Otonomy OTO-413 — Treatment of Hidden Hearing Loss

Discussion in 'Research News' started by Michael Larsen, Jan 9, 2018.

  1. Watch Hazel share good news about tinnitus
    1. hopes

      hopes Member

      Tinnitus Since:
      02/2020
      Cause of Tinnitus:
      Unknown
      So i have read some pages from this topic and if I am right, OTO-413 seems to only target acute hidden hearing loss, not chronic?
       
    2. Eliot Martin

      Eliot Martin Member

      Tinnitus Since:
      10/2021
      Cause of Tinnitus:
      Medications
      Where have you read that?
       
    3. aorelia

      aorelia Member

      Tinnitus Since:
      2021
      Cause of Tinnitus:
      Headphones
      I believe OTO-313 was initially targeting acute tinnitus. Have not seen that with OTO-413.
       
    4. hopes

      hopes Member

      Tinnitus Since:
      02/2020
      Cause of Tinnitus:
      Unknown
      OTO-313: early onset tinnitus
      OTO-413: having tinnitus is exclusion criteria
       
    5. Eliot Martin

      Eliot Martin Member

      Tinnitus Since:
      10/2021
      Cause of Tinnitus:
      Medications
      The exclusion criteria for OTO-413 is because some patients might not notice the improvement in hearing due to their LOUD tinnitus. Nothing more.
       
    6. Survivor234
      Hurting

      Survivor234 Member

      Tinnitus Since:
      2021
      Cause of Tinnitus:
      Noise-induced/Headphones
      Isn't OTO-413 designed to repair hair cells? If so, why is tinnitus excluded, considering noise-induced tinnitus is caused by bent or damaged hair cells?
       
    7. d'Wooluf

      d'Wooluf Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      unknown
      Answered in the post above yours. It's about getting a clean result in a clinical trial. It's not about equity.
       
    8. Survivor234
      Hurting

      Survivor234 Member

      Tinnitus Since:
      2021
      Cause of Tinnitus:
      Noise-induced/Headphones
      You don't understand. If OTO-413 repaired damage to hair cells, then those with noise-induced tinnitus should be a shoo-in for the treatment because success could also be measured by a reduction in tinnitus.
       
      • Agree Agree x 3
    9. d'Wooluf

      d'Wooluf Member

      Tinnitus Since:
      2010
      Cause of Tinnitus:
      unknown
      They're taking a hearing loss treatment to the FDA, not a tinnitus treatment. Any improvement in tinnitus would be a flow-on result of improvement in hearing. Improved hearing is the primary outcome.

      In any case, tinnitus is notoriously difficult to measure. If including tinnitus sufferers muddies the waters when it comes to measuring hearing, where's the upside in including them? It makes getting FDA approval a little less likely.
       
    10. Justin Mills

      Justin Mills Member

      Tinnitus Since:
      2 year
      Cause of Tinnitus:
      loud music
      OTO-413 doesn't work by repairing hair cells. It works by regenerating cochlear synapses.
       
      • Agree Agree x 2
      • Like Like x 1
      • Informative Informative x 1
    11. ColinUK

      ColinUK Member

      Tinnitus Since:
      2013 initial, worsened 2020
      Cause of Tinnitus:
      Initial Music Gig, Worsened Cinema or possible covid
      Unless it actually worked, I think it wouldn't be too hard to measure if people said "ooh, I don't have tinnitus anymore." I do think with a lot of these drugs it's a shame there's not a scatter gun approach at the start. Get a large group of people with different issues then narrow stuff down. With the ears it's all guesswork and theory at the moment. What if restoring the synapse does nothing on its own for hearing, but it could work for tinnitus or ear pain / sensitivity? They could be onto a winner but we will never know.

      I mean I hope that some of these drugs do something for someone and they can make it to market so people can try, but with how many different issues are caused by ear damage, it would be really great to know if any of these drugs have potential to relieve any of them.
       
      • Agree Agree x 2
    12. Matchbox
      Wishful

      Matchbox Member

      Location:
      BC Canada
      Tinnitus Since:
      August 2020
      Cause of Tinnitus:
      Noise Induced, Prednisone (drones), Barotrauma (distortions)
      They are one in the same man.
       
    13. Survivor234
      Hurting

      Survivor234 Member

      Tinnitus Since:
      2021
      Cause of Tinnitus:
      Noise-induced/Headphones
      Then why are they excluding people with tinnitus? Aren't some forms of tinnitus caused by dead or broken synapses?

      Furthermore, why did Otonomy state that OTO-413 repairs the ear rather than regenerates?
       
    14. AfroSnowman
      Balanced

      AfroSnowman Member Podcast Patron Benefactor

      Tinnitus Since:
      April 16 2019
      Cause of Tinnitus:
      Nonnatural energy source
      I think tinnitus is just another layer of complexity for a study looking at hearing restoration.
       
      • Like Like x 1
    15. Lucifer

      Lucifer Member Podcast Patron Benefactor Hall of Fame

      Location:
      Prison
      Tinnitus Since:
      -
      Cause of Tinnitus:
      -
      But can’t they list tinnitus as a secondary outcome?
       
      • Good Question Good Question x 1
    16. AfroSnowman
      Balanced

      AfroSnowman Member Podcast Patron Benefactor

      Tinnitus Since:
      April 16 2019
      Cause of Tinnitus:
      Nonnatural energy source
      Nope, only hearing.
       
    17. OptimusPrimed
      Spaced

      OptimusPrimed Member Benefactor

      Tinnitus Since:
      10/2007
      Cause of Tinnitus:
      Acoustic trauma - Repeated gun blasts
      I don't think this is the drug we're waiting for. They said on the Tinnitus Talk Podcast that there were no reports of tinnitus improving with the usage of the drug in the trials. Maybe the drug would have an application as an adjunct therapy with Dr. Susan Shore's device or something; but outside of that I remain skeptical.
       
    18. Survivor234
      Hurting

      Survivor234 Member

      Tinnitus Since:
      2021
      Cause of Tinnitus:
      Noise-induced/Headphones
      How is that different from regenerating hair cells?
       
    19. 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
      They also are excluding patients with bothersome tinnitus from the trial. So, chances are, if someone did have tinnitus that wasn't "bothersome," any improvement wouldn't be significant on a TFI anyway.
       
    20. OptimusPrimed
      Spaced

      OptimusPrimed Member Benefactor

      Tinnitus Since:
      10/2007
      Cause of Tinnitus:
      Acoustic trauma - Repeated gun blasts
      Upon further investigation, many experts in the field are theorizing that cochlear synaptopathy may in fact be responsible for some tinnitus and hyperacusis. Check out this quote from Dr. Charles Liberman. There may be a benefit of such drugs for those suffering from tinnitus or hyperacusis.

      In Conversation with Professor Charles Liberman

      Since acoustic overexposure is the most reliable way to produce tinnitus and hyperacusis in humans, and since both perceptual anomalies can occur without audiometric shifts, and since auditory-nerve synapses are the most vulnerable elements in noise damage, it was natural to hypothesise that synaptopathy might be a key elicitor of tinnitus and hyperacusis. There is now evidence from animal models that this type of peripheral neural loss is transformed into hyperactivity (both spontaneous and sound-evoked) throughout the central auditory pathways, as central neuronal circuits rebalance the excitatory and inhibitory inputs in response to decreasing ascending signals. It’s intriguing that, in some cochlear implant users, simply turning on the implant, and thereby restoring spontaneous activity to heretofore silent auditory nerve fibres, can attenuate the tinnitus percept. It suggests that reconnecting silenced spiral ganglion neurons to hair cells could also be a treatment for tinnitus. It might also be a cure for some types of hyperacusis, but see below.
       
      • Like Like x 2
      • Informative Informative x 2
    21. Justin Mills

      Justin Mills Member

      Tinnitus Since:
      2 year
      Cause of Tinnitus:
      loud music
      The difference is synapses are more vulnerable and take the brunt of the damage.

      @OptimusPrimed is spot on, that is the primary underlying cause for tinnitus and hyperacusis. I fully believe that regenerating the cochlear synapses will be the most effective way possible to reverse tinnitus. All the lost sensory input that is causing the overstimulation of neurons and ringing sounds would be restored.

      Hidden Hearing Loss: The Effects of Synaptopathy
       
      • Like Like x 2
      • Agree Agree x 1
    22. UKBloke

      UKBloke Member Benefactor

      Tinnitus Since:
      1991
      Cause of Tinnitus:
      Loud Music / family history
      Now I'm confused. Do we assume OTO-413 may be the treatment we're looking for or not?
       
      • Good Question Good Question x 1
    23. AfroSnowman
      Balanced

      AfroSnowman Member Podcast Patron Benefactor

      Tinnitus Since:
      April 16 2019
      Cause of Tinnitus:
      Nonnatural energy source
      Could be but we have yet to get any evidence at all that regenerative medicine impacts tinnitus. I'm waiting for the first hint of evidence that it will help, right now it is all just theory. That being said it makes sense to me.
       
      • Like Like x 2
    24. Geatly

      Geatly Member

      Tinnitus Since:
      12/2021
      Cause of Tinnitus:
      Noise induced, by jackhammering into concrete on constructio
      • Informative Informative x 2
    25. Joeseph Stope
      Innocent

      Joeseph Stope Member

      Tinnitus Since:
      1992
      Cause of Tinnitus:
      noise? infection? negative stress? other?
      When I first joined up here I thought tinnitus was all about damaged or missing hair cells.

      If there's one thing I've learned since then is that there are a lot more "moving parts" in the inner ear.
       
      • Agree Agree x 2
      • Like Like x 1
    26. 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
      These are great points, and I am aware of and agree that synaptopathy may be one of the underlying conditions causing tinnitus and/or hyperacusis. As someone who had progressive synaptopathy issues for about a decade prior to getting "hear it all time" tinnitus, I can anecdotally say there may be a correlation.

      However, that doesn't change that Otonomy isn't accepting patients with "bothersome tinnitus" into the OTO-413 trial, nor are they testing for it. So, within the scope of the Phase 2 in-progress, unfortunately they won't comment on tinnitus improvement or be able to provide any data/evidence that OTO-413 improves the tinnitus symptom vs placebo.

      They will either add tinnitus to a Phase 3 / Pivotal as an experimental outcome, or we'll have to wait and see what the early tinnitus-having recipients of the drug say.
       
      • Informative Informative x 2
      • Like Like x 1
    27. Joeseph Stope
      Innocent

      Joeseph Stope Member

      Tinnitus Since:
      1992
      Cause of Tinnitus:
      noise? infection? negative stress? other?
      It's great to have someone who knows the jargon and puts an optimistic slant on it. Not much I can add with my limited knowledge of medicine or the auditory system other than to say that Otonomy is fighting its corner in Bureaucracy-land where the costs in time and money are very high and where hearing tests in a sample (PTA WIN etc) yield concrete results whereas tinnitus tests get kind of mixed up with mood and placebo and might vary over time.

      So the way to get FDA approval is with concrete results.

      Once the drug hits the market, well, we can try for ourselves once the good doctor prescribes it.
       
      • Like Like x 1
    28. 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 appreciate the comment, however I am but a simple liquid hydrocarbon.

      The requirements to get a drug to product are simple: Identify a clear patient population, demonstrate that a drug is safe or with non-severe side effects on that population, demonstrate that it reliably performs better than placebo.

      The more variables the trial adds, reduces the clarity on patient population. That puts the likelihood of this product (and the underlying work / knowledge) of ever reaching the final production state.
       
Loading...

Share This Page