New University of Michigan Tinnitus Discovery — Signal Timing

[Joeseph Stope]

From what I understand, the DCN (dorsal cochlear nucleus, a region of the brainstem targeted by the University of Michigan device) acts as a relay. It receives information from the cochlea (hair cells and related structures) as well as somatosensory input from the trigeminal system (teeth, jaw) and the cervical system (neck). When these non-cochlear regions send large amounts of data, they can excite the DCN, which may create or intensify the tinnitus percept. This is still somewhat theoretical, but it seems to be a well-supported model.

In simple terms, using the neck as a pathway (for example, by sending electrical signals through it to the DCN) provides another way of reaching the area where tinnitus from hearing loss is generated. This approach may help with tinnitus caused mainly by either hearing loss or TMJ and neck problems, since both types of input converge on the same region of the brain. This is why the trials for the University of Michigan device focused on people with somatic tinnitus. That does not mean people whose tinnitus is caused solely by TMJ or neck problems, but rather those who can influence their tinnitus through movements or input from the jaw, neck, or related areas. Otherwise, a person might not benefit from the device at all, or at least not as much as someone who can demonstrate a clear connection between somatic input and their tinnitus.

Please note that I am not a scientist. I am, in fact, the least qualified person I know. So take this with a grain of salt.

Well, it's nice to have someone who can translate things down to my level.

I spend a lot of time wondering what caused the latest spike. Most of the time, I would put it down to some noise event. Another plausible explanation is my poor sleep pattern. I can fall asleep pretty easily, but I tend to wake up in the early hours of the morning, around 5:00. From then on, it's usually a mix of the radio, the sound machine, and drifting in and out of light sleep until it's time for breakfast.

Oddly enough, if I do manage to sleep for another hour, say from 8:00 to 9:00, once I wake up my tinnitus often spikes.

Another explanation I sometimes consider is garlic or herbs in a roast chicken for dinner, but that's easy enough to avoid.

To explain my most recent spike, I focused on the support page where one sufferer mentioned that his tinnitus started from "dead-weight lifting." You know, lifting weights in the gym. That seems like a handy explanation and matches up somewhat with my own experience. I suppose, at a stretch, it could tie in with your theory, especially regarding the neck or the back.

 

[Josh NH USA]

Is anyone else as nervous as I am for October 13, 2025? I feel like my life is at stake. I've survived three years of constant ringing in my right ear, and finding hope has been a real challenge. The Q&A on October 13 is going to hit me hard either way.

This thread and community have kept me from doing anything too drastic. I hope everyone has a great weekend.

Would anyone be interested in brainstorming a list of questions for Auricle that we can compile here?

1. Has the FDA application been filed?
2. What is the current FDA approval status?
3. What is the projected timeline for product availability?
4. What is the projected cost?
5. Will insurers cover the cost?
6. Has the Veterans Association expressed interest?
7. What can I, or other consumers, do to help?

 

[Watasha]

Is anyone else as nervous as I am for October 13, 2025? I feel like my life is at stake. I've survived three years of constant ringing in my right ear, and finding hope has been a real challenge. The Q&A on October 13 is going to hit me hard either way.

This thread and community have kept me from doing anything too drastic. I hope everyone has a great weekend.

Would anyone be interested in brainstorming a list of questions for Auricle that we can compile here?

1. Has the FDA application been filed?
2. What is the current FDA approval status?
3. What is the projected timeline for product availability?
4. What is the projected cost?
5. Will insurers cover the cost?
6. Has the Veterans Association expressed interest?
7. What can I, or other consumers, do to help?

I could be wrong, but they've been collecting questions for a couple of months and have probably already started consolidating them. There might still be a link to submit questions somewhere, but I doubt it.

 

[Joeseph Stope]

Is anyone else as nervous as I am for October 13, 2025? I feel like my life is at stake. I've survived three years of constant ringing in my right ear, and finding hope has been a real challenge. The Q&A on October 13 is going to hit me hard either way.

This thread and community have kept me from doing anything too drastic. I hope everyone has a great weekend.

Would anyone be interested in brainstorming a list of questions for Auricle that we can compile here?

1. Has the FDA application been filed?
2. What is the current FDA approval status?
3. What is the projected timeline for product availability?
4. What is the projected cost?
5. Will insurers cover the cost?
6. Has the Veterans Association expressed interest?
7. What can I, or other consumers, do to help?

Well, I'm the opposite! I have it in my left ear, since 1992 — thirty-three years ago. It's no longer the awful threat it once was, but the hyperacusis is still a big problem.

So I'm waiting for the printout, as listening to TV, a smartphone, or internet speakers will bring on a tinnitus spike. I take it a bit laid back. I've been through so many doctors and therapies, some of which have helped, mind you.

I'll be very happy if this effort by Professor Shore is a general step forward in understanding tinnitus and how to manage it. If it could turn down the volume or cure my hyperacusis, that would be beyond wonderful.

 

[DimLeb]

Is anyone else as nervous as I am for October 13, 2025? I feel like my life is at stake. I've survived three years of constant ringing in my right ear, and finding hope has been a real challenge. The Q&A on October 13 is going to hit me hard either way.

This thread and community have kept me from doing anything too drastic. I hope everyone has a great weekend.

Would anyone be interested in brainstorming a list of questions for Auricle that we can compile here?

1. Has the FDA application been filed?
2. What is the current FDA approval status?
3. What is the projected timeline for product availability?
4. What is the projected cost?
5. Will insurers cover the cost?
6. Has the Veterans Association expressed interest?
7. What can I, or other consumers, do to help?

Just keep your expectations low. We all want to hear something positive at last, but unfortunately, with the pace Auricle has shown so far, I don't believe anything truly spectacular will come out of this Q&A.

 

[dd314]

Would anyone be interested in brainstorming a list of questions for Auricle that we can compile here?

1. Has the FDA application been filed?
2. What is the current FDA approval status?
3. What is the projected timeline for product availability?
4. What is the projected cost?
5. Will insurers cover the cost?
6. Has the Veterans Association expressed interest?
7. What can I, or other consumers, do to help?

Here's a question I hope gets asked: What the fuck is "somatic tinnitus"? I can modulate only one of my sounds, and it's not even the worst one. Does that mean the device won't help me with the other sounds?

 

[kingsfan]

Well, I'm the opposite! I have it in my left ear, since 1992 — thirty-three years ago. It's no longer the awful threat it once was, but the hyperacusis is still a big problem.

So I'm waiting for the printout, as listening to TV, a smartphone, or internet speakers will bring on a tinnitus spike. I take it a bit laid back. I've been through so many doctors and therapies, some of which have helped, mind you.

I'll be very happy if this effort by Professor Shore is a general step forward in understanding tinnitus and how to manage it. If it could turn down the volume or cure my hyperacusis, that would be beyond wonderful.

I'll also be waiting to read a recap here, as I can't really listen to anything anymore either, especially live events where there might be mic pops or other sudden sounds.

 

[Josh NH USA]

Here's a question I hope gets asked: What the fuck is "somatic tinnitus"? I can modulate only one of my sounds, and it's not even the worst one. Does that mean the device won't help me with the other sounds?

I've wondered about this rather vague concept as well. I also recall that Dr. Shore's earlier studies focused on noise-induced tinnitus in animals, such as guinea pigs and possibly mice, in relation to the DCN. However, I'm not sure that noise-induced necessarily means somatic in any strict sense.

My understanding is that the somatic element simply indicates that the tinnitus mechanism involves the somatosensory system, which might apply to most, if not all, cases of tinnitus. If the DCN is indeed the "root of tinnitus," as Dr. Shore has stated, then treatments that suppress tinnitus activity at the DCN would likely be broadly effective.

 

[Joeseph Stope]

Just keep your expectations low. We all want to hear something positive at last, but unfortunately, with the pace Auricle has shown so far, I don't believe anything truly spectacular will come out of this Q&A.

I'll second that!

It's so easy to fall into the trap of thinking, "What kind of juice shop is this anyway? I've been waiting here for… {insert number of years you've had tinnitus} years! What kind of service is this?"

The sad truth is that tinnitus, and hearing loss too, are among the orphans of medical research. We should be grateful that Susan Shore dedicated, what is it, twenty or thirty years, of her working life to developing a potential cure, and I suppose we should also thank the University of Michigan for supporting her work.

I'll be watching the big show from a distance because of my hyperacusis, just as I watch the musicians at a party from afar. And I really do enjoy it, seeing others have fun and celebrate brings me joy. Is that the Osmosis Effect, the Doppler Effect, or something else? Either way, I have a great time, and yes, people always come up to me, encouraging me to join in.

 

[dd314]

I've wondered about this rather vague concept as well. I also recall that Dr. Shore's earlier studies focused on noise-induced tinnitus in animals, such as guinea pigs and possibly mice, in relation to the DCN. However, I'm not sure that noise-induced necessarily means somatic in any strict sense.

My understanding is that the somatic element simply indicates that the tinnitus mechanism involves the somatosensory system, which might apply to most, if not all, cases of tinnitus. If the DCN is indeed the "root of tinnitus," as Dr. Shore has stated, then treatments that suppress tinnitus activity at the DCN would likely be broadly effective.

Most of the top LLMs I've talked to about tinnitus say that some tinnitus originates in higher-order structures, such as the auditory cortex. They also say that only tinnitus which can be modulated by movements of the face or neck involves the dorsal cochlear nucleus.

I know Dr. Shore probably understands this far better than these LLMs do, but it still makes me worry that her approach might not be the ultimate solution for tinnitus. I really hope I'm wrong.

 

[Josh NH USA]

Most of the top LLMs I've talked to about tinnitus say that some tinnitus originates in higher-order structures, such as the auditory cortex. They also say that only tinnitus which can be modulated by movements of the face or neck involves the dorsal cochlear nucleus.

I know Dr. Shore probably understands this far better than these LLMs do, but it still makes me worry that her approach might not be the ultimate solution for tinnitus. I really hope I'm wrong.

If by LLM you mean large language models, then I find it hard to put too much trust in what they say. A few days ago, I asked one a question related to my profession and received a definitive answer. I then copied and pasted that same answer back into the same LLM to check it, and it told me the information was incorrect. In other words, the LLM directly contradicted itself.

 

[Applejuice]

Most of the top LLMs I've talked to about tinnitus say that some tinnitus originates in higher-order structures, such as the auditory cortex. They also say that only tinnitus which can be modulated by movements of the face or neck involves the dorsal cochlear nucleus.

I know Dr. Shore probably understands this far better than these LLMs do, but it still makes me worry that her approach might not be the ultimate solution for tinnitus. I really hope I'm wrong.

The somatic component and the DCN are seen more as the tinnitus doorway into your brain. Ideally, you would want to reach the auditory cortex, but that is still impossible with noninvasive treatment.

Multitone tinnitus has been excluded from trials, probably for the sake of simplicity, so we will not know more until the device can be used after FDA approval. I believe there is still plenty of room for improvement, as there is much left to test, including multitone cases.

 

[AfroSnowman]

"Multitone tinnitus has been excluded from trials"

When I look at the exclusions for the study from ClinicalTrials.gov, it lists:

Exclusion Criteria:

• Diagnosis of Meniere's disease
• Diagnosis of Semicircular Canal Dehiscence
• Unilateral or bilateral cochlear implant recipients
• Diagnosis of acoustic neuroma
• Evidence of retrocochlear disease
• Certain medications and conditions (will be reviewed at screening)

But nothing about excluding multi-tone tinnitus. Where did you find the multi-tone exclusion?

 

[Kam75]

As a reminder, Susan Shore stated during the interview that she is unsure if the device will be effective for individuals with non-somatic tinnitus, as it was only tested on those with somatic tinnitus. However, I remember that she also said she hopes the device will help millions of tinnitus sufferers.

I am unsure if millions of tinnitus sufferers experience only somatic tinnitus, so let's hope it will help both types.

 

[SafeMusicFan]

I will look at today's Q&A as an opportunity to learn more about:

• Where we are now
• What we can expect in the short to mid-term future (the coming months to two or three years)
• What the main challenges ahead are

The fact that this event is taking place is a positive sign. It shows transparency and indicates that progress is actually being made. That alone is more reassuring than hearing nothing at all.

I'm sure there will be some updates, though I don't expect major announcements or breakthroughs. I would be thrilled if there were, of course, but setting expectations too high only risks disappointment. That would be unfortunate, because this kind of open communication is already a very positive step forward.

 

[Markku]

I will look at today's Q&A as an opportunity to learn more about:

• Where we are now
• What we can expect in the short to mid-term future (the coming months to two or three years)
• What the main challenges ahead are

The fact that this event is taking place is a positive sign. It shows transparency and indicates that progress is actually being made. That alone is more reassuring than hearing nothing at all.

I'm sure there will be some updates, though I don't expect major announcements or breakthroughs. I would be thrilled if there were, of course, but setting expectations too high only risks disappointment. That would be unfortunate, because this kind of open communication is already a very positive step forward.

Thanks for the excellent overview and outlook.

We did some prep yesterday, and in just a couple of hours from now, it's go time.

When you join the Crowdcast interface for the Q&A, you can also add your own questions and upvote those submitted by others.

Tinnitus Quest Live: The Long-Awaited Auricle Update with Susan Shore & Jon Pearson

Register now for Tinnitus Quest Live: The Long-Awaited Auricle Update with Susan Shore & Jon Pearson on crowdcast, scheduled to go live on October 13, 2025, 10:00 AM PDT.

www.crowdcast.io

 

[Pixelito]

From what I understood, they said they need to do at least 16 more months of testing, possibly more, before they're ready for FDA submission.

I'd better start working on my mindfulness.

 

[be6z]

The timeline shown in the presentation was only indicative. Jon mentioned that a lot of work has already been done to get the device ready for FDA application, but there's still much more to do. I can't tell which years correspond to each first or second half, but the general idea is that there will be at least another year of device development before the FDA submission. They don't yet know if additional requirements will be needed, but if not, it would follow pathway one, which could move things along much faster.

I understand this timeframe might feel a bit disappointing, but Dr. Shore seems quite confident about the device's effectiveness. I also got the impression she believes it could be even more effective if used for longer than the six weeks tested in the trial.

I don't have a link to the presentation, but I believe one will be posted once the video with captions becomes available.

Lastly, I personally think we should be grateful for the work being done on tinnitus. From the outside, it's easy to wonder why they aren't doing certain things, but if it were that simple, someone would already have done it.

 

[SafeMusicFan]

This was insightful. My personal conclusion is that work on getting the device released is very much alive, though it's being done cautiously. Unfortunately, the regulatory process is slow. I appreciate that they were honest about it and didn't offer a fake marketing deadline.

This may feel like an ever-returning "someday" to many. Yet, the reality is that there's now something with strong scientific grounding that has shown impressive results in human trials and is being refined to meet market standards.

It will certainly take time, still several years. My estimate is at least five before a limited market release in the United States, and a few more for the rest of the world. But I'm confident that something with this level of scientific evidence will eventually reach the market in some form. Meanwhile, research into other approaches will continue to be funded and developed, thanks to catalysts like Tinnitus Quest.

If we lived in any other era of human history, there would have been nothing—only the "live with it" mantra. This is a period of transition, which is already a significant improvement. Personally, I prefer to stay cautiously optimistic. I remain fully convinced that real treatments will start to appear within the next two decades, with steadily improving effectiveness. Long? Yes. Forever? Most likely not—and that makes me happy.

 

[Josh NH USA]

This was insightful. My personal conclusion is that work on getting the device released is very much alive, though it's being done cautiously. Unfortunately, the regulatory process is slow. I appreciate that they were honest about it and didn't offer a fake marketing deadline.

This may feel like an ever-returning "someday" to many. Yet, the reality is that there's now something with strong scientific grounding that has shown impressive results in human trials and is being refined to meet market standards.

It will certainly take time, still several years. My estimate is at least five before a limited market release in the United States, and a few more for the rest of the world. But I'm confident that something with this level of scientific evidence will eventually reach the market in some form. Meanwhile, research into other approaches will continue to be funded and developed, thanks to catalysts like Tinnitus Quest.

If we lived in any other era of human history, there would have been nothing—only the "live with it" mantra. This is a period of transition, which is already a significant improvement. Personally, I prefer to stay cautiously optimistic. I remain fully convinced that real treatments will start to appear within the next two decades, with steadily improving effectiveness. Long? Yes. Forever? Most likely not—and that makes me happy.

My candid reaction: I watched the informative Q&A and felt reassured that some hope is still alive and well. Then I sighed and prepared myself for at least sixteen more months, though probably years. The suffering continues, but the darker thoughts are postponed.

 

[kingsfan]

The timeline shown in the presentation was only indicative. Jon mentioned that a lot of work has already been done to get the device ready for FDA application, but there's still much more to do. I can't tell which years correspond to each first or second half, but the general idea is that there will be at least another year of device development before the FDA submission. They don't yet know if additional requirements will be needed, but if not, it would follow pathway one, which could move things along much faster.

I understand this timeframe might feel a bit disappointing, but Dr. Shore seems quite confident about the device's effectiveness. I also got the impression she believes it could be even more effective if used for longer than the six weeks tested in the trial.

I don't have a link to the presentation, but I believe one will be posted once the video with captions becomes available.

Lastly, I personally think we should be grateful for the work being done on tinnitus. From the outside, it's easy to wonder why they aren't doing certain things, but if it were that simple, someone would already have done it.

View attachment 62880

Well I've seen all I need to see.

 

[DimLeb]

The timeline shown in the presentation was only indicative. Jon mentioned that a lot of work has already been done to get the device ready for FDA application, but there's still much more to do. I can't tell which years correspond to each first or second half, but the general idea is that there will be at least another year of device development before the FDA submission. They don't yet know if additional requirements will be needed, but if not, it would follow pathway one, which could move things along much faster.

I understand this timeframe might feel a bit disappointing, but Dr. Shore seems quite confident about the device's effectiveness. I also got the impression she believes it could be even more effective if used for longer than the six weeks tested in the trial.

I don't have a link to the presentation, but I believe one will be posted once the video with captions becomes available.

Lastly, I personally think we should be grateful for the work being done on tinnitus. From the outside, it's easy to wonder why they aren't doing certain things, but if it were that simple, someone would already have done it.

View attachment 62880

Well, someone already did. It was Lenire, and even with much more sketchy science and trial design. I really don't know what to say.

I'm 31 now, from Europe. I hoped I would have a few years of relative youth left when something emerges, just to "be there" if things get too bad. With this news, I'll be at least 41 (10 years the earliest for the device to come to Europe or so, is my guess) for that to maayybee happen.

Oh well, back to taking my Magnesium and Betahistine.

 

[AfroSnowman]

The timeline shown in the presentation was only indicative. Jon mentioned that a lot of work has already been done to get the device ready for FDA application, but there's still much more to do. I can't tell which years correspond to each first or second half, but the general idea is that there will be at least another year of device development before the FDA submission. They don't yet know if additional requirements will be needed, but if not, it would follow pathway one, which could move things along much faster.

I understand this timeframe might feel a bit disappointing, but Dr. Shore seems quite confident about the device's effectiveness. I also got the impression she believes it could be even more effective if used for longer than the six weeks tested in the trial.

I don't have a link to the presentation, but I believe one will be posted once the video with captions becomes available.

Lastly, I personally think we should be grateful for the work being done on tinnitus. From the outside, it's easy to wonder why they aren't doing certain things, but if it were that simple, someone would already have done it.

View attachment 62880

I wish Jon had spoken a little more about the dates he meant to indicate on this chart. I read this slide as showing that the earliest submission to the FDA would be in the second half of 2026, and the earliest FDA clearance would be in the first half of 2027.

 

[be6z]

It will certainly take time, still several years. My estimate is at least five before a limited market release in the United States, and a few more for the rest of the world.

I agree with almost everything you said, but why do you think it will take 5 years? Maybe I'm just overly hopeful, but I believe that in about 16 months they'll have the device ready for FDA submission, and it will be submitted shortly after, in line with their more optimistic timeline.

I wish Jon had spoken a little more about the dates he meant to indicate on this chart. I read this slide as showing that the earliest submission to the FDA would be in the second half of 2026, and the earliest FDA clearance would be in the first half of 2027.

I had trouble following the dates, too, and think it was just a general overview. I listened again to parts of the presentation, and he said it would take about 16 months to get the device ready for FDA submission. If no additional data were required, they could submit to the FDA shortly after that. However, if more data were needed, it would add more time to the process, possibly more than a year.

 

[tobyharrixon]

Those of you outside the US, would you consider traveling to the US for treatment?

 

[dipp]

By the time the device reaches the market, I won't be able to hear the frequencies of my most bothersome tinnitus sounds. That's it for me. Susan Shore's device just won't work in my case. It'll simply be too late.

I need to find a way to process the fact that I won't see my tinnitus reduced in my lifetime. I'm done. It's hard to accept.

 

[Fightthearmy]

I agree with almost everything you said, but why do you think it will take 5 years? Maybe I'm just overly hopeful, but I believe that in about 16 months they'll have the device ready for FDA submission, and it will be submitted shortly after, in line with their more optimistic timeline.

I heard they're short by 3 million, according to Pearson.

 

[withintention]

I understand the timeline now.

There's timeline 1, which is the optimistic one. In this scenario, they submit in the first half of 2027 and receive clearance sometime in 2028.

Then there's timeline 2, which is the pessimistic one. In this case, they realize there's more work to do before submitting to the FDA, so they don't submit until 2028 and receive clearance in the first half of 2029.

 

[Meyer37]

I heard they're short by 3 million, according to Pearson.

$3M? That seems like such a small amount of money for a device that could change millions of lives.

Surely there are more than a few people in the music industry with tinnitus who could cover that without even thinking twice. Until then, I'm going to consider increasing my monthly contribution to Tinnitus Quest!

 

[vttbx]

I just watched the Q&A session. I may have missed it, but did they mention any specific amount of hearing loss that could affect its effectiveness?