New University of Michigan Tinnitus Discovery — Signal Timing

[Pixelito]

It's hard to believe that Auricle would invest so much time and effort into a product with only a 10% success rate. If real-life experiences confirmed this, product sales would be dead within a year.

Like with Lenire, very few are going to pay thousands of dollars for something that gives them almost no chance of working. They might initially, but over time, interest will wane if the facts emerge that way.

I do think there is a negative skew on the results. We can only wait and see.

 

[RunningMan]

The placebo effect doesn't cut your tinnitus by 75% and 11 dB for almost two months. I'm not a tinnitus expert, but that I know. A decrease like that is physiological, not psychological. I don't think there has been a tinnitus sufferer who had the placebo effect for more than some days.

Did you actually review the study or read my comments? No one has said that the placebo arm of the study reduced tinnitus by 75% or 11 dB. And no one said that the active treatment group responded solely due to the placebo effect, either. Here is a comparison of the active vs. control/placebo for all participants in the study:

Okay, so there were people who didn't receive the treatment but had their tinnitus worsen. Is this what the data says?

No, the people who had tinnitus worsened had treatment in one of the arms of the study. There were some from both groups.

If Lenire had a success rate in the high 80s percentile but no placebo, and we assume a 20 percent improvement for the placebo, that still leaves Lenire at the high 60s percentile for improvement, which is more than Auricle. Am I missing something here? This comparison doesn't seem to add up. I'd appreciate any insights you could provide. Thank you!

I wouldn't assume 20%; it's probably higher, especially with questionnaire-based participant feedback. But as mentioned, real-world results may turn out to be far more disappointing than the study results, just like with Lenire. We can only hope that's not the case and keep our expectations in check.

You cannot say it's physiological without an objective measure I'm afraid, and there isn't one.

True. We need objective measures. And even then, the placebo effect will come into play.

 

[dj_newark]

No, the people who had tinnitus worsened had treatment in one of the arms of the study. There were some from both groups.

What do you attribute the worsening to? The device or to external events? I know at least one person from the study who had their tinnitus worsen attended a rock concert during the trial.

 

[Muggumbo]

This is just a theory, but I honestly believe the 30-minute daily use held the results back. You're essentially trying to retrain a part of your brain. I really want to see what happens when people use it for an hour or two daily.

 

[RunningMan]

It's hard to believe that Auricle would invest so much time and effort into a product with only a 10% success rate. If real-life experiences confirmed this, product sales would be dead within a year.

I don't know about that. At this point, that still doesn't seem to be happening with Lenire.

What do you attribute the worsening to? The device or to external events? I know at least one person from the study who had their tinnitus worsen attended a rock concert during the trial.

I would attribute it to the device unless there were specifics provided to conclude otherwise, such as if the participant was using the dreaded Tinnitus Mix or attended a rock concert without hearing protection. The tones themselves could be a factor in the sound levels used. Some people had increased tinnitus with Lenire, as well. The PP group results show exclusions for those who worsened or had no benefit, but it doesn't provide more specific information.

 

[AfroSnowman]

What do you attribute the worsening to? The device or to external events? I know at least one person from the study who had their tinnitus worsen attended a rock concert during the trial.

As a long-time reader of this site, it seems like 10% of people experience episodes of worsening at any given time. Sometimes, it is because of an identifiable external event, i.e., a fire alarm; most seem likely to just happen for no reason, though. Of course, that doesn't stop folks from finding something to attribute it to.

What I'm suggesting is that the level of worsening seen in this study is pretty representative of the normal background rate of worsening at any given time in the tinnitus population.

 

[dj_newark]

I don't know about that. At this point, that still doesn't seem to be happening with Lenire.

I would attribute it to the device unless there were specifics provided to conclude otherwise, such as if the participant was using the dreaded Tinnitus Mix or attended a rock concert without hearing protection. The tones themselves could be a factor in the sound levels used. Some people had increased tinnitus with Lenire, as well. The PP group results show exclusions for those who worsened or had no benefit, but it doesn't provide more specific information.

Thank you but I highly doubt that. The tones the device plays are very quiet; about 5-10 decibels. By comparison a whisper is 30 decibels. In other words, the sounds that the device uses are about as loud as your own breathing. So I'm finding it hard to believe something like that alone could increase tinnitus.

 

[Pixelito]

This is just a theory, but I honestly believe the 30-minute daily use held the results back. You're essentially trying to retrain a part of your brain. I really want to see what happens when people use it for an hour or two daily.

And beyond the 6-week trial period, which Dr. Shore believed would increase effectiveness.

 

[RunningMan]

Thank you but I highly doubt that. The tones the device plays are very quiet; about 5-10 decibels. By comparison a whisper is 30 decibels. In other words, the sounds that the device uses are about as loud as your own breathing. So I'm finding it hard to believe something like that alone could increase tinnitus.

Where did you come up with 5-10 dB? It's many, many times louder than that. And Dr. Shore said you have to be able to hear it for it to be effective. The study allowed participants with general hearing loss of -50 dB and hearing loss of -55 dB at the tinnitus frequencies.

Here's what it says in the study information:

The treatment spectrum (eFigure 2B) consisted of the tinnitus spectrum scaled to 40 dB SL above the audiogram spectrum and limited to an output no greater than 90 dB SPL at any frequency.

Personalized treatment spectrum example (blue) is calculated as a
subject's tinnitus likeness (red) set at 40 dB above the subject's hearing threshold (black) in dB SPL.

This spectrum is digitized and programmed into the device as the signal to be delivered to the subject. The amplitude is limited to 95 dB SPL and is delivered together with an electrical stimulus delivered a short time after the auditory stimulus (as determined by the preclinical studies).

There was some concern being expressed earlier in this thread regarding the audio levels of these tones, so this has come up before in this discussion:

https://www.tinnitustalk.com/posts/689124

And beyond the 6-week trial period, which Dr. Shore believed would increase effectiveness.

In the Q&A, she didn't say she thought it would increase effectiveness or that she expected it to. She just thought it was possible. It's also possible that you could habituate to the device over the longer term and that it could become less effective. The study is the best we have to go on for now.

 

[Paulmanlike]

In the Q&A, she didn't say she thought it would increase effectiveness or that she expected it to. She just thought it was possible. It's also possible that you could habituate to the device over the longer term and that it could become less effective. The study is the best we have to go on for now.

Thank you for clarifying this for the discussion. It always amazes me how people read into things 'what they want' when all that matters is facts. Of course, we all hope that increased duration will lead to better results, but this is, of course, positive speculation.

 

[Utdmad89]

Thank you for clarifying this for the discussion. It always amazes me how people read into things 'what they want' when all that matters is facts. Of course, we all hope that increased duration will lead to better results, but this is, of course, positive speculation.

It's not a fact that you could habituate to the device over a longer period, though, is it?

Like 90% of this thread is speculation.

 

[Pixelito]

In the Q&A, she didn't say she thought it would increase effectiveness or that she expected it to. She just thought it was possible. It's also possible that you could habituate to the device over the longer term and that it could become less effective. The study is the best we have to go on for now.

I think her exact quote was:

It is possible that longer times than 6 weeks may be even more effective.

I just meant to enforce the possibility. Of course, it's only speculation until that has been tested, but it's still encouraging.

 

[Jonno02]

It'd be awfully quiet if there were no speculation, and instead, we only posted factual study news.

 

[Jim Vasilakis]

There is no evidence that you habituate to the device. There is evidence that increasing the treatment duration causes more benefits, as shown in Study 2. That's a fact.

 

[Utdmad89]

It'd be awfully quiet if there were no speculation, and instead, we only posted factual study news.

And what would be wrong with that? Just writing stuff about the device with no real information is quite irritating.

 

[RunningMan]

There is no evidence that you habituate to the device. There is evidence that increasing the treatment duration causes more benefits, as shown in Study 2. That's a fact.

No, the study does NOT show that it was more effective when receiving "active treatment beyond six weeks." In just the last few days, I've read a few factually incorrect comments in this thread about the study. In fact, after the crossover, the results were worse, so they didn't even include half the study results in the final analysis, let alone show that tinnitus decreased with more than six weeks of active treatment.

The study simply doesn't show ongoing improvement with more than six weeks of active treatment. This is why Dr. Shore says it's just possible it could be more effective rather than certain or expected, but there's no evidence in the study results it will continue to decrease tinnitus with more months of active treatment. And it's possible that treatment will become less effective over time and that you will need to keep using it just to maintain at least some of the benefit you achieved initially (assuming you are among those that actually had a benefit, discounting for placebo). The study doesn't confirm either, so both are just speculations of what is possible.

Here are the actual results from both phases of the study:

 

[slc]

What do you attribute the worsening to? The device or to external events? I know at least one person from the study who had their tinnitus worsen attended a rock concert during the trial.

Dr. Shore addressed worsening of tinnitus in the Q&A:

Were the reported cases where people's tinnitus worsened long lasting or even permanent? Or did their tinnitus return to baseline?

Only one patient experienced tinnitus worsening possibly associated with using the device during active treatment. Other instances of worsening were related to noise overexposure events during the trial (eg. attending a rock concert).

These returned to within one std. deviation of baseline.

 

[Jonno02]

And what would be wrong with that? Just writing stuff about the device with no real information is quite irritating.

Allow people to speculate, discuss, and talk about it. What harm does it cause you? It might be a coping mechanism or a form of therapy for them. Yes, we get the same questions popping up time and time again, but you can just keep scrolling rather than let it anger you.

Back-and-forth discussion, regardless of whether it's straight facts or not, is a fundamental principle of a forum. If you find speculative discussion annoying, there's a really simple solution—don't click on the thread and check FDA/Google yourself for any factual updates.

 

[Watasha]

Allow people to speculate, discuss, and talk about it. What harm does it cause you? It might be a coping mechanism or a form of therapy for them. Yes, we get the same questions popping up time and time again, but you can just keep scrolling rather than let it anger you.

Back-and-forth discussion, regardless of whether it's straight facts or not, is a fundamental principle of a forum. If you find speculative discussion annoying, there's a really simple solution—don't click on the thread and check FDA/Google yourself for any factual updates.

Maybe. Or it may be a form of ruminating impairing their ability to habituate to a degree. The irritating part is that when calls are made for volunteers for simple tasks, it is usually only a small handful, but there's plenty of energy around from everyone else to speculate about what we do not know.

@Utdmad89 (in my opinion) is not trying to restrict anyone's ability or right to speculate or engage in forum activity. This site is often the location of breaking news (which makes it great), which is why many check it regularly for updates in the field.

 

[Jonno02]

Maybe. Or it may be a form of ruminating impairing their ability to habituate to a degree. The irritating part is that when calls are made for volunteers for simple tasks, it is usually only a small handful, but there's plenty of energy around from everyone else to speculate about what we do not know.

@Utdmad89 (in my opinion) is not trying to restrict anyone's ability or right to speculate or engage in forum activity. This site is often the location of breaking news (which makes it great), which is why many check it regularly for updates in the field.

Many people can't habituate, but many can. But it's an entirely subjective condition, and I don't think hypothesizing about our best potential treatment to date is in any way impairing habituation.

People can discuss a treatment without volunteering 'for simple tasks.' The two aren't even remotely related so I don't see any connection in the slightest.

I agree, Tinnitus Talk is a cornerstone of tinnitus news. But it's also a forum. If the admins don't want people to discuss potential treatments, they'd lock this sub-forum and only approve factual news updates. Whatever personal preference people may have about speculative posts doesn't supersede this.

I'm sure those who are so well-habituated won't be annoyed by speculative posts, no matter how repetitive they may be anyway.

 

[RunningMan]

I wonder if the person who went to the rock concert wore earplugs. Seven people actually had worsened tinnitus in the study and were excluded from the PP analysis along with those who had no benefit. Negating the person who went to the rock concert increases the earlier figures I gave by about 3%, so it doesn't move the needle that much.

Also, it's possible that some people had increased anxiety at the beginning of the study that their anxiety eased after becoming more comfortable using the device over time, and that the decreased anxiety lessened their tinnitus. The placebo side of the study showed a drop in tinnitus also, where no bimodal treatment was used.

If you're not habituating because you're reading posts in this thread, it's possible your tinnitus is just too severe and variable to habituate, not to mention hyperacusis, noxacusis, reactivity, TTTS, ETD, etc. which might apply.

 

[slc]

No, the study does NOT show that it was more effective when receiving "active treatment beyond six weeks." In just the last few days, I've read a few factually incorrect comments in this thread about the study. In fact, after the crossover, the results were worse, so they didn't even include half the study results in the final analysis, let alone show that tinnitus decreased with more than six weeks of active treatment.

Another possibility is that sham nerve stimulation was the corporate that inhibited improvement when the group moved over to being treatment group.

The study simply doesn't show ongoing improvement with more than six weeks of active treatment. This is why Dr. Shore says it's just possible it could be more effective rather than certain or expected, but there's no evidence in the study results it will continue to decrease tinnitus with more months of active treatment. And it's possible that treatment will become less effective over time and that you will need to keep using it just to maintain at least some of the benefit you achieved initially (assuming you are among those that actually had a benefit, discounting for placebo). The study doesn't confirm either, so both are just speculations of what is possible.

Here are the actual results from both phases of the study:

View attachment 56832

I also noticed that once the placebo group had become part of the treatment group, the treatment was not effective.

Research on why that was the case might add insight into bimodal treatment. It seems that being exposed to, what I'm assuming, tones not calibrated for treatment inhibited the efficacy of actual treatment. Another possibility is that being exposed to sham nerve stimulation was the inhibitory factor.

My big question is, why did this occur, and what were the mechanisms involved? This opens up a world of potential for further research. I'm not sure how one would study this, but it does seem to offer a hint at untangling the mystery of developing effective treatments.

 

[Watasha]

Many people can't habituate, but many can. But it's an entirely subjective condition, and I don't think hypothesizing about our best potential treatment to date is in any way impairing habituation.

Many can and many can't. That said, many professionals would suggest that constant reinforcement COULD present a barrier. That's just a fact that's not really debatable. And in my case, it was only a suggestion, not an absolute statement. Notice that I used the phrase "MAY be a form of ruminating" in the original post.

People can discuss a treatment without volunteering 'for simple tasks.' The two aren't even remotely related so I don't see any connection in the slightest.

No one is saying what some CAN or CAN'T do. I'm only expressing frustration in that if you have the time and energy do to one, you can certainly do the other. Especially considering one is far more likely to improve our outcomes over the long-term.

I agree, Tinnitus Talk is a cornerstone of tinnitus news. But it's also a forum. If the admins don't want people to discuss potential treatments, they'd lock this sub-forum and only approve factual news updates. Whatever personal preference people may have about speculative posts doesn't supersede this.

NOONE has suggested the admins or moderators change the rules.

I'm sure those who are so well-habituated won't be annoyed by speculative posts, no matter how repetitive they may be anyway.

Agreed, not likely to be annoyed from a tinnitus perspective by speculative posts, but they could be annoyed that there's time and energy to speculate and complain but not to advance the cause when given an opportunity.

 

[Jonno02]

Many can and many can't. That said, many professionals would suggest that constant reinforcement COULD present a barrier. That's just a fact that's not really debatable.

Is it a suggestion or a non-debatable fact? Isn't logging onto a tinnitus website itself reinforcement? So, discussing treatment options isn't any more reinforcement than coming here in the first place.

No one is saying what some CAN or CAN'T do. I'm only expressing frustration in that if you have the time and energy do to one, you can certainly do the other. Especially considering one is far more likely to improve our outcomes over the long-term.

People can post on a forum without further involvement and 'volunteering for simple tasks.' If that frustrates you, it's quite odd but something you're entitled to feel.

NOONE has suggested the admins or moderators change the rules.

I never claimed they did? It was simply a justification that people are more than entitled to continuously speculate on this thread whether or not some people get annoyed about it.

Agreed, not likely to be annoyed from a tinnitus perspective by speculative posts, but they could be annoyed that there's time and energy to speculate and complain but not to advance the cause when given an opportunity.

Advance the cause? I do apologize if this comes across as rude. We really need a reality check sometimes. We're at the mercy of researchers. As great a support network as this forum is, it has achieved absolutely zero in advancing any treatment. All we do is discuss other people's work. Sure, there may be ways to get further involved for those who wish to interview researchers, which provides some fantastic additional information (and people do very much appreciate the work behind the scenes), but that does nothing to advance the possibility of a treatment. The hope of every single person ever registered here is a cure. And as selfish as I know it is, a cure is all I'm interested in—respect to those who get more involved, though.

As this is derailing the thread now, I'll make this my last post about this.

 

[slc]

We can, at least to a limited extent, determine how Tinnitus Talk might have affected researchers and even research. The Q&A with Dr. Shore is one example. It alerted her to concerns within this community. The efforts of @Hazel and @Markku (and others) who have cataloged, collated, and attended tinnitus conferences either to present or pose questions (sometimes informed by members here) may have opened the eyes of some researchers — albeit much of the research seems stuck in past models, e.g., Jastreboff, but not all.

I hope some researchers do read Tinnitus Talk. Perhaps this site has or will inform research or at least raise questions for them. Even dialog about the Michigan research, concerns, questions, etc., might be helpful down the road as further iterations of Dr. Shore's approach are tested. Sharing treatment info (after Auricle is hopefully released) might help members refine and learn the strengths and weaknesses of bimodal treatment using Auricle, something akin to the Lenire User Experiences thread. I won't argue our discussions here had an impact on Lenire research — I don't think it did — but it certainly alerted us to user experiences.

At the risk of going off-topic, Tinnitus Talk has been so very useful in terms of support and sharing approaches that have helped people deal with and even, in some cases, mitigate and reduce symptoms.

It would be ideal if researchers were checking Tinnitus Talk. Perhaps some of them might speak up if that is the case.

 

[Watasha]

Is it a suggestion or a non-debatable fact? Isn't logging onto a tinnitus website itself reinforcement? So, discussing treatment options isn't any more reinforcement than coming here in the first place.

People can post on a forum without further involvement and 'volunteering for simple tasks.' If that frustrates you, it's quite odd but something you're entitled to feel.

I never claimed they did? It was simply a justification that people are more than entitled to continuously speculate on this thread whether or not some people get annoyed about it.

Advance the cause? I do apologize if this comes across as rude. We really need a reality check sometimes. We're at the mercy of researchers. As great a support network as this forum is, it has achieved absolutely zero in advancing any treatment. All we do is discuss other people's work. Sure, there may be ways to get further involved for those who wish to interview researchers, which provides some fantastic additional information (and people do very much appreciate the work behind the scenes), but that does nothing to advance the possibility of a treatment. The hope of every single person ever registered here is a cure. And as selfish as I know it is, a cure is all I'm interested in—respect to those who get more involved, though.

As this is derailing the thread now, I'll make this my last post about this.

Aye yai yai... You're right, we are getting derailed. I'd love to discuss this elsewhere.

Closing points:

• The tinnitus community is notorious for its lack of mobilization and volunteer efforts in the community-at-large.
• A lot of people here have no problem speculating/venting but then clam up/disappear when a simple drive is being conducted to vote for a study, thank a fundraiser, etc., and that frustrates people.
• Routinely checking a tinnitus website can most certainly be a barrier to habituation for some.
• I completely disagree that we can't make a difference. Believe it or not, politicians do listen to their constituents if they're loud and persistent enough and I couldn't disagree with you more that we are completely helpless in that regard with respect to researchers.
• Susan Shore's device is going to help a lot of people (prior to electrical stimulation of the ear being widely available) and I can't wait until we have more facts on FDA approval, the device and its distribution.
• We are all in the same team. Best wishes.

 

[RunningMan]

I also noticed that once the placebo group had become part of the treatment group, the treatment was not effective.

Research on why that was the case might add insight into bimodal treatment. It seems that being exposed to, what I'm assuming, tones not calibrated for treatment inhibited the efficacy of actual treatment. Another possibility is that being exposed to sham nerve stimulation was the inhibitory factor.

My big question is, why did this occur, and what were the mechanisms involved? This opens up a world of potential for further research. I'm not sure how one would study this, but it does seem to offer a hint at untangling the mystery of developing effective treatments.

Indeed, this has been mentioned earlier as well. I posted direct comparisons to the first trial, which used 4-week treatment and washout periods, which did not show this same effect as the 6-week periods of the second trial. So that extra 2 weeks made all the difference unless something else was changed, as well.

https://www.tinnitustalk.com/posts/699003

 

[Bhaveen]

Regarding the placebo effect:

From my understanding, when thinking about the placebo effect, say someone is unwell, they get a placebo and recover, and the illness and symptoms go away.

So, regarding the placebo effect some participants experienced in Dr. Shore's clinical trial, are we saying that their tinnitus volume reduced, in which case that's a win, or did it stay the same, but because they thought they were being treated, they said they had improved?

I guess what I'm thinking is that whether there's a placebo effect or not, it's a good outcome for the patient. If the tinnitus volume has decreased because of the placebo effect and the mind is doing its thing, it is not such a bad thing.

 

[RunningMan]

Regarding the placebo effect:

From my understanding, when thinking about the placebo effect, say someone is unwell, they get a placebo and recover, and the illness and symptoms go away.

So, regarding the placebo effect some participants experienced in Dr. Shore's clinical trial, are we saying that their tinnitus volume reduced, in which case that's a win, or did it stay the same, but because they thought they were being treated, they said they had improved?

I guess what I'm thinking is that whether there's a placebo effect or not, it's a good outcome for the patient. If the tinnitus volume has decreased because of the placebo effect and the mind is doing its thing, it is not such a bad thing.

The placebo/control side of the study showed a reduction in tinnitus volume as measured with TinnTester. See my recent screenshots in this thread which show the reduction in loudness. There was also a reduction in TFI and THI scores based on the questionnaires.

 

[Bhaveen]

The placebo/control side of the study showed a reduction in tinnitus volume as measured with TinnTester. See my recent screenshots in this thread which show the reduction in loudness. There was also a reduction in TFI and THI scores based on the questionnaires.

That is quite amazing. I just brought it up in other posts when talking about what percentage of people could benefit. They always subtract the placebo percentage, but I think this can be kept as people have benefited.