New University of Michigan Tinnitus Discovery — Signal Timing

Thanks for your write up. With the disappointments over these last couple years of FX-322 and Lenire it is easy to imagine that nothing is ever going to work. But from reading about the science and solid scientific process behind this device I was already optimistic,and reading your first hand account that it does indeed do something really helps me be patient knowing that this could very well be publicly available in the near term.

I don’t know about the rest of you but my tinnitus is the 24/7 can hear above everything, oftentimes quite loudly above everything sort of noise. Life goes on but it is definitely a daily challenge to a greater or lesser degree. That being said, every once in a great while I have a quiet day, still always there but all that stuff about habituation, pushing it off to the back ground, only noticing it when you look for it, it all seems so possible and if I could get that that would be enough. Thinking that something could actually help, something might finally lessen it a bit, man oh man, well that is like knowing that Christmas is coming even if it is a year away.

Of course I don’t want to get too excited as I can’t afford to have my heart broken again (looking at you FX-322, Lenire, and the 1 year delay in this device due to COVID-19).

 

I know Dr. Shore's device is no cure but even a mere 50% volume reduction would be night and day for me and would probably allow me to sleep without meds again. If it does turn out to be effective on me I can see myself using the device permanently, or at least until a real cure is found (restoring hair cells / synapses). So in that aspect I would literally worship Dr. Shore as a life savior. I can't wait to fly to the USA to try it.

One of my concerns is long-term effectiveness. Assuming the device is initially successful at suppressing the sound, could the brain somehow learn over time to find other ways to recreate again the missing frequency in a way that bypasses the initial patterns of the bimodal stimulation? So we would need to find new settings with different timings every once in a while? I'm not pretending to know about this stuff but I don't think I'm prepared to re-experience that emotional rollercoaster of returning to silence and thinking I'm cured only to be hit back with screaming T just a couple days later. The first time it happened was like being thrown back into a nightmare from which I can't wake up.

Too bad about the COVID-19 delay. COVID-19 has fucked my life over in so many ways and for all I know could even be the cause of my tinnitus. Fuck COVID-19.

 

Personally, the worst part of tinnitus, even worse than horrendous noise I am subjected to every waking moment, is the possibility and perhaps probability that it can and will get worse. Every day is like walking on eggshells, constantly trying to stay one step ahead of any dangerous sounds. Carefully planning each trip out of the house or even just to the kitchen. Gauging each environment. Checking its decibel level. Inserting and changing earplugs. Dreading that the motorcycle that passed by unexpectedly or that fork I accidentally dropped on the tile floor will mean a new tone or increase of the enumerable already present ones. The disconnection from the world around me is severe, lonely, and incredibly depressing.

Having some form of treatment to lessen any worsening back down to a tolerable level would mean having those connections back, a life of so much less worry... an insurmountable amount of weight lifted off my shoulders.

 

I've had noise induced tinnitus 2 years now. I understand what you're going through.

Let me offer some experience though. I don't leave the house without earplugs in my pocket. I work a noisy job. I wear them when I'm working. I have encountered tens of situations exposed to unpredictable loud noises. None of them caused a permanent new tone. The worst was very loud, and my tinnitus was very loud the next day.

The deal is, your emotional response makes the noise grow three fold, and it only makes it worse.

Recognize it's there. Protect yourself. But no. There is no probability that it will get worse. Quite the contrary.

If you continue to protect your ears and make smart choices, you will both get more used to it, lowering your emotional response, AND statistically there's a good chance you will also have somewhat of lessening of the noise as the months turn into a year, etc.

Really easy to say and hard to know in your heart.

Hell I'm up now at 2:30 because it's bothering me, but not in the hopeless way it used to. It's familiar now.

I'm waiting on a cure too, and I think about it every day.

My message is just, do NOT, under any circumstances operate emotionally under the guise that this is "probably going to get worse".

I wish peace to you. Let's stay on topic from now on.

 

I can modulate my tinnitus with secondary sounds, but not my main sound. I have been wondering if it would help me.

 

Susan Shore's device has been tested on people with somatic tinnitus only, so it may help you in part.

As for non-somatic tinnitus (which cannot be modulated), Shore does not know if it can be treated by her device.

I too have tinnitus that I can "modulate" (in fact I can only make it worse if I open my mouth wide, but not reduce it). This is due to the aggravation of my tinnitus in 2020 due to the Naproxen.

 

I can modulate my tinnitus too, but like you it is made worse.

 

The critical bit is that it changes, not whether it gets better or worse. As I understand it, this is taken as an indication that stretching/pulling specific nerves impacts your tinnitus and it therefore makes it more likely that electric stimulation on that nerve will be able to impact your tinnitus.

 

I can never modulate my main sound, but only secondary sounds.

 

Well it is all just speculation twiddling our thumbs while waiting for a treatment right?

That being said, she limited her study to folks with somatic tinnitus because she felt that was the best shot to see a clear response, she (I believe) has said clearly that she doesn’t know if it will work for non-somatic, not that it won’t. In any case unless you have to take out a mortgage for it, I’d think you’d want to try anyway.

 

There should be an update on this tech considering people have donated and put valuable time into it. There are students who have worked on this, and it’s been over 20 years now. Somatic patients are the only ones in trial, due to what is the outdated system of honing in on isolated data, 2 decades worth. Meanwhile, Elon Musk is planning on a trial that puts computer chips in human brains; tapping into anticipated thought within a year. Removing barriers and taking risks sometimes works.

 

For anyone that is worried about Dr. Shore's age or why she is taking so long, you have to understand she studied under the great Neurosurgeon Carl Wainwright.

World's Oldest Neurosurgeon Turns 100

 

It's not that encouraging; no one here wants to wait for Susan Shore to reach 100 years of age to finally bring her device to market

 

I sure wish we had some type of dates to look forward to. At this point it is anyone’s guess.

 

The trial should be finished in May of next year (one month before that of OTO-313).

Results will probably come a few months after that?

ClinicalTrials.gov: Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts

 

2020 - 2024 was the target pre-COVID-19; based on that I'd guess 2024-2026 at this point because of the degree to which all sorts of R&D and manufacturing problems continue to plague supply chains and complicate clinical trials.

I don't, presently, have any contacts at the lab -- I let my last line go dark without getting the address of the research assistant who'd be replacing them. I can no doubt come up with another contact, as a former trial participant, but if anyone presently has an active line of comms to that lab and feels like trying to get a straight answer to "hey, how has COVID-19 impacted your 2022-2024 production timeline?" that would be cool.

If not, I will ask at some point.

 

No news about Susan Shore's device?

 

To Kam75:
Please see my previous comment regarding Dr. De Ridder's assessment (towards the end of the Tinnitus Talk Podcast interview) that her device was only concerned with habituation/mindfulness, not reduction or elimination.

Episode 17: Tinnitus, Ingrained in the Brain? — Prof. Dirk De Ridder

Do I have this right? It contradicts the statements about Dr. Shore's device that were made in our Chicago Tribune Health & Wellness Article from January 2018.

Is this far closer to Lenire, so close in fact that it is not worth waiting for?

I truly hope I am wrong.

 

I listened to this a while ago and after hearing this, I went back and read/watched/listened to Shore and various explanations of her work and device. They all say they decrease the actual precept, not habituate the patient. In fact in contrast to Lenire, which claimed long lasting effects (habituation), with Shore's device the participants reverted to baseline within a couple weeks of stopping, which would seem to indicate that it impacts the symptoms.

 

To AfroSnowman:

Thanks very much for clarifying that.

Your commentary was very important in reassuring us.

 

Professor Dirk De Ridder was very ill informed as regards Dr. Shore's device and his opinion of tinnitus origin does not include a specific region of the brain like the dorsal cochlear nucleus. Dr. Shore, through science based on thorough research, has identified hyper excitable cells in the DCN as a probable source of tinnitus origin and aims to calm these cells. It is therefore not a ‘habituation’ device.

What is interesting is that some forum-based hard research involving Trobalt, which aims to target hyperexcitable cells, showed success in treating tinnitus patients, however the side effects were too severe. It is however, being formulated.

I thought Dirk De Ridder was a cool guy but he is wrong to be dismissive of Dr. Shore who has a solid sham controlled Phase 1 trial done with good results.

As for Lenire, an average 12.7 point reduction in the TFI with no placebo group comparison indicates terrible science and results that mirror placebo effect in other tinnitus trials. It seems to me like it a nothing device, or at best a placebo effect device. Its approach is very different to Dr. Shore in what area it stimulates.

We will know more next year after the Phase 2 clinical trial involving 300 patients will be finished. Just a point of note, a Phase 2 clinical trial of that magnitude is something Dirk De Ridder has never even come close to assembling so it is a bit arrogant to be dismissive of it, particularly as he has been wrong in his many past assumptions in relation to the origin and treatment of tinnitus.

 

I listened to the De Ridder podcast last night, and from what I understood, he and his colleagues have done brain imaging of patients during different periods of their tinnitus affliction and has seen trends that the origin of the sounds moves through different neural networks in the brain depending on how long they have had tinnitus.

His theories at least provide answers as to why some people have hearing loss without developing tinnitus while other do.

 

Has anyone read anything from Shore about whether she has seen a time limitation to the overexcitement of fusiform being tied to tinnitus? That would seem like an observable phenomenon. Did she observe the activity of fusiform cells in the DCN in humans or only critters?

 

Hello everyone, long time lurker here. Just a quick question about the device if anyone from either of the trial can answer or if anyone knows. Is the device specifically individually calibrated to person, or is it that every device is the same?

 

What device? Has anyone seen the device? Is anyone participating in the clinical trial?

So far it looks like the device is in the wishes and dreams of tinnitus sufferers. If you want the device to exist, you must become a believer. Let's pray together...

 

Device:

https://www.in2being.com/tinnitus-treatment-device

 

Very cool. Gives me hope when the time comes that this can move quickly to market.

 

Looks like it has its own battery and setting the tinnitus frequency and other parameters is done via USB and PC/MAC software. There are thick cables running from the board to the case back panel. Probably output for earphones and the electrode.

There are 300 patients participating in the clinical study, right? Anyone out there to cheer us up with something positive from the ongoing study?

 

My word, how did you find out about that.

Can you imagine if that was all it took to reduce your tinnitus? Just hook up to a HDD caddie once a day... After 2021 being such a dud in terms of positive research news coming out (compared to what I was wishing), I really hope 2022 gives us all something a bit brighter on the horizon. I don't care what I got to plug in or inject if it works

 

Is this Dr. Shore's device?