HLAA to Hold Patient-Focused Drug Development Meeting with FDA on May 25, 2021

Discussion in 'Awareness & Fundraising' started by Diesel, May 13, 2021.

    1. Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      I thought it would be beneficial for members of Tinnitus Talk to register for this meeting, or at the very least, submit comments on living with symptoms of hearing loss (Tinnitus, Hyperacusis, Noxacusis, et al). This is an opportunity for people suffering with these conditions to have their experience with the symptoms sent directly to the FDA. To those that think that the FDA & Drug Developers don't give enough attention / don't care about our suffering, this is your chance to make a tangible impact.

      Below is a link to the HLAA Registration Page:

      HearingLoss.org: HLAA to Hold Externally-Led Patient-Focused Drug Development Meeting for People and Families Living with Sensorineural Hearing Loss

      If you scroll down, you can submit comments as a person living with hearing loss & its symptoms. I encourage all to register and submit a comment.

      For more on the FDA program itself:

      FDA.gov: Externally-led Patient-Focused Drug Development Meetings
       
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    2. PortugalTheMan
      Shocked

      PortugalTheMan Member

      Location:
      Portugal
      Tinnitus Since:
      01/2021
      Cause of Tinnitus:
      Anxiety / Maybe years listening to music on headphones
      Done!
       
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    3. Christiaan
      Inspired

      Christiaan Member Podcast Patron Benefactor Hall of Fame

      Location:
      The Hague, the Netherlands
      Tinnitus Since:
      2016
      Cause of Tinnitus:
      2016: headphones, 2020: worsened thanks to Rammstein
      Capture d’écran 2021-05-13 à 16.21.37.png
       
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    4. serendipity1996
      No Mood

      serendipity1996 Member Podcast Patron Hall of Fame

      Tinnitus Since:
      2011 - T, 2016- H, relapsed 2019
      Cause of Tinnitus:
      noise-induced
      This is a really great initiative backed by Tinnitus Talk as well as all of the big guns - Frequency Therapeutics, Otonomy, Decibel Therapeutics etc.

      I submitted comments about hyperacusis and tinnitus and how current treatment options are failing us and the urgency of biomedical solutions.

      Importantly, all comments will be compiled in a written Voice of the Patient report, which will be produced a few months after the event. This is a really good chance to make your voice heard and draw attention to these devastating consequences of hearing damage!

      The event itself will also have closed captioning available for those of us unable to listen to the audio.
       
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    5. Markku
      Inspired

      Markku Founder Staff Podcast Patron Benefactor Hall of Fame Advocate

      Tinnitus Since:
      04/2010
      Cause of Tinnitus:
      Syringing
      Yes! We were keen to have a little presentation, but unfortunately the structure of the PFDD meetings do not allow partner organizations to present during the live meetings.

      Even so, please do everyone send your comments/questions via the form @Diesel linked to.

      :thankyousign:
       
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    6. TuxedoCat
      No Mood

      TuxedoCat Member Podcast Patron Benefactor Ambassador Advocate

      Location:
      US
      Tinnitus Since:
      April 2017
      Cause of Tinnitus:
      high frequency hearing loss
      Love this! I just submitted my comments.

      Thanks for posting @Diesel!
       
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    7. lapidus

      lapidus Member Benefactor

      Location:
      Sweden
      Tinnitus Since:
      1999
      Cause of Tinnitus:
      Noise induced
      Done!
       
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    8. serendipity1996
      No Mood

      serendipity1996 Member Podcast Patron Hall of Fame

      Tinnitus Since:
      2011 - T, 2016- H, relapsed 2019
      Cause of Tinnitus:
      noise-induced
      The event will be starting in an hour! There will be live captions available too.

      Sensorineural Hearing Loss Externally-Led...
       
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    9. ajc

      ajc Member

      Tinnitus Since:
      11/2002; spike 2009; worse 2017-18
      Cause of Tinnitus:
      Loud music - noise damage
      It's great how the FDA representative said that the FDA shouldn't be considered as some kind of monolithic adversarial entity and that the FDA employees are humans too and suffer from diseases themselves.
       
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    10. serendipity1996
      No Mood

      serendipity1996 Member Podcast Patron Hall of Fame

      Tinnitus Since:
      2011 - T, 2016- H, relapsed 2019
      Cause of Tinnitus:
      noise-induced
      Did anyone else watch this and catch the guy on the panel who has tinnitus and hyperacusis from a gunshot when he was 18? He had normal hearing beforehand, and that instant of noise was basically life-changing for him which feels so relatable for many of us. He also has hyperacusis-induced migraines and vertigo. I was actually worried that hyperacusis wouldn't get a mention at all.

      Hidden hearing loss and speech-in-noise was unsurprisingly flagged as a massive issue by most speakers. The inadequacies of hearing aids and current therapies were highlighted too.
       
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    11. serendipity1996
      No Mood

      serendipity1996 Member Podcast Patron Hall of Fame

      Tinnitus Since:
      2011 - T, 2016- H, relapsed 2019
      Cause of Tinnitus:
      noise-induced
      Omg when the presenter said they had a comment from someone who said "I have tried psychological help and sound therapy although these treatments have been of limited use" - that was ME. I submitted the comment to the presenters a few weeks ago so was not expecting that haha. That was just after Michael from Ontario's excellent phone call.
       
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    12. AUTHOR
      AUTHOR
      Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      It was good to see that hyperacusis was recognized on this call. I was a little disappointed that hyperacusis and "pain" were not more explicitly used in the audience polling. They used "headache" a few times, if I recall correctly.

      I was also a little disappointed that the panel was a little too focused on hearing aid improvements at the end to address what they valued as issues, when clearly the limitations of a device will never resolve their issues to begin with. Kind of a conundrum. And the reason why we need regen drugs.
       
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    13. Tezcatlipoca
      Question it

      Tezcatlipoca Member

      If they did that, then the panel fundamentally misunderstands us.
       
    14. AUTHOR
      AUTHOR
      Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      I'd have to go back and re-listen to Panel #2: Current and Future Treatments.

      The audience call-in had two people call in and reference regenerative medicine and struggles with hyperacusis.

      The panelists though, several had tinnitus. But none had hyperacusis, or didn't mention it. The panel definitely did not seem as informed on the several treatments in the pipeline, and what symptoms/issues they may be able to resolve. What was interesting is that a number of them mentioned issues like, hearing more clearly in noise, listening to music, having less distortion; which if they understood the drugs in clinical trials, would know that these would help all of the above. Instead focused these issues on hearing aids / CIs; which seemed counterintuitive to me. Meanwhile, when drugs were brought up, only one panelist really said anything of value and that was to "have extremely low expectations." I don't necessarily disagree there, as this the drugs in the pipeline are first gen and highly imperfect. But it would have been nice to have a panelist with some insight on the future treatments.

      This panelist discussion reminded me of the Henry Ford quote, “If I had asked people what they wanted, they would have said faster horses.”
       
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    15. serendipity1996
      No Mood

      serendipity1996 Member Podcast Patron Hall of Fame

      Tinnitus Since:
      2011 - T, 2016- H, relapsed 2019
      Cause of Tinnitus:
      noise-induced
      Incidentally, I have to say I was struck by how many participants reported persistent fatigue as a result of their hearing loss - to the point that they would have to take naps or consult doctors, as one woman put it. I think this just goes to show that you can't just brute force your way to hearing better, or 'strain' your ears harder - it is extremely cognitively taxing to deal with.
       
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    16. Tezcatlipoca
      Question it

      Tezcatlipoca Member

      Wow, that is a huge letdown.
       
    17. serendipity1996
      No Mood

      serendipity1996 Member Podcast Patron Hall of Fame

      Tinnitus Since:
      2011 - T, 2016- H, relapsed 2019
      Cause of Tinnitus:
      noise-induced
      To be fair, I feel it was balanced out by a fair number of people calling in saying they want regenerative treatments.
       
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    18. Tezcatlipoca
      Question it

      Tezcatlipoca Member

      I guess that's good, but we won't be properly represented until the people that represent us also say what we are saying.
       
    19. AUTHOR
      AUTHOR
      Diesel

      Diesel Member Benefactor Ambassador Hall of Fame Advocate

      Tinnitus Since:
      1-2019
      Cause of Tinnitus:
      20+ Years of Live Music, Motorcycles, and Power Tools
      I was honestly not surprised, and not let down. The industry and patient representation has a status quo; one that is clearly rejected or challenged by many posters in the Research News section. The HLAA is also part of that status quo as well. This isn't uncommon for any established industry that hasn't seen any real innovation in decades. The product consumers (patients/doctors) really can't see beyond what the industry is providing them, they've accepted that as the norm. This is the case with hearing aids and cochlear implants.

      To me, the important outcomes are that the consumer demands solutions that hearing aid and cochlear implant providers can't possibly provide: Hearing clarity in noisy environments. The ability to listen to music clearly. The ability to reduce/reverse hearing loss progression. Any alternative to a device to 'try.'

      So, the demand is there, it's just the established device industry doesn't have an incentive or ability to respond. This creates the opening for regenerative/restorative treatments.
       
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