New University of Michigan Tinnitus Discovery — Signal Timing

[Toby1972]

If the device works, I'll be the second one here to get a Dr. Shore tattoo.

But that's not until my wedding day. I'll tell my wife that I wanted to have her picture taken, but the intern took it on for cost reasons... (I'm trying to regain my sense of humor with the news).

 

[PeterPan]

The graphic is interesting (source).

It shows the loudness of the sham group being reduced by about 5 dB (almost 50%) at the end the 12 weeks period, and progressively improving. Maybe because most (?) of the trial participants have had tinnitus for less than 1 year and we are seeing natural improvement, with the device accelerating the natural improvement?

Also, in the original trial the loudness levels returned to baseline after the end of the 8 weeks. Has the additional 2 weeks of treatment in this new trial caused the reduction to be maintained, have the device/device settings changed during this new trial, or has the nature of the cohort changed (or something else?). I suspect it may be related to the cohort?

So, it would be very interesting to see how the treatment performs with people who have had tinnitus for a longer term.

 

[AfroSnowman]

Thankfully, however, the team relaxed that particular criteria in Phase 2 and made it a max hearing loss of -50 dB.

Might even be higher for clinical use.

 

[ploughna]

Might even be higher for clinical use.

I'd hope that your hearing simply needs to be good enough to hear the sound at the appropriate level - Lenire has a limit of -80 dB at higher frequencies for this reason.

 

[AnthonyMcDonald]

Very true. If her theory is right about the DCN, it's only a matter of time before someone can stimulate it directly and completely eliminate tinnitus!

Not to derail this topic, but this is kind of what XEN1101 does.

 

[Mentos]

@Mentos, what did you think about Dr. Shore's Phase 2 results?

Hi Nick, considering we haven't seen a publication yet and what we know is only based on teaser presentation, I would remain cautiously optimistic. The first indicators suggest a real breakthrough, but we know the devil is in the details which we will only know after official publication (all exclusion criteria, % of responders, sham treatment results, what about atonal tinnitus, etc.).

The graphic is interesting (source).

View attachment 52239

It shows the loudness of the sham group being reduced by about 5 dB (almost 50%) at the end the 12 weeks period, and progressively improving. Maybe because most (?) of the trial participants have had tinnitus for less than 1 year and we are seeing natural improvement, with the device accelerating the natural improvement?

Also, in the original trial the loudness levels returned to baseline after the end of the 8 weeks. Has the additional 2 weeks of treatment in this new trial caused the reduction to be maintained, have the device/device settings changed during this new trial, or has the nature of the cohort changed (or something else?). I suspect it may be related to the cohort?

So, it would be very interesting to see how the treatment performs with people who have had tinnitus for a longer term.

Maybe the sham arm improvement comes from a kind of prolonged residual inhibition effect?

 

[Alue]

I don't think 32% of population has tinnitus, more like 10-20% or even lower. If 1 out of 3 people had it, then the overall awareness would be much greater and it would be taken seriously. In my personal circle, for example, I know (and I asked about tinnitus) around 50 people and found out only 3 have tinnitus - me, my mother and my psychiatrist. Everyone else hadn't even heard of it...

Hyperacusis must have a very very low percentage, but there are many degrees of it and people might not know they actually have it. If you have tinnitus and you find some sounds uncomfortable, even mildly, that could very well be some kind of hyperacusis.

Okay, people are getting hung up on the 32% which is a generous figure, the highest figure out of any study I saw. But tinnitus itself isn't all that uncommon. Point being, I still think hyperacusis is pretty rare. At least what I would call hyperacusis, although sometimes I feel like I'm talking about a completely different condition with some people...

I talked with an audiologist that I saw recently and asked them how many patients she's had with hypercusis through the course of her career. She said 'a handful', but then kept describing misophonia. Totally not the same thing. One is annoying the other can be completely debilitating.

Is there any sort of metric for diagnosing hyperacusis, like an official diagnosis? I have one on paper from my ENT, but is there some sort of criteria to be met?

 

[Karen1979]

You're very early in with it all. Believe me; you need to try and give it until around 2024 and then take a view. There's a very good chance you'll be just fine with your tinnitus (if it has persisted) by then. If not though, it's good to know that a robust treatment is there if needed. At this point, I have a feeling Dr. Shore has opened the flood gates and the technology will start to improve in leaps and bounds.

Thank you so much. Yes, I believe this will show others (and the fact they are looking at at the mapping of tinnitus now, reminds me of the early days of Parkinson's and treatment for that has come on leaps and bounds) where to aim.

And yes, just knowing that something is out there helps a lot.

 

[InNeedOfHelp]

Hi Nick, considering we haven't seen a publication yet and what we know is only based on teaser presentation, I would remain cautiously optimistic. The first indicators suggest a real breakthrough, but we know the devil is in the details which we will only know after official publication (all exclusion criteria, % of responders, sham treatment results, what about atonal tinnitus, etc.).

Maybe the sham arm improvement comes from a kind of prolonged residual inhibition effect?

I'm not happy with this either. 50% dB reduction in the placebo group with only auditory stimulation (like many other audio apps, Lenire, notch audio therapy) makes me doubt the actual value and importance of dB reduction in general.

If you can perceive 50% dB reduction in the sham and not have any clinical significant TFI reduction in the sham, it means that dB reduction is basically worthless?

Adding on top of that, the barely clinical significant TFI score in the active treatment with 75% dB reduction makes me doubt it even more.

CBT has basically the same TFI reduction.

Based on the posts here, it seems that I'm the only one not celebrating here, so maybe it is just me...

 

[DimLeb]

I talked with an audiologist that I saw recently and asked them how many patients she's had with hypercusis through the course of her career. She said 'a handful', but then kept describing misophonia. Totally not the same thing. One is annoying the other can be completely debilitating.

Is there any sort of metric for diagnosing hyperacusis, like an official diagnosis? I have one on paper from my ENT, but is there some sort of criteria to be met?

Well, hyperacusis is a far less studied condition and we know a lot less about it than tinnitus. It can take many different forms as I've read on this forum during the last 1.5 years that I've been here. Before it all began for me, I would have said that it's all misophonia and it's just psychological reasons that a person dislikes being around sound. I couldn't have imagined that there are actual pathological reasons and ear injury that would cause pain or increased perceived loudness of sounds.

In my experience, many doctors deal with it like they know better, patronising and even victimising us. For example, since my tinnitus onset, I have a weird vibrating/muscle twitching/TTTS sensation in my ears when I hear sudden noises or speaking to one person in relative quiet (doesn't happen always). With more noise around it just disappears. But still, it can become quite uncomfortable. Nearly all of the doctors I've seen, dismissed it as "there is no such condition". Well...

I don't think there is a solid diagnosis for hyperacusis or misophonia. There are some tests like LDL or so, but still they don't know show anything about what is really happening. *shrugs*

 

[Bart]

I'm not happy with this either. 50% dB reduction in the placebo group with only auditory stimulation (like many other audio apps, Lenire, notch audio therapy) makes me doubt the actual value and importance of dB reduction in general.

If you can perceive 50% dB reduction in the sham and not have any clinical significant TFI reduction in the sham, it means that dB reduction is basically worthless?

Adding on top of that, the barely clinical significant TFI score in the active treatment with 75% dB reduction makes me doubt it even more.

CBT has basically the same TFI reduction.

Based on the posts here, it seems that I'm the only one not celebrating here, so maybe it is just me...

Maybe the TFI scores reflect the fact that the participants' tinnitus was of fairly recent onset <one year, so habituation yet has to do its part of reducing the distress in general, so even with a good reduction in intensity, the TFI scores would still be significant because participants will only be happy with total silence. Just a theory.

Anyway, with that being said, although I'm carefully optimistic, it's much too early to draw conclusions from this, keeping the Lenire debacle in mind, but finally they start to tackle the root cause of tinnitus and not just treat the symptoms and pretend that it's not as bad.

 

[Hazel]

I'm not happy with this either. 50% dB reduction in the placebo group with only auditory stimulation (like many other audio apps, Lenire, notch audio therapy) makes me doubt the actual value and importance of dB reduction in general.

If you can perceive 50% dB reduction in the sham and not have any clinical significant TFI reduction in the sham, it means that dB reduction is basically worthless?

Adding on top of that, the barely clinical significant TFI score in the active treatment with 75% dB reduction makes me doubt it even more.

CBT has basically the same TFI reduction.

Based on the posts here, it seems that I'm the only one not celebrating here, so maybe it is just me...

I am always skeptical about any trial results until I get the full information. I think it's healthy after all the previous failed treatments we've seen.

I agree 100% regarding the TFI reduction, that's very underwhelming and indeed at the same level as CBT trials, but also at the same level as the many previous sound therapy devices we've seen. Somehow, they always end up with an average TFI reduction of about 15 points, with 13 being the 'clinically significant' threshold. Did you guys know the 13-point threshold was picked because that's what you get by simply waiting a year and doing nothing (not even administering a placebo, just doing nothing)? So, when Dr. Shore presented those results, my heart kind of sank, especially because she presented this before the loudness reduction results.

As for the loudness reduction, I will first of all say that I really commend Dr. Shore for even doing this at all. Very few trials include this as an outcome measure, even though it's the most important thing to patients. The excuse of course is always that it's too hard to measure — which is true to some extent.

Anyway, the loudness reduction results do look impressive at first glance, very impressive even. Many here would give an arm and a leg for a 75% reduction! But it does raise many questions. The biggest one for me is how was this measured? And indeed, the loudness improvement in the sham arm makes you wonder. This could be some kind of placebo effect. And will the loudness reduction sustain over time? I think Dr. Shore mentioned they did a 30-week follow-up, but I did not see those results in her slides, so that would be something to look out for.

 

[Nick47]

I agree 100% regarding the TFI reduction, that's very underwhelming and indeed at the same level as CBT trials

@Hazel, I remember the mean starting TFIs in Phase 1 were low, like around 30. We need to know the mean TFI starting values of Phase 2, because if they are in the region of 30-50, a 15-20 point reduction is huge.

 

[Hazel]

@Hazel, I remember the mean starting TFIs in Phase 1 were low, like around 30. We need to know the mean TFI starting values of Phase 2, because if they are in the region of 30-50, a 15-20 point reduction is huge.

That is true, and we currently do not have that information, because the TFI chart presented only showed a baseline represented as '0' so we cannot know what TFI score that represents.

Typically, they start with an average TFI of about 50-60 as a baseline. Lenire's TENT-A2 study started with 50 and this recent sound therapy study from Grant Searchfield started with 60. (The latter by the way, achieved an average TFI reduction of 17.8 points, almost exactly the same as Shore's study.)

Still, if you are right and they started with an average TFI in the 30-50 range, I would argue they picked the wrong target group in the first place. In my opinion, the selection should always be skewed towards, or at least include a significant proportion of, severe sufferers. It is not a given that a good result for mild sufferers will translate into an equal or greater reduction for severe sufferers.

 

[UKBloke]

I wonder if it's going to help people like me who have good days and bad days of tinnitus. I'm having about 18 good days a month (days where it is not annoying) due to the fact that I recently removed trigger points in my neck.

My tinnitus is similar to yours in as much as I can go a couple of weeks where life is manageable but then out of nowhere (like the last 10 days of November for example) the symptoms rise to truly shocking, almost overwhelming levels, and things get extremely tough.

You're a long-termer like me, and we're still here so I guess we've automated the process of coping with the day-to-day through these cycles. Nevertheless, having a gadget other than masking that actually aims to calm the neuronal excitability (even if it were only to a small degree like 15%) would be life-changing.

In answer to your question, although I genuinely don't know, intuition says yes, if those neurons in the DCN have fired up and are at full-throttle then a device that aims to modulate that discordance should have an effect regardless of where we are in the ongoing cycle. I suppose the only way we're going to find out is by trying the device ourselves.

 

[InNeedOfHelp]

That is true, and we currently do not have that information, because the TFI chart presented only showed a baseline represented as '0' so we cannot know what TFI score that represents.

Typically, they start with an average TFI of about 50-60 as a baseline. Lenire's TENT-A2 study started with 50 and this recent sound therapy study from Grant Searchfield started with 60. (The latter by the way, achieved an average TFI reduction of 17.8 points, almost exactly the same as Shore's study.)

Still, if you are right and they started with an average TFI in the 30-50 range, I would argue they picked the wrong target group in the first place. In my opinion, the selection should always be skewed towards, or at least include a significant proportion of, severe sufferers. It is not a given that a good result for mild sufferers will translate into an equal or greater reduction for severe sufferers.

It's interesting, right? Presenting decrease without giving any actual starting values says extremely little.

I respect that Dr. Shore is very careful and avoids any type of speculation, but "we" have been presented initial trials results without knowing if it was considered successful or not. I'm sure Dr. Shore knows that baseline values are critical to draw conclusions. I'm curious what Dr. Shore's own conclusion is, if she is happy with the result or not. All we can do is speculate at this stage. And push for a Tinnitus Talk Podcast

 

[Mathew Gould]

I am always skeptical about any trial results until I get the full information. I think it's healthy after all the previous failed treatments we've seen.

I agree 100% regarding the TFI reduction, that's very underwhelming and indeed at the same level as CBT trials, but also at the same level as the many previous sound therapy devices we've seen. Somehow, they always end up with an average TFI reduction of about 15 points, with 13 being the 'clinically significant' threshold. Did you guys know the 13-point threshold was picked because that's what you get by simply waiting a year and doing nothing (not even administering a placebo, just doing nothing)? So, when Dr. Shore presented those results, my heart kind of sank, especially because she presented this before the loudness reduction results.

As for the loudness reduction, I will first of all say that I really commend Dr. Shore for even doing this at all. Very few trials include this as an outcome measure, even though it's the most important thing to patients. The excuse of course is always that it's too hard to measure — which is true to some extent.

Anyway, the loudness reduction results do look impressive at first glance, very impressive even. Many here would give an arm and a leg for a 75% reduction! But it does raise many questions. The biggest one for me is how was this measured? And indeed, the loudness improvement in the sham arm makes you wonder. This could be some kind of placebo effect. And will the loudness reduction sustain over time? I think Dr. Shore mentioned they did a 30-week follow-up, but I did not see those results in her slides, so that would be something to look out for.

I don't understand how there could be a 50-75% loudness reduction, but only 15 points on TFI. Are you trying to say they should have started with a group of people with higher TFI? I think TFI is somewhat BS. Some days I will have a TFI score of 50 and some days it will be 15.

 

[Damocles]

If the device works, I'll be the second one here to get a Dr. Shore tattoo.

Actually @Toby1972, I think you'll be about the 6th.

Will have to get in line behind @Bambam0, @IntotheBlue03, @Stayinghopeful, @CRGC and @AnthonyMcDonald to get that magnificent bodhisattva permanentized on your left butt cheek.

As for me, I've been thinking about getting a linearb tattoo with his catchphrase "smoke 'em if you got 'em" written below it.

Because, on his ignore list or not, credit where credit's due. He said it:

The tech works.

 

[Sironketchup]

A tear is just running down my cheek.

 

[Bart]

Some days I will have a TFI score of 50 and some days it will be 15.

That is why TFI scores take an average per week and not per day. TFI also does not necessarily say something about perceived loudness but more about the impact of tinnitus on someone's life, which is different for everyone.

 

[Fightthearmy]

Based on the posts here, it seems that I'm the only one not celebrating here, so maybe it is just me...

No, I think based on this information, we can't say anything adds up. That may be a problem of the presentation. But this is precisely why scam treatments can thrive in clinics and ineffective ones in development are reported as success. It seems like any arbitrary parameters can be chosen to represent criteria of a successful treatment, like the '0' used here as a baseline.

 

[Kam75]

As a very severe tinnitus sufferer (I have 4 sounds in my head including an ultra high-pitched sound, a dental drill sound and an electric sound), I also literally shed a few tears when I heard the good results of Susan Shore's device.

I want to be optimistic like most of you, this disease is messing up my life on many levels. But it's hard not to be sceptical when you see all the potential treatments that have failed.

I've been on Tinnitus Talk for almost 4 years, and I've seen some disappointments.

Every day I read the news (because I like to be informed about the world), and almost every week or every month at least, I read articles like "a patient cured of AIDS", "a blind man regained his sight", "cancer will soon be cured"... but absolutely nothing about tinnitus.

How come there are never any articles about Susan Shore, when she is one of the few people trying to do something about this disease? According to articles on the Internet, millions of people on Earth suffer from disabling tinnitus. Why then is it only on Tinnitus Talk that Susan Shore is mentioned?

Apart from a few articles on the results of the Phase I trial of Susan's device, there is hardly anything about her available. How do you explain this when this kind of information is likely to be of interest to millions of people?

I can't help but wonder.

 

[Nick47]

This is an important point. What does your current audiogram look like? I have a circa -43 dB notch @ 4 kHz and would therefore have been excluded from using this device based on Dr. Shore's Phase 1 criteria. Thankfully, however, the team relaxed that particular criteria in Phase 2 and made it a max hearing loss of -50 dB.

It's a strange one for me too.

Bilateral tinnitus. Normal audiogram in the left ear. 80 dB + 90 dB drops all the way through from 4000 Hz - 8000 Hz in the right ear from an SSNHL in 2015.

So I could only wear the ear piece in my good ear and I have doubts it would help.

 

[@dam]

This is why being able to measure subjective tinnitus is almost as crucial as curing tinnitus. We wouldn't be having opinions on how well or bad the TFI is. We are getting very close thanks to the Bionics Institute and a couple of other companies around the globe, where you could literally see tinnitus in the brain before and after the treatment.

 

[Hazel]

I don't understand how there could be a 50-75% loudness reduction, but only 15 points on TFI.

I don't understand that either and have no explanation for it!

Are you trying to say they should have started with a group of people with higher TFI? I think TFI is somewhat BS. Some days I will have a TFI score of 50 and some days it will be 15.

I am saying trials should focus mostly on severe sufferers, as they need the most help, and currently TFI (however imperfect) is probably the best way of measuring that. But yeah, it's a very poor outcome measure in general; from my perspective (and as long as we lack a truly objective measure) it could be replaced by something like: "on a scale from 1-5, how much has this treatment improved your life?". But perhaps there are good reasons why almost no tinnitus study takes that approach (?).

 

[ploughna]

I'm curious what Dr. Shore's own conclusion is, if she is happy with the result or not.

Since she said FDA approval is being applied for, you would think this indicates that she must have some reasonable level of confidence in the efficacy. Hopefully a clearer picture will emerge going forward because, right now, what we know is that some presumably objective method to measure loudness showed a good reduction but the subjective opinion of improvement from the participants was minimal. Did the measurements show loudness reduction, but participants didn't perceive it? As many have stated here, hard to know what to make of it.

Also, loudness continued to decrease post-study, what about TFI I wonder - any further improvement, or did the 15-20 TFI point improvement coincide with the 75% loudness reduction?

Having said all that, it's still the first ever larger scale well designed study that shows objective and sustained improvement, the Professor seems happy with the results, a company is in place to commercialize and FDA approval is being sought, so apart from the TFI score (which many agree is not the best measure in the first place), it's not a bad place to be.

Would be interesting to couple this treatment up with the objective tinnitus measuring test that's being developed (in Australia?) - in the future I suspect!

 

[ploughna]

Bilateral tinnitus. Normal audiogram in the left ear. 80 dB + 90 dB drops all the way through from 4000 Hz - 8000 Hz in the right ear from an SSNHL in 2015.

So I could only wear the ear piece in my good ear and I have doubts it would help.

Don't rule it out - I saw a mention recently (I think somewhere on this forum) of data showing that a cochlear implant in one ear reduced tinnitus in both ears for a significant number of people.

 

[AfroSnowman]

Since she said FDA approval is being applied for, you would think this indicates that she must have some reasonable level of confidence in the efficacy. Hopefully a clearer picture will emerge going forward because, right now, what we know is that some presumably objective method to measure loudness showed a good reduction but the subjective opinion of improvement from the participants was minimal. Did the measurements show loudness reduction, but participants didn't perceive it? As many have stated here, hard to know what to make of it.

Also, loudness continued to decrease post-study, what about TFI I wonder - any further improvement, or did the 15-20 TFI point improvement coincide with the 75% loudness reduction?

Having said all that, it's still the first ever larger scale well designed study that shows objective and sustained improvement, the Professor seems happy with the results, a company is in place to commercialize and FDA approval is being sought, so apart from the TFI score (which many agree is not the best measure in the first place), it's not a bad place to be.

Would be interesting to couple this treatment up with the objective tinnitus measuring test that's being developed (in Australia?) - in the future I suspect!

TFI is so problematic that I largely discount it as a metric. But let me put a bit of a narrative on these numbers and theorize why that 15-20 point reduction in TFI is all we see from a 75% reduction in tinnitus loudness.

First of all, that reduction in TFI represents roughly a drop in one class of tinnitus distress; "not a problem (0 to 17), small problem (18 to 31), moderate problem (32 to 53), big problem (54 to 72), very big problem (73 to 100)"

If the average participant came in around a 50, they dropped from a borderline big problem to a borderline small problem.

This isn't insignificant. But again TFI is a really poor way to measure tinnitus, it measures our emotions about tinnitus. Though there is a life changing functional difference in a 75% reduction in tinnitus loudness for severe tinnitus sufferers (hearing, concentration, relaxation, lack of a pain response), an average person with average tinnitus in the study might still express irritation that they can hear it in a quiet room or that when they go to bed at night they need to put on a fan and the TFI captures their annoyance they need to listen to this sound at all. In short TFI, the measurement of how we feel about tinnitus, probably isn't linear, we can greatly reduce the volume yet still be troubled that there are phantom sounds at all.

Secondly, maybe the 30 weeks wasn't enough time to capture the habituation process for the new quieter tinnitus. I think, as a rule of thumb, we normally think of someone with 'normal tinnitus' taking 9-12 months to really get over the hump.

 

[InNeedOfHelp]

Since she said FDA approval is being applied for, you would think this indicates that she must have some reasonable level of confidence in the efficacy. Hopefully a clearer picture will emerge going forward because, right now, what we know is that some presumably objective method to measure loudness showed a good reduction but the subjective opinion of improvement from the participants was minimal. Did the measurements show loudness reduction, but participants didn't perceive it? As many have stated here, hard to know what to make of it.

Also, loudness continued to decrease post-study, what about TFI I wonder - any further improvement, or did the 15-20 TFI point improvement coincide with the 75% loudness reduction?

Having said all that, it's still the first ever larger scale well designed study that shows objective and sustained improvement, the Professor seems happy with the results, a company is in place to commercialize and FDA approval is being sought, so apart from the TFI score (which many agree is not the best measure in the first place), it's not a bad place to be.

Would be interesting to couple this treatment up with the objective tinnitus measuring test that's being developed (in Australia?) - in the future I suspect!

Actually this made me think of a member who had a 15 dB reduction, I think from 80 dB to 65 dB (I think it was after stem cells?). I cannot find the exact post. It was objectively measured decrease in dB with software. And he said he still rates his tinnitus as extremely bothersome, it barely changed his TFI. This correlates with the study results here, which makes me wonder. If the tinnitus is loud, it stays loud, despite the "small" reduction of 15 dB.

 

[Skydog07]

I don't mean to derail from this amazing news, but as someone who now has more than tinnitus to worry about, do you guys think this device getting FDA approval and becoming available to the public will affect hearing loss research in anyway?