New University of Michigan Tinnitus Discovery — Signal Timing

Haha thanks @Damocles - I like hope

I read recently 'where there is even just a 1% chance, there's always hope.'

 

I don't remember my tinnitus being somatic until I took Naproxen in 2020 that greatly and permanently worsened my tinnitus and made one of the sounds somatic.

In fact this sound only increases if I open my mouth wide (so when I yawn or when I eat for example).

This wasn't the case before. So tinnitus can become somatic (I've read of another case here on Tinnitus Talk).

But I don't recommend taking this medication just to use Dr. Shore's device of course!

 

That's interesting as I had the same when taking Paracetamol and Mirtazapine, resulting in a 10 day spike. If I opened my mouth, I'd hear something like wind sheer or the effect when listening into a sea shell, like the ocean's breeze.

I cannot modulate my tinnitus now by the way.

Since bimodal stimulation has shown to reduce TFI on areas other than the cheek/jaw/neck, such as the tongue/wrist/vagus nerve, I suspect that somatic tinnitus will make no difference with this treatment.

 

Is there confirmation if this will be an at-home device or will it require a trained professional?

 

Does the tinnitus return back to baseline immediately after stopping whatever neck turn or somatic action?

The only thing that seems to affect my tinnitus volume other than noise is massaging around my ears and head, as in either a head massage or trying to clear the Eustachian tubes.

This will increase the tinnitus volume but it stays amplified for a while.

Having what I suspect are ETD issues as well as palinacousis, and maybe some sinus issues, may be exacerbating - or partly contributing - to my problem and volume.

 

I have somatic tinnitus so I would meet that requirement of Dr. Shore’s device, but what about hearing loss? I know the requirement is to have no more than 50 dB of hearing loss, but at what frequency range?

I have normal hearing from 250 Hz to 3000 Hz and mild to moderate high frequency sensorineural hearing loss at 4000 Hz (30 dB), 6000 Hz (40 dB), and 8000 Hz (45 dB). I fear if we have a 2-year wait for the device, my hearing could get worse and be below 50 dB by that time. Does anyone know what 50 dB actually means?

 

I have bi-modal, multi-tone tinnitus that is not somatic. However, I can activate an additional hiss on the right side of my head upon touching my scalp/face (right side only). Touching acts like an immediate on/off switch. The hiss will sustain with continued pressure... I can send myself personal morse code messages... Ha!

What category do you good people think I fall in as far as applicability to Dr. Shore's treatment?

 

Yes, immediately.

I can employ three basic manoeuvres which allow me to modulate my tinnitus. These are:

• Yawning or opening my jaw wide as if I were going to yawn (picture a Dentist visit for the latter one).
• Stretching (experience this when I wake up first thing).
• Tympanic suction via silicon earplugs (basically if I chew with my musicians earplugs in, the resulting pressure changes make my tinnitus fluctuate).

All of these changes cease as soon as I stop whichever of the above I'm doing and volume returns to baseline.

I've never experienced anything like this, but then take a look at Head Tapping / "The Reddit Tinnitus Cure". Similar manoeuvre with varying effects. Up for some, down for others, and always returns to baseline.

So yeah...

I also have ETD (severely in my left ear), and yes it exacerbates all of the tinnitus symptoms. Luckily the ETD is something you can alleviate while the tinnitus isn't. I'd take severe ETD issues over the torture of tinnitus any day. Just the equalisation issues on their own would be heaven.

With this I concur.

Before 2009, I had mild, monotonal, unilateral tinnitus in my right ear, which later progressed to moderate, monotonal, bilateral tinnitus.

In those days, never did I once notice an ability to increase it via any movement. The only thing that ever changed or made it worse were colds and flus.

So yes, non-somatic tinnitus can definitely develop into somatic tinnitus.

With this I also concur.

And with this I concur most profoundly.

Please do not screw around with your tinnitus for the sake of making it somatic. That's just asking for trouble.

The majority of us seem agreed it's unlikely to make a difference. So let's all just relax, watch a box set, and wait for the thing to do its magic.

 

Strangely enough I tried this but didn't seem to have any effect at all - only rubbing or massaging, which I assume is moving mucus around. Unfortunately though it makes the tinnitus louder, never quieter.

Without derailing the thread, were there any specific ETD treatments that worked for you?

MODERATOR EDIT:

@Damocles, wisely, moved the ETD discussion elsewhere of his own accord. Discussion continues → here.

 

This will be the 30 years of research device.

 

Couldn't agree more - be very careful. Mine was stable/non-somatic/unilateral until I had an accidental noise exposure that worsened my condition considerably. Now it's somatic, bi-lateral, much louder and highly reactive!

 

I wonder what is going on behind the scenes with the development of Dr. Shore's device and setting up trainings for professionals to make sure they help their patients.

Also, I'm curious why the news hasn't jumped all over this, yet. Not that I want to wait in line to try this out, but I'm kind of surprised that it is flying under the radar for the moment.

Finally, in order to be first in line, should we be asking our ENTs to look into this or should we be telling our audiologist to keep tabs on Dr. Shore's device? Or, should we all be looking into EU vacations if the EU is going to get things first?

 

I asked the same question previously, this is indeed very strange. There is not a single article on the Internet about the positive results of the device. Maybe this is because the information we have is not official? Maybe we will see some articles about it once the results of the Phase II are published?

Is it even possible for an American device like this to be commercialized first in the EU?

 

Any reasonable investor would look for a way to make a profit as soon as possible. If profit is faster in the EU than in the US, it would be logical...

 

I remember that survey. I've found none of the above movements modulate my tinnitus, however a few of my tones do seem to react if I press on my zygomatic arch (the long skinny bone just below the temple), even one of the tones that I thought was just 'head' tinnitus.

 

Absolutely nothing. Why should any professional engage in training on a tinnitus treatment that is not approved nor has any results publicly published? The only action potentially taken right now is exploring the network of who might be able to distribute the treatment in the future. We are a long way from training sessions.

Because there are no results published, no presentations available, just a first look into the research behind closed doors. There are 1000s of in-vitro/in-vivo/preliminary study results shared for 1000s of diseases every month. Logically the media will not pick those up either. It's an inner circle thing, mostly hyped up by ourselves.

No, because ENTs and audiologists don't follow the research news nearly as close as the people on Tinnitus Talk. This treatment is still pretty far away from the clinic. The only public domain where some of the initial findings were published is on Tinnitus Talk.

And no, the EU will not get this treatment early. The research is partially funded with VA grants. Jon Pearson from Auricle already said the US will have initial focus on the launch of the treatment.

 

Dr. Shore has been researching her method for 20 years as I understand it. It's likely we'll see her device released in a year or two, hopefully less!

 

Will people from the EU be allowed to fly over to the US to get the device, do you think?

 

@SmallRonnie, I think there is a high likelihood that this treatment will have to be "dialed in" by a physician, therefore making just owning the device 1/2 the process. I personally see the Tinnitus Talk community trying to establish a way for people overseas to get treatment by using local hotels (or completely rent-free retreats dedicated to their recovery) and healthcare providers. Occipital Neuralgia & Trigeminal Neuralgia has a similar set up already in place led by the surgeons that perform the decompression surgeries. They allow you to simply call, discuss your issue via telehealth, agree if you meet the criteria, then give you a local hotels number who has their special rate. These rates are usually almost half off, so around 40-60 dollars a night.

Simply put, even if no one in this community were to try and render aid; if there is a market for effective treatment, there is a market for facilitating it.

 

Yes, I wouldn't be surprised if that was possible. The US based healthcare system is more commercially focused then we have in the EU.

I'd expect to see some early adopters in the EU too, like the Brai3n clinic of Dirk de Ridder and others.

 

Ya sure, why not.

 

Absolutely!!! They will happily take your money, I promise.

 

Well, the global media made a huge buzz in 2012 about Dr. Kilgard, who is all talk and nothing to show for it.

 

Let's hope 2023 brings this device to market.

I can fully modulate my tinnitus with teeth, neck etc so I should be a good candidate.

 

Even if the papers say good stuff, Dr. Shore might not release the device for another year or two. She's not going to move quick on her work that took 20 years. It still has to be approved by the FDA which will take up to 2 years and then they will look into manufacturing it which could take a year with the shortage of stuff from COVID-19.

I don't see the device being available in the next 3 years. Sorry.

 

I haven't been watching this thread in a while - has Susan Shore mentioned the volume and frequency of the signals? For all my hyperacusis bros out there.

 

I don't think it's wise to make such false statements on Tinnitus Talk without any proof backing it up.

The average length of time for clearance under the traditional 510(k) pathway is 177 days, or nearly six months. Just 19% of devices on the 510(k) pathway are cleared within three months.

The average number of days it takes to clear a device via 510(k) varies according to the device category. Anesthesiology devices have the longest average length to approval, averaging 245 days. Toxicology devices are the shortest on-average, at just 163 days.​

Dr. Susan Shore has nothing to do with launching this device. A commercial investor is not going to "take its time" to get return on investment.

My expectation is that there will be a lucky few with the device next Christmas and we can anticipate a very small launch at the end of this year with a very select amount of service providers and devices. In 2024 scaling up to have wider availability of the device.

 

@Hottopic29 is maybe overly pessimistic with his outlook, but you are overly optimistic. The FDA won't approve the device before the Phase 2 results are officially out and then after that there is the manufacturing (which I don't think they'll start before approval), setting up the infrastructure, training audiologists et cetera. This won't happen as quick as you think. It's much more likely that it'll be mid-late 2024 before there's any initial availability.

Dr. Shore co-owns Auricle and she won't allow anything to be hurried if there's risk of botching things up.

But we're all talking out of our asses, speculation and guesswork at best...

 

I'm only going on a ~timeframe mentioned by a fellow lecturer at the UoM where he said to the audience 'when it comes to market, in about a year.' This lecture was posted at the end of October 2022. He was right about the results being good, which he let slip and we found out with our updates 6 weeks later.

@2noist, like you said, it's still speculation all the same. It's well established that FDA approval is ~6 months like @InNeedOfHelp said. The question of timeframes for launch largely depends on 2 factors:

1. When will the formal application of FDA approval commence?
2. How many units can the manufacturing company make each month?

So, let's say:

• 6 months to publish the results of the Phase 2 trial - June 2023.
• FDA approval - December 2023.

Training of audiologists does worry me a little. They come across as dumb at the best of times when it comes to tinnitus and hyperacusis. In theory it's basic anatomy and physiology (placement of two pads on the trigeminal nerve and dorsal column nerve and ear piece in one ear).

Doing some reading over Christmas on animal studies, I'm leaning towards the electrical stimulation doing most of the work. Almost like more targeted tDCS if you like. The animals had tinnitus diminished just by stimulating the DCN with electrical impulses.

• Alleviation of tinnitus with high-frequency stimulation of the dorsal cochlear nucleus: a rodent study
• Tinnitus suppression by electrical stimulation of the rat dorsal cochlear nucleus

So worrying about matching your tinnitus to the exact frequency or about multi-tonal tinnitus may not be such a necessary worry.

 

This pretty much sums it up! I'm just happy that it's now 2023 and we're starting to have some options to look forward to. After multiple disappointments from other potential treatments, I'm just happy to know that the research looks ever more robust and a tinnitus specific treatment is, in fact, moving forward to commercialization.

Hang in there folks!

Happy New Year all.