New University of Michigan Tinnitus Discovery — Signal Timing

[dj_newark]

No one accused you of harassing Auricle.

However, posts like yours, which criticize the lack of daily, weekly, or monthly updates and frame it as if they are killing people or being intentionally apathetic, disincentivize Auricle from engaging with the community.

Several people who have posted in this thread have even gone to the extent of messaging Auricle employees on their private Facebook, LinkedIn, and other platforms.

You're welcome to express your frustration, just as I am to express mine. But sentiments like yours, which suggest they are killing people, and the lengths others are going to out of desperation to criticize or disparage Auricle, are entirely counterproductive.

OK, that's good of you to clarify, but you are still attributing behavior to me that wasn't mine. I did not ask them for daily, weekly, or monthly updates. No reasonable person would ask that. However, in the 4 years of Pearson being CEO, we have one Q&A with Dr. Shore, which we appreciate deeply. But nothing since, and even a statement such as "we are working diligently" could have a massive impact on the community's wellbeing.

 

[delta784]

Feel free to browse through the Research News category. I'm not counting KV7 drugs because, at best, I'm only 50/50 on them.

Since Auricle deals with signal timing, do you think it will work for ototoxic, non-somatic tinnitus? I'm in pain.

 

[RebelScum]

Since Auricle deals with signal timing, do you think it will work for ototoxic, non-somatic tinnitus? I'm in pain.

All we can do here is guess. Some may point out that somatic tinnitus was a requirement for the Auricle trials and conclude that it must mean it will only work for somatic cases. However, there's still the possibility that it may work for non-somatic tinnitus as well. Perhaps they believed somatic cases would yield better results, but without any testing on non-somatic cases, no one can know for sure.

 

[IYIiKe]

OK, that's good of you to clarify, but you are still attributing behavior to me that wasn't mine. I did not ask them for daily, weekly, or monthly updates. No reasonable person would ask that. However, in the 4 years of Pearson being CEO, we have one Q&A with Dr. Shore, which we appreciate deeply. But nothing since, and even a statement such as "we are working diligently" could have a massive impact on the community's wellbeing.

Another Q&A session would be completely pointless and a waste of resources from Auricle's perspective.

The company has already explained why they won't be providing updates and has shared everything that can reasonably be expected from a business developing such a device.

For instance, why would anyone assume they aren't working diligently? By whose standards? Do you want random dates and fictitious deadlines that are beyond Auricle's control—deadlines that could shift dramatically during the accreditation process? That's exactly the kind of game they can't afford to play. Nothing they say will satisfy everyone, as expectations are exceedingly high, and most people have almost no understanding of the process they are navigating.

This is not just the sentiment the CEO has expressed in the past; it's also the feedback Markku gave when asked for an update.

Instead of accepting this reality, some people irrationally claim that Auricle is harming others by simply doing what they said they were going to do.

I'm willing to bet that even if Auricle announced things were going well, the usual critics would still complain about the product not being available before FDA approval.

 

[Dkellz]

Another Q&A session would be completely pointless and a waste of resources from Auricle's perspective.

The company has already explained why they won't be providing updates and has shared everything that can reasonably be expected from a business developing such a device.

For instance, why would anyone assume they aren't working diligently? By whose standards? Do you want random dates and fictitious deadlines that are beyond Auricle's control—deadlines that could shift dramatically during the accreditation process? That's exactly the kind of game they can't afford to play. Nothing they say will satisfy everyone, as expectations are exceedingly high, and most people have almost no understanding of the process they are navigating.

This is not just the sentiment the CEO has expressed in the past; it's also the feedback Markku gave when asked for an update.

Instead of accepting this reality, some people irrationally claim that Auricle is harming others by simply doing what they said they were going to do.

I'm willing to bet that even if Auricle announced things were going well, the usual critics would still complain about the product not being available before FDA approval.

The clinical trials began a decade ago. It's fair to say that the process has not been fully optimized overall.

 

[Jonno02]

The clinical trials began a decade ago. It's fair to say that the process has not been fully optimized overall.

10 years is a drop in the ocean for researching, designing, and developing a brand-new medical device, especially when done in partnership with a university.

 

[UKBloke]

10 years is a drop in the ocean for researching, designing, and developing a brand-new medical device, especially when done in partnership with a university.

What's your point of view on 26 years of research? 11 years ago on the first post of this thread, Susan Shore stated in an interview that they were excited about this device because, "It's not just something we cooked up. It's based on 15 years of research."

 

[Gb3]

Once again, something happened. If you recall, it was the pandemic that delayed their most recent clinical trial.

 

[Jonno02]

What's your point of view on 26 years of research? 11 years ago on the first post of this thread, Susan Shore stated in an interview that they were excited about this device because, "It's not just something we cooked up. It's based on 15 years of research."

Because it's a brain condition, tinnitus is one of those things that just takes as long as it takes to resolve. In an alternate universe, we might have accidentally stumbled upon a cure years ago, like a drug designed for something else that, by pure chance, turns out to cure tinnitus. There are probably drugs out there right now that, if modified into an isomeric form, could potentially have an effect on tinnitus. Sometimes, it really is total chance.

This isn't a physical condition where the root cause is easily identified, treatments can be developed to address the issue, and the effectiveness of those treatments can be objectively measured, like with a punctured lung or a broken bone. The research to get to that point is incredible. Sure, at the end of the day, it's reduced to a little box that goes "beep" and "bzzt," but the discovery and timing behind that box are absolutely amazing.

I'm just glad that it only took 26 years to reach the discovery of the claimed fundamental source of tinnitus, and not 36.

 

[dj_newark]

Another Q&A session would be completely pointless and a waste of resources from Auricle's perspective.

The company has already explained why they won't be providing updates and has shared everything that can reasonably be expected from a business developing such a device.

For instance, why would anyone assume they aren't working diligently? By whose standards? Do you want random dates and fictitious deadlines that are beyond Auricle's control—deadlines that could shift dramatically during the accreditation process? That's exactly the kind of game they can't afford to play. Nothing they say will satisfy everyone, as expectations are exceedingly high, and most people have almost no understanding of the process they are navigating.

This is not just the sentiment the CEO has expressed in the past; it's also the feedback Markku gave when asked for an update.

Instead of accepting this reality, some people irrationally claim that Auricle is harming others by simply doing what they said they were going to do.

I'm willing to bet that even if Auricle announced things were going well, the usual critics would still complain about the product not being available before FDA approval.

Tinnitus since 2023??? You're new to the game, so you can't understand my frustration. Mine started in 1990 and has been severe since 1996. Judge all you want, but three decades of this hasn't been easy.

 

[Nick47]

There are probably drugs out there right now that, if modified into an isomeric form, could potentially have an effect on tinnitus. Sometimes, it really is total chance.

@Jonno02, fair points on the research of this treatment modality. I read a paper yesterday about the L-isomer of Baclofen possibly being effective (2012). Additionally, it has been claimed that electrical stimulation of the cochlea has been known to be effective since the 1970s. The frustration is, why has there been no further development?

 

[delta784]

Tinnitus since 2023??? You're new to the game, so you can't understand my frustration. Mine started in 1990 and has been severe since 1996. Judge all you want, but three decades of this hasn't been easy.

Sadly, not everyone has the same mental strength. I'm only one month off the medication, and I am terrified, even though it's moderate.

 

[Dkellz]

10 years is a drop in the ocean for researching, designing, and developing a brand-new medical device, especially when done in partnership with a university.

But after the clinical trial, hasn't the software and hardware of the device remained unchanged? It's been ready to launch since then. If you think they've handled this within a reasonable timeline, you're kidding yourself.

 

[IYIiKe]

Tinnitus since 2023??? You're new to the game, so you can't understand my frustration. Mine started in 1990 and has been severe since 1996. Judge all you want, but three decades of this hasn't been easy.

You didn't respond to anything in the post you quoted. Nothing in that post changes whether I had tinnitus in 1603, 1967, 1999, or any other time. This isn't a "Suffering Olympics." There are no gold stars for how long someone has had tinnitus.

I'm pretty sure anyone with moderate to severe tinnitus for a month knows what it would be like to have it indefinitely. Tinnitus sucks. That's why we're all here. But setting unrealistic expectations for yourself or others will only lead to disappointment.

What information are you expecting Auricle to provide that hasn't already been shared?

 

[Nick47]

It's been ready to launch since then. If you think they've handled this within a reasonable timeline, you're kidding yourself.

@Dkellz, it cannot be launched as a medical device without approval, and the approval process is the reason for the delay. We don't know the exact cause of the delay—it could be due to incompetence, issues with the trial, or problems with the data. We simply do not know.

As I've said before, putting all your eggs in one basket is not wise.

I encourage you to explore other treatments that will begin human trials next year for tinnitus patients. Three options come to mind, but that's a discussion for another thread, not this one.

 

[Jonno02]

@Jonno02, fair points on the research of this treatment modality. I read a paper yesterday about the L-isomer of Baclofen possibly being effective (2012). Additionally, it has been claimed that electrical stimulation of the cochlea has been known to be effective since the 1970s. The frustration is, why has there been no further development?

I would suggest that there has been no further development because there is no objective measurement for testing treatment efficacy. For example, if there were a blood marker for tinnitus that could be objectively observed to decrease with the start of a treatment, we might see more active interest from larger companies.

The discovery of such a biomarker could potentially spark an arms race for tinnitus treatment.

But after the clinical trial, hasn't the software and hardware of the device remained unchanged? It's been ready to launch since then. If you think they've handled this within a reasonable timeline, you're kidding yourself.

Just for some perspective:

It took three months of submission preparation after all qualification testing was completed, followed by three months of back-and-forth during the actual submission process, just to change a detector in one of our lab instruments due to an irreparable hardware failure. In total, it took half a year for a like-for-like swap. The actual hardware was installed and qualified in a day by the manufacturer. The delay occurred because this system is involved in measuring a chemical within a medical device.

Susan Shore is submitting a completely new device, so it will take time to prepare.

If we're still waiting on a submission two years from now, then, yes, there would be no excuse for that.

 

[IvanRus]

As far as I understand, the working mechanisms of Lenire for tinnitus and Dr. Shore's device are almost the same. So why is Lenire considered ineffective? From what I know, clinical trials showed it had even higher effectiveness than Dr. Shore's device (around 80%). However, we still don't have a cure.

 

[PeterPan]

So why is Lenire considered ineffective? From what I know, clinical trials showed it had even higher effectiveness than Dr. Shore's device (around 80%).

In the Dr. Shore device, the tone played matches the frequency of the tinnitus. This is not the case with the Lenire device. The Lenire team analyzed trial participants who, by chance, had tinnitus at the same frequency as the tone played by the device but found no improved response in these cases.

The 80% figure is highly misleading. It represents the percentage of people who experienced some level of improvement, including those who saw only marginal or non-significant benefits.

 

[Ferna]

As far as I understand, the working mechanisms of Lenire for tinnitus and Dr. Shore's device are almost the same. So why is Lenire considered ineffective? From what I know, clinical trials showed it had even higher effectiveness than Dr. Shore's device (around 80%). However, we still don't have a cure.

The studies conducted by Lenire lack scientific rigor. If I remember correctly, they did not include a control group, among other factors, which significantly undermines its value as a treatment. In contrast, Susan Shore has 20 years of research with a higher-quality study methodology. So, even if Lenire claims an effectiveness rate of 80%, that figure is highly unlikely to be accurate.

 

[IYIiKe]

As far as I understand, the working mechanisms of Lenire for tinnitus and Dr. Shore's device are almost the same. So why is Lenire considered ineffective? From what I know, clinical trials showed it had even higher effectiveness than Dr. Shore's device (around 80%). However, we still don't have a cure.

Lenire and Dr. Shore's devices are not the same. Dr. Shore's device relies on the precise timing of electrical impulses, developed through years of research, to attenuate specific aspects of the dorsal cochlear nucleus.

 

[pants]

I would suggest that there has been no further development because there is no objective measurement for testing treatment efficacy. For example, if there were a blood marker for tinnitus that could be objectively observed to decrease with the start of a treatment, we might see more active interest from larger companies.

The discovery of such a biomarker could potentially spark an arms race for tinnitus treatment.

There seems to be some progress in objectively measuring tinnitus:

Bionics Institute trialling world first diagnostic tool to measure tinnitus

Researchers at the Bionics Institute in Melbourne have developed a world first test to objectively measure tinnitus with a brain imaging technique that uses near-infrared light.

hearingpractitionernews.com.au

 

[SarahMLFlemmer]

Sadly, not everyone has the same mental strength. I'm only one month off the medication, and I am terrified, even though it's moderate.

How did you develop tinnitus? Mine is also medication-induced (Accutane) and only one somatic maneuver.

 

[slc]

As far as I understand, the working mechanisms of Lenire for tinnitus and Dr. Shore's device are almost the same. So why is Lenire considered ineffective? From what I know, clinical trials showed it had even higher effectiveness than Dr. Shore's device (around 80%). However, we still don't have a cure.

Lenire's advertising was somewhat misleading. Upon closer reading, it became clear that Lenire only claimed a certain percentage of users were less bothered by their tinnitus—not that the decibel level was reduced or that the tones shifted to a more bearable pitch. Similar relief might be found by joining a support group where participants share coping strategies and provide emotional support.

Lenire's electrical stimulation targets the tongue, while Auricle stimulates the trigeminal nerve on the face. In Auricle's case, the timing between sound and electrical stimulation is calibrated. Auricle also uses a dual calibration process with white noise, specifically including the frequency or frequencies of an individual's tinnitus.

The Lenire User Experiences thread on Tinnitus Talk is a valuable resource. A few users have reported a reduction in severity (beyond just an emotional response), but most have not noticed an improvement, and some even report worsening symptoms.

It has been a while since I reviewed the studies, but there are likely other significant differences, including study design, that I haven't mentioned.

 

[dd314]

It's marginally off-topic, but the entire FDA is getting gutted, apparently. The last time Trump was in office, he cut a tremendous amount of red tape within the FDA. Regardless of your politics, this should be good for us, right?

 

[Joey72]

It's marginally off-topic, but the entire FDA is getting gutted, apparently. The last time Trump was in office, he cut a tremendous amount of red tape within the FDA. Regardless of your politics, this should be good for us, right?

A majority of the funding for the FDA comes from drug companies. That should tell you something. If Trump goes after the drug companies, that's not going to hurt my feelings.

 

[Gb3]

It's marginally off-topic, but the entire FDA is getting gutted, apparently. The last time Trump was in office, he cut a tremendous amount of red tape within the FDA. Regardless of your politics, this should be good for us, right?

Yes, Trump wants Americans to have access to treatments and medicines that can help us. Despite what the liberal media says, he is focused on what is best for the people!

 

[Jonno02]

Yes, Trump wants Americans to have access to treatments and medicines that can help us. Despite what the liberal media says, he is focused on what is best for the people!

Ah, yes, having a notoriously anti-scientific figure who once suggested injecting bleach as a solution for COVID-19 will undoubtedly speed up approvals for safe treatments, right?

YouTube and Google are already overrun with snake oil salesmen touting tinnitus "cures." Do you really want to open the door to more manipulation and make these scams legal if the FDA can no longer protect consumers?

Also, companies pay a fee whenever they submit or notify the FDA about a product for any reason. This doesn't mean they own the FDA or control its employees. In fact, if someone has previously worked for a company, they cannot participate in reviewing that company's submissions.

The real reason many conservatives hate the FDA is because it approved Mifepristone, giving women a choice regarding unwanted pregnancies. If we think Lenire's business practices are questionable, just wait to see what kind of products could hit the market if the FDA's authority is weakened.

 

[LBE]

Putting partisan considerations aside, if the FDA undergoes any major structural changes, I would expect delays. What will happen to the review teams? Will they lose or gain members in the process? New members will need to be hired and brought up to speed. Will there be new regulatory policies? Teams will need time to learn, implement, and follow them. And what about pending approvals? Someone will have to decide if the review process should continue as usual or if it needs to be restarted due to potential policy changes.

I work in the public sector, and I've never seen reorganization or restructuring speed things up. I really hope this will be an exception, but more than that, I hope Auricle gets its approval before the end of January, because after that, who knows what will happen?

 

[Kam75]

Anyway, @Markku previously mentioned that the timelines discussed here on Tinnitus Talk for the potential launch of Susan Shore's device are unrealistic.

I don't think the device will be available on the market before 2030, and it likely won't be accessible outside the United States before 2035...

 

[IYIiKe]

2026 seems realistic.