New University of Michigan Tinnitus Discovery — Signal Timing

[DebInAustralia]

Who the hell can quiet their tinnitus by poking around their jaw?

Me...

 

[Mentos]

To UKBloke:

This eligibility criteria has been narrowed to a truly absurd degree, especially regarding:

1) The time window of more than 6 months but less than 1 year;
2) No greater than mild or moderate hearing loss;
3) Unilateral tinnitus only preferred;
4) "Certain medications" will exclude a prospective client;
5) Your tinnitus must be reduced by clenching the jaw;
6) No various associated aural debilitating conditions.

What is the true negligible percentage of tinnitus sufferers who can actually conform to all of these requirements?

When in 2024 or 2025 this device is available, and these are ultimately determined to be standard requirements, it will not avail or benefit any of our 32,000 or so current Tinnitus Talk subscribers. At the very least, we will have had tinnitus for far too long.

I'm afraid the reason for narrowing the criteria is that with current broader ones the treatment didn't work.

 

[sssing]

This is the weirdest criterion for me. Who the hell can quiet their tinnitus by poking around their jaw?

I feel quite down because I can only increase my tinnitus when I clench my jaw. I cannot reduce it... Oh Lord, where on earth are my abnormal neural circuits?

 

[PeterPan]

I'm afraid the reason for narrowing the criteria is that with current broader ones the treatment didn't work.

With such a small sample size in their last trial I'm not sure how they could draw any meaningful conclusions about effectiveness let alone the type of person it works on!

 

[UKBloke]

I'm afraid the reason for narrowing the criteria is that with current broader ones the treatment didn't work.

I'm beginning to think the next revised criteria will be:

• tinnitus onset >5 seconds but preferably less than 1 minute
• somatic tinnitus, present only when patient clenches jaw

Treatment: unclench jaw.

 

[frpp]

I'm beginning to think the next revised criteria will be:

• tinnitus onset >5 seconds but preferably less than 1 minute
• somatic tinnitus, present only when patient clenches jaw

Treatment: unclench jaw.

100%. I hate to be negative, I really do, but with the insane wait time and ridiculous exclusion criteria "Dr" Snore's device is most likely a bust for the majority of tinnitus patients if not for everyone. Regenerative medicine is on the way and by the time her device is out it most likely won't even matter.

 

[weab00]

100%. I hate to be negative, I really do, but with the insane wait time and ridiculous exclusion criteria "Dr" Snore's device is most likely a bust for the majority of tinnitus patients if not for everyone. Regenerative medicine is on the way and by the time her device is out it most likely won't even matter.

She's riding out her paycheck straight into retirement. It'll be another Regain/Lenire.

 

[Chriscom]

This is the weirdest criterion for me. Who the hell can quiet their tinnitus by poking around their jaw?

I had never tried this before, but I get a very slight but definite reduction in volume by clenching my jaw. Certainly not something I could do enough to help.

I agree that the latest exclusion-criteria list is awfully specific across an odd group of characteristics, and that by the time the device sees the light of day, if ever, it'll be a sideshow at best.

I'm not a scientist or researcher, that's just my sense of it.

 

[Mentos]

According to an email I received from Dr. Susan Shore, the date of 2023 was a mistake and will be corrected shortly on the ClinicalTrials site. The study should be completed by fall 2021.

 

[Chriscom]

According to an email I received from Dr. Susan Shore, the date of 2023 was a mistake and will be corrected shortly on the ClinicalTrials site. The study should be completed by fall 2021.

That's a fairly significant mistake! Good to hear, thanks for sharing.

 

[GlennS]

According to an email I received from Dr. Susan Shore, the date of 2023 was a mistake and will be corrected shortly on the ClinicalTrials site. The study should be completed by fall 2021.

 

[GoatSheep]

This is the weirdest criterion for me. Who the hell can quiet their tinnitus by poking around their jaw?

Haven't been in this thread in a while. Where is this updated criteria about reducing tinnitus with jaw clenching posted?

ClinicalTrials.gov still just lists:

• Must be able to modulate their tinnitus with a somatic maneuver

 

[Ozwel]

The point about FX-322 and others is they can heal some parts of your body and therefore reduce your tinnitus but to me those chemical approaches are only here to mask your symptoms. I guess many of us will be very happy to mask their tinnitus but to me the point is to find how to heal the source of the problem.

Many people have hearing loss but they don't have tinnitus. Healing tinnitus means healing the source of the condition: it's neurological, it's a defense mechanism we miss as tinnitus sufferers. If you keep the condition and heal the synapses/hair cells, tinnitus may go away (I insist on "may") but if you ever lose your integrity again tinnitus will come back.

I agree if I have to repair my ear every year or every 5 years to mask my tinnitus I will indeed do it, but I'm also a fan of researches that are trying to heal the real problem: our limbic system and our fusiform cells.

So I'm a bit sad to read the last page, I feel like it hasn't progressed much in 3 years, which is already quite some time.

And by the way, opening my jaw will only make my tinnitus louder since it kind of "closes" my ear, as if the eardrum was blocked. Clenching doesn't change a thing.

 

[serendipity1996]

The point about FX-322 and others is they can heal some parts of your body and therefore reduce your tinnitus but to me those chemical approaches are only here to mask your symptoms. I guess many of us will be very happy to mask their tinnitus but to me the point is to find how to heal the source of the problem.

Many people have hearing loss but they don't have tinnitus. Healing tinnitus means healing the source of the condition: it's neurological, it's a defense mechanism we miss as tinnitus sufferers. If you keep the condition and heal the synapses/hair cells, tinnitus may go away (I insist on "may") but if you ever lose your integrity again tinnitus will come back.

I agree if I have to repair my ear every year or every 5 years to mask my tinnitus I will indeed do it, but I'm also a fan of researches that are trying to heal the real problem: our limbic system and our fusiform cells.

So I'm a bit sad to read the last page, I feel like it hasn't progressed much in 3 years, which is already quite some time.

And by the way, opening my jaw will only make my tinnitus louder since it kind of "closes" my ear, as if the eardrum was blocked. Clenching doesn't change a thing.

Wait, why would FX-322 only mask the symptoms? The whole point of their approach is that it targets the underlying problem to have a disease-modifying effect lmao and not just 'mask symptoms.'

 

[weab00]

The point about FX-322 and others is they can heal some parts of your body and therefore reduce your tinnitus but to me those chemical approaches are only here to mask your symptoms. I guess many of us will be very happy to mask their tinnitus but to me the point is to find how to heal the source of the problem.

Many people have hearing loss but they don't have tinnitus. Healing tinnitus means healing the source of the condition: it's neurological, it's a defense mechanism we miss as tinnitus sufferers. If you keep the condition and heal the synapses/hair cells, tinnitus may go away (I insist on "may") but if you ever lose your integrity again tinnitus will come back.

What, how? You've got it reversed, biologically restoring an organ to its original function means that the underlying damaged is fixed, whereas sending electrical impulses to the trigeminal nerve means that the underlying damage remains and that you're susceptible to setbacks. The limbic theory is outdated, it's seen more as a product of rather than a result of tinnitus. It's possible to get tinnitus again after bioregenerative medicine if you're an idiot or unlucky I guess, but usually tinnitus is the result of years of chronic overexposure and now we're educated.

 

[FGG]

The point about FX-322 and others is they can heal some parts of your body and therefore reduce your tinnitus but to me those chemical approaches are only here to mask your symptoms. I guess many of us will be very happy to mask their tinnitus but to me the point is to find how to heal the source of the problem.

Many people have hearing loss but they don't have tinnitus. Healing tinnitus means healing the source of the condition: it's neurological, it's a defense mechanism we miss as tinnitus sufferers. If you keep the condition and heal the synapses/hair cells, tinnitus may go away (I insist on "may") but if you ever lose your integrity again tinnitus will come back.

I agree if I have to repair my ear every year or every 5 years to mask my tinnitus I will indeed do it, but I'm also a fan of researches that are trying to heal the real problem: our limbic system and our fusiform cells.

So I'm a bit sad to read the last page, I feel like it hasn't progressed much in 3 years, which is already quite some time.

And by the way, opening my jaw will only make my tinnitus louder since it kind of "closes" my ear, as if the eardrum was blocked. Clenching doesn't change a thing.

Opening your jaw doesn't "close your ears" but it does change the position of your jaw relative to your soft tissues and trigeminal nerve. Branches from the trigeminal nerve innervate the middle ear. This is why TMJ can be strongly correlated to tinnitus severity and it sounds like something you may want to rule out as a cofactor in your case.

 

[tommyd87]

The point about FX-322 and others is they can heal some parts of your body and therefore reduce your tinnitus but to me those chemical approaches are only here to mask your symptoms. I guess many of us will be very happy to mask their tinnitus but to me the point is to find how to heal the source of the problem.

Many people have hearing loss but they don't have tinnitus. Healing tinnitus means healing the source of the condition: it's neurological, it's a defense mechanism we miss as tinnitus sufferers. If you keep the condition and heal the synapses/hair cells, tinnitus may go away (I insist on "may") but if you ever lose your integrity again tinnitus will come back.

I agree if I have to repair my ear every year or every 5 years to mask my tinnitus I will indeed do it, but I'm also a fan of researches that are trying to heal the real problem: our limbic system and our fusiform cells.

So I'm a bit sad to read the last page, I feel like it hasn't progressed much in 3 years, which is already quite some time.

And by the way, opening my jaw will only make my tinnitus louder since it kind of "closes" my ear, as if the eardrum was blocked. Clenching doesn't change a thing.

There are also actually others who can reduce and/or eliminate their tinnitus using hearing aids and this flies in the face of the fact that it is purely a neurological condition. Consequently no one has actually demonstrated why tinnitus is solely a neurological condition when in the vast majority of cases it has shown to be caused by/prevalent in people with some kind of hearing issue.

 

[Cal18]

Mine gets lower by pushing/tucking my jaw. The criteria change is insane and I'm approaching 4 years, this makes me lose some hope in this treatment for sure. Looking at it from a more positive perspective, I guess they did that because even though it might be able to help others with longer/shorter time frames, this criteria will likely give the study the best outcome in order to push it to market sooner. I hope it was strategic and not because it doesn't work for other time frames.

 

[GoatSheep]

Can anyone please tell me where this criteria update regarding jaw clenching reducing tinnitus and whatever additional criteria additions are posted?

 

[Mentos]

According to an email I received from Dr. Susan Shore, the date of 2023 was a mistake and will be corrected shortly on the ClinicalTrials site. The study should be completed by fall 2021.

The dates on the ClinicalTrials.gov page are already updated to the following ones:

Estimated Primary Completion Date: December 2021
Estimated Study Completion Date: May 2022

 

[Cal18]

I just wanted to repost the criteria info here because I want to emphasize that two of the points include the word "preferably". So they might be willing to accept participants who are close to these parameters but perhaps do not fit them exactly. Which also means you may not need to fit within these parameters for the treatment to work.

 

[GoatSheep]

I feel quite down because I can only increase my tinnitus when I clench my jaw. I cannot reduce it... Oh Lord, where on earth are my abnormal neural circuits?

I don't think you have any reason to feel down. The only place I can find that "softening" tinnitus through "applying pressure to their head or clenching their jaw" is mentioned in this Gizmodo article.

I think this may be a case of general example of modulation being given (to the reporter) that was taken as a specific requirement to meet the criteria to use the device. The article states "That could mean the device won't work for the 20 percent to 40 percent of tinnitus sufferers without that particular quirk". We know from other research that an estimated 80% of sufferers have somatic tinnitus (the type that can be modulated by certain body movements), so it would seem this statement is referring to that research, in my opinion.

The Gizmodo article was published on January 3, 2018. The same day the University of Michigan News published an article on the device also. Their article states:

"They recruited a particular kind of tinnitus sufferer for their study: those who can temporarily alter their symptoms if they clench their jaws, stick out their tongues, or turn or flex their necks. These maneuvers, Shore says, appear to be self-discovered ways of changing the activity of fusiform cells—providing an external somatosensory signal to modulate their tinnitus."

As you can see, there is only reference to modulation (increase or decrease), not specifically to a decrease and they mention more than strictly jaw movements. In addition, the ClinicalTrials.gov website criteria list states:

• Must be able to modulate their tinnitus with a somatic maneuver

The trial information wasn't posted until August 8, 2018, so I'd say the actual trial posting is more accurate than the Gizmodo article published long before the trial posting.

 

[GBB]

I don't think you have any reason to feel down. The only place I can find that "softening" tinnitus through "applying pressure to their head or clenching their jaw" is mentioned in this Gizmodo article.

I think this may be a case of general example of modulation being given (to the reporter) that was taken as a specific requirement to meet the criteria to use the device. The article states "That could mean the device won't work for the 20 percent to 40 percent of tinnitus sufferers without that particular quirk". We know from other research that an estimated 80% of sufferers have somatic tinnitus (the type that can be modulated by certain body movements), so it would seem this statement is referring to that research, in my opinion.

The Gizmodo article was published on January 3, 2018. The same day the University of Michigan News published an article on the device also. Their article states:

"They recruited a particular kind of tinnitus sufferer for their study: those who can temporarily alter their symptoms if they clench their jaws, stick out their tongues, or turn or flex their necks. These maneuvers, Shore says, appear to be self-discovered ways of changing the activity of fusiform cells—providing an external somatosensory signal to modulate their tinnitus."

As you can see, there is only reference to modulation (increase or decrease), not specifically to a decrease and they mention more than strictly jaw movements. In addition, the ClinicalTrials.gov website criteria list states:

• Must be able to modulate their tinnitus with a somatic maneuver

The trial information wasn't posted until August 8, 2018, so I'd say the actual trial posting is more accurate than the Gizmodo article published long before the trial posting.

This device sounds very similar to Lenire which as far as I'm aware is agnostic to this somatic modulation trait. Why then is this a prerequisite for the U of M device to function properly, when it is not for other similar treatments?

 

[GoatSheep]

This device sounds very similar to Lenire which as far as I'm aware is agnostic to this somatic modulation trait. Why then is this a prerequisite for the U of M device to function properly, when it is not for other similar treatments?

From what I gather from the UMich article I mentioned above, the patient having this external somatosensory ability to modulate their tinnitus provides a pathway for the device to affect the hyperactive fusiform cells that is already proven to do so. They attach the electrode to the area where the patient's movement can modulate their tinnitus.

I don't actually think they've specifically ruled out the ability of the device to work for those who don't have this subtype of tinnitus. I haven't seen that specifically stated anywhere. I think it is just what they felt would provide the most success for the trial.

Similarly, they exclude benzo usage (I was excluded for this via email communication) because we know for many it can have a usually positive effect on their tinnitus and they don't want to skew their results. That doesn't mean once the device is released someone taking benzos couldn't use it and see improvement that is stemming from the device usage, in addition to what they experience from benzo usage. It could also be because of the possibility benzos have an effect on plasticity, but that seems to be debated here. I'm certainly not as well researched as others on that matter.

 

[Sevv]

Even if Dr. Shore is seemingly doing a pretty disappointing job, bimodal stimulation is still a promising therapy option (if there were a proper device). Unfortunately we're not at the point where we can get individualised treatment like @kelpiemsp who got a big reduction in tinnitus and even in visual snow. There is potential, but researchers aren't tapping into it very well...

 

[Mathew Gould]

100%. I hate to be negative, I really do, but with the insane wait time and ridiculous exclusion criteria "Dr" Snore's device is most likely a bust for the majority of tinnitus patients if not for everyone. Regenerative medicine is on the way and by the time her device is out it most likely won't even matter.

Is any of this regenerative medicine going to work on somatic tinnitus or tinnitus from neck/jaw issues?

 

[Mathew Gould]

The dates on the ClinicalTrials.gov page are already updated to the following ones:

Estimated Primary Completion Date: December 2021
Estimated Study Completion Date: May 2022

She will be 80 years old and still collecting a paycheck from the University and her BS device won't help anyone. Must be nice.

 

[frpp]

Is any of this regenerative medicine going to work on somatic tinnitus or tinnitus from neck/jaw issues?

Actually there is a professor at Harvard working on a project to regrow new disks for the jaw joint. I can't speak too much about the neck but there are a lot of companies working on regenerating and remyelinating nerves, so I really hope those help.

 

[gregmech26]

I emailed them to be placed on their tinnitus research mailing list.

I live within an hour away so hopefully something good may come out of it.

 

[KotaDomowa]

I hope Dr. Shore's device will be released this year...