MemberUhm... Somatic tinnitus is DEFINITELY chronic. I've had it for 30 years!My 6 stages of grief.
What does she mean by no news as of yet
Guys, for our sakes, let's slowly back off this, and look at other trials.
I'm not going to lie, the fact they always kept stressing somatic tinnitus and not just chronic tinnitus always gave me doubts.
But hey at least she
replied so there must be some confidencez I guess...
New University of Michigan Tinnitus Discovery — Signal Timing
- Thread starter Hudson
- Start date
Based on the research I read, it boils down to cells that fire together, wire together. Cells that fire apart, wire apart. I think that by firing a shock before the tone in damaged auditory systems, it is supposed to suppress. I know with my stuff, I am able to achieve some measure of inhibition of my tinnitus.
Hopefully, FX-345 works down to 4 kHz... I always wondered what would happen if they mixed FX-345 with stem cells or PRP. I think the FX-345 will make it to market before bimodal. There are just too many permutations with bimodal.
On the other hand, improving hearing tremendously improves tinnitus for many people. So there is a great correlation that would be beneficial.
I find that unlikely, as FX-345 hasn't even started phase 1 yet. But then again, this thread was started 10 years ago, so...
- Dec 17, 2014
- 163
- Tinnitus Since
- 11/2013
- Cause of Tinnitus
- Zithromycin acoustic trauma 2022
No. The last update from Dr. Shore is still the email she sent in April. From that, we know that their next steps are to 1) publish the data from their most recent phase 2, and 2) to move on with the process of getting FDA approval. What isn't exactly clear to me is when she'll start the FDA process: after submitting the study to a journal, or only after the study is published. Her email suggests the latter.
I think it's (somewhat?) safe to assume the results were positive. If they were negative, it wouldn't have made any sense for her to indicate that they would move on with getting FDA approval. Now, how positive the results were, and which patients benefited the most from it, is anybody's guess at this point.
AfroSnowman
Member
- Jul 23, 2019
- 1,074
- Tinnitus Since
- 04/2019
- Cause of Tinnitus
- Nonnatural energy source
In my sample set of one, I had my hearing suddenly severely damaged instantly giving me severe tinnitus, after a half year or so my hearing remarkably healed and apparently returned to baseline (preexisting mild hearing loss ~30 dB >4 kHz) but the tinnitus didn't change one bit.
So in my little sample set of one, maybe underlying hearing loss was a precondition to me getting tinnitus, but reversing the triggering damage did nothing to undo the condition once established.
- Dec 18, 2015
- 618
- 45
- Tinnitus Since
- 03/2015
- Cause of Tinnitus
- Noise induced, loud rock concert
Did you have some form of tinnitus accompanying your mild hearing loss prior to tinnitus becoming severe?
That is a very real possibility that we all have to keep in mind when thinking about the potential benefits about regenerative drugs. On the other hand, like the person you're replying to said, even stuff as limited as hearing aids help some people.
In any case, this discussion is interesting but I'm not sure why we're even having it here, as Dr. Shore's work has nothing to do with regeneration.
AfroSnowman
Member
- Jul 23, 2019
- 1,074
- Tinnitus Since
- 04/2019
- Cause of Tinnitus
- Nonnatural energy source
- May 16, 2021
- 75
- Tinnitus Since
- 2009
- Cause of Tinnitus
- Visual Snow Syndrome, possibly TMJD/Cervical Instability
Can anyone give me some expectations?
Will Dr. Shore's device be helpful for visual snow syndrome induced tinnitus? It's somatic so it would meet the criteria I guess, but I have no clue why I got it honestly, it's comorbid with TMJ/D, neck and ETD issues.
Will Dr. Shore's device be helpful for visual snow syndrome induced tinnitus? It's somatic so it would meet the criteria I guess, but I have no clue why I got it honestly, it's comorbid with TMJ/D, neck and ETD issues.
- Dec 17, 2014
- 163
- Tinnitus Since
- 11/2013
- Cause of Tinnitus
- Zithromycin acoustic trauma 2022
- Feb 11, 2019
- 801
- Tinnitus Since
- 01/2014
- Cause of Tinnitus
- Headcold/Flu
I seem to recall that Clinical Trial Results were supposed to be released in July.
I check her Site frequently, and all we still have is that notice posted on 09/07/21 (which, after nearly a year, states that it is "nearly market ready").
Our Chicago Tribune in their Health & Wellness Section had a lengthy article about this in 01/05/2018 (and about how it would be available soon), and my faith and other's in this has been tested more severely than Abraham's when God told him to slay his son.
I still submit that, like my migraines, the real treatments will have to come from drugs.
- Mar 2, 2018
- 280
- Tinnitus Since
- 2/2018
- Cause of Tinnitus
- Rock 'n Roll
Looking at the trial, those it will not work for are:
1) Tinnitus >1 year
2) >Moderate hearing loss
3) Any vestibular causes
It is also being tested for unilateral tinnitus, although that may just be because it is easier for subjects to rate loudness and pitch as the other ear does not impair this.
Completion date this month, so they couldn't have been analysing any data yet.
Good to see a large group of 400. Big difference to Lenire's 20 odd.
I kindly disagree with 1), 2) and 3). We do not know for who the treatment works yet. As for the scope of the trial, you want to make sure your trial proves significance so you will set clear criteria to do so. Not being included in the criteria does not mean it does not work for you.
This device has only been tested on 20 people too. Based on those assumptions criteria were set for the next trial.
That is not what the trial description implies. Just because they aren't including a certain set of people as participants doesn't mean it won't work for them.
I stand corrected and see your point. It just makes the trial more specific and allows for better results I guess. I just looked at who was included in Phase 2.
Similar to OTO-313 using <6 months, which does not mean it will not work for >6 months?
- Mar 2, 2018
- 280
- Tinnitus Since
- 2/2018
- Cause of Tinnitus
- Rock 'n Roll
@Nick47, when it comes to getting a drug or device through FDA approval, setting narrow trial parameters is key. If they took every instance of whatever they were trying to treat under the sun, nothing would get through. You still may be right, but we have a few anecdotes of people who had been suffering a lot longer than a year and experienced positive results in Phase 1. Let's hope it's that way for Phase 2 and beyond!
There's no proof that standing on your head might not cure cancer yet, so why not try it?
Point being that the prove-a-negative approach is a backwards one. Those evaluating treatments want evidence that it will work for them, not go on a wing and a prayer.
Yup, and for those who are outside of the acceptance criteria, this study isn't going to provide that specific evidence.
In addition to this, this study is also not evidence that it won't work for them. Absence of evidence isn't evidence of absence.
To give you a bit of insight as to why it still is useful: quite often, results do transfer over to different populations that aren't exactly the same as the population in the initial study. For example, we often start studies on rats because we see a reasonable amount of transferrable findings to humans. Just because you haven't been selected in the rat study doesn't mean you won't benefit from it.
[USER=35136]@GlennS[/USER], very true. It's not up to me to prove it doesn't work. It's for them to prove it does.
But given the well-established intractability of tinnitus how likely is it that those outside the acceptance criteria will benefit?
I mean, we already have studies suggesting it will work (i.e. Neuromod's) which turn out to not even be trustworthy.
Is it reasonable to leave a huge percentage of tinnitus sufferers guessing like this?
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