New University of Michigan Tinnitus Discovery — Signal Timing

[Pixelito]

I'm encouraged by the potential, but at the same time, I'm a bit floored by the timeline.

What have they been doing for the past two years?

 

[tobyharrixon]

I'm encouraged by the potential, but at the same time, I'm a bit floored by the timeline.

What have they been doing for the past two years?

Making a presentation...

 

[BadNeighbors]

There has been a drop in the number of FDA approvals. While the decrease could be due to many factors, the rate of delays in meeting review deadlines has risen from 4 percent to 11 percent.

I'm really disappointed that Auricle didn't submit sooner. I wish I understood better why they didn't. I'm afraid that when they finally do submit, the approval process will take longer, and the FDA will have an even larger backlog of applications to work through.

FDA review of drugs is slowing while application delays are growing, analysis finds

The upheaval at the FDA appears to be taking a toll on the pharmaceutical industry, according to a new analysis of key agency metrics.

www.statnews.com

 

[dipp]

I personally also have ETD and spasm issues so I hesitate to get on an airplane. But who knows in 10 years' time lol.

I haven't been on a plane since I developed tinnitus and hyperacusis. Flying to the USA simply wouldn't be an option for me unless I experienced major improvement.

I'm glad your tinnitus doesn't cause major issues when it comes to international travel or planning weekends with friends.

My despair made me look a while ago for ways to travel to the US via boat.

It goes from Southampton to New York. Expensive, takes a long time, and inconvenient, yes, but maybe it's an option.

 

[Kam75]

I have always wondered what would happen to this device if, unfortunately, Susan Shore were to pass away before it was brought to market.

Now that we have learned that more tests need to be carried out, which will take many more years, and given Shore's advanced age, this is a legitimate question.

However, in ten years' time, my "young" life will already be behind me, so the hope I had for this device has largely faded, as it has for many of us.

Fun fact, if I may say so: while rereading my old posts on Tinnitus Talk, I remembered that I wrote a few years ago in this thread that there would be peace between Palestine and Israel before the device was released.

I didn't imagine that peace would come so quickly, but here we are.

 

[UKBloke]

Now that the dust has settled a little further over these past few days, I would like to say that the thing that still p*sses me off perhaps the most about the way this whole situation has played out is the chart below (which I'm finding increasingly difficult to locate online - but maybe that's just me).

The moment UMich released this chart, and then announced that the device worked so well on the Treatment 1 arm that they needed to scrap the Treatment 2 arm, they got themselves clean out of having to answer why it was that those patients who received the sham on Treatment 1 experienced practically no benefit at all receiving the active treatment on the 2nd arm.

In fact, if anything, the chart shows that the loudness level began to tick back up at the end of the active treatment phase on those patients. I mean, it's literally the elephant in the room, and to date, Susan Shore has said nothing (to the best of my knowledge) to actually address this fact.

 

[Josh NH USA]

Now that the dust has settled a little further over these past few days, I would like to say that the thing that still p*sses me off perhaps the most about the way this whole situation has played out is the chart below (which I'm finding increasingly difficult to locate online - but maybe that's just me).

The moment UMich released this chart, and then announced that the device worked so well on the Treatment 1 arm that they needed to scrap the Treatment 2 arm, they got themselves clean out of having to answer why it was that those patients who received the sham on Treatment 1 experienced practically no benefit at all receiving the active treatment on the 2nd arm.

In fact, if anything, the chart shows that the loudness level began to tick back up at the end of the active treatment phase on those patients. I mean, it's literally the elephant in the room, and to date, Susan Shore has said nothing (to the best of my knowledge) to actually address this fact.

View attachment 62992

@UKBloke, for context, that is one of the figures accompanying Dr. Shore's journal article published after the most recent human study. It is easy to find online; it is eFigure 5 in the supplement to the article.

I have attached a PDF of the full text of her article, along with the supplement that contains the chart you mentioned. I acknowledge your keen observation, but it is important to view it in the context of all the other data.

Also, you will notice in eFigure 4 that the TFI scores went down quite consistently. Lastly, for those who have not read the first ten or so pages of this thread, I encourage you to look back at linearb's observations as a participant in Dr. Shore's first human study. His description was that the loudness did not seem to decrease much subjectively, but he reported that the treatment still helped.

 

[Fightthearmy]

Not sure where the sass is coming from, but okay.

I'm glad your tinnitus doesn't cause major issues when it comes to international travel or planning weekends with friends. Appreciate that.

It's wordings like "probably" and the generic "you" that I have a problem with if you are trying to point out that these deterrents are of a relatively exclusive kind. Besides, why shouldn't the vast majority be able to take the necessary time off work, including planning ahead? Why shouldn't most people be able to schedule appointments across the globe with relative ease, except for those who would put themselves at considerable risk by flying?

 

[AbateFaria92]

What strikes me the most is that no other research groups seem to be pursuing the same approach or attempting to replicate these findings, even though this procedure has long been shown to be effective.

This should be standard practice in the scientific community. When a breakthrough is reported, it should—indeed, it must—be replicable, not only in principle but also in practice.

That is good science, and it is what allows new discoveries to emerge. It seems to me that they have only scratched the surface of what can be achieved with somatosensory stimulation, but now all their efforts are being diverted toward bureaucracy and meeting FDA approval requirements (to be clear, I do not blame them for this).

As far as I can see, all the articles are open source, and Dr. Shore has given many talks explaining the science behind the work in detail.

Why is Tinnitus Quest not funding further research on this topic?

 

[Josh59]

In any case, even if the device becomes available only in a few years, we should acknowledge the extensive research and remarkable career of Dr. Susan Shore. I truly hope her work will inspire other researchers and laboratories to continue exploring this path, whether through new molecules or other ways to reduce the abnormal brain hyperactivity in the auditory pathways.

When you take a step back, it becomes clear that there are not many researchers truly dedicated to understanding and treating our conditions, including hyperacusis. That is why it is so important to recognize and support the few teams, like Dr. Shore's, who are genuinely advancing the understanding and management of these disorders.

Let us hope that Tinnitus Quest will bring new momentum to research. It is also up to us to support these efforts and share them across our networks.

 

[Markku]

Why is Tinnitus Quest not funding further research on this topic?

For one thing, no one has applied to research this area. Even if we wanted a specific topic to be explored, we cannot compel researchers to pursue it. Our entire process depends on researchers taking the initiative to submit grant applications to us.

(That said, we certainly hope that through our events, such as last week's Tinnitus Hackathon in Germany, the dialogue and brainstorming will inspire new ideas or encourage revisiting past ones that may have been overlooked.)

Let us hope that Tinnitus Quest will bring new momentum to research. It is also up to us to support these efforts and share them across our networks.

That's our goal. Follow Tinnitus Quest on Instagram, where we share regular updates. We're already the largest tinnitus organization there in terms of followers. We also hope more people will consider becoming monthly supporters, as even $3/month helps our cause more than most realize. Every contribution adds up.

 

[Josh59]

That's our goal. Follow Tinnitus Quest on Instagram, where we share regular updates. We're already the largest tinnitus organization there in terms of followers. We also hope more people will consider becoming monthly supporters, as even $3/month helps our cause more than most realize. Every contribution adds up.

Thank you very much for your message and for all the work you are doing with Tinnitus Quest.

I already follow your Instagram page closely and regularly share your updates on X, BlueSky, Threads, and other platforms. I really like the spirit of the project and do what I can to help spread the word.

 

[Watasha]

For one thing, no one has applied to research this area. Even if we wanted a specific topic to be explored, we cannot compel researchers to pursue it. Our entire process depends on researchers taking the initiative to submit grant applications to us.

(That said, we certainly hope that through our events, such as last week's Tinnitus Hackathon in Germany, the dialogue and brainstorming will inspire new ideas or encourage revisiting past ones that may have been overlooked.)

That's our goal. Follow Tinnitus Quest on Instagram, where we share regular updates. We're already the largest tinnitus organization there in terms of followers. We also hope more people will consider becoming monthly supporters, as even $3/month helps our cause more than most realize. Every contribution adds up.

Would Tinnitus Quest ever consider creating a separate account, for example, an endowment, that people can donate to where only the income would be used to fund research while the principal balance remains untouched? This would create a permanent source of funding for the charity.

Thank you for all that you, Hazel, and all of the volunteers do.

 

[UKBloke]

I acknowledge your keen observation, but it is important to view it in the context of all the other data.

I couldn't disagree more with this point.

We ought to be way past contextualizing tinnitus science in this way.

Providers of tinnitus treatment devices really should position themselves to complete the following most basic question with a binary answer:

Does your device reduce the volume of a person's tinnitus?

Yes or no?

 

[kingsfan]

Besides, why shouldn't the vast majority be able to take the necessary time off work, including planning ahead? Why shouldn't most people be able to schedule appointments across the globe with relative ease, except for those who would put themselves at considerable risk by flying?

I would assume cost is the main factor. Beyond the price of travel and lodging, I am willing to bet the treatment itself will be very expensive. I imagine that even those of us in the United States will struggle to afford it.

 

[Markku]

Would Tinnitus Quest ever consider creating a separate account, for example, an endowment, that people can donate to where only the income would be used to fund research while the principal balance remains untouched? This would create a permanent source of funding for the charity.

Yes, it's something we've talked about. An endowment would be a great way to create steady, long-term funding for research. The challenge is that it only really makes sense once there's a big enough starting amount. For example, a $1 million fund earning around 4 to 5 percent per year would generate about $40,000 to $50,000 annually for research. With smaller amounts, the yearly return just isn't enough to make a real impact. For now, we're focused on growing our donor base, but once we reach that level, it's definitely something we'd like to set up.

Help us find that big initial donor

 

[Fightthearmy]

I would assume cost is the main factor. Beyond the price of travel and lodging, I am willing to bet the treatment itself will be very expensive. I imagine that even those of us in the United States will struggle to afford it.

It goes without saying, though it has nothing to do with the topic of logistics.

 

[DimLeb]

My despair made me look a while ago for ways to travel to the US via boat.

It goes from Southampton to New York. Expensive, takes a long time, and inconvenient, yes, but maybe it's an option.

Yeah, a transatlantic voyage… Southampton to New York… Hmm, I think I've seen that before, and I'm pretty sure it didn't go well, LOL. At least not for a guy named Jack.

But jokes aside, it isn't easy to arrange such a trip, even for ordinary people, let alone for people like us whose ears seem to hate us and come up with new ways to torture us every single day.

 

[Fightthearmy]

Yeah, a transatlantic voyage… Southampton to New York… Hmm, I think I've seen that before, and I'm pretty sure it didn't go well, LOL. At least not for a guy named Jack.

But jokes aside, it isn't easy to arrange such a trip, even for ordinary people, let alone for people like us whose ears seem to hate us and come up with new ways to torture us every single day.

You were how old?

 

[antonio77]

I am 55 years old, and I understand that I will likely die with tinnitus given the circumstances. There is nothing available that could realistically work within the next five years. As I get older, my body will not respond the same way it once did, so even if something becomes available within ten years, I know it probably will not help me either.

 

[ColinUK]

I am 55 years old, and I understand that I will likely die with tinnitus given the circumstances. There is nothing available that could realistically work within the next five years. As I get older, my body will not respond the same way it once did, so even if something becomes available within ten years, I know it probably will not help me either.

I wouldn't lose all hope. Research is focusing on hearing loss and targeting older age groups since all of us experience some degree of hearing loss as we age. If they find an effective treatment for hearing loss, and if hearing loss is indeed the main cause behind tinnitus, I believe age won't be a limiting factor.

 

[PeterPan]

The moment UMich released this chart, and then announced that the device worked so well on the Treatment 1 arm that they needed to scrap the Treatment 2 arm, they got themselves clean out of having to answer why it was that those patients who received the sham on Treatment 1 experienced practically no benefit at all receiving the active treatment on the 2nd arm

What the researchers are saying is that they can only compare one treatment group to another if both begin at the same baseline TFI. Because treatment group 1 did not return to baseline at week 12, which they had expected would happen, they cannot conduct any analysis on treatment group 2. As a result, any questions about the poor performance of treatment group 2 are dismissed using this explanation. I believe Susan Shore was asked about this in the interview, and she referred to that reasoning.

However, it's quite clear that there is a problem here, since we can compare treatment group 2 beginning at 12 weeks against doing nothing, or we can compare it with how treatment group 1 performed starting at week zero. Or we can simply conclude that those in treatment group 2 experienced no improvement throughout the treatment.

What we really need are multiple independent researchers to conduct similar trials. Based on the treatment group 2 results, I'm not entirely confident that we would see positive outcomes. It's frustrating and disappointing that there is so little enthusiasm within the medical community about a potential therapy for such a widespread condition, and that there is no meaningful funding to support it.

 

[Pixelito]

I am 55 years old, and I understand that I will likely die with tinnitus given the circumstances. There is nothing available that could realistically work within the next five years. As I get older, my body will not respond the same way it once did, so even if something becomes available within ten years, I know it probably will not help me either.

This discussion is literally about a treatment that should be available within five years.

Auricle aside, we seem to be living in a promising time for tinnitus research. There are several other treatments currently in testing, and I believe that within ten years, we could see multiple options available on the market.

Have faith, and don't assume that aging will reduce your chances of a positive outcome.

 

[UKBloke]

Susan Shore was asked about this in the interview, and she referred to that reasoning.

Yes, she was asked about this, and I believe the first time she referred to the "cross-over" effect was during the Tinnitus Hub Q&A.

If you remember, at that time (a couple of years ago), she was asked specifically about the group that underwent the active treatment in weeks 13-18, and how their response didn't tally with those who'd received the active treatment in weeks 1 - 6.

With the greatest respect to Susan Shore, she ignored the main part of the question and focussed instead on those who'd received the active treatment in weeks 1 - 6.

To the best of my knowledge, she still hasn't addressed the obvious point, which is: why do you think it is that when a patient underwent UMich's control treatment first (which should in fact have rendered no medical or cross-over effect whatsoever), did the subsequent active treatment fail to work?

The moment I read her initial response to all of this in the original Tinnitus Hub Q&A, I was certain they were not going to file with the FDA.

I still find this whole cross-over business extremely troubling because either; their device is so capricious that it will just randomly not work, or, their control isn't actually inert, and instead exerts some kind of negative (to the active treatment) effect when applied prior to a series of active treatment sessions.

It's easy to spin the successes and say the active treatment was so good in weeks 1 - 6 that it just kept on working all the way into week 12, but I personally believe Susan Shore will want to resolve the above problem.

I still think Hubert Lim offered the best solution to all of this.

If I remember rightly, in the interview with him I watched some time ago, he suggested giving everyone control first for 6 weeks, then switching the bi-modal stimulation on at week 12 for one group only, and see what happens. Seems to make good sense.

 

[Hotrock]

I am 55 years old, and I understand that I will likely die with tinnitus given the circumstances. There is nothing available that could realistically work within the next five years. As I get older, my body will not respond the same way it once did, so even if something becomes available within ten years, I know it probably will not help me either.

55 years old is still a young man! You have plenty of time to see a cure, treatment, or even a reversal of tinnitus and hearing loss in your lifetime, especially as AI begins to benefit research.