Frequency Therapeutics — Hearing Loss Regeneration

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

    1. Foncky
      Tired

      Foncky Member Benefactor

      Location:
      Europe
      Tinnitus Since:
      March 2004
      Cause of Tinnitus:
      Music. Balloon. Genes.
      Or maybe we just didn't know about it, because no internet ?
       
    2. Vinnitus
      Tired

      Vinnitus Member Benefactor

      Location:
      Amsterdam
      Tinnitus Since:
      28/04/2016
      Cause of Tinnitus:
      Acoustic Trauma
      Well, if I understand the research of Liberman and Shore correctly, it is the synaptic loss in the inner-ear which triggers a loss of auditory input to the dorsal cochlear nucleus. As the brain searches for homeostasis and wants to keep the input on the same level, the input of the somatosensory nerves becomes more pronounced (i.e. hyperactivated). Both auditory and somatosensory nerves ultimately come together in the DCN. This would explain the somatic Tinnitus a lot of us have (hearing tones when moving jaw, turning head, etc) as this involves stimulating the facial nerves. This is of course hugely simplified.

      If that's the case (and if I understood correctly), supplying the DCN with enough auditory stimulation due to the repaired synapses might result in toning down of the somatosensory nerve hyperactivity by the brain (seeking homeostasis again) and thus possibly toning down Tinnitus. At least the somatic Tinnitus...
       
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    3. Vinnitus
      Tired

      Vinnitus Member Benefactor

      Location:
      Amsterdam
      Tinnitus Since:
      28/04/2016
      Cause of Tinnitus:
      Acoustic Trauma
      Well, last time I went outside they are still taking the same audiograms for people with hearing loss and still trying to sell hearing aids to them, just like they did a few decades ago (only the hearing aids became arguably "more advanced"). The research might have continued, but I am sure not on the level as we see it now. There's a graph somewhere on this forum which shows the annual increase in research articles on Tinnitus and/or hearing loss, so I am fairly sure it is not that we "just didn't know about it", but rather that "nothing much happened".

      However, I am sure the introduction of the internet makes it a whole lot easier for research groups to share their findings, increase their collective knowledge so they don't have to reinvent the wheel, and hence get us a treatment faster.

      So yeah, interesting times I still think.
       
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    4. AUTHOR
      AUTHOR
      RB2014
      Confused

      RB2014 Member Benefactor

      Location:
      US
      Tinnitus Since:
      12/2014 became noticable
      Cause of Tinnitus:
      Loss of hearing and then stress and anxiety
      I experiment on myself enough to know that when I have my hearing aides in my T can be a 1 or a 0 some days. If I pull them out my T can get to a 5 within minutes. When I put my hearing aides in and start hearing sound it goes back to a 0 or a 1. Our brains are pretty plastic and will adjust accordingly.
      There are so many conditions of H and T, but a general statement would be that when the hearing loss is corrected the T will go away. I have proven this in myself many many times and I think I am a typical example of getting T by having hearing loss and activated by anxiety.
       
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    5. serendipity1996
      No Mood

      serendipity1996 Member Podcast Patron Hall of Fame

      Tinnitus Since:
      2011 - T, 2016- H, relapsed 2019
      Cause of Tinnitus:
      noise-induced
      It's impossible for any of us to say for certain but the tone of the articles, as others have mentioned, seems to be cautiously optimistic. How bad is your hearing loss? xx
       
    6. cornelius

      cornelius Member

      Tinnitus Since:
      2002
      Cause of Tinnitus:
      several acoustic traumas, always physician denial
      @RB2014 Could you also tell us please how is the sharpness and comfort of your hearing along with tinnitus depending on volume and dynamic fluctuations when you wear hearing aids ? I mean : are the surrounding sounds becoming metallic / distorded along with tinnitus raise when surrounding volume and dynamics are raising, peaking etc ?
      Nearly all hearing loss and tinnitus sufferers I've asked including me have this. I believe this phenomen should be more taken in consideration, assuming like some researchers that amplifying sound in the ear could lead to even more deleterious lesions. Unless you are lucky enough not having this issue.
       
    7. AUTHOR
      AUTHOR
      RB2014
      Confused

      RB2014 Member Benefactor

      Location:
      US
      Tinnitus Since:
      12/2014 became noticable
      Cause of Tinnitus:
      Loss of hearing and then stress and anxiety
      I don't think I have what you are talking about. My tinnitus does not go up in volume and sounds do not become more distorted. If there is a very high volume then yes, my tinnitus will get worst, but with normal volume my tinnitus will go down with the sounds coming into my ear.
      My left ear is worst than my right ear and I attribute that to not wearing a hearing aid in my left ear the first 10 years. I think not stimulating those frequencies makes the hair cells die faster. Its only speculation though, but my understanding and ability to hear are much better in my right ear after wearing a hearing aide in it for a longer time than my left.
       
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    8. attheedgeofscience
      No Mood

      attheedgeofscience Member Podcast Patron Mighty Benefactor Hall of Fame

      Location:
      Denmark
      Tinnitus Since:
      Resolved since 2016
      Cause of Tinnitus:
      Unknown (medication, head injury)
      By 2018, the journalist means/meant clinical trials; not market launch.
       
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    9. Vinnitus
      Tired

      Vinnitus Member Benefactor

      Location:
      Amsterdam
      Tinnitus Since:
      28/04/2016
      Cause of Tinnitus:
      Acoustic Trauma
      That explains. The sudden pace and optimism of things already caught my amazement. Of course that is not how it should be. :p Well, clinical trials it is then. Fair enough.
       
    10. tomytl
      Grumpy

      tomytl Member Benefactor

      Tinnitus Since:
      10 Years
      Cause of Tinnitus:
      unknown
      It's absolutely amazing that we have now 2 highly specilized companies working on regeneration programs. Decibel and Frequency has a lot of knowledge. And if they can run trials within 18 monthes, would be very nice.
       
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    11. Reinier
      Not amused

      Reinier Member Podcast Patron Benefactor

      Location:
      Netherlands
      Tinnitus Since:
      06/2015
      Cause of Tinnitus:
      Explosion starting engine
      So they will be phase 1 clinical trials.
      They must have researched their approach for some years.

      When they give an indication for when to expect clinical trials phase 1, they must be pretty confident. Phase one is only to see if there are no adverse effects in humans. But still, this surely can be placed under positive news.
      News that keeps me going (-;
       
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    12. Rasmus
      Cool

      Rasmus Member

      Location:
      Denmark
      Tinnitus Since:
      around 02/2015
      Cause of Tinnitus:
      Not sure maybe to much noise
      Im just a little curious are people hype about this because it can cure maybe hearing loss or maybe T ? :)
       
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    13. Reinier
      Not amused

      Reinier Member Podcast Patron Benefactor

      Location:
      Netherlands
      Tinnitus Since:
      06/2015
      Cause of Tinnitus:
      Explosion starting engine
      Yes, maybe. That is what the researchers at these companies are working for.
      Cure or improve.
      See different links.
       
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    14. Mricha37

      Mricha37 Member

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Car subwoofers for 6 years
      I believe these companies know more than they are leading on. Why would they release research that has cost them millions of dollars and years of work prior to clinical trials.

      There's a race for a treatment between multiple companies. I'm freakin' stoked!! :)
       
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    15. cornelius

      cornelius Member

      Tinnitus Since:
      2002
      Cause of Tinnitus:
      several acoustic traumas, always physician denial
      Let's hope that optimization of safety along with transparency will prevent crooks from hiding some dangerous side effects in this race. There was a link on the forum about a case in clinical trials for some diseases in China. The true seal of safety and efficiency might be the first and genuine patients themselves talking about how they feel, maybe even some years after the treatments launches
       
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    16. Rings-a-Bell

      Rings-a-Bell Member

      Location:
      Barbados
      Tinnitus Since:
      April 2016
      Cause of Tinnitus:
      Accoustic Trauma
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    17. Twitch

      Twitch Member

      Location:
      Earth
      Tinnitus Since:
      2014
      Cause of Tinnitus:
      Unknown
      One problem I envisage is strict enrolment criteria and will likely require participants to have profound hearing loss for enrollment for phase 1 at least.

      I hope the companies widen the scope of their target market not just to cover 'profound' hearing loss but also other ear/balance related conditions + tinnitus. I fear if the regenerative treatments cover profound hearing loss only, it will be a bitch to get any treatment that comes to market for off label use for tinnitus.
       
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    18. Aaron123

      Aaron123 Member

      Tinnitus Since:
      00/0000
      Cause of Tinnitus:
      Irrelevant
      Frequency is very clear that their leading indication is "chronic noise induced hearing loss". They are not clear about the level of loss, but my reading is that they might not restrict the treatment/trials to severe/profound loss. (It's just marketing, but their web page on hearing loss has people with earbuds and at concerts. These don't necessarily lead to severe or profound deafness.) They also make it clear that the injection method is in common use with an existing billing code so the main cost would be for the drug.

      The bigger question isn't coverage for tinnitus, it is whether insurance companies would pay to restore high frequency hearing loss with otherwise normal hearing or to restore "mild" hearing loss that doesn't require hearing aid. At least in the US, hearing aids aren't typically covered by insurance so it seems like it might be a stretch to get reimbursement for regeneration in a case where a hearing aid is not required. It would be very useful to have much more sophisticated testing, and it is entirely possible that the need to be reimbursed might drive broader use of high frequency hearing tests or other advanced (or perhaps not net used) testing if the results of such tests resulted in insurance reimbursement.
       
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    19. Mricha37

      Mricha37 Member

      Tinnitus Since:
      2008
      Cause of Tinnitus:
      Car subwoofers for 6 years
      The real question is what would the cost be of the drug? Would it be cheaper than a lifetime of hearing aids? My brother has purchased in his life conservatively 60,000 in aids, not to mention hundreds of thousands in private schools and speech therapy since he was born.

      I hope in a few years they would have an estimated cost, if it's 100,000 no way could I ever afford that. If 10,000 I'd go tomorrow and write a check.
       
    20. spingee
      Wtf

      spingee Member

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    21. Michael Larsen
      Surfing

      Michael Larsen Member

      Tinnitus Since:
      2000
      Cause of Tinnitus:
      Noice
      Does anyone know if you can pay to be first on the list for a clinical trial
       
    22. AUTHOR
      AUTHOR
      RB2014
      Confused

      RB2014 Member Benefactor

      Location:
      US
      Tinnitus Since:
      12/2014 became noticable
      Cause of Tinnitus:
      Loss of hearing and then stress and anxiety
      I'm pretty sure you can't pay to be on the list of the clinical trial.

      I get what you guys are saying, but really no one knows what will happen if this is applied to humans. That is why they will begin their testing on people with severe to profound hearing loss. If someone comes in with a 25db loss, which is not much, and then loses another 25db because of this procedure, they are going to be pretty ticked off. Look at the Novartis trial. Some people got worst after the injection.

      Aaron123, I like your optimism and I think this will be a procedure that anyone can do with any type of loss, just not for the clinical trials.

      Last time I went in for a simple procedure for my nose they wanted $5k after insurance to cover doctor, supplies, and 4 hours in a room at the hospital. I'd pay $5k easily. Really if I could get back my hearing I'd write a check for $50k or even $100k and just take out of loan on my house. Hearing aides are not covered and that is correct, but most ENT procedures are covered. I would think this would be covered by insurance if your hearing reaches a certain point, probably in the severe to profound range.

      For what its worth, I'm in the states and I think I might be a candidate. I'm in the moderate(low) to severe/profound (high) range right now. I think even then my hearing is considered to good for most trials.
       
    23. Samir
      Obedient

      Samir Manager Staff Benefactor Ambassador Advocate

      Location:
      Sweden
      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Accoustic trauma
      Good point!

      But what could they be hiding? That the treatment is more effective than they let us believe? That it can be used in other applications? They want to be involved in more than just hearing disorders. I'm thinking they might see hearing disorders as an easy way in, to get things started and get the cash flowing.

      I can't seem to find the page now, but I think I read the other day that Frequency already has some kind of skin-related treatment ready for the market. I may have looked at a different company, I don't know. I will see if I can find it again. But you can tell by the paragraph above that they want to do more than hearing restoration.

      Without doubt, the future looks bright! :) Thanks to brilliant scientists, excellent science and technology, and people who have the vision and courage to take risks and build enterprises that pursue the impossible in order to enrich people's lives.
       
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    24. InfiniteLoop
      Relaxed

      InfiniteLoop Member Benefactor

      Location:
      Redwood City, California
      Tinnitus Since:
      01/21/2014
      Cause of Tinnitus:
      High frequency hearing loss in left ear from head trauma (?)
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    25. acufenero
      Starving

      acufenero Member

      Tinnitus Since:
      August 2014
      Cause of Tinnitus:
      Acoustic trauma
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    26. Samir
      Obedient

      Samir Manager Staff Benefactor Ambassador Advocate

      Location:
      Sweden
      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Accoustic trauma
      Yes, this is my concern too. The general idea seems to be that people who have least to lose and most to gain are the most favorable trial candidates. I think this is common practice in other trials as well for other kind of disorders or diseases.

      I doubt it's possible to widen the scope of indications that much. They might as well just call it TMPCAD - The Magic Pill to Cure All Diseases. I might be wrong. But tinnitus is thought to be a secondary symptom of hearing loss. The best way to test that hypothesis is to create a treatment for hearing loss and get it out to patients who have both hearing loss and tinnitus.

      How do you normally get prescription drugs without a prescription? You can ask the same supplier. Even if you somehow get the drug you would still need a trained professional to administer it for the best outcome, not just some herbalist Joe from downtown.

      But I can feel your frustration! I would hate it too if there was a treatment for "profound" hearing loss, but not for moderate or mild hearing loss. It's as if these are all different indications! Well, they are not! They are all the same indication, namely "hearing loss". It's just different levels of severity. I don't think they can compare this to formal medical classifications like Type I diabetes, and Type II diabetes. No way! It's just audiologists who found the need to "classify" people with profound, severe, moderate and mild hearing loss by looking at their "gold standard" audiograms.

      Take sensorineural hearing loss and conductive hearing loss! Now that's two different medical classifications! But all levels of sensorineural hearing loss, i.e. "hearing loss", have one thing in common: damage to the sensory and/or neural cells of the cochlea.

      I think the investigators might target people with severe or profound hearing loss during the trials. But once they come out of the trials and prepare for market release they will undoubtedly market the product for all levels of (sensorineural) "hearing loss".

      I agree though that they should include people with moderate or mild hearing loss. For Trial 1, I would assume they will target the "profound" group in small numbers, then profound and "severe" for Trial 2 and in larger numbers, then profound, severe and "moderate" and in even larger numbers for Trial 3. Then lastly profound, severe, moderate and "mild" group in the post-trial sales phase.

      These are important questions that no one seems to ask. No one except the patients with hearing loss who are waiting and hoping for a cure. You don't see the researchers and journalists discuss "hearing loss" in these terms. As I stated above, I think they might include only people with profound hearing loss in the early clinical trial. But I expect them to expand that scope as they progress to the next phases that follow.

      Correct me if I'm wrong, but my understanding is that profound, severe, moderate and mild hearing loss is not part of the medical classification. My impression is that this 4 level "classification" is something that audiologists came up with while looking at their precious audiograms. It may also play an important role with insurance companies when you make a disability claim. Maybe you want to sue your employer for work related hearing loss. This might be an example where the level of disability might play an important role.

      Under ICD-9 system, sensorineural hearing loss is classified as 389.1. This in turn can be classified in greater detail.

      • 389.10 Sensorineural hearing loss, unspecified
      • 389.11 Sensory hearing loss, bilateral
      • 389.12 Neural hearing loss, bilateral
      • 389.13 Neural hearing loss, unilateral
      • 389.14 Central hearing loss
      • 389.15 Sensorineural hearing loss, unilateral
      • 389.16 Sensorineural hearing loss, asymmetrical
      • 389.17 Sensory hearing loss, unilateral
      • 389.18 Sensorineural hearing loss, bilateral

      This is how sensorineural hearing loss indications are described under 389.1.

      • "Due to lesions of the cochlea and the auditory division of the eighth cranial nerve; problem of cellular dysfunction rather than airborne conduction
      • "Hearing loss caused by a problem in the inner ear or auditory nerve. A sensorineural loss often affects a person's ability to hear some frequencies more than others. This means that sounds may be appear distorted, even with the use of a hearing aid. Sensorineural losses can range from mild to profound"
      • "Hearing loss resulting from damage to the cochlea and the sensorineural elements which lie internally beyond the oval and round windows. These elements include the auditory nerve and its connections in the brainstem"
      Source: http://www.icd9data.com/2015/Volume1/320-389/380-389/389/389.1.htm

      There is mention of "mild to profound" as a "range" of sensorineural hearing loss at the root entry of the code system. But there is no mention of this "range" in the detailed description of each of the underlying codes.

      So the disease or disability is classified by type, rather than severity in the medical classification systems. However, severity might be used in disability and insurance claims systems. But we are discussing the medical part of things. So in this context at least, "profound" unilateral, sensory hearing loss is the same condition as "mild" unilateral, sensory hearing loss. Any treatment will have to match the condition or disease, not its severity.

      You have now touched on a key issue! (y)

      If you have "mild" unilateral, sensory hearing loss, do you then qualify as 389.17? So you have sensory lesions but because your audiologist classified it as "mild" you may not be able to get reimbursement for the treatment from the insurance company.

      I predict that the access to treatment in the first years will be a struggle between patients, insurance companies and audiologists. From the looks of it, audiologists might have the final and decisive word. Because people that don't have sensory lesions severe enough won't get reimbursement from their insurance company for the treatment. They will have to pay out of their own pockets. I'm sure many will do just that. But this is another reason that we need a treatment on the market as soon as possible. So that many more people may afford it in the coming years, because with time, and with availability of a successful treatment the insurance companies will have to change their policy.

      Yeah... they have to prove you have that high frequency sensory cell lesion. How can you prove that with a standard "golden standard" hearing test that goes only up to 8000 Hz? I totally understand what you're saying, and I agree. A successful treatment for hearing loss would be completely game changing, not only for patients. It would also shake up the medical establishment! They would have to come up with a better "golden standard" for auditory assessments.

      Currently OAE and ABR tests are a good complement to the standard audiogram, but they are rarely ever used. They are almost exclusively used on newborn babies, and on patients that are almost deaf and will undergo cochlear implant operation. They will have to start using OAE and ABR more extensively, until we get better diagnostic tools.
       
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    27. Samir
      Obedient

      Samir Manager Staff Benefactor Ambassador Advocate

      Location:
      Sweden
      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Accoustic trauma
      Just to be clear, someone named Samuel Thomas commented:
      Screenshot:
      comment.png

      How can he have received this therapy when the clinical trial has not started yet? Have they started doing pre-clinical studies on humans?
       
    28. RaZaH
      Cheeky

      RaZaH Member Benefactor Hall of Fame

      Location:
      Reykjavík, Iceland
      Tinnitus Since:
      2012/04
      Cause of Tinnitus:
      Benzo + loud noise
      It looks like a joke to me .
       
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    29. AUTHOR
      AUTHOR
      RB2014
      Confused

      RB2014 Member Benefactor

      Location:
      US
      Tinnitus Since:
      12/2014 became noticable
      Cause of Tinnitus:
      Loss of hearing and then stress and anxiety
      It is a joke. He is pretending he is a mouse. The mice have been cured, just not humans.
      tiny squeaks....
      eating cheese....
      hates cats.....
       
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    30. Samir
      Obedient

      Samir Manager Staff Benefactor Ambassador Advocate

      Location:
      Sweden
      Tinnitus Since:
      12/2016
      Cause of Tinnitus:
      Accoustic trauma
      I hope this means that they will use FDA Accelerated Approval Program.

      Yeah, it's a joke.

      Here is the Facebook profile of that individual:
      https://www.facebook.com/profile.php?id=100009531257369

      According to his profile he or she likes Donald Trump, and a community called "I hate Stephen Shand for what he has done" - a man who raped and killed a teenager.

      Tell me more! :cat:

      Where might I find this individual?...
      o_facecoverz.com-1324245459696.png

      :ROFL:
       
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