Hough Ear Institute's Hair Cell Regeneration Project

Discussion in 'Research News' started by all to gain, Oct 2, 2019.

    1. Thuan

      Thuan Member

      Location:
      California
      Tinnitus Since:
      05/2018
      Cause of Tinnitus:
      Ear infection
      If that's the case, then it seems quite redundant to do the tinnitus study. If the pill passes clinical trials for hearing loss issues, then I'm sure many of us will jump to buy it and see if it works for tinnitus! By that point, we'll know for ourselves if it works for tinnitus or not. And if many of us report that it doesn't work or have some relief, then the ongoing tinnitus study is moot. And it's also moot if many of us report that it has helped them through word of mouth. Speaking on the consumer side of things...
       
      • Agree Agree x 1
    2. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      According to Hough Ear Institute, the only benefit from conducting the PoC (Proof of Concept) study is to receive coverage from insurance if the pill’s prescribed solely for tinnitus.

      Hence if the pill is FDA approved for treating damage caused by ototoxicity, there is nothing stopping a specialist from prescribing the pill off-label to treat tinnitus.

      I am certain that many wouldn’t care about paying full price for the pill if their PoC study isn’t done for tinnitus prior to its release. That’s assuming it’s a successful treatment.

      Thus while the PoC study is necessary and beneficial to obtain cheaper access to the treatment, it isn’t necessarily as urgent as Hough Ear Institute has claimed. The treatment can be made available off-label simply after completing the FDA trial(s).
       
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    3. WillBeNimble
      Buzzed

      WillBeNimble Member Podcast Patron Benefactor

      Location:
      Ohio
      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Acoustic Damage from earphones
      It's not moot though. What Hough is hoping is that it becomes covered by insurance, which if it does, saves a lot of money for the sufferer.
       
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    4. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      I agree, however most patients (especially those outside America) actually aren’t eligible to get the treatment through the insurance anyway. Thus while I would wholly agree that doing the study is not moot it isn’t as beneficial for many as you may think.

      For example, I would need to pay the actual full retail amount if I obtained it in America. Alternatively in Australia I’d need to do the same, unless they subsidise this through the pharmaceutical benefits scheme. This is where our government pays for or covers a significant portion of a number of medications.

      Thus the pill’s release is possibly a bigger priority for majority of candidates than it being covered by insurance.
       
    5. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      Further follow up and further clarification from Hough Ear Institute:

      QUESTION:
      ANSWER:
      So at this stage it is evident that they want to push the treatment through a phase 2 trial for tinnitus. Despite Oblato being very interested in treating tinnitus, they were not able to fully fund the trial.

      It is also evident that Hough Ear Institute has come out with different and seemingly contradictory claims about the status of the phase 2 trial.

      First they said that the phase 2 trials will be starting this year and that according to what others like @FGG have claimed is that they will be testing for cochlear implant trauma as it is the quickest method for approval. Now they are saying that the trial will be delayed until the proof of concept study for tinnitus is finished.

      I am actually somewhat glad that we know now exactly where Hough Ear Institute stands regarding the pill, however I am not actually thrilled about their miscommunication/contradictory information in relation to the planned progress and testing methodology.

      Is anyone interested in having a discussion with them and/or doing a Q and A follow-up to discuss the pill? This was put forward as an option.
       
    6. ajc

      ajc Member

      Tinnitus Since:
      11/2002; spike 2009; worse 2017-18
      Cause of Tinnitus:
      Loud music - noise damage
      Just ask Justin De Moss to come back to Tinnitus Talk, he had already answered many questions here before.

      He really needs to clear the waters, Hough is appearing like a scam almost now... all the contradictory information and miscommunications is really hard to swallow.
       
      • Agree Agree x 5
    7. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      It’s possibly not the case but I feel like Oblato and Hough have confidence it works for the hearing loss side but don’t have confidence that it works for tinnitus. Thus the burning question is why won’t Oblato fund this on their own or at least the rest of it if they are absolutely keen to investigate tinnitus.

      @Hazel would you be interested in setting up another discussion with Hough.
       
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    8. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      So seeming we haven’t heard back from @Hazel, what sort of questions would people want to ask Hough in the event that we don’t get another talk done through @Hazel?
       
    9. Hazel
      Dreaming

      Hazel Director Staff Podcast Patron Benefactor Hall of Fame Advocate

      Location:
      the Netherlands
      Tinnitus Since:
      10/2017
      Cause of Tinnitus:
      one-sided hearing loss (of unknown origin)
      Apologies for not answering sooner. I had an insanely busy work week. (My tinnitus work is on a volunteer basis, next to my day job, as most of you know.)

      We're happy to mediate another round of questions for you guys. We can collect the questions in this thread, and then @Markku and I will forward them to Hough.

      I don't see much value in another podcast episode so soon after the last one, since I doubt there'll be enough news to fill an episode with.
       
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    10. Mentos

      Mentos Member Benefactor

      Location:
      Cracow, Poland
      Tinnitus Since:
      03/2015
      Cause of Tinnitus:
      Noise induced, loud rock concert
      Once Hough collects money for the proof of concept study, how much time is needed to start the phase 2 for tinnitus?
       
    11. tommyd87

      tommyd87 Member

      Tinnitus Since:
      1999
      Cause of Tinnitus:
      tmj music
      Justin was happy doing a call/interview/chat/whatever, although at this point I am thinking a text Q&A seems better.

      Why don't we wait a week or so and see what gets asked. As it stands I got many questions I want answered, although I will leave these for the time being as others have actually probably got the same questions. I will ask them though at a later time if they haven't been put up.
       
    12. Thuan

      Thuan Member

      Location:
      California
      Tinnitus Since:
      05/2018
      Cause of Tinnitus:
      Ear infection
      @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 label and/or the insurance company doesn't cover it because the study wasn't objective, rather subjective for example, then a patient could take it - for any reason they wanted to assuming that a) their Dr. is willing to write a script for the drug for an indication that the drug has not been approved for (and thus potentially putting their medical license in jeopardy) b) they don't mind paying the full market value of the drug - which can be thousands if not tens of thousands of dollars.​

      My interpretation is that it can be used off-label but doctors' might be not willing (due to the nature of off-label use jeopardizing medical license but is entirely dependent on the doctor's choice) and if the doctors are willing, then it concerns about insurance coverage.

      I see that some people can misinterpret assumption "A" regarding off label use can put doctor's "medical license in jeopardy" as an interpretation that it can not be used off-label.

      Expanding on the general confusion:
      @tommyd87 main concern, and probably the general consensus, is that the extra tinnitus study is unnecessary when a clinical trial for hearing loss is being conducted because the general assumption is that curing hearing loss cure tinnitus (but that has not yet been proven so everyone's just banking on this assumption).

      Personally, I would be in favor of a tinnitus study once the hearing loss trial show positive results in phase 2. If it does show positive results from the hearing loss study, then I think it would be necessary to do a tinnitus study. The issue is that it would be an entire waste of both money and time if the hearing loss study do not show positive results. Again, the assumption is the correlation between hearing loss and tinnitus. Based on that assumption, if it shows no efficacy regarding hearing loss, then it would be unlikely to help tinnitus and thus prematurely conducting hearing loss study and tinnitus study at the same time is jumping the gun.

      @Justin De Moss Thank you for your interaction and discussion at Tinnitus Talk.

      With that being said, I can understand everyone's frustration at the slow pace of things. As someone who had mild tinnitus developing into moderate tinnitus 3 months ago, I'm also desperate and impatient to push for fast results. We're all impatient that a tinnitus study is needed to be funded when a hearing loss study is already green lit.
       
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    13. Rb86

      Rb86 Member

      Tinnitus Since:
      5/31/19
      Cause of Tinnitus:
      Noise
      @Justin De Moss I haven't read the others' apparently disrespectful posts but let it roll off your back.

      I can tell you all I've had numerous emails with Justin and he gives a shit. Genuinely. I've also been the frustrated hopeless and angry guy on here too.

      I honestly get both sides. We need a cure yesterday and it's hard to pull off. Really hard.

      Continue to fight the good fight. Putting a dent in, if not curing tinnitus would be one of the most righteous feats for mankind the world over.

      Anxiously waiting.
       
      • Like Like x 15
    14. Piney

      Piney Member

      Tinnitus Since:
      March 2018
      Cause of Tinnitus:
      Shingles virus
      I got an email stating Hough were entering Phase 2 trials, not sure if it meant now or in the future.
       
      • Informative Informative x 5
    15. wwtsai

      wwtsai Member Benefactor

      Tinnitus Since:
      2016
      Cause of Tinnitus:
      SNHL
      Can you post the language from the email? Thanks.
       
      • Good Question Good Question x 2
    16. Piney

      Piney Member

      Tinnitus Since:
      March 2018
      Cause of Tinnitus:
      Shingles virus
      You’re a hero – a hearing hero! You’ve implemented safer hearing practices with your family and already had or at least scheduled everyone’s annual hearing exam. WOW! I’m so grateful for your dedication to your children’s future and success.

      Because you’re so invested in this beautiful gift of sound, I want to share with you the hope for hearing restoration. Some of you might suffer from hearing loss damage that you’ve been told can’t be fixed. Maybe your parents’ hearing is deteriorating. It’s possible that your child even has some form of hearing loss like Eloise, who I mentioned in my last email.

      Hearing loss causes deteriorating relationships and adds more obstacles to life. But there is a hope dawning on the horizon! Hough Ear Institute has spent over two decades researching and creating medicines with the hope of restoring hearing. And today, I’m proud to tell you that we are closer than ever! Our proprietary hearing loss pill is entering phase 2 FDA clinical trials, and we have so much more in the works. This pill is the closest science has ever been to hearing restoration – apart from a device or expensive technology. Simply put, this pill works to regrow the nerve endings in the inner ear to restore hearing function and make it better. We are closing in on something that was once thought impossible!

      And because you’re a hearing hero, I knew you’d want to be part of this amazing adventure into scientific breakthroughs! You have the opportunity to partner with this work and build a legacy of hearing restoration. How? Well I thought you’d never ask!

      Put your money where your ears are – literally! Your donation of any amount keeps this research moving ahead, even during a pandemic. If you’re a new donor to HEI, or your gift is over $1000, it will be matched 100% (for a limited time). That means you can DOUBLE your impact with just one donation!!

      Become an advocate at your child’s school for the hearing impaired. Let your voice be heard and show your local educators that you care about those kids who are struggling because of hearing loss. Rally behind your local officials to implement annual hearing testing in schools.
      Continue to practice healthy hearing practices and get those annual tests scheduled for next year!

      You and your kids are the reason why we are doing this work. You’re also the way we are able to do the work. Will you continue your heroic efforts in hearing health and give to Hough Ear Institute today? Will you give hope to kids just like Eloise?

      Sincerely,
      sig.jpg
      JUSTIN DE MOSS, M.A., CFRE
      Chief Philanthropy Officer
       
      • Like Like x 3
    17. Rb86

      Rb86 Member

      Tinnitus Since:
      5/31/19
      Cause of Tinnitus:
      Noise
      Just letting you all know... Per email conversation, funding has not reached all the way to the goal, but it is now close enough that they're starting their proof of concept study for tinnitus TOMORROW!!!!
       
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    18. DebInAustralia
      No Mood

      DebInAustralia Member Benefactor Advocate

      Location:
      Geelong, Victoria
      Tinnitus Since:
      30/12/13
      Yes, Justin emailed me that last night. Great news! Do you know how long this proof of concept study will take before we have something more concrete to hope for?
       
    19. Rb86

      Rb86 Member

      Tinnitus Since:
      5/31/19
      Cause of Tinnitus:
      Noise
      I sure don't. But it's my hope that this trial will serve our community really well, because Frequency Therapeutics is only testing for hearing regrowth and not really focusing on tinnitus like this trial will do. I'm hoping we have direct information on how people's tinnitus reacts to this drug.
       
    20. BBakkers
      Not amused

      BBakkers Member Podcast Patron Benefactor

      Location:
      Netherlands
      Tinnitus Since:
      2011, Spike 2019, Spike 2020
      Cause of Tinnitus:
      1e Loud Music, 2e earwax irrigation, 3e padel tennis
      So where can we find the link to this clinical trial?
       
      • Good Question Good Question x 5
    21. Brians81
      Gloomy

      Brians81 Member

      Location:
      Indiana
      Tinnitus Since:
      April 23 2020
      Cause of Tinnitus:
      Noise induce trauma
      This great news. I hope we will hear about this proof of concept study on tinnitus and I hope this treatment may help us all. Praying to God for this miracle to happen ✝️
       
      • Like Like x 3
    22. Nobody19

      Nobody19 Member Podcast Patron Benefactor

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Clubbing
      Frequency Therapeutics is also testing the effect of their drug on tinnitus, but their main focus is hearing regrowth.
       
    23. weab00
      Alone

      weab00 Member Benefactor

      Location:
      depression-ville
      Tinnitus Since:
      04/2019
      Cause of Tinnitus:
      music, concerts, whiplash; 08/20 H worsening
      Can someone provide a link for the commencement of Phase 2 for the pill? The only thing I can find is the copy paste on this forum. Is there at least a screenshot or something?
       
      • Good Question Good Question x 1
    24. Thuan

      Thuan Member

      Location:
      California
      Tinnitus Since:
      05/2018
      Cause of Tinnitus:
      Ear infection
      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 their Hough Ear Institute website if they're starting clinical trials on their advertised "Pill", and especially including a direct link to ClinicalTrials.gov.
       
    25. Rb86

      Rb86 Member

      Tinnitus Since:
      5/31/19
      Cause of Tinnitus:
      Noise
      Are they though?

      I recall from Tinnitus Talk Podcast when asked about tinnitus, that Carl LeBel said they aren't testing for that, but that one or two patients mentioned to their ENT doctor that the tinnitus had improved during the trial.
       
    26. Rb86

      Rb86 Member

      Tinnitus Since:
      5/31/19
      Cause of Tinnitus:
      Noise
      To my knowledge, Hough Ear Institute is doing a proof of concept study to show the pill is effective for tinnitus, so that investors will feel it is worthy of spending money on clinical trials. I don't know how they're doing the proof of concept. I don't know if that means humans or not.

      I'll email Justin De Moss and see if he can answer that here.
       
    27. Nobody19

      Nobody19 Member Podcast Patron Benefactor

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      Clubbing
      https://clinicaltrials.gov/ct2/show/NCT04120116?term=frequency+therapeutics&draw=2&rank=1

      Secondary Outcome Measures :

      Tinnitus Assessment [ Time Frame: Screening to Day 210 ]
      Measured by the Tinnitus Functional Index (TFI), with a scale ranging from 0 to 100 that defines severity categories based on 25 self-reported answers.
       
    28. GregCA
      Jaded

      GregCA Member Benefactor Hall of Fame

      Tinnitus Since:
      03/2016
      Cause of Tinnitus:
      Otosclerosis
      What's the difference between a "proof of concept study" and a "clinical trial"?
       
      • Good Question Good Question x 6
    29. Kendra

      Kendra Member

      Tinnitus Since:
      08/2017
      Cause of Tinnitus:
      SSNHL/ Acoustic Trauma
      I believe (could be wrong) a proof of concept can use animals or other means to show it has the potential to work. While a clinical trial needs to be done on humans to show it works and is usually the next step.
       
      • Like Like x 1
    30. Joeseph Stope
      Innocent

      Joeseph Stope Member

      Tinnitus Since:
      1992
      Cause of Tinnitus:
      noise? infection? negative stress? other?
      The big unanswered question is of course: "Will this work for chronic tinnitus (i.e. more than 3 … 6 months duration)?"
       
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