New University of Michigan Tinnitus Discovery — Signal Timing

[Dkellz]

Well, Dr. Shore could have decided to give up after a few years and looked at a research topic other than tinnitus. Where would we then be?

Exactly where we are now, it seems.

 

[F-u-T]

Well, Dr. Shore could have decided to give up after a few years and looked at a research topic other than tinnitus. Where would we then be?

We would be in the exact same place we are now. Unfortunately.

 

[UHPTS]

Well, Dr. Shore could have decided to give up after a few years and looked at a research topic other than tinnitus.

It's anything but easy to find and finance a new project.

Where would we then be?

Perhaps exactly where we are.

 

[Nick47]

Let it rest now, guys.

For now, let's look at other promising avenues. I look forward to the new Tinnitus Talk Podcast episode next week.

This thread can come back to life when the device is announced.

 

[Jonno02]

Unfortunately, this thread has gone down an avenue of people with zero experience or idea of what an FDA submission actually involves deciding that this device is dead in the water because we haven't seen FDA approval from a publication in six months.

 

[GlennS]

Unfortunately, this thread has gone down an avenue of people with zero experience or idea of what an FDA submission actually involves deciding that this device is dead in the water because we haven't seen FDA approval from a publication in six months.

I suspect this comment won't age well, but as always, time will tell.

When it comes to Susan Shore, history is on the side of "hurry up and wait."

-

 

[Jonno02]

I suspect this comment won't age well, but as always, time will tell.

When it comes to Susan Shore, history is on the side of "hurry up and wait."

View attachment 56915-

I am not talking about whether it works or not.

My comment is purely aimed at people who have zero idea of what it's like to prepare a regulatory submission deciding that because it's taking so long, the device is dead. If you've never been a part of a medical device regulatory submission, you are totally naive to the hoops you need to jump through and the level of documentation preparation required, all of which costs money. And I doubt Auricle has the headcount or the funds to make this an expedited process.

I'm obviously not saying I know any inside information or needlessly defending how long it's taken, but I do prepare regulatory submissions in a professional capacity for both Class II and III. And it ain't a quick thing to do.

 

[Bhaveen]

I am not talking about whether it works or not.

My comment is purely aimed at people who have zero idea of what it's like to prepare a regulatory submission deciding that because it's taking so long, the device is dead. If you've never been a part of a medical device regulatory submission, you are totally naive to the hoops you need to jump through and the level of documentation preparation required, all of which costs money. And I doubt Auricle has the headcount or the funds to make this an expedited process.

I'm obviously not saying I know any inside information or needlessly defending how long it's taken, but I do prepare regulatory submissions in a professional capacity for both Class II and III. And it ain't a quick thing to do.

I'd like to get your thoughts on the current timelines. Do you think Auricle is on track with their progress? Specifically, I'm wondering if it's normal for a clinical trial to be completed in 2022, a paper to be published in mid-2023, and for them to be hesitant about disclosing their planned FDA submission dates. I'm trying to determine if their pace is typical or if they might be moving slowly.

Thanks!

 

[Dkellz]

I am not talking about whether it works or not.

My comment is purely aimed at people who have zero idea of what it's like to prepare a regulatory submission deciding that because it's taking so long, the device is dead. If you've never been a part of a medical device regulatory submission, you are totally naive to the hoops you need to jump through and the level of documentation preparation required, all of which costs money. And I doubt Auricle has the headcount or the funds to make this an expedited process.

I'm obviously not saying I know any inside information or needlessly defending how long it's taken, but I do prepare regulatory submissions in a professional capacity for both Class II and III. And it ain't a quick thing to do.

You're adding 'the device is dead' to people pointing out that the submission is labored and seems held back / slow. Those things are in no way exclusive of each other - it feels like you've added the 'device is dead' part to be dramatic.

I haven't seen anyone here say that the device is dead or will never come out.

 

[Jonno02]

I'd like to get your thoughts on the current timelines. Do you think Auricle is on track with their progress? Specifically, I'm wondering if it's normal for a clinical trial to be completed in 2022, a paper to be published in mid-2023, and for them to be hesitant about disclosing their planned FDA submission dates. I'm trying to determine if their pace is typical or if they might be moving slowly.

Thanks!

It's impossible to tell if they're on track. In my experience with preparing a regulatory submission, and bearing in mind that the company I work for has around 100 full-time regulatory experts, internal timelines always either go overdue or you make it by a matter of hours. And that's from a global $9B+ turnover company. As I said, Auricle most definitely does not have the resources or the headcount to make water-tight milestones, and I think that's why they've removed any mention of these.

We never disclose our regulatory timelines or progression externally. While there are no rules about it, many regulators do not appreciate it as any delays in the approval process, or god forbid a rejection, look like it's the regulator's fault as an announcement you've submitted can sometimes be viewed as an overconfident "it's only a matter of time until we're approved." In the past 6-8 months, the FDA has not consistently met its own internally recommended timelines.

A lot of scientific investigation reports are just not suitable for a regulator either. You might have to re-write years' worth of data to remove sections (sometimes less is more to a regulator) or completely reformat it into a regulatory-friendly layout. You don't want to leave something in a development report that the regulator asks for more detail on, and it's totally irrelevant, so you remove it. Re-doing these reports takes time, and going back through your internal approval process for these also takes time. Nothing moves fast.

As anecdotal as this is, here's a little story from my company's start of this year. One of our gas chromatography/mass spectrometry instruments within our lab failed suddenly and was beyond repair. This instrument is used to control raw material quality in one of our manufacturing processes. It's absolutely critical to the business. We managed to procure a brand new, absolutely identical instrument from the supplier and carry out all of our required internal validation and verification activities within three weeks; we had scientists working around the clock confirming installation qualification, operational qualification, performance qualification, and test method migration from the old system—an enormous amount of work.

It then took our regulatory department 2.5 months to prepare a notification (note: notification, NOT a submission) to the FDA to inform them that one of our quality control instruments had been swapped for a like-for-like model and validated.

The regulatory business is slow.

So, in my opinion, Auricle is up against it. I don't know exactly who they're working with, but even regulatory consultants are slow as they don't have the knowledge and history with the device the development team does. But, again, this is just my opinion; there is absolutely nothing I can see that will stop this from getting approval. It's just a time game.

 

[be6z]

But, again, this is just my opinion; there is absolutely nothing I can see that will stop this from getting approval. It's just a time game.

Out of interest, do you think there are any concerns with the study that may make them have to do additional studies, or would you normally expect this sort of study results to be sufficient for approval, but it may take a while to tick all the boxes?

 

[Dkellz]

It's impossible to tell if they're on track. In my experience with preparing a regulatory submission, and bearing in mind that the company I work for has around 100 full-time regulatory experts, internal timelines always either go overdue or you make it by a matter of hours. And that's from a global $9B+ turnover company. As I said, Auricle most definitely does not have the resources or the headcount to make water-tight milestones, and I think that's why they've removed any mention of these.

We never disclose our regulatory timelines or progression externally. While there are no rules about it, many regulators do not appreciate it as any delays in the approval process, or god forbid a rejection, look like it's the regulator's fault as an announcement you've submitted can sometimes be viewed as an overconfident "it's only a matter of time until we're approved." In the past 6-8 months, the FDA has not consistently met its own internally recommended timelines.

A lot of scientific investigation reports are just not suitable for a regulator either. You might have to re-write years' worth of data to remove sections (sometimes less is more to a regulator) or completely reformat it into a regulatory-friendly layout. You don't want to leave something in a development report that the regulator asks for more detail on, and it's totally irrelevant, so you remove it. Re-doing these reports takes time, and going back through your internal approval process for these also takes time. Nothing moves fast.

As anecdotal as this is, here's a little story from my company's start of this year. One of our gas chromatography/mass spectrometry instruments within our lab failed suddenly and was beyond repair. This instrument is used to control raw material quality in one of our manufacturing processes. It's absolutely critical to the business. We managed to procure a brand new, absolutely identical instrument from the supplier and carry out all of our required internal validation and verification activities within three weeks; we had scientists working around the clock confirming installation qualification, operational qualification, performance qualification, and test method migration from the old system—an enormous amount of work.

It then took our regulatory department 2.5 months to prepare a notification (note: notification, NOT a submission) to the FDA to inform them that one of our quality control instruments had been swapped for a like-for-like model and validated.

The regulatory business is slow.

So, in my opinion, Auricle is up against it. I don't know exactly who they're working with, but even regulatory consultants are slow as they don't have the knowledge and history with the device the development team does. But, again, this is just my opinion; there is absolutely nothing I can see that will stop this from getting approval. It's just a time game.

This is an excellent insight into the regulatory process for sure. Your statement effectively outlines the inherent challenges in the regulatory submission process, particularly for companies with limited resources. However, why can't we compare this to Neuromod's Lenire? It's clear that despite starting later, Neuromod's more efficient use of resources and potentially more effective regulatory strategy enabled it to reach the market in about three years. Despite starting clinical trials in 2014, Auricle is still in the regulatory process ten years later. Did Neuromod have more backing/demand/funding? I'm not sure.

The challenges Auricle faces are not insurmountable. Neuromod, a company with comparable funding and backing, overcame similar hurdles with Lenire. With the right strategy and potential external support, Auricle can also navigate the regulatory landscape successfully. This is the point that's being made. Despite the lengthy regulatory process from 2014 to the present, it's important to focus on the potential for improvement in Auricle's approach, rather than just the FDA application times.

 

[gameover]

Neuromod, a company with comparable funding and backing,

Not even close. Last I checked, Neuromod received €40-50M in total funding over the years. Auricle cannot be anywhere near that. Still, somehow, they got enough funding to keep paying Pearson, the CEO, for almost five years now. I hope the investors want to see results just as much as we want to see treatment.

 

[Jonno02]

Out of interest, do you think there are any concerns with the study that may make them have to do additional studies, or would you normally expect this sort of study results to be sufficient for approval, but it may take a while to tick all the boxes?

Not really. It's a well-executed study. It's difficult for me to provide any objective evidence as the devices I normally deal with, a placebo would mean death. I cannot see them having to do any more studies, but I need to emphasize here, which many people gloss over, that a successful clinical trial doesn't mean you're ready for submission. That shows the efficacy of your device, which is probably 10% of the overall evidence a regulatory body wants to see. Other examples of things they want are: proof of validation (software, hardware, methods, installation qualifications, operation qualification, performance qualifications, performance verifications, etc.), supplier agreements to ensure continuity of like-for-like parts, supplier risk assessments, accreditation, site audits, research reports backing up the science, quality management systems, non-conformance and corrective action processes, disaster recovery plans etc. The list goes on; it's not a case of "Look, our device worked in a clinical trial! We can submit!"

This is an excellent insight into the regulatory process for sure. Your statement effectively outlines the inherent challenges in the regulatory submission process, particularly for companies with limited resources. However, why can't we compare this to Neuromod's Lenire? It's clear that despite starting later, Neuromod's more efficient use of resources and potentially more effective regulatory strategy enabled it to reach the market in about three years. Despite starting clinical trials in 2014, Auricle is still in the regulatory process ten years later. Did Neuromod have more backing/demand/funding? I'm not sure.

The challenges Auricle faces are not insurmountable. Neuromod, a company with comparable funding and backing, overcame similar hurdles with Lenire. With the right strategy and potential external support, Auricle can also navigate the regulatory landscape successfully. This is the point that's being made. Despite the lengthy regulatory process from 2014 to the present, it's important to focus on the potential for improvement in Auricle's approach, rather than just the FDA application times.

I think Neuromod had bigger funding behind them. In my experience, university ventures generally move very slowly for two reasons:

1. University researchers also have other duties, such as lecturing; they don't devote all their time to research.
2. Universities don't tend to work to a regulatory level during development, which requires a lot of remediation down the line, and have little experience dealing with regulators.

I work in the private sector, not a government-funded laboratory. We see privately funded start-ups that promise the world pop up all the time. 24 months later, they're dissolved. Start-ups, as Neuromod was until a few years ago, need to get the cash rolling in. In the case of Neuromod, entirely in my opinion, it means that they launched a device with almost zero working track record. But they need the funds to stay afloat. With Dr. Shore not needing that private capital to stay afloat, she's been allowed to properly develop the science from the ground up, which has taken a long time. But that means when this device does launch, I hope we have a good chance it works better than Lenire.

I doubt Auricle are 'in the regulatory process ten years later' - are they? They have only recently begun the regulatory process after the most recent trial was published. See my reply to @be6z above about what regulators require; a clinical trial is a tiny piece of the puzzle.

 

[withintention]

Super informative post, @Jonno02!

That's also why it was such a big deal that Auricle got support from the UMich Innovation Partnership program. They help bridge the funding gap from research to successful launch and also provide a lot of other non-financial support in the form of advice and connections.

That's huge. Auricle doesn't need to rely solely on greedy and over-eager investors like Neuromod probably did.

All I see are positive signs that this device is being brought to market maturely and thoughtfully.

 

[selcuk46]

I have been following this thread for about 1.5 years now, and I check for any developments once a month or so. Well, no significant progress can be seen. However, it's nice to see that people keep believing in it.

To be honest, if this was really a major tool or whatever it is to get any kind of relief, then it would have gotten financial support from major companies, as the profits can be huge.

I am very skeptical about this device. I hope I am mistaken.

 

[Jonno02]

I have been following this thread for about 1.5 years now, and I check for any developments once a month or so. Well, no significant progress can be seen. However, it's nice to see that people keep believing in it.

To be honest, if this was really a major tool or whatever it is to get any kind of relief, then it would have gotten financial support from major companies, as the profits can be huge.

I am very skeptical about this device. I hope I am mistaken.

In the last 1.5 years, they published their final study and said they were preparing for FDA submission. We're not getting updates on the progress, but I'd say that's pretty major.

Not everybody wants to sell to a large company when they develop something. I think the University of Michigan will own a significant portion of the device, so it's not just as simple as Dr. Shore selling up and cruising off into the sunset. I'd much prefer the development team full of scientists and engineers that created the device remain in control than a company that doesn't really care about the treatment but wants to make a quick dollar.

 

[DebInAustralia]

I have been following this thread for about 1.5 years now, and I check for any developments once a month or so. Well, no significant progress can be seen. However, it's nice to see that people keep believing in it.

To be honest, if this was really a major tool or whatever it is to get any kind of relief, then it would have gotten financial support from major companies, as the profits can be huge.

I am very skeptical about this device. I hope I am mistaken.

I have been following Dr. Shore's device since 2013.

Why would you state that you are very skeptical about the device?

We have been enlightened that Auricle has the financial resources to market the device, so that is not a valid concern.

 

[Bhaveen]

I sympathize with the posts discussing how long this process is taking and how slow it seems. I share the frustration of this condition. However, credit must be given to Dr. Shore. She has walked into her office every day for the past 20+ years, relentlessly trying to solve the same challenging problem. Imagine working on the same issue for even one year, facing setbacks and failures along the way. I know I couldn't have endured for 20 years. Dr. Shore will definitely see this through.

 

[Cmspgran]

Well, I just watched the HHF live webinar with Dr. Shore and thought it was fantastic. I learned a little more about the science, which reinforced my confidence that the device really does work. We had some excellent questions at the end.

I'm absolutely confident that this device, when released, will have a massive impact on millions, and I do hope I'm one of them! Here's to its release, hopefully, sooner rather than later.

 

[AfroSnowman]

We had some excellent questions at the end.

Details, please!

 

[marqualler]

Well, I just watched the HHF live webinar with Dr. Shore and thought it was fantastic. I learned a little more about the science, which reinforced my confidence that the device really does work. We had some excellent questions at the end.

I'm absolutely confident that this device, when released, will have a massive impact on millions, and I do hope I'm one of them! Here's to its release, hopefully, sooner rather than later.

I agree. It was a great webinar. She did a great job walking through the mechanism of the studies and explaining specifically why they are targeting the nerve they are targeting. I'm really glad I got to watch it. I can't remember the specific questions that were asked, and a lot of them were sort of already answered in the Tinnitus Hub Q&A (which got a shoutout in HHF's wrap-up email), but there was an interesting anecdote she shared about an audiologist who got to "try" the device herself with tinnitus in both ears and after using it and targeting only one ear with the treatment, her tinnitus resolved (not sure if entirely but got better) in both ears.

I'm curious to see if @Hazel has seen any discussion, formal or informal, about Susan Shore's research / the device itself at the TRI 2024.

 

[Nick47]

@Cmspgran, @marqualler, fair play to you both!

 

[MiaVIL]

Hiding the most important information such as when will the device be available and when are they going to submit for FDA approval is a huge red flag.

 

[Nick47]

Dr. Shore explained the science well and in more detail, citing other research teams.

Summary:

• She said sound therapy is NOT EFFECTIVE, which most of us know.
• All causes of hearing loss lead to the same pathological changes causing tinnitus, i.e., noise, Aspirin, Cisplatin, and infections.
• Future research should look at those who get tinnitus versus those who do not after hearing damage.

 

[IYIiKe]

Hiding the most important information such as when will the device be available and when are they going to submit for FDA approval is a huge red flag.

No, it's not; it's standard business practice.

 

[BlueMoon86]

there was an interesting anecdote she shared about an audiologist who got to "try" the device herself with tinnitus in both ears and after using it and targeting only one ear with the treatment, her tinnitus resolved (not sure if entirely but got better) in both ears.

Oh, so the device treats each ear individually? That's not good news for people with hearing loss like me. I was hoping my hearing ear would be enough.

 

[beefling]

Hiding the most important information such as when will the device be available and when are they going to submit for FDA approval is a huge red flag.

 

[Bambam0]

but there was an interesting anecdote she shared about an audiologist who got to "try" the device herself with tinnitus in both ears and after using it and targeting only one ear with the treatment, her tinnitus resolved (not sure if entirely but got better) in both ears.

Based on Dr. Shore's (well-understood) tight-lipped approach to sharing information about the study, the fact that she shared this at all is WILD.

 

[Muggumbo]

Hiding the most important information such as when will the device be available and when are they going to submit for FDA approval is a huge red flag.

I'm not calling you out specifically, but I see this a lot in this thread. It's completely possible that the device could end up being junk, but the slow progress doesn't logically give us any clue about how effective it is.

If I were going to sell a piece of junk to a desperate population of tinnitus sufferers, I would be talking about it a lot and hyping it up.

Whether Auricle is slow, strapped for resources, or incompetent at getting FDA approval doesn't mean anything about the device's efficacy. The only thing we have to go off of is the study. There are some positive things and negative things about the study. All we can do is wait and see (and complain about how long they're taking).