New University of Michigan Tinnitus Discovery — Signal Timing

[ColinUK]

Wow, what a complete disconnect and utterly cold response to the community they are supposed to be focused on helping.

The more this goes on, the more surprised I'll be if this device ever comes to market. At their pace, regenerative treatments will be available before this.

All the years of research and money, positive press, and declaration of positive results, for it only to be handed over to people who don't even deem their target patient population it's supposed to help worthy of any information or progress updates.

Truly disgusting, in my opinion.

 

[chinup]

Essentially, their thinking is that no matter how carefully you phrase things, there will always be misinterpretations and people will always want to know more, so it doesn't serve anyone well in the end. It's also not common practice for healthcare companies to make public statements about investigational devices.

Auricle agrees to give an update, raises the hopes of severe tinnitus sufferers, and then unilaterally shuts it down, ultimately making things worse than if they'd never agreed to communicate with the community. I'm sorry, but that is amateur. In my line of work, your professional reputation would be questioned for waffling like that with suffering and desperate people.

I am losing confidence in the group behind this product and am all in favor of pursuing other avenues, as @Nick47 has mentioned and as @Markku and @Hazel have tried to establish with Tinnitus Quest. There were too many eggs in Auricle's basket lately, as it were. They're not the only show in town.


Thank you for your efforts @Markku. They're appreciated. I'm sorry it didn't work out. Let's just let them do whatever it is they're doing in peace.

 

[MichaelBull]

It is disappointing to hear such news from Auricle. While I understand their reasoning from their perspective, it is a hard pill to swallow for people with moderate to severe tinnitus.

It makes sense that they want to be very careful to avoid any misinterpretations going forward, as stated. However, they must also understand that this will breed a lot of skepticism, as it does not demonstrate their confidence in the potential efficacy of their device.

If they prefer not to be contacted directly (which, to clarify, I do understand), it would be helpful if they set up something as simple as an email newsletter that people could sign up for. This newsletter could provide updates on the information we actually want to know (when FDA approval has been reached, initial rollout details, real-world effectiveness data post-rollout, etc.). This way, they can keep the communication one-way (from their end) rather than us chasing them. It would take very little effort to set up.

Either way, it's probably healthier overall not to focus too much on potential treatments (easier said than done, I know!). At the end of the day, being aware of these potential treatments will only be of interest or help once they are actually available and there is significant real-world data to show they work in at least a substantial number of cases. Until then, regularly checking tinnitus forums and treatments will do more harm than good for your mental health. It's best to distract yourself with real life as much as possible (as hard as that can be).

Best wishes to Auricle, nonetheless! I will check back on them, perhaps towards the end of 2025, to see if any progress has been made. My fingers are crossed for them and us.

 

[Bhaveen]

Color me surprised.

I'm surprised, actually... It's not much to ask for a small update or insight.

Personally, I feel that Auricle should have a leader who is experienced in launching therapeutic medical devices with huge potential. I don't see anything groundbreaking in the devices launched by the CEO Jon Pearson.

It's all good hiding behind a complex FDA process and rollout model, but inexperienced management is at the heart of it.

 

[Joeseph Stope]

It's crazy to see sarcastic responses to someone eager to get an update on a device that might help their fight against tinnitus.

No offense intended. As a matter of fact, @Nick47 viewed my smiley message as humorous, just as I had intended.

On another theme, I had written myself off from the Auricle device as I can not easily change the volume of my tinnitus by moving my jaw/neck. However, a few mornings back, just as I woke up, I had a big stretch — arms, neck, etc. And yes, it did increase the volume of my tinnitus quite clearly — for as long as my stretch lasted. So, maybe there's hope for me and others.

 

[MiaVIL]

Absolutely, it is within Auricle's right to do as much or as little public relations as they choose. However, waffling like this is very unprofessional. They must not truly understand what suffering and isolation are like. I hope they are never put in such a desperate situation like many of us are here.

They had the opportunity to provide a bit of hope or something to hold onto, and they chose to be cold and wishy-washy. This is a medical device that may have the potential to reduce human suffering, not an album or a phone launch. They need to remember exactly who they are doing this for and show some compassion.

Their lack of communication makes me feel like they're abandoning the device.

Anyway, that's my emotional, female take on it.

 

[UHPTS]

Absolutely, it is within Auricle's right to do as much or as little public relations as they choose. However, waffling like this is very unprofessional. They must not truly understand what suffering and isolation are like. I hope they are never put in such a desperate situation like many of us are here.

They had the opportunity to provide a bit of hope or something to hold onto, and they chose to be cold and wishy-washy. This is a medical device that may have the potential to reduce human suffering, not an album or a phone launch. They need to remember exactly who they are doing this for and show some compassion.

Their lack of communication makes me feel like they're abandoning the device.

Anyway, that's my emotional, female take on it.

I must say that even though I'm a male, I feel the same.

...Just let them do their work and rest assured that they are doing their best to get the device to market.

Well, if @Markku said that after the call with Auricle's CEO, then it looks like Auricle is doing something, and @Markku and @Hazel are OK with the progress but can't tell us more. I can not imagine why they would lie to us. They would put their own reputation at stake.

 

[Tim Dziwisch]

Bad news:

Auricle has decided not to release any statement at this time. We're disappointed, obviously, as we were expecting to be able to give you some more insight. But they want to stick to their strategy of focusing on their mission rather than engaging with the public. Essentially, their thinking is that no matter how carefully you phrase things, there will always be misinterpretations and people will always want to know more, so it doesn't serve anyone well in the end. It's also not common practice for healthcare companies to make public statements about investigational devices.

We are of course free to speak about the challenges of bringing a medical device to market in general, about which we did learn more through the call with Jon. At this time, however, we will make no further attempts to mediate between the public and Auricle. We would also strongly recommend anyone who wants to know more to refrain from contacting Auricle or anyone associated with it, as it will serve no purpose. Just let them do their work and rest assured that they are doing their best to get the device to market.

An honest question for you: What is your opinion? I think we will get other treatments before the Auricle. It's a shame what they're doing. Can you explain the regulatory process in general? What are the hurdles that we might not see at the moment?

I come from Germany, the land of rules, and here in Europe, they just say that a medical device with a CE logo is safe for people, so there are no big hurdles. You don't have to prove that the treatment really works. I can't imagine it's that hard in the US compared to the EU. But if I only have three workers, it's impossible. So you have an end product that proves a big market, and then you say, "Okay, let's wait, let's do everything slowly." From an economic point of view alone, I can't understand how you can act like that. It doesn't make any sense, in my opinion.

Neuromod, which doesn't have such good treatment with their Lenire, has a completely different approach and has thus inspired much more confidence than Auricle, which doesn't reveal anything at all. I wish they would take a better approach and explain to us what hurdles we generally overlook that need to be overcome. It's not a drug that can cause side effects, in my opinion.

 

[Joey72]

Absolutely, it is within Auricle's right to do as much or as little public relations as they choose. However, waffling like this is very unprofessional. They must not truly understand what suffering and isolation are like. I hope they are never put in such a desperate situation like many of us are here.

They had the opportunity to provide a bit of hope or something to hold onto, and they chose to be cold and wishy-washy. This is a medical device that may have the potential to reduce human suffering, not an album or a phone launch. They need to remember exactly who they are doing this for and show some compassion.

Their lack of communication makes me feel like they're abandoning the device.

Anyway, that's my emotional, female take on it.

I could not have said it better.

 

[Jonno02]

I come from Germany, the land of rules, and here in Europe, they just say that a medical device with a CE logo is safe for people, so there are no big hurdles. You don't have to prove that the treatment really works.

Not quite. CE marking is proving the safety of your device via a notified body by showing you adhere to the Medical Device Regulations. It's a huge task.

 

[999]

At least Auricle told @Markku that it's not happening any time soon [he can correct me if I'm wrong.]

I assume there will be nothing in 2025 or 2026, either FDA approval or a device rollout.

That does not mean the project is a failure because they still had good results from their last study. They updated us indirectly via @Markku last week, and I am still glad they did that much, but I was hoping they would ultimately release a statement.

The question now is if we should try Lenire. People are saying it could cause an increase in perceived tinnitus and/or hearing damage. I would welcome an explanation for why those same concerns would not be true for the potential Auricle device. I need to know why people are waiting for one device over the other.

 

[lymebite]

The question now is if we should try Lenire.

@linearb said earlier he was thinking he would go ahead and try Lenire. He was a participant in the Susan Shore clinical trial, so it says a lot to me if he thinks it might be worth a shot to try Lenire.

 

[Nick47]

I advise readers to broaden their horizons and explore other research areas. Many people invest too heavily in one specific area, and I must remind myself not to do the same constantly. Whether it's thinking, "We just need to reduce fusiform activity in the DCN; that's the answer," or believing that "potassium channel openers for epilepsy are the golden ticket because Retigabine worked for some and Prof. Thanos Tzounopoulos prevented animals from developing tinnitus." It's easy to get fixated.

We've seen this pattern with many treatments over the years, as evidenced by discussions on various threads. Recently, treatments like OTO-313, OTO-413, FX-322, and Lenire have all shown promise in initial trials but eventually failed in further trials or real-world applications.

Based on two human trials, about 50% of people on this thread will say these treatments don't work. The real-world efficacy might be even lower.

I am stressed and struggling, but I know that no amount of arguing or contacting Auricle staff will change the situation.

 

[Bob3382]

Bad news:

Auricle has decided not to release any statement at this time. We're disappointed, obviously, as we were expecting to be able to give you some more insight. But they want to stick to their strategy of focusing on their mission rather than engaging with the public. Essentially, their thinking is that no matter how carefully you phrase things, there will always be misinterpretations and people will always want to know more, so it doesn't serve anyone well in the end. It's also not common practice for healthcare companies to make public statements about investigational devices.

We are of course free to speak about the challenges of bringing a medical device to market in general, about which we did learn more through the call with Jon. At this time, however, we will make no further attempts to mediate between the public and Auricle. We would also strongly recommend anyone who wants to know more to refrain from contacting Auricle or anyone associated with it, as it will serve no purpose. Just let them do their work and rest assured that they are doing their best to get the device to market.

Thank you for taking the time to speak with them and report back.

It's too bad we are all kept in the dark. It gives me absolutely ZERO confidence in Auricle.

 

[UKBloke]

There's clearly a distinction between doing proper science and trialing that science in the proper way. I'm not going to go into detail about why I believe the Shore lab and associates should and could have avoided the situation we're all in now. Suffice it to say, I think in the end, they just simply dropped the ball.

Aside from the obvious deleterious effect of the trial extending the usage time between arms, I've got growing concerns over the reliability of their control - or at least the way the control was designed. It seems reasonable to me to speculate that the FDA might have similar concerns, too.

I'm no fan of Neuromod right now, but on the other side of the bi-modal fence, Dr. Hubert Lim recently gave a fascinating interview regarding trial control. He was candid enough to discuss his meetings with the FDA where control design for Lenire TENT-A3 was concerned. Their solution of six weeks of sound only, then six weeks of sound + stimulation to see whether or not the addition of stimulation makes a clinically significant difference seems very robust to me and a common-sense way to control for something that by definition is difficult to control for.

Dr. Lim also stated that the documentation for TENT-A3 will be released imminently and that Lenire has demonstrated it works better for people in the moderate -> severe category (his words, not mine).

I don't believe we should give up hope on the UMich device. Still, when Auricle refuses to communicate, people will obviously interpret that as things have taken a downward turn, which, until we're updated, might not even be the case.

 

[MaxRabbit]

I honestly don't think they'll hear back from Jon Pearson. Given the flippant response we got from the one communication we had with him, it seems he just doesn't care.

You are the only person who read it right. Damn, one of the few times it would be nice to be wrong?

This device has no real-world application claim to work, and the further it's delayed, the more we wait to see if it works at all.

I struggle to see any ENT solving or even treating tinnitus, which keeps my skepticism going. Funding needs to go to new PhDs focused on brain science.

 

[UHPTS]

There's clearly a distinction between doing proper science and trialing that science in the proper way. I'm not going to go into detail about why I believe the Shore lab and associates should and could have avoided the situation we're all in now. Suffice it to say, I think in the end, they just simply dropped the ball.

Aside from the obvious deleterious effect of the trial extending the usage time between arms, I've got growing concerns over the reliability of their control - or at least the way the control was designed. It seems reasonable to me to speculate that the FDA might have similar concerns, too.

You got me a bit confused here. Do we still believe that Susan Shore's research and device are legit?

 

[Joeseph Stope]

I advise readers to broaden their horizons and explore other research areas. Many people invest too heavily in one specific area, and I must remind myself not to do the same constantly. Whether it's thinking, "We just need to reduce fusiform activity in the DCN; that's the answer," or believing that "potassium channel openers for epilepsy are the golden ticket because Retigabine worked for some and Prof. Thanos Tzounopoulos prevented animals from developing tinnitus." It's easy to get fixated.

We've seen this pattern with many treatments over the years, as evidenced by discussions on various threads. Recently, treatments like OTO-313, OTO-413, FX-322, and Lenire have all shown promise in initial trials but eventually failed in further trials or real-world applications.

Based on two human trials, about 50% of people on this thread will say these treatments don't work. The real-world efficacy might be even lower.

I am stressed and struggling, but I know that no amount of arguing or contacting Auricle staff will change the situation.

I agree with you to a certain extent: Progress is usually made through the contributions of many individuals. The steam engine was invented around the time of the Roman or Byzantine Empire, but it was initially designed to open and close a door, or so it is said. In 1700s England, they approached it differently.

The invention of the hypodermic syringe had to wait for the development of a hollow steel needle. One good thing about reading research is that it tends to cheer you up. There are bright minds out there working to make a difference. Of course, there are also let-downs.

 

[Pixelito]

I think the FDA approval is the least of everybody's worries.

A year ago it was. The longer this drags out, the more it becomes something of a worry.

 

[UKBloke]

Do we still believe that Susan Shore's research [is] legit?

TL;DR - Yes; I've always said I think she has done good science/research.

Do we still believe that Susan Shore's device [is] legit?

TL;DR - I'm not sure we can really answer that question at this point.

============================================

Factors governing control/trial design are something we should consider, I think. Also, the extended treatment time that rendered half the pivotal trial results unusable leaves many unanswered questions.

Regarding the control, I've had a lot of back-and-forth in my own mind about that. Something hasn't quite sat right with what was pitched as an "auditory only" arm and yet involved:

To facilitate blinding during the control treatment (auditory only), participants were instructed to place the electrodes in the same position during both treatment phases and for both phases of the study. These two factors effectively blinded participants and study teams to the treatment phase (control vs. active). In the pilot and the present studies, all participants reported quickly habituating to the electrical stimulus, which was close to threshold, making the stimulus difficult to detect. Participants stated that they could not tell whether they were receiving the control or active treatment.

With the inclusion of electrodes during both treatment phases, including auditory only and the evident Q & A about whether or not participants believed they were receiving the control or active treatment, I'm now of the view that the above control design was not robust enough. There seems to be too much opportunity for a participant to start wondering about permutations, which is obviously the last thing we want to see happen in a clinical trial. I couldn't quite grasp all of this until watching Dr. Lim's recent interview that clarified a few things (52 minutes onwards is very interesting).

I know this discussion divides people, but I personally have chosen not to rely on UMich's control data at all (for the aforementioned reasons). They've already told us we can't rely on the second part of the trial after washout, so where does that leave us?

There's only one graph from the recent trial that UMich released that I'm willing to entertain, and that is the Changes in overall TFI scores in the PP population (0 -> 6 weeks). In answer to your question, I believe that the first chart demonstrates unequivocally that Dr. Shore has done good, promising research that translated into a treatment in humans. Unfortunately, my caveat with all of that, including the chart, is that I'm additionally only willing to entertain the Active treatment arm and not the Control, which lowers the bar considerably. The redundant data only compounds things.

 

[WilRic]

Is the position Auricle has taken really that surprising? Surely this thread self-evidently proves their point (and may have contributed to their decision).

I'm not being critical of anyone at all, but given how keenly interested people are in the device, anything they say will be raked over with a fine-tooth comb. It's just human nature. Their decision to say nothing has already caused people to speculate about what's going on (which is perfectly understandable).

It may be worthwhile remembering that when Lenire was going through all of this, it was a pretty well-established company. It had that whole history with "MuteButton," it had secured multiple rounds of seed funding and had been through regulatory submissions in Europe. It had a lot of people and resources to allocate to public relations (some might say they focused too much on PR and not enough on science, but that's another debate!).

The indications are that Auricle is a much smaller outfit. In conjunction with any FDA submission, it probably is also in the process of spinning up the business and sorting itself out internally (more speculation!). My point is public relations takes time and money. Even just formulating a basic press release regarding an update involves more time and money than you might suspect. Then, you have to allocate resources to deal with the inevitable follow-ups that would flow every single time you give an update. If there's a misunderstanding or hiccup along the way, you've then got to divert even more resources into smoothing that over.

I'm disappointed as well. But I don't think people should jump to the conclusion that something is 'wrong' because they've decided to take this course. It may be the right one in the circumstances.

 

[PeterPan]

"Participants stated that they could not tell whether they were receiving the control or active treatment."

Why didn't they have a question at the end something like: "In either weeks 1-6 OR 12-17 you were subject to a low level electric shock. Which do you think it was?"

And then compare what they thought with what actually happened. If the responses indicated that the participants couldn't tell, that would put to bed any speculation about placebo...

 

[UHPTS]

TL;DR - Yes; I've always said I think she has done good science/research.

TL;DR - I'm not sure we can really answer that question at this point.

============================================

Factors governing control/trial design are something we should consider, I think. Also, the extended treatment time that rendered half the pivotal trial results unusable leaves many unanswered questions.

Regarding the control, I've had a lot of back-and-forth in my own mind about that. Something hasn't quite sat right with what was pitched as an "auditory only" arm and yet involved:

With the inclusion of electrodes during both treatment phases, including auditory only and the evident Q & A about whether or not participants believed they were receiving the control or active treatment, I'm now of the view that the above control design was not robust enough. There seems to be too much opportunity for a participant to start wondering about permutations, which is obviously the last thing we want to see happen in a clinical trial. I couldn't quite grasp all of this until watching Dr. Lim's recent interview that clarified a few things (52 minutes onwards is very interesting).

I know this discussion divides people, but I personally have chosen not to rely on UMich's control data at all (for the aforementioned reasons). They've already told us we can't rely on the second part of the trial after washout, so where does that leave us?

There's only one graph from the recent trial that UMich released that I'm willing to entertain, and that is the Changes in overall TFI scores in the PP population (0 -> 6 weeks). In answer to your question, I believe that the first chart demonstrates unequivocally that Dr. Shore has done good, promising research that translated into a treatment in humans. Unfortunately, my caveat with all of that, including the chart, is that I'm additionally only willing to entertain the Active treatment arm and not the Control, which lowers the bar considerably. The redundant data only compounds things.

For the Dr. Lim interview you shared, I set YouTube not to recommend videos from that channel (Dr. Cliff) some time ago. It's a sales channel with zero useful information.

Dr. Lim joined Neuromod only after Lenire device was finished. I'm not sure what his further contribution was. Marketing? Joining Neuromod made him financially attached to the product, and hence, anything he claims can be disregarded. Based on what he said in the interview, all of us who purchased Lenire became their guinea pigs. They never did other experiments besides testing various device settings on people. The video, especially toward the end, was just another attempt to persuade people that despite negative reviews, Lenire works.

In her last webinar, Dr. Shore said that even though the electrical stimuli were below the feeling threshold, they could still see the somatosensory neurons react to it. I don't recall any mention of this in any of her papers. I guess we have to believe her.

I want to believe that Susan Shore's device works and will be deployed to the market. Unfortunately, things are pointing in different directions.

 

[Dkellz]

A year ago it was. The longer this drags out, the more it becomes something of a worry.

I agree here. It's really hard to not make Lenire comparisons when looking at FDA submission and the post rollout - which in retrospect the Neuromod team has seemingly done efficiently, regardless of what we think the capabilities of the device are exactly.

That is what makes this all worrying IMO; Auricle seems to be completely inept at taking on this process and challenge & after a detailed, hour-long phone call with Auricle leadership, the admins of Tinnitus Talk created Tinnitus Quest; I think that says it all about their conversation and the feelings post call.

 

[Bhaveen]

Towards the end of the video, Dr. Lim discusses how the device doesn't help everyone and, in some cases, may even worsen the condition. They are actively working to enhance the device as more data becomes available.

Let's not forget that Dr. Lim successfully treated @kelpiemsp with his previous techniques. So, let's see what he brings to Neuromod. Perhaps, in time, they might acquire the expertise from Auricle, considering that Auricle isn't making much progress. I'm sure we can all agree that their knowledge, patents, and so on could be valuable in the right hands.

 

[Bob3382]

The longer this drags out, the more it becomes something of a worry.

If they are not in the process of FDA approval, they would shut down Auricle. It is the only reason Auricle exists.

 

[kajag111]

Because Auricle will not release a statement, everyone on here is ready to tear them apart, claiming they aren't legitimate?

 

[Muggumbo]

I agree here. It's really hard to not make Lenire comparisons when looking at FDA submission and the post rollout - which in retrospect the Neuromod team has seemingly done efficiently, regardless of what we think the capabilities of the device are exactly.

That is what makes this all worrying IMO; Auricle seems to be completely inept at taking on this process and challenge & after a detailed, hour-long phone call with Auricle leadership, the admins of Tinnitus Talk created Tinnitus Quest; I think that says it all about their conversation and the feelings post call.

I imagine Tinnitus Quest is something that has been in the works for a while.

We know from the data that this device will not work for everyone. I look at this device as a step on the road to superior treatments.

 

[Bhaveen]

Because Auricle will not release a statement, everyone on here is ready to tear them apart, claiming they aren't legitimate?

I wouldn't say not legitimate. The trial data speaks more for itself than any of us could.

I would use the phrase "not capable."

And bear in mind @Markku and @Hazel — who spoke with Auricle — haven't dismissed our concerns... and silence speaks volumes.

 

[UKBloke]

I set YouTube not to recommend videos from that channel (Dr. Cliff) some time ago. It's a sales channel with zero useful information.

You won't get any argument from me on that point. It is the same with the other Internet audiologist into TRT, whose name I shan't mention. I'm always interested in listening to what Dr. Lim has to say, however.

Dr. Lim joined Neuromod only after Lenire device was finished. I'm not sure what his further contribution was. Marketing?

From his own statement in the interview, he's clearly been involved with the FDA over TENT-A3, so perhaps a bit more than just marketing.

all of us who purchased Lenire became their guinea pigs. They never did other experiments besides testing various device settings on people. The video, especially toward the end, was just another attempt to persuade people that despite negative reviews, Lenire works.

I agree. There seems to have been an element of customer guinea-pigging where Lenire is concerned. I also don't like the way they've advertised it, especially the glossy videos from way back.

I always had a problem with Neuromod's control/placebo argument. That's why I was so bullish about UMich. Years ago, in the interview Ross O'Neill gave Tinnitus Talk, he was clear about how difficult it is to control for a placebo. At the time, I just thought he was playing a bit of a "get out of jail free" card, but I have to say I've come around to his way of thinking.

The more I've thought about putting auditory stimulus into an Active and Control group in a bimodal trial, the more concerned I've been about it. Auditory stimulus literally is a tinnitus treatment. It's the treatment of choice for those fortunate enough to experience tinnitus only at night, masked by a fan.

The control design of TENT-A3 has, I believe, addressed that dichotomy with a robust control. The imminent release of more data coincides well with my two main concerns over the UMich trial, but I have to say - these are just my concerns; others may not share them. I'm interested to see what TENT-A3 reveals, however.

In her last webinar, Dr. Shore said that even though the electrical stimuli were below the feeling threshold, they could still see the somatosensory neurons react to it. I don't recall any mention of this in any of her papers. I guess we have to believe her.

Quite.

Because Auricle will not release a statement, everyone on here is ready to tear them apart, claiming they aren't legitimate?

I don't see any issue with people sticking to facts.