New University of Michigan Tinnitus Discovery — Signal Timing

[DaveFromChicago]

Nearly can be up for interpretation. It can mean a few years.

This is the actual definition of "nearly":

near·ly
[ˈnirlē]
ADVERB

1. very close to; almost:
   "David was nearly asleep" ·
   just about · about · practically · virtually · all but ·

Three years is not very close to anything or "just about" to occur in my humble estimation.

 

[kingsfan]

I guess no news is better than bad news... aggravating though. Back to my tomb then. I will awaken in 2023 to check on results.

 

[Bambam0]

Nearly can be up for interpretation. It can mean a few years.

He was probably referring to the device itself. Once FDA approves it I bet it's released quickly. That's the whole purpose of the Auricle Corporation being set up. To market and sell the device. They're obviously working with the FDA already.

 

[SR88]

Everyone needs to chill a bit. The study will be concluding this month and it will be unblinded during the FDA approval process. The pace will be determined by the FDA. I have faith that the company will do their part to go as fast as possible as they certainly have the incentive.

 

[Uklawyer]

it will be unblinded during the FDA approval process

The study will be unblinded during the FDA approval process?

I don't get it...

 

[Gb3]

The study will be unblinded during the FDA approval process?

I don't get it...

He's incorrect.

 

[GlennS]

I can't believe she is now talking about 2023.
Dr. Shore... everything has been so slow...

(deep cut here) She kind of reminds me of Jimmy Page's constant teasing of new solo projects (which has gone on for over 20 years now).

 

[Linari5]

Let's face it. We aren't going to know anything until at least the end of next year. Results must not be that spectacular or she would be pushing a little faster to cash in. I have been a big believer in Dr. Shore's work, but at this point she is turning into a joke...

So much drama here. She is a professional medical researcher developing a novel treatment for tinnitus - the scientific process is rigorous and there are innumerable factors to be considered. I always knew this would be 2023. I don't understand how people can get upset at a deadline they ASSUMED on their own ends.

Dave, you keep on referring to this article, who was quoted saying that it was about to be ready for release? Dr. Shore, or someone associated with her? It doesn't seem her style or anything like what I've heard her say.

Are you sure it wasn't just a "reporter" trying to make their article more click bait worthy? I'm just wondering if your frustration should be placed with the journalist, not with Dr. Shore et al.

I do a lot of work with the press and I can tell you it is a PITA because they frequently get the information wrong or take a different angle than what you are actually saying,

Exactly. Maybe he was referring to Auricle, the commercial arm. Which, arguably, IS actually ready. But the research is the ox pulling the cart here. The cart is already done but the ox isn't.

Totally, F-u-T.

I wish I had made that comment about this becoming a joke, especially given that carrot-in-front-of-a-stick 09/07/21 notice about how this was nearly ready for release.

A question from a non-scientific prole: How is it that in spite of disappointing results Lenire is now available throughout Europe and in their preparation for upcoming USA release has established a headquarters in Oakbrook, IL? (Which, BTW, is not far from me). How have Neuromod been able to move this so much faster and not be hampered by what Dr. Shore cites as various difficulties?

I think I could summarize it this way: they are very different approaches -

Neuromod - no placebo/not great science, investors and commercial stakeholders driving things, top goal is profit no matter what.
Auricle - placebo controlled/rigorous science, goal is not solely financial, but more medical/research driven.

 

[PeterPan]

So much drama here. She is a professional medical researcher developing a novel treatment for tinnitus - the scientific process is rigorous and there are innumerable factors to be considered

I'm not buying it. As others have said, they could have done all the stats pre-work in advance and just plug in the numbers when they become available at the end of the trial. Probably would take no longer than an afternoon to determine whether the trial has been successful and to what extent.

 

[Jerad]

I'm not buying it. As others have said, they could have done all the stats pre-work in advance and just plug in the numbers when they become available at the end of the trial. Probably would take no longer than an afternoon to determine whether the trial has been successful and to what extent.

@PeterPan, so are you suggesting there's a reason they haven't released any results yet (i.e. perhaps they were disappointing)? I dunno how all this works for sure, to be honest. It's fun to speculate, but we don't want to cause ourselves unnecessary worry either. I hope the results are tops.

 

[GlennS]

So much drama here. She is a professional medical researcher developing a novel treatment for tinnitus - the scientific process is rigorous and there are innumerable factors to be considered. I always knew this would be 2023. I don't understand how people can get upset at a deadline they ASSUMED on their own ends.

So I assume when it shifts to 2024 you will be the first to tell us all to stop being upset once again? Maybe an annual ritual?

 

[DaveFromChicago]

So I assume when it shifts to 2024 you will be the first to tell us all to stop being upset once again? Maybe an annual ritual?

Great point about this "annual ritual" (which I have encountered every year since January 2018, when our Chicago Tribune reported that it was "almost ready.")

If Dr. Shore's theory regarding the misfiring fusiform cells in the DCN is correct, then why hasn't it been universally acknowledged with very numerous researchers around the World working off the same premise?

Also, I believe you coined the quite clever term "hopium"; this is what I have had to relinquish regarding all this Dr. Shore / Auricle business.

 

[UHPTS]

If Dr. Shore's theory regarding the misfiring fusiform cells in the DCN is correct, then why hasn't it been universally acknowledged with very numerous researchers around the World working off the same premise?

I've been thinking the same. There were some attempts to adopt this idea. There was this wrist band that produces haptic sensation together with sound stimuli. Maybe some other devices which I don't recall now.

We had Dr. Lim, who was portrayed almost as a God who will save us all from tinnitus. He went to work for Lenire so the device had to work. It didn't.

I'm adding word "rigorous" to my list of BS words.

rigorous /ˈrɪɡ(ə)rəs/ - adjective (meaning): I need way more time and money to continue my "research"...

 

[David S]

If Dr. Shore's theory regarding the misfiring fusiform cells in the DCN is correct, then why hasn't it been universally acknowledged with very numerous researchers around the World working off the same premise?

I think future will show that tinnitus is much more of a cochlea thing than a brain ting. I like the theory of broken OHC. Once broken they will be hypersensitive and react to very little sound stimulation. That would also explain distortions and reactive tinnitus. If right, OTO-313 might work in many more cases as long as your tinnitus originates from the cochlea. No matter if you have had tinnitus for one year or five years.

 

[Chinmoku]

I'm not buying it. As others have said, they could have done all the stats pre-work in advance and just plug in the numbers when they become available at the end of the trial. Probably would take no longer than an afternoon to determine whether the trial has been successful and to what extent.

And as I said earlier, and as is done in many other areas of science, put the graduate students to work on a preprint to be released as soon as possible (as they do for example in maths and physics with arXiv.org) and submit for publication to a journal later. If the results are positive the peer review may ask for improvements or details but won't reject the paper.

No drama here. There are people who are taking their lives and could be possibly saved.

 

[InNeedOfHelp]

I think future will show that tinnitus is much more of a cochlea thing than a brain ting. I like the theory of broken OHC. Once broken they will be hypersensitive and react to very little sound stimulation. That would also explain distortions and reactive tinnitus. If right, OTO-313 might work in many more cases as long as your tinnitus originates from the cochlea. No matter if you have had tinnitus for one year or five years.

The problem is that neuroplasticity kicks in after some time and starts seeing the tinnitus signal as normal. Even though OTO-313 might take away some of the ear symptoms, your brain plasticity/brain has to find a way to adjust again to the improved hearing. We do not know if that happens, if neuroplasticity takes place again or if tinnitus remains.

I agree that once the synapses/hair cells recover we should be able to handle sounds better and spike less. I guess this is most important for me. I hate the tinnitus but I hate the continuous fear of it worsening and the limitations in life much more. I would be more in peace if I'd know this condition wouldn't potentially worsen.

 

[Padraigh Griffin]

No one has a clue on the neuroplasticity of tinnitus. There is not one shred of evidence that it gets 'stuck in the brain'. Only 'theories'.

Why have people who have had cochlear implants sometimes have immediate cessation of their tinnitus?

The only solid scientific evidence that backs up anyone's theory lies in the work of Dr. Susan Shore. Everything else is conjecture and theories. There is significant evidence that the DCN and/or hyperexcitability of misfiring neurons is a cause of tinnitus, maybe not all tinnitus, but certainly quite a lot.

Let us see what the results bring.

 

[ajc]

There is not one shred of evidence that it gets 'stuck in the brain'. Only 'theories'.

Interesting though that there are studies where they've cut tinnitus sufferers' auditory nerve, and tinnitus remains in about 50% or more of those people. Why?

 

[Gb3]

Interesting though that there are studies where they've cut tinnitus sufferers' auditory nerve, and tinnitus remains in about 50% or more of those people. Why?

Can you show those studies?

 

[ajc]

Can you show those studies?

A literature search identified 18 papers mentioning tinnitus status after vestibular nerve section, describing the experiences of a total of 1318 patients. The proportion of patients in whom tinnitus was said to be exacerbated postoperatively ranged from 0% to 60%, with a mean of 16.4% (standard deviation 14.0). The proportion of patients in whom tinnitus was unchanged was 17% to 72% (mean 38.5%, standard deviation 15.6), and in whom tinnitus was said to be improved was 6% to 61% (mean 37.2%, standard deviation 15.2).

The effect of vestibular nerve section upon tinnitus

 

[David S]

Interesting though that there are studies where they've cut tinnitus sufferers' auditory nerve, and tinnitus remains in about 50% or more of those people. Why?

Sounds reasonable. 50% cochlea based. The rest is brain related or related to other nerve conflicts (somatic).

 

[Gb3]

Sounds reasonable. 50% cochlea based. The rest is brain related or related to other nerve conflicts (somatic).

I agree. I believe I read one study where they said they can give a better prognosis depending on the origin of tinnitus.

 

[Padraigh Griffin]

Interesting though that there are studies where they've cut tinnitus sufferers' auditory nerve, and tinnitus remains in about 50% or more of those people. Why?

I'm no expert but does the DCN not lie beyond the auditory nerve? In that hyperexcitability in the DCN would be unaffected by sectioning of the vestibular nerve?

Those god damn fusiforms would still be firing away and creating the tinnitus sound.

I'll say it again, it is the only scientific theory of tinnitus that has sound backing in both animal and human models and hopefully soon to be announced comprehensive Phase 2 400 participant results.

The largest placebo controlled tinnitus study ever.

Every other 'theory' is just that. Stuck in the brain is just a theory.

I believe that reducing or eliminating the hyperexcitability (by neuromodulation or potassium channel modulators) might suppress or even cure tinnitus.

It could all be in the DCN. Best evidence we have to date is that it is certainly a component at least.

 

[DaveFromChicago]

There are people who are taking their lives and could be possibly saved.

Great point.

This infuriatingly, self-absorbed sluggishness about finding an effective treatment is like standing on a Pier and watching people thrash about until they drown while the life-preserve makers (who are quite aware of those in the water) incomprehensibly feel no need to make ASAP a floating preserver.

 

[Gb3]

Does anyone know how they were able to identify if the animal models had somatic tinnitus?

 

[Jerad]

Great point.

This infuriatingly, self-absorbed sluggishness about finding an effective treatment is like standing on a Pier and watching people thrash about until they drown while the life-preserve makers (who are quite aware of those in the water) incomprehensibly feel no need to make ASAP a floating preserver.

You know what it reminds me of, @DaveFromChicago? Titanic. Tinnitus represents the ship going down and we're the passengers in peril, the current Tinnitus Talk community. The ship's sinking and lives are on the line. Those fortunate will survive with habituation, which represents the lifeboats. Those who can get on a lifeboat are fine; they'll be okay. Those who can't are drowning in the icy cold waters of the Atlantic, grabbing onto pieces of debris or anything to survive. They're at the mercy of the Carpathia, a nearby ship coming to the rescue. Susan Shore is that ship. Will she arrive in time and save us? Or, like the infamous tragedy from 1912, only rescue 705 of 2,200; 1,500 lost. Time will tell.

 

[Mathew Gould]

Hey, before I get any hopes up in Germany, with a possible game changer coming out to those of you in the USA.

How much later will the device be available in Europe (as long as we are not conquered by Putin haha)? Can I buy it from someone here (for triple the price)?

I will try and pay for everything. Until then, I will continue to sleep about 3-4 hours a night, be unable to work and have headphones with masking sounds on all day long.

Try taking probiotics. They made me sleep from 3-4 hours a night to 7 hours instantly.

 

[Mathew Gould]

The cool thing about the study was the measured drop in volume of the tinnitus. I think somewhere in the scale of ~8 dB reduction on average. That is the big deal.

How do they measure an 8 dB reduction?

 

[Ela Stefan]

I'm no expert but does the DCN not lie beyond the auditory nerve? In that hyperexcitability in the DCN would be unaffected by sectioning of the vestibular nerve?

Those god damn fusiforms would still be firing away and creating the tinnitus sound.

I'll say it again, it is the only scientific theory of tinnitus that has sound backing in both animal and human models and hopefully soon to be announced comprehensive Phase 2 400 participant results.

The largest placebo controlled tinnitus study ever.

Every other 'theory' is just that. Stuck in the brain is just a theory.

I believe that reducing or eliminating the hyperexcitability (by neuromodulation or potassium channel modulators) might suppress or even cure tinnitus.

It could all be in the DCN. Best evidence we have to date is that it is certainly a component at least.

DCN is just one part of the brain stem affected by tinnitus. There are other parts over there affected by tinnitus.What do you do with them? Look here:

Cochlear Nucleus

 

[AfroSnowman]

How do they measure an 8 dB reduction?

I believe they used a tinnitus measurement software. I imagine they measured the external volume that matched or masked the tinnitus.