New University of Michigan Tinnitus Discovery — Signal Timing

[RunningMan]

These results do not look good. Very little real change unless I am reading it incorrectly.

Some inconsistencies bring questions, as mentioned in some earlier posts, and it wasn't a large test group, but 5 dB better than a placebo (control group) in tinnitus reduction is noticeable, but of course we hope for more. And it could be better or worse for anyone in particular, especially with continued use.

 

[Bambam0]

In an effort to keep this thread optimistic, we have no idea about what sustained or long-term use could yield. The results were better with the trial time increased from 4 to 6 weeks. There could very easily be a reality in which consistent use or medium term use of the device reduces the tinnitus volume further.

We also don't know what things like micro-dosing Psilocybin, LLLT, meditation, and other cell rejuvenating, plasticity increasing, theta wave-inducing therapies could do in conjunction with using the device.

I will be doing all of the above (as I already do) when I get my hands on an Auricle device to maximize results.

Regardless of the eventual outcomes for all of us, we're getting very close.

 

[Gabriel]

-10 dB(+) doesn't look good to you?

It's -3 dB during washout.

If you put a song at 40 dB and then at 37 dB, would you hear the difference?

Honestly, it is not impressive at all, unfortunately.

 

[Jonno02]

It's -3 dB during washout.

If you put a song at 40 dB and then at 37 dB, would you hear the difference?

Honestly, it is not impressive at all, unfortunately.

Why focus on washout? Susan Shore has never claimed the device is a one-and-done deal. We may need to use it continuously for the rest of our lives.

 

[Nick47]

The results were better with the trial time increased from 4 to 6 weeks. There could very easily be a reality in which consistent use or medium term use of the device reduces the tinnitus volume further.

Is this true? In the Phase 1 trial the mean reduction was around 7 dB. In the Phase 2 around 6 dB, but the difference being it lasted longer and improved in the washout up to 11-12 dB. Consistent use "could" lead to further improvements - or not. The issue many pointed out and wanted to look deeper at is why the placebo-first group DID NOT respond?

We also don't know what things like micro-dosing Psilocybin, LLLT, meditation, and other cell rejuvenating, plasticity increasing, theta wave-inducing therapies could do in conjunction with using the device.

I'm with you that for best results, treatments should be combined. So medication + CBT + electrical/bimodal stimulation is likely to produce better gains than any alone.

 

[Ngo13]

It's -3 dB during washout.

If you put a song at 40 dB and then at 37 dB, would you hear the difference?

Honestly, it is not impressive at all, unfortunately.

It was -3 dB at washout for the control group. The active group ended at -10 dB.

I was also under the impression that most people's tinnitus loudness is 5-15 dB SL (above hearing threshold). It's not the same as measuring it yourself compared to ambient noises. For example, I can hear my tinnitus over a conversation which is 60 dB but my audiologist measured my tinnitus loudness to be less than that. When I questioned her, she said that the sound is perceived louder in your own head, similarly to how your voice is, even though it's not that loud.

All that being said, a -10 dB reduction could effectively reduce someone's tinnitus by half or more. I think a lot of us would take any relief we can get at this point.

 

[@dam]

The Phase 2 results are the perfect example of looking at a half-full glass, looking at the first active treatment, vs. looking at the second active treatment. Which overshadows which? The first active group had a continuous improvement trajectory until the 6 weeks were up. Is it fair to assume, had they continued for months, their tinnitus would have continued going down?

Dr. Susan Shore's integrity sort of worked against her in these results, and painted a confusing picture. Still I would take that over Lenire's results, which didn't even have a placebo group.

 

[Nick47]

The Phase 2 results are the perfect example of looking at a half-full glass, looking at the first active treatment, vs. looking at the second active treatment. Which overshadows which?

Or looking without a glass and just looking objectively at what was published? In the way someone without tinnitus looked at the results. Ask yourself, if you gave the study to a scientist with no emotional investment, what would they see? They would see both groups!

Is it fair to assume, had they continued for months, their tinnitus would have continued going down?

It's a reasonable hypothesis but I would never assume it, no.

 

[Gb3]

Or looking without a glass and just looking objectively at what was published? In the way someone without tinnitus looked at the results. Ask yourself, if you gave the study to a scientist with no emotional investment, what would they see? They would see both groups!

It's a reasonable hypothesis but I would never assume it, no.

I think that's what the people who peer reviewed the results did.

 

[GregCA]

If you put a song at 40 dB and then at 37 dB, would you hear the difference?

Yes, see Doubling Power vs. Doubling Output.

Not "half as loud" different, but noticeable.

 

[AnthonyMcDonald]

It's -3 dB during washout.

If you put a song at 40 dB and then at 37 dB, would you hear the difference?

Honestly, it is not impressive at all, unfortunately.

I would absolutely, without a doubt, notice any decrease in my tinnitus, subtle as it may be, because my tinnitus has never decreased, even by 0.01 dB.

 

[Nick47]

I think that's what the people who peer reviewed the results did.

Correct, but we don't know their thoughts.

 

[Josh59]

I'm inclined to believe that if my tinnitus drops by a few decibels thanks to the device, it's possible (conditional) that it will continue to drop following a reduction in anxiety.

A domino effect of sorts.

But we need to be sure that it works on reactive tinnitus with or without hyperacusis. That's the question I'm asking myself and that many people here are asking themselves.

 

[RunningMan]

It's -3 dB during washout.

If you put a song at 40 dB and then at 37 dB, would you hear the difference?

Honestly, it is not impressive at all, unfortunately.

These two files have a 3 dB difference for comparison. There is a noticeable difference. But the active treatment should actually provide a better reduction for most people. Much remains to be seen.

 

[Gb3]

Correct, but we don't know their thoughts.

So they don't have to agree with the conclusion that is published?

 

[Nick47]

So they don't have to agree with the conclusion that is published?

I don't know but I don't think so. They get to see it earlier but what role they have on the paper being published, I don't know. There are a few researchers here that may be able to answer.

 

[ErikaS]

I'm inclined to believe that if my tinnitus drops by a few decibels thanks to the device, it's possible (conditional) that it will continue to drop following a reduction in anxiety.

A domino effect of sorts.

But we need to be sure that it works on reactive tinnitus with or without hyperacusis. That's the question I'm asking myself and that many people here are asking themselves.

Couldn't agree more. Once some of us get a glimpse of improvement for the first time, it will allow anxiety to calm, which will have a great benefit on the tinnitus as a whole. And with regard to reactivity, that's all I truly want to know at this point. If it can have any positive effect on reactivity OR could it possibly have an adverse effect.

 

[Anomalous]

I don't know but I don't think so. They get to see it earlier but what role they have on the paper being published, I don't know. There are a few researchers here that may be able to answer.

This article gives a pretty good explanation on the role of peer reviewers:

→ The Task of the Referee

 

[chinup]

For those wondering how loud the audio input is, you can find the details on the study article under the "Supplemental Content" tab → "Supplement 1 PDF". (Link to study).

It is 40 dB above the hearing threshold but no more than 90 dB.

So if you have no hearing loss, you'll be blasting a 90 dB tone directly into your ears for 30 minutes every day?

If so, this will likely not be viable for those of us with noxacusis and minimal hearing loss. I'm also not surprised that some participants in the study got worse if that's actually the volume level.

Surely I'm not interpreting what you're saying correctly? That seems dangerously loud.

EDIT: It seems like the actual treatment spectrum is lower in volume judging from the PDF. It's somewhat confusing:

 

[Pitseleh]

So if you have no hearing loss, you'll be blasting a 90 dB tone directly into your ears for 30 minutes every day?

I would say that if you have no hearing loss, you'll be blasting 40 dB. If your hearing loss is 20 dB, you'll be blasting 60 dB. If your hearing loss is 50 dB, you'll be blasting 90 dB. If your hearing loss is more than 50 dB, you'll still be blasting 90 dB, as it's the limit.

But the graph shows it's a bit more complicated than that, so I really have no idea.

Still, I agree with you, I'm really surprised about those numbers Sounds like a lot of dB, but I'm pretty bad with figures overall, so yeah...

 

[UKBloke]

So if you have no hearing loss, you'll be blasting a 90 dB tone directly into your ears for 30 minutes every day?

If so, this will likely not be viable for those of us with noxacusis and minimal hearing loss. I'm also not surprised that some participants in the study got worse if that's actually the volume level.

Surely I'm not interpreting what you're saying correctly? That seems dangerously loud.

EDIT: It seems like the actual treatment spectrum is lower in volume judging from the PDF. It's somewhat confusing:

View attachment 55135

One thing I've noticed about dB is that's quite a varied and confusing scale/system. There's sound pressure levels (literally the pressure of sound moving through air) and then there's perceived volume, which don't appear to be the same thing.

Then there's this inverse square law thing going on when it comes to a halving (or 6 dB reduction) of volume, which is why I'm not convinced by @Gabriel's analogy of knocking a 40 dB fader back to 37 dB. It's not the same as a 3 dB reduction in perceived volume - well, to my understanding at least!

In time hopefully we can get more info, perhaps from Dr. Shore herself, about how patients' hearing perceive these dB figures in real-world use.

 

[Nick47]

I would say that if you have no hearing loss, you'll be blasting 40 dB. If your hearing loss is 20 dB, you'll be blasting 60 dB. If your hearing loss is 50 dB, you'll be blasting 90 dB. If your hearing loss is more than 50 dB, you'll still be blasting 90 dB, as it's the limit.

That's exactly as I interpreted it, however only at the tinnitus frequency.

Having had time to digest the paper, the next question is when will the device be granted FDA approval.

I had guessed middle of May - middle of June for the publication.

So I'm guessing September 2023 for FDA approval. I can't confirm but did someone say the FDA approval request (full, not preliminary) was done in December 2022?

 

[awake 44]

That's exactly as I interpreted it, however only at the tinnitus frequency.

Having had time to digest the paper, the next question is when will the device be granted FDA approval.

I had guessed middle of May - middle of June for the publication.

So I'm guessing September 2023 for FDA approval. I can't confirm but did someone say the FDA approval request (full, not preliminary) was done in December 2022?

I cannot pinpoint the source, but I remember precisely: Dr. Shore submitted the request for FDA approval at the same time she submitted the publication for peer review.

 

[Nick47]

I cannot pinpoint the source, but I remember precisely: Dr. Shore submitted the request for FDA approval at the same time she submitted the publication for peer review.

That fits in with what I've heard. So 6 months ago. We should surely hear this year if it's approved?

 

[AfroSnowman]

That fits in with what I've heard. So 6 months ago. We should surely hear this year if it's approved?

The other question that crosses my mind is how close are they to commercialization once they get approval. I guess the two big things will be manufacturing and distribution. I wonder if they will start with the Lenire model of selling out of their own clinic while waiting to develop an audiologist network.

 

[dj_newark]

That fits in with what I've heard. So 6 months ago. We should surely hear this year if it's approved?

I think I was the one who said I thought that she submitted to the FDA when she submitted her paper to be published. It just made the most sense to me, though I had no direct knowledge at the time.

If we assume that's correct, then she submitted her device to the FDA as a De Novo device. However, when Lenire got that classification in March, she likely had to re-submit her device as a 510(k) device. The FDA's goal is to have a decision on a 510(k) Class II device (which is what we think the Michigan device is) within 90 days. But these timelines always seem to stretch on longer than we'd hope, so I think this year is a more realistic estimate.

 

[awake 44]

I think I was the one who said I thought that she submitted to the FDA when she submitted her paper to be published. It just made the most sense to me, though I had no direct knowledge at the time.

If we assume that's correct, then she submitted her device to the FDA as a De Novo device. However, when Lenire got that classification in March, she likely had to re-submit her device as a 510(k) device. The FDA's goal is to have a decision on a 510(k) Class II device (which is what we think the Michigan device is) within 90 days. But these timelines always seem to stretch on longer than we'd hope, so I think this year is a more realistic estimate.

I understand you and your point of view is logical. However, now we are building our expectations on assumptions, not facts. To be honest, the date when the device is approved is not that important for me. I feel safe, as the data are promising. And that is the most important part.

 

[Jonno02]

Even if they submitted to the FDA the day the publication came out, I'd be astounded if it wasn't approved this year.

 

[Joeseph Stope]

We can be cheered that there's a selection of therapies "in the pipeline". Which one will be successful? Well, don't pin all your hopes on one. Based on the posts in this thread, it seems like Dr. Shore's device will help some sufferers, but not others.

Just like Lenire, Tinnitus Retraining Therapy etc., etc.

So if you belong to one of the lucky people, don't walk away and forget us.

 

[DaveFromChicago]

We can be cheered that there's a selection of therapies "in the pipeline". Which one will be successful? Well, don't pin all your hopes on one. Based on the posts in this thread, it seems like Dr. Shore's device will help some sufferers, but not others.

Just like Lenire, Tinnitus Retraining Therapy etc., etc.

So if you belong to one of the lucky people, don't walk away and forget us.

I just turned 69. I frankly don't have much time left insofar as waiting for an effective treatment is concerned.

The last time I saw my ENT Doctor, I asked him when an effective treatment would be available, and (I kid you not) he actually shouted, "In about 100 years!" and left the room.