed. Really, what makes sense is a way to image the cochlea like we do the brain for patients with MS or other neurological conditions.

      Back to the 20,000 Hz measurement problem. Currently, intratympanic drugs enter into the base of the cochlea first, which hits the highest frequencies first, and then work their way towards the apex, where low frequency detection exists. You might say, well wait a minute, so let's make 200 Hz the magic number. Well, problem is, some people's hearing wears from the high-frequency down, while others from various locations and outward. Since the condition is extremely heterogeneous and highly individual, so is the success criteria.

      See example below:

      different%20aspects%20of%20organ%20of%20Corti.png
       
    15. SD7
      Angry

      SD7 Member

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      Hearing isn't cumulative in nature like that unfortunately. Each subset of frequency is independent of the other, so it's possible to be able to hear 7000 Hz better than 250 Hz. Knowing if one could hear 20 kHz doesn't give any indication of how great ones hearing is with respect to the lower frequencies or how well the cochlea is doing as a whole. Paradoxically, reaching the higher frequencies is easier than the lower ones since the cochlea curls towards the apex where the lower frequencies are sheltered.
      While it's true the audiogram in a sense reflects higher hair cell count with respect to the outer cells which have a 3:1 ratio with respect to the inner cells that are measured with Speech in Noise or Word Scores, it isn't true that hearing high frequency tones is significantly better. Speech is much more than quantity; it's also quality and that's in part why Frequency puts so much emphasis on Speech in Noise and Word Scores. There is currently no fix for Speech Clarity and Perception while there does exist hearing aids which, although not great, do compensate for the volume of certain frequencies. If by "High Frequency" hear you mean ultra high frequencies like those found near 20 kHz, those frequencies serve less practical purpose than those found at 4 kHz-7 kHz which help distinguish between a S and an F.
       
    16. Survivor234
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      Survivor234 Member

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      Do you think that is possible? Also, based on what you tell me, it looks like hearing loss is going to be a multiple-treatment procedure. Perhaps, for hearing loss to truly be eliminated, you'd need a combination of hair cell repair, regeneration, and synaptopathy.

      Also, based on the graph, is it possible to get back your hearing for 20,000 Hz but lack the ability to hear 15,000 Hz? Furthermore, do we need to create a drug delivery system that can curve into the cochlea? Perhaps a flexible needle or something?
       
    17. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

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      100%.
      Yes. The drug itself needs more development to diffuse more deeply. It seems ill advised to have a physical object (needle) entering the cochlea; it is liquid-filled. Otonomy claims to have full penetrance into the cochlea with a single dose (no references though), and it seems as though FX-345 can get deeper on a single dose. It's really just a matter of time / money until scientists figure out a way to get an intratympanic FX-drug to diffuse more deeply with one or more doses. The sooner one of these firms can get positive cashflow from a 1st gen drug, the higher the likelihood of them discovering a formulation that covers the whole cochlea and/or can be multi-dosed.
       
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    18. Survivor234
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      Survivor234 Member

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      But the drug is for hair cell regeneration, right? Wouldn't the goal then be to determine if the hair cells have been regenerated? Perhaps a big reason why Frequency Therapeutics hasn't been transparent about why they have the results that they do is because they don't know why they have those results. They don't know why some of their patients got better while others didn't and they probably have no way of knowing. They can make estimates, guesses, etc. but they don't have a good way of determining whether regeneration is working at all, if it is why it isn't working, etc.

      I have lost the ability to hear beyond 12,000 Hz. That is severe hearing loss for my age (19) and it will undoubtedly get worse as I get older. It also makes me significantly more susceptible to greater hearing damage, speech, etc. I want to be able to avoid losing my hearing and regain what I have lost. This means that I can't tolerate this kind of ambiguity.
       
    19. Survivor234
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      Survivor234 Member

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      100% what? That imaging of the cochlea is possible (in which case I would like evidence - I would also like to know your qualifications as you know significant amounts of information pertaining to the ear), or that hearing loss removal is going to be a multi-treatment procedure?
      Unfortunately, whatever drug delivery system Otonomy has come up with is patented so it's unlikely Frequency Therapeutics could use it or anything similar to it. I feel like competition, at least in the case of medical research, seems to be more of a hindrance than a benefit. Especially considering that these companies are already on FDA payroll and competing for the same pot of money (which surely would be counterproductive).

      By the way, why is it ill-advised to have a physical object enter the cochlea?
      If the drug's success is impaired by the lack of a solution which covers the whole cochlea or is multi-dosed, then it may not make money at all regardless of whether the drug itself should've been able to do those things and successfully regenerates hair cells.
       
    20. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

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      Frequency has observed human inner and outer hair cells being regrown in human cochlea with FX-322 in-vitro. The drug working in a living human is more difficult to observe, it requires sampling in ways that don't harm the patient, and using models that help understand what is happening.

      The sample size of patients isn't big enough yet to make a bonafide prediction on who the drug will help the most, who will see mixed results, who it won't help. That's why clinical trials exist. That's why they're in Phase 2B with the drug.
       
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    21. SD7
      Angry

      SD7 Member

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      Right. I mentioned that part because you had said "High frequency hearing is significantly better and actually reflects higher amounts of hair cells." It's important to remember that the audiogram only attempts to see if the outer hair cells are functioning, not the inner ones. I don't think there's any doubt that the ultra high frequencies will be regened before the lower ones in the grand scheme of things.

      I think Frequency has been one of the most transparent companies and I say this having no financial (no stock) or personal (I believe my issue is primarily synapse related, you'll see me sweating next year around summer when Pipeline and Otonomy take the stage) reason.

      As discussed prior with both me and @Diesel, there is no way to see how any hair cells have been reached because of the protective nature of the cochlea but their intermediate results are not bad even though they could be better.

      Not sure about your history but if hearing loss doesn't affect your day to day and it's primarily your tinnitus troubling you, I think you're in good company for the future of this regen medical field. Rest easy.
       
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    22. Survivor234
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      Survivor234 Member

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      That's true. I now realize that I am wrong about that and that high frequency hearing doesn't tell you too much about how many hair cells are regenerated.
      Had they achieved 100% regeneration? What was the kind of damage done to the cochlea in the jar?
      It's my hearing loss that troubles me, not my tinnitus. My tinnitus has actually gotten significantly quieter over the days after I realized I had it (I am 100% sure I had before that realization but I only started taking action recently). There are some spikes but they are always temporary and never reach the highs of my past baseline.

      I also think tinnitus is going to be completely healed by Dr. Susan Shore's device which deals with overactive neurons that are causing the tinnitus and that's, at least in comparison to Frequency Therapeutics or Otonomy, actually commercializing soon.
       
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    23. SD7
      Angry

      SD7 Member

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      If I remember right they used Gentamicin for uniform destruction, I don't remember them presenting pictures (this happened before my ears were damaged). During their last R&D they showcased a Mouse Cochlea which had recovered a huge chunk of their IHCs and some OHCs where there was nothing before.
      Really happy to hear about your tinnitus and you're right there's a real chance the Shore device may diminish what is left. I actually think, given your age, if you drop headphones and protect your ears in loud situations you will be fine in the long run. Just pop in plugs when volume gets near loud bar levels if you really want to protect you ears going forward.
       
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    24. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

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      100% regeneration needs better definition.

      I can only recall prior webinars.

      They mentioned in a prior JP Morgan presentation that they had acquired thousands of donated human cochlea to test in-vitro. In my own research, donated organs usually includes a copy of the expired patient's medical records. So, it could have been a range of just older people, or those that died of causes that didn't affect their cochleas. It's likely they had a range of hearing loss levels in the cochleas from age-related, noise, etc. to work with. It's also possible they had agents available to kill off the hair cells, then applied FX-322 to demonstrate regrowth.
       
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    25. Survivor234
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      Survivor234 Member

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      I think, in general, tinnitus will probably be solved by Susan Shore's device (or whatever device improves upon that one). Tinnitus is caused by overactive neurons (which may, in turn, be caused by other factors such as sinus infections, anxiety, TMJ, bent hair cells, etc.) so addressing those neurons and suppressing them would eliminate tinnitus in most people.

      Recovering hearing loss is another issue entirely and that is going to be the purview of Otonomy, Frequency Therapeutics, and whatever other company/scientists want to take the step forward to stop hearing loss will take it from there and I will be paying attention (because I'll likely go deaf or have bad hearing earlier than most people).

      My tinnitus is definitely not as bad as the tinnitus of many other people. I was very lucky, considering the degree of my hearing loss and my abuse of my ears, for my tinnitus to have decreased as much as it did. It has gotten good enough that I sometimes think it is just white or background noise. However, I am still interested in getting rid of tinnitus and seeing a cure both because of the people who do have severe, debilitating tinnitus that can't be dealt with through CBT or habitation like me and because I still am annoyed by tinnitus and would rather do without it.

      I don't see what age has to do with it though. I think protecting your ears should be done by everyone. Furthermore, it should probably be public knowledge that the volumes of any computer are actually measured in decibels so that headphone users and others can avoid using those amounts. I killed off a good chunk of my hearing and got tinnitus because I didn't know this.
      Have they successfully managed to regrow all inner ear hair cells within the cochlea? That is what 100% regeneration means for me.
       
    26. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

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      @Survivor234, we can find out in the Phase 2b trials if there is any improvement in audiograms since they are testing at the high of 16 kHz. They will do these tests first before giving them FX-322 to have a baseline, then compare before and after injection results.

      If a few patients could have improvements at 8 kHz in the Phase 1b trials, I can’t see why not more patients could have more improvements between 16-8 kHz or lower in the Phase 2b trials.
       
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    27. SD7
      Angry

      SD7 Member

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      Interesting... Also I don't think you'll go deaf or even have bad hearing earlier than most people. Just be vigilant going forward.
      You're right they should. I only mention age because the older population didn't respond as well to the regen. This could be because of either lack of support cells or stria degeneration or something else they don't know.
       
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    28. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

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      Then the answer is no.

      They have observed regrowth in areas of missing / dead / damaged inner and outer hair cells. Progenitor Cell Activation ONLY appears to work on the LGR5+ Support Cells when the adjacent daughter cell (the hair cell) is missing/dead/damaged.

      If there is a hair cell that is normal, has some slight wear but is intact, then the neighboring "mother" Progenitor Cell won't activate and create a new daughter cell. Therefore, it isn't possible to have a 100% regenerated cochlea with all new cells.

      The best you would end up with are brand new, "green" cells where dead ones once existed, and untouched "worn" / "original equipment from birth" cells that aren't dead enough for PCA to activate. They still might not even be working up to normal specification, either. That wouldn't qualify as 100% regenerated.

      Best case scenario is you'd have to make trips back to the ENT for a re-up of FX-322 injections as those "worn" cells started to advance more quickly and started to die off and are able to be regenerated.

      Alternative case, is there's some way to WIPE OUT all Inner and Outer hair cells, leaving the progenitors in place, and then running a whole-cochlea PCA process to get them all to regen as "green" again. But that is highly risky.
       
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    29. Survivor234
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      Survivor234 Member

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      As for what I said about Susan Shore's device, I hope I'll get corrected if I am wrong.

      According to trials, there are some cases where tinnitus only decreased among participants rather than eliminated entirely (only two participants actually reported that their tinnitus was gone). Susan Shore's device is certainly better than nothing (like taking Melatonin for instance) but eliminating tinnitus is going to be the product of further research and improvements.

      However, I think Susan Shore is right on the money though in regards to dealing with tinnitus. Many other treatments aren't directly treating the tinnitus insofar as dealing with the underlying symptoms. Obviously this could work, and it has, but tinnitus is arguably caused by more than just bent hair cells and is strictly caused by the brain. It's neurological, not physical, so we shouldn't be surprised if merely regrowing hair cells doesn't actually deal with tinnitus (at least for some people).

      That's interesting btw. The progenitor cells should still be there regardless. Why isn't regen working on them? What is the "older population"? 40+, 50+, etc.?
      I already have bad hearing. I can only hear up to 13 kHz overall (and that's just being optimistic; I can realistically only hear up to 12 kHz). And there's no way to go but downward from there.
       
    30. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

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      The Age-Related trial was 65+. Stria deterioration is common past 65. So it's possible their strias were too far deteriorated to support renewed hair cells.
       
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