New University of Michigan Tinnitus Discovery — Signal Timing

[Kam75]

I humbly admit that I tend to be a rather negative person in life, because my motto is, "Expect the worst so you are prepared for anything."

However, when it comes to Auricle, I genuinely want to believe that it will work, even if only to reduce tinnitus and finally allow me to sleep again.

I would like to remind everyone, since the latest messages in this thread have been somewhat pessimistic, that during the first phase of testing, two people were completely free of tinnitus.

I do not know how long this lasted for them, but in my opinion, it is still a remarkable achievement.

 

[AfroSnowman]

Well, I'm still excited about the upcoming Q&A. If the news were truly bad, I think we'd get a written statement. Why would they put themselves through a Q&A full of desperate, disappointed people? I figure the range of outcomes is, on the low end, a statement about where they are in the process, and possibly even the announcement of a follow-up study like Lenire had to do. On the optimistic side, it could be a "light at the end of the tunnel" update, with hopes for a 2026 release.

If nothing else, tinnitus has taught me patience in the face of things beyond my control. I'm glad they're reaching out to the community, because in the end, this is still the only potentially impactful treatment that might become available to the public in the short term.

 

[Bhaveen]

Well, I'm still excited about the upcoming Q&A. If the news were truly bad, I think we'd get a written statement. Why would they put themselves through a Q&A full of desperate, disappointed people? I figure the range of outcomes is, on the low end, a statement about where they are in the process, and possibly even the announcement of a follow-up study like Lenire had to do. On the optimistic side, it could be a "light at the end of the tunnel" update, with hopes for a 2026 release.

If nothing else, tinnitus has taught me patience in the face of things beyond my control. I'm glad they're reaching out to the community, because in the end, this is still the only potentially impactful treatment that might become available to the public in the short term.

Hmmm… if they need another trial, I would think they would already know that. For me, if they believe announcing a Q&A in August and then waiting until October to tell us they need another trial is "good engagement," then they lack understanding. Still…

 

[2noist]

Hmmm… if they need another trial, I would think they would already know that. For me, if they believe announcing a Q&A in August and then waiting until October to tell us they need another trial is "good engagement," then they lack understanding. Still…

It would be better than keeping us in the dark for years to come.

If there's another trial, at least it means the product isn't shelved.

 

[Joeseph Stope]

It would be better than keeping us in the dark for years to come.

If there's another trial, at least it means the product isn't shelved.

I hope that Professor Shore is strong, healthy, and enjoying her retirement.

Duh… what was that story about Fermat's Last Theorem?

 

[IYIiKe]

Well, I'm still excited about the upcoming Q&A. If the news were truly bad, I think we'd get a written statement. Why would they put themselves through a Q&A full of desperate, disappointed people? I figure the range of outcomes is, on the low end, a statement about where they are in the process, and possibly even the announcement of a follow-up study like Lenire had to do. On the optimistic side, it could be a "light at the end of the tunnel" update, with hopes for a 2026 release.

If nothing else, tinnitus has taught me patience in the face of things beyond my control. I'm glad they're reaching out to the community, because in the end, this is still the only potentially impactful treatment that might become available to the public in the short term.

I think you need to look at the practical side. Tinnitus Quest had just recently had William Shatner endorse it. Companies like Auricle, like it or not, do not target the moderate/severe sufferers. They're simply too small of a market. They get a marketing bump and probably by now have at least net positive news to share.

 

[Bhaveen]

It would be better than keeping us in the dark for years to come.

If there's another trial, at least it means the product isn't shelved

I think this talk of more trials and the product being shelved is probably the result of years, even decades, of promising treatments turning out to be disappointing. Or perhaps I'm too optimistic. I'm expecting real progress to be announced in October, not "stationary" news. Surely even they realize that an event like October is meant for positive updates. Why build anticipation only to share bad news, unless you're completely unhinged?

 

[2noist]

I think this talk of more trials and the product being shelved is probably the result of years, even decades, of promising treatments turning out to be disappointing. Or perhaps I'm too optimistic. I'm expecting real progress to be announced in October, not "stationary" news. Surely even they realize that an event like October is meant for positive updates. Why build anticipation only to share bad news, unless you're completely unhinged?

A new trial would be a positive update compared to them deciding to shelve the project. It's all about perspective.

If the FDA wasn't satisfied with the latest trial, they might require another one. I guess we'll find out in October.

 

[Bhaveen]

A new trial would be a positive update compared to them deciding to shelve the project. It's all about perspective.

If the FDA wasn't satisfied with the latest trial, they might require another one. I guess we'll find out in October.

My understanding is that they have been consulting with and engaging with the FDA throughout the trial process, unless my memory is wrong. Personally, it would be disappointing…

 

[Jonno02]

You can also do a pre-submission with the FDA, where you go over your proposed trials and they let you know if they're satisfied with the setup.

Who knows what was actually done.

 

[withintention]

Are there any theories about why a large minority of subjects in the trial did not experience relief?

 

[Applejuice]

Are there any theories about why a large minority of subjects in the trial did not experience relief?

Well, not really. We do know they used a personal frequency for the trial, but the timing, electrode placement, session length, and overall trial duration were standardized.

So it could be any of those factors. Still, this is all speculation for now, and it will probably become clearer once the device is cleared by the FDA. At that point, they will be free to adjust the device for each individual and see if changes in the parameters produce different results for non-responders.

 

[dd314]

Are there any theories about why a large minority of subjects in the trial did not experience relief?

A decrease of 13 TFI points was used as the threshold for success. If they had lowered that to 11 or 9, there would probably have been many more responders than the reported 60 percent.

 

[Hazel]

Registration for the 13 October Q&A is now open! As mentioned before, it will be recorded and live-streamed from California. The recording will be published after the event.

You can register here

If you would like to submit questions in advance, you can do so here. Please understand that we will not be able to ask everyone's questions. The more precise and concise your question, the more likely we are to use it.

Just a reminder/clarification that we are not in any way commercially affiliated with Auricle. We are organizing this event as a service to the community, but please don't take this as us endorsing or promoting the company/device.

We hope to see many of you there. The wait has been long, so I imagine we will get high attendance.

 

[Barry17]

But what do the neck and jaw have to do with hearing loss?

This device cannot cure the cause of tinnitus or progressive hearing loss and damage.

Or am I missing something?

 

[alwaysmasking]

But what do the neck and jaw have to do with hearing loss?

This device cannot cure the cause of tinnitus or progressive hearing loss and damage.

Or am I missing something?

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.

 

[Furetto]

Are there any theories about why a large minority of subjects in the trial did not experience relief?

Also, the frequency of the tinnitus identified by participants could have been inaccurate, since it is very difficult to match precisely.

 

[dd314]

But what do the neck and jaw have to do with hearing loss?

This device cannot cure the cause of tinnitus or progressive hearing loss and damage.

Or am I missing something?

Essentially, hearing loss causes the brain to turn up the gain on auditory signals to the point where it accidentally picks up electrical noise from the face, tongue, and neck. This happens because auditory signals come from the cranial nerves, and they are all integrated together inside the brainstem (DCN). That is what the LLMs tell me, and Gemini explained this to me a while ago.

 

[TheEarGuy]

Are there any theories about why a large minority of subjects in the trial did not experience relief?

I would assume that some patients did not receive relief because their tinnitus was not caused by the pathology being treated, or because the device was incorrectly calibrated. The majority of patients did respond, which is a good sign, but I remain cautious.

I also suffer from dry eye along with tinnitus. Study results for new dry eye treatments often look promising at first, but the outcomes rarely reflect what happens in the general population. This seems common in many studies that focus on patient-reported symptom relief. Placebo controls alone are not always enough to validate the changes observed in the experimental group.

Even so, I am cautiously optimistic. Her results have been both repeatable and significant. What is really needed now are real-world experiences reported online to see how effective it truly is.

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.

I believe this is correct based on the little I have looked into it. It is not exclusively for patients with TMJ or neck issues, although they would likely respond well if that is the root cause of their tinnitus. My tinnitus was caused by Lexapro (SSRI). The exact mechanisms behind SSRI-induced tinnitus are not fully understood yet, but the tinnitus it gave me does happen to respond to somatic actions.

There is some evidence from animal models that the DCN is influenced by serotonin.

If that study reflects how the human DCN reacts to serotonin, it is plausible that the device could work well for tinnitus induced by SSRIs. I imagine the same could apply to many others with drug-induced tinnitus, even outside of serotonin modulators. As long as your tinnitus reacts to somatic actions, regardless of the cause, you are a candidate, since that points toward issues with the DCN.

 

[AfroSnowman]

I'm so excited for the Oct 13 Q&A. I've been rereading the second study, and to me it looks incredibly positive. I mean, the crossover didn't work because there was no washout, or rather, the washout was irrelevant because the response continued to improve after the end of the active phase. For me, even after 6 years, tinnitus has a profound impact on my day-to-day life. To imagine that we may be given a timeline or at least an end-of-the-tunnel view for a real treatment that could lower the noise by 50% or more feels like a life-changing event. Anyway, I think it is something worth getting excited for.

I know every treatment before has been useless, but from the studies showing animal response to the reported reduction in noise perception via their minimal masking software, there is enough evidence for me. I think this is going to be the real deal for a lot of us.

 

[Cyborg]

I'm so excited for the Oct 13 Q&A. I've been rereading the second study, and to me it looks incredibly positive. I mean, the crossover didn't work because there was no washout, or rather, the washout was irrelevant because the response continued to improve after the end of the active phase. For me, even after 6 years, tinnitus has a profound impact on my day-to-day life. To imagine that we may be given a timeline or at least an end-of-the-tunnel view for a real treatment that could lower the noise by 50% or more feels like a life-changing event. Anyway, I think it is something worth getting excited for.

I know every treatment before has been useless, but from the studies showing animal response to the reported reduction in noise perception via their minimal masking software, there is enough evidence for me. I think this is going to be the real deal for a lot of us.

I can't agree more. What's also different in this case is that, to my understanding, Jon Pearson is involved in this Q&A, clearly marking this an Auricle event. Last year's webinar was more of a university event. To me, that suggests that we may get updates on the commercialization. Which is exactly what we need right now. The research part has already shown efficacy (in a lab context).

But I get it, some of us cope better with having some hope despite the risk of disappointment. For others, the disappointment can be so big that they would spiral, so they remain skeptical. Every one of us should do whatever they need to carry on!

 

[Saba]

I've been praying for a treatment for the tinnitus community for the past 16 months. The Catholic Church has designated 2025 as the Year of Hope. What better timing could there be for a treatment to be revealed this year, offering not only hope but also a deeper faith that science can provide effective help for all who struggle and suffer with debilitating tinnitus.

 

[AfroSnowman]

I can't agree more. What's also different in this case is that, to my understanding, Jon Pearson is involved in this Q&A, clearly marking this an Auricle event. Last year's webinar was more of a university event. To me, that suggests that we may get updates on the commercialization. Which is exactly what we need right now. The research part has already shown efficacy (in a lab context).

But I get it, some of us cope better with having some hope despite the risk of disappointment. For others, the disappointment can be so big that they would spiral, so they remain skeptical. Every one of us should do whatever they need to carry on!

And in the same theme, those of us who have been here a while remember how the great excitement about Lenire and then FX-322 melted into crushing disappointment. The message boards leading up to those collapses were filled with a constant buzz of manically optimistic comments and projections. In retrospect, it was clear that Lenire was based on shaky science and, with some slick marketing, shifted from being presented as a tinnitus reduction treatment to a habituation device. FX-322, also surrounded by heavy marketing hype, failed in its phase 2b clinical trial, which to many of us felt like a pump-and-dump stock market scheme. That combination really put the whole community on its heels. I know I was truly crushed by the FX-322 failure, and I will always be more protective of my emotions when looking at the next possible treatment.

But the lead-up to this could not be more different. Auricle has completely refused to engage in marketing, the phase 2 trial was a success, and it actually reduces tinnitus volume rather than simply measuring how well we cope with the sound.

Five years ago, it really felt like we were on the brink of the first treatments, and our hearts were broken not only by the failures but also by the sense that we had been purposefully misled. Susan Shore's line of research has been nothing but quiet, grinding, painfully slow, fully transparent, and methodical academic work. Step by step. All substance, no show. This is how real science works.

Of course, I have learned my lesson and never want to expose myself to that crushing disappointment again, so I hold my heart back a little on this. Maybe it will never come to market. Maybe, even if it does, it will not work for me. But I think we finally have a real reason to hope, and having that hope, that a treatment may be in sight to meaningfully address this miserable condition, makes my day brighter.

 

[Joeseph Stope]

Doctor, make me young again.
What's that expression they use? "Curb your enthusiasm," or something like that.

Thirty years of research, and now after the final dress rehearsal, the premiere night performance has been announced. I can hardly wait for curtain-up time, and I am as fixated as the rest of you.

I have already braced myself for the following outcomes:
a) Auricle turns out to be a wonder machine that cures everybody. Hurrah! We can all go home. (I will miss the camaraderie, no doubt about that.)
b) It cures a portion of us, the somatic tinnitus group. They will go home, while the rest of us will still be hanging in here.
c) It somehow lowers the volume for some of us, but not all of us. In my view, that is still a big win.
d) It somehow lowers the volume for all of us.

Now, if option d) happens, that will really be something. Big Pharma will get involved, which most likely will lead to further advances and new developments.

So hope for the best and prepare for the worst, and you will not be too disappointed if things do not work out for you.

The launch of Auricle is a big step, and even if it turns out to be less than expected, it will still move research forward, just like the Frequency trials of three or four years ago.

By the way, the scientists seem to be making big strides in scanning technology lately, which will hopefully help us understand what is actually happening in the cochlea and the brain.

 

[kingsfan]

Has anyone asked how this device will handle multi-tonal tinnitus and sounds that are difficult to match, such as static or oscillating tones?

 

[AfroSnowman]

Has anyone asked how this device will handle multi-tonal tinnitus and sounds that are difficult to match, such as static or oscillating tones?

I couldn't cite a reference for this, but I'm quite sure the question has been asked before, and the answer was that it works for multi- and variable tones.

 

[Joeseph Stope]

@AfroSnowman, and in the same theme, those of us who have been here a while remember how the great excitement about Lenire and then FX-322 melted into crushing disappointment. The message boards leading up to those collapses were filled with a constant buzz of manically optimistic comments and projections. In retrospect, it was clear that Lenire was based on shaky science and, with some slick marketing, shifted from being presented as a tinnitus reduction treatment to a habituation device. FX-322, also surrounded by heavy marketing hype, failed in its phase 2b clinical trial, which, to many of us, felt like a pump-and-dump stock market scheme. That combination really put the whole community on its heels. I know I was truly crushed by the FX-322 failure, and I will always be more protective of my emotions when looking at the next possible treatment.

I've lived through much the same experience. Not with Lenire—I did the TRT thing, and in a strange way it did help. That's tinnitus. Who knows? Pepper and salt might help one in a million, but not the other 999,999. Still, because of noise, aging, or both, it made a comeback.

I became a member shortly before discovering and joining this message board. I was completely taken by the prospect of Frequency's research and proposed cure. I was even going to invest in their shares, but I've always been frightened of finance. I've never owned a share in my life, so I postponed and prevaricated. I recall the enthusiasm we felt while awaiting the Phase 2 results. The share price had climbed from $15 to $55, and then this German bloke posted that he was smart enough to get out while the going was good—and he was right.

The abuse that the poor man received for being a "low-down whatever"… he was only being open and honest. Looking back, I can see it was comedy gold, reality surpassing fiction. At the time, though, I was shocked that calculating fund managers could so blatantly misuse the trust of suffering patients who had set their hearts, souls, and savings on escaping tinnitus hell. Hollywood should adapt it into a movie.

Humor is cruel, but if you can muster the strength to see the comical side, even though it isn't easy, that's when you know you're starting to mend.

The entire concept: a research firm that does not yet have a market-ready product issuing shares, paying staff in stock options, and operating on belief, hope, or prayer that future sales will happen? Now that's what I call leverage.

It's got to be a once-in-a-century event. Touch wood, as they say.

 

[Escalado]

I'm so excited for the Oct 13 Q&A. I've been rereading the second study, and to me it looks incredibly positive. I mean, the crossover didn't work because there was no washout, or rather, the washout was irrelevant because the response continued to improve after the end of the active phase. For me, even after 6 years, tinnitus has a profound impact on my day-to-day life. To imagine that we may be given a timeline or at least an end-of-the-tunnel view for a real treatment that could lower the noise by 50% or more feels like a life-changing event. Anyway, I think it is something worth getting excited for.

I know every treatment before has been useless, but from the studies showing animal response to the reported reduction in noise perception via their minimal masking software, there is enough evidence for me. I think this is going to be the real deal for a lot of us.

Can you link me to the second study, please, @AfroSnowman? I got such a lift from reading your response, though not in a "getting carried away" way.