New University of Michigan Tinnitus Discovery — Signal Timing

[DeanD]

I'm glad someone asked this question and the answer truly shows how uncaring, incompetent, and ineffective our federal government is, especially the the US Veterans Administration!

One billion a year spent on tinnitus claims and along comes the first viable treatment for tinnitus in the history of warfare, yet administrative chiefs in that organization just sit there with their thumbs up their arse instead of pushing for funding to get this device out to the hundreds of thousands of vets suffering from deliberating tinnitus. Absolutely shameful and embarrassing! Heads should roll in that organization!

The problem is, it isn't proven in the real world.

Imagine if they had poured millions or billions in to Lenire to get out on large scale to the masses quickly. It would largely have been an embarrassment. It was also considered to be 'the treatment' before it was launched.

I also haven't seen anything to suggest this cures tinnitus, but rather reduces it, with the proviso that regular sustained use 'could' have that desired effect. Powers at be will see this as a symptom reducer, not cure (even though we know how life changing the reduction of symptoms would be). It's a lot of ifs and maybes for the balance sheet.

I'm not dismissing Auricle. The agonizing wait continues, but until this is proven in the real world and has the backing of the leading medical counsel to the Government, it isn't going to be pushed forward.

If this launches and works successfully, heads will slowly turn in its direction - but not before.

 

[Joeseph Stope]

This thread is starting to feel like a revamped version of the Lenire one before Lenire was released...

May the outcome be a different one

What's that old expression... different strokes for different folks. There's (different) horses for (different) courses. So don't go and boogie all night long in the disco just yet. Keep your eye on the incoming results.

I'm a bit flabbergasted at this so-called barrier that the FDA (is this correct?) has set up. If they don't allow it -- for whatever reason -- go over the border to Canada, Mexico, or Jamaica? Try it out there.

 

[Watasha]

Yes, I should. I've always wondered why Veterans' associations in the US, and there must be many, have never campaigned aggressively for more funding for tinnitus research? If I had severe intrusive tinnitus that resulted from serving my country, I'd be raising bloody hell with my Senators and Congressional representatives to push for major research funding. I would think Veterans' associations would have a lot of clout and support from the public on this issue. Maybe they have campaigned and I don't know. Any veterans on here know the answer?

I think @TuxedoCat tried reaching out to some in the past in her community. The struggle is probably reaching the top brass and getting them to care. I feel like if you could get the ear of a congressmen it could make a big difference.

 

[RunningMan]

Let's pray something comes out of this. Let this decade be the decade when tinnitus was cured.

Well, it's no cure, but apparently an effective treatment, and from the graphs, it looks like there's 5 dB to 6 dB better reduction with the active treatment vs. the control group (placebo), both at the end of the active treatment and at the end of the washout of period 1. Somewhere in the range of 6 dB to 10 dB reduction is perceived half as loud. Dr. Shore used the 6 dB figure in her answers as being half as loud.

So, it's significant vs. the control group, despite not being a cure.

 

[llecrup]

Silence to me is simply not hearing the ringing.

That, plus significant improvement in the third and fourth stages of slow-wave sleep, and in the REM stage.

 

[Nick47]

local market has about roughly 40 million people whom would definitely give it a go

Where have you plucked 40 million from?

 

[Jonno02]

I'm not going to regurgitate the same old stuff I've posted before. But unless you've dealt with the FDA, you don't know how particular regulatory bodies are. Auricle, on this front anyway, are not purposely taking longer than is reasonably expected.

I just hope they have the commercialisation partners in place to make this a substantially paced rollout.

And I kinda see a lot of almost passive aggressive comments about this device or Dr. Shore. She's the only researcher that's achieved anything in this space. We are not experts in the physiology of this, she is. And with a device like this it's not like she's being obstructive, they genuinely won't be able to answer most of our questions until it's in the field and the populace using it is in the thousands or tens of thousands.

 

[AmePerdue]

What does Dr. Shore mean by no one experiences true silence? Does she mean that even those without tinnitus don't experience silence or what? Or was she referring to the patients undergoing the treatment? We had an example of @kelpiemsp who experienced silence from a somewhat similar device (University of Minnesota).

I've had tinnitus for 2 years, it's 2 years too long and yet recent enough that I can remember just relaxing in the countryside at night in winter with zero external noise and hearing that faint hissing, thinking "huh, interesting, silence isn't really silence". It wasn't tinnitus because I really had to pay attention to it to notice it and I would never have noticed it without actively "listening" to silence, not just merely being in a place without sound. I think she means in layman's terms that the tinnitus sound is not a new and separate kind of auditory sensation, it's the baseline sound sort of going haywire due to the sound processing in the brain losing its fine tuning for whatever reason.

 

[DimLeb]

I've had tinnitus for 2 years, it's 2 years too long and yet recent enough that I can remember just relaxing in the countryside at night in winter with zero external noise and hearing that faint hissing, thinking "huh, interesting, silence isn't really silence". It wasn't tinnitus because I really had to pay attention to it to notice it and I would never have noticed it without actively "listening" to silence, not just merely being in a place without sound. I think she means in layman's terms that the tinnitus sound is not a new and separate kind of auditory sensation, it's the baseline sound sort of going haywire due to the sound processing in the brain losing its fine tuning for whatever reason.

I've read many people experience some kind of weird noise in silence that they don't even register as tinnitus and really I don't know what that is, but many other people, including me, were experiencing true silence. Nothing, nada. I still remember sitting still and quietly in my living room with no one else in the house, with no street sound or so as well (I live in a suburb with rarely anyone passing by and generally quiet neighbours).

I even closed my ears for more quietness and I was very fast scared by all that nothingness I could experience in silence. I believe I would have noticed some sound having very trained ears (from music making), but there wasn't.

 

[eagerUser]

I've had tinnitus for 2 years, it's 2 years too long and yet recent enough that I can remember just relaxing in the countryside at night in winter with zero external noise and hearing that faint hissing, thinking "huh, interesting, silence isn't really silence". It wasn't tinnitus because I really had to pay attention to it to notice it and I would never have noticed it without actively "listening" to silence, not just merely being in a place without sound. I think she means in layman's terms that the tinnitus sound is not a new and separate kind of auditory sensation, it's the baseline sound sort of going haywire due to the sound processing in the brain losing its fine tuning for whatever reason.

I clearly remember sitting in silence and reading books, I even closed my ears to not be distracted by other people's noise. When closed, I could only hear air pressure which I think is normal.

 

[ErikaS]

Reading Dr. Shore's answers and learning from those like @Jonno02 regarding the regulatory process doesn't make me any less optimistic about what this treatment could do for so many. It is obviously frustrating to not know any information that could give an idea on a type of timeline, but Dr. Shore is a very smart woman and she started putting her Auricle "team" together in 2019. I highly doubt they are wasting any kind of time, this is literally her baby of her lifelong career and research so I am going to remain optimistic that the ducks are sitting in a row and ready to go with next steps such as manufacturing, mass production, distribution, and education as soon as their device is approved.

Until then, I will continue to take my low dose Ativan as this still helps with my reactivity and mood, and I meet with a Neurologist mid September to just discuss medications like Keppra. Also currently working with a practitioner to regulate my nervous system, calm limbic safety signals, and doing some LLLT on the brain and around the ears. AKA, going to do what I can to function and remain in a calmer state until this comes out!

 

[BobbieJay-1954]

"Hey Bobbie, is there anything you want for Christmas this year?"

"The Auricle device to be FDA approved and distributed."

"...How about an Amazon gift card?"

Jokes aside, very well done @Markku with the formatting and, as always, thank you for your time and efforts. I know these answers have stirred the pot again with our emotions but I'm still remaining optimistic. Our time is coming soon everyone. Just hang on a little longer!

 

[Jim Vasilakis]

No one is doubting Dr. Shore's integrity. What many people have noted is that she has continuously taken her sweet time on many occasions, such as insisting on publishing her Phase 2 study first instead of proceeding with the regulatory process.

That probably stems from the fact that her tinnitus isn't bothering her. If it was a scientist with disabling tinnitus, I guarantee you the device would be in the market right now. I remember reading articles in 2019 on how this device was "market ready" and we are at 2023 right now.

I don't want to sound ungrateful but even though my tinnitus is mild, it has derailed my life completely and is causing a lot of grief on my family. I can't practise my degree or socialize anymore. Yeah, that's partially on me but it's also on my tinnitus. So for once I would really appreciate it if she didn't take her sweet time and come above timetable estimations.

 

[Ryan Scott]

What does Dr. Shore mean by no one experiences true silence? Does she mean that even those without tinnitus don't experience silence or what? Or was she referring to the patients undergoing the treatment? We had an example of @kelpiemsp who experienced silence from a somewhat similar device (University of Minnesota).

There is research and belief that everyone has some level on tinnitus; however, there is too much background noise in nature to where most people can't hear it. This is why if you put people who "don't" have tinnitus into one of those engineered quiet rooms and tell them to only come out once they hear a noise, the majority of them will come out fairly quickly.

 

[Jonno02]

No one is doubting Dr. Shore's integrity. What many people have noted is that she has continuously taken her sweet time on many occasions, such as insisting on publishing her Phase 2 study first instead of proceeding with the regulatory process.

You write up your study and send off to a publisher. They can take months to review and come back with comments.

Publications are not difficult. They take little time to prepare. After publication submission they were probably data crunching, carrying our statistical analysis, analyzing the data for trends, getting the data, reports and regulatory support files into a submission-ready state, bringing in a QMS for Auricle, getting ISO compliant e.g., 9001 etc.

It's not just a case of "Study done. Submit." Once my company conclude clinical trials, it takes a team of about 50 people from technical scientists, data scientists, regulatory associates, process engineers, quality engineers etc about 4 months to be submission ready. Auricle won't have a tenth of this resource, but luckily this device is only Class 2, so the submission isn't quite as intense. Even Auricle getting a functioning QMS takes time.

As much as I want this device strapped to my head tomorrow, I don't agree that she's taking her sweet time because I know how much of a pain in the A the regulatory process is.

Their preparations for manufacturing etc are a different situation, and I hope they are being proactive there.

 

[Markku]

That probably stems from the fact that her tinnitus isn't bothering her. If it was a scientist with disabling tinnitus, I guarantee you the device would be in the market right now. I remember reading articles in 2019 on how this device was "market ready" and we are at 2023 right now.

Would she have been able to do all this work, an admirable career in the field, with disabling tinnitus? I guess it depends what your definition of disabling tinnitus is. It does rub me the wrong way though to suggest that she would do better or be more motivated if she suffered more from tinnitus... I don't buy that thinking.

She has received an unimaginable number of emails (which in part drove her to agree to this Q&A in an effort to reduce that workload) over the years from people suffering a great deal, with suicidal ideation to boot. She is no stranger to emails where a person is threatening suicide due to debilitating tinnitus, or receiving hate mail. She is capable of empathy and she does not intentionally want to delay people's access to the treatment. The progress may seem slow, but she has always done things very much by the book, which is something we don't see from many others in the tinnitus space.

I know it's distressing having to wait, and wait, and wait... I for one am eager to see this thing in the real world where previous hopes have faltered (I remain cautiously optimistic until we have much more user experiences available.) I am happy she isn't cutting corners. Also, knowing how much garbage science and trash publications there are regarding tinnitus, she should be applauded for the level she's at. Tinnitus is still such a small field even though the patient population is immense, so at least I am very appreciative of folks like her.

And tinnitus isn't sexy for researchers. We constantly hear how hard it is to attract new talent. Getting new, good PhD students in the field is a struggle. So those we get and the good ones we already have, I feel like we should not be too critical of. In Dr. Shore's case, as laymen we just aren't privy to all the ongoings and I think it's healthy to give the benefit of the doubt even when we're struggling with the wait.

Anyway, my 2 cents...

 

[StoneInFocus]

...I interpret the below graph to mean that the group that experienced the treatment in weeks 1-6 did much better than the group that experienced the treatment in weeks 13-18...

A crossover study is the strongest possible design for a clinical trial, but only if there is recovery (or return to baseline) after the first treatment period during the washout phase... What we saw was that the treatment after 6 weeks was so long lasting that we did not see recovery. In fact, we saw a continued treatment effect up to 12 weeks (and beyond). For that reason the crossover did not work for the second study. This is called a "crossover effect" and it means that the second treatment period was biased by the first period. When that happens, it is not statistically valid to analyze the second half of the study. That is why we focused our analysis only on the first period.

Correct me if I'm wrong but isn't she dodging the question here? She's basically saying that she did not analyze the results of the second study because the tinnitus volume of the first group (the group that received the actual treatment in the first six weeks instead of the audio only) did not return to baseline after 12 weeks.

That still does not explain why the tinnitus volume of the people that received the active treatment after the first 12 weeks of audio only treatment actually seemed to increase instead of decrease?

 

[Erik.Swe]

So it seems it doesn't work if you have intermittent tinnitus. That's what I have in my right ear. Two different tones (1560 Hz and 955 Hz). I don't even know the cause of those tones.

 

[Utdmad89]

So it seems it doesn't work if you have intermittent tinnitus. That's what I have in my right ear. Two different tones (1560 Hz and 955 Hz). I don't even know the cause of those tones.

Where has that been stated?

 

[2noist]

Where has that been stated?

But it was for trial eligibility. Obviously you can try the device for intermittent tinnitus when it's out in the market...

 

[Gb3]

So it seems it doesn't work if you have intermittent tinnitus. That's what I have in my right ear. Two different tones (1560 Hz and 955 Hz). I don't even know the cause of those tones.

She said they didn't test Meniere's patients because they have intermittent tinnitus. She never said it wouldn't work for intermittent tinnitus.

 

[ZFire]

That probably stems from the fact that her tinnitus isn't bothering her. If it was a scientist with disabling tinnitus, I guarantee you the device would be in the market right now.

If a scientist were burdened with genuinely "disabling" tinnitus, there's a probable chance, their ability to pursue research might be severely compromised. The pace of progress would grind to an even slower crawl than the one you're currently lamenting and whining about.

EDIT: I see @Markku already spotted the contradiction here too.

 

[Jim Vasilakis]

If a scientist were burdened with genuinely "disabling" tinnitus, there's a probable chance, their ability to pursue research might be severely compromised. The pace of progress would grind to an even slower crawl than the one you're currently lamenting and whining about.

EDIT: I see @Markku already spotted the contradiction here too.

The word disabling was wrong. I meant more like bothering tinnitus. The kind you still want to get rid of but it's not debilitating.

I meant no offense to Dr. Shore, she is my best hope so far but the fact that she has very mild tinnitus and she has probably been habituated for years if not decades has definitely played a part.

 

[slc]

Thank you so much @Markku and all those involved for your wonderful work on this. I'm a bit verklempt, Yiddish for choked up, and also relieved and more hopeful as I read the questions and answers.

 

[Ngo13]

Correct me if I'm wrong but isn't she dodging the question here? She's basically saying that she did not analyze the results of the second study because the tinnitus volume of the first group (the group that received the actual treatment in the first six weeks instead of the audio only) did not return to baseline after 12 weeks.

That still does not explain why the tinnitus volume of the people that received the active treatment after the first 12 weeks of audio only treatment actually seemed to increase instead of decrease?

View attachment 55525

This is what I'm most disappointed about as I really thought she would answer it. It's not about Auricle or getting our hands on the device but the actual study itself. It's my main concern with the device and dashes my hopes. To me, it practically invalided her conclusions and makes me lean more towards placebo than the device actually working. There was a small discussion in the paper that the sound only treatment could actually worsen tinnitus, although I don't really understand the mechanism.

Also, it makes me chuckle because right now "sound therapy" is the main "treatment" for tinnitus. So, are we truly saying, with hard data, that audio only makes tinnitus worse? Even with a washout period? Something is fishy here.

 

[SarahMLFlemmer]

This is what I'm most disappointed about as I really thought she would answer it. It's not about Auricle or getting our hands on the device but the actual study itself. It's my main concern with the device and dashes my hopes. To me, it practically invalided her conclusions and makes me lean more towards placebo than the device actually working. There was a small discussion in the paper that the sound only treatment could actually worsen tinnitus, although I don't really understand the mechanism.

Also, it makes me chuckle because right now "sound therapy" is the main "treatment" for tinnitus. So, are we truly saying, with hard data, that audio only makes tinnitus worse? Even with a washout period? Something is fishy here.

Can someone please explain to me what is meant by "washout" period? I'm trying to make sense of it, but can't seem to.

 

[2noist]

Can someone please explain to me what is meant by "washout" period? I'm trying to make sense of it, but can't seem to.

During washout nothing is done, no active or placebo treatment at all, just chill.

 

[Utdmad89]

This is what I'm most disappointed about as I really thought she would answer it. It's not about Auricle or getting our hands on the device but the actual study itself. It's my main concern with the device and dashes my hopes. To me, it practically invalided her conclusions and makes me lean more towards placebo than the device actually working. There was a small discussion in the paper that the sound only treatment could actually worsen tinnitus, although I don't really understand the mechanism.

Also, it makes me chuckle because right now "sound therapy" is the main "treatment" for tinnitus. So, are we truly saying, with hard data, that audio only makes tinnitus worse? Even with a washout period? Something is fishy here.

12 weeks without it returning to the baseline would be an awful long time for it to be a placebo.

 

[haha ear go eeee]

Did any of the trial participants have loudness or pain hyperacusis? Do you think the treatment is appropriate for patients with tinnitus who also present with either type of hyperacusis? Could the treatment improve the hyperacusis as well?

The majority of patients did not report hyperacusis.

Okay, so what happened to the minority of patients that did report hyperacusis? What were the results? Did they worsen?

 

[Jim Vasilakis]

This is what I'm most disappointed about as I really thought she would answer it. It's not about Auricle or getting our hands on the device but the actual study itself. It's my main concern with the device and dashes my hopes. To me, it practically invalided her conclusions and makes me lean more towards placebo than the device actually working. There was a small discussion in the paper that the sound only treatment could actually worsen tinnitus, although I don't really understand the mechanism.

Also, it makes me chuckle because right now "sound therapy" is the main "treatment" for tinnitus. So, are we truly saying, with hard data, that audio only makes tinnitus worse? Even with a washout period? Something is fishy here.

I seriously doubt a placebo can reduce the loudness of tinnitus by 2x. That's a very noticeable difference and the improvement lasted for several weeks.