New University of Michigan Tinnitus Discovery — Signal Timing

[MiaVIL]

I have to agree with @Dkellz.

People are suffering terribly, and here we are having this device that has been researched for over 20 years and is supposedly proven to work with the science to back it up, but then when it's announced that it works, it's just put on a shelf to collect dust with no news.

It is super slow for people in the US, and people outside the US are not even in the pipeline.

I mean, this is more than cruel and shows a serious lack of empathy for the suffering that is going on. If they believe in the device and they have the science, why on earth is it with people who appear to have no capacity to get this to the patients who need it worldwide?

Indeed, this is either mismanagement, incompetence, or they know it doesn't do anything. If you had a viable tinnitus treatment that worked, wouldn't you be pushing this through shouting from the rooftops to get it out and available worldwide to help people suffering and get mega-rich in the process? They haven't even got a website.

I can't get how any of this makes any sense.

I understand what you're saying, but if they didn't think it would work or weren't planning on going ahead with the device, they wouldn't have had the webinar.

 

[RebelScum]

Yeah, even cynically, if this is a "scam" or doesn't work, why not release it and make some quick cash off the early adopters before the word spreads about how "it doesn't work"? The fact that this is not what they did tells me they believe in it enough to do everything "by the book." We may not like "the book," but it is what we have.

Unfortunately, "shouting from the rooftops" would do nothing to speed things along.

 

[Rich123]

Will Dr. Shore's device come out in the next few years?

 

[Jupiterman]

this is either mismanagement, incompetence, or they know it doesn't do anything. If you had a viable tinnitus treatment that worked, wouldn't you be pushing this through shouting from the rooftops to get it out and available worldwide to help people suffering and get mega-rich in the process? They haven't even got a website.

I can't get how any of this makes any sense.

It makes perfect sense to me.

 

[RunningMan]

Everyone else? LOL, you're on Jupiter for sure. Who else will there be but the highly motivated bunch that is us to test this thing? Get in line, try it out, and speak the truth if it works or not. I'm not sure what you're even cautioning for. I still have hyperacusis in one ear, which is potentially inner ear nerve damage that this device will not resolve. I will still give it a whirl as long as the sound stimulus is below my tolerance level.

It only uses one ear, so you should be good with the tolerance by using the ear without hyperacusis.

 

[Utdmad89]

Round and round and round.

 

[beefling]

I'm gettin' déjà vu.

 

[gameover]

The big question here is - is the for-profit medical system really the right approach. Are we really benefiting from entrepreneurship and capitalism? Or should it be nationalized? Arguably it would suck more.

I think the real issue here is that medical solutions - devices or drugs - for urgent issues should be fast tracked. Unfortunately, tinnitus is not considered an urgent issue. It sucks, but in the end, yes, let's be glad Dr. Shore wanted to pursue this, and by all the accounts we have, they are doing their best to get it to the market. I wish their best was better than it is, but it is what it is...

I am skeptical as they come, but I don't think this is a scam. We are probably expecting too much, but I still remain convinced it will be more effective for more people than anything else we have seen before, which is really nothing, just scammy products or therapies (TRT, Lenire, Neosensory, etc).

 

[Jonno02]

It makes perfect sense to me.

Even though this post is still large, I had a bigger response about how multiple people here are purposely obtuse and ignoring the plethora of information posted about the regulatory process and why it's taking Auricle so long.

But I have deleted it because it's much simpler to ask this, and this isn't explicitly aimed at you @Jupiterman, but at several people doing the same thing:

Why are you here, then? If you truly believe there is no hope for this device, you've said your piece. We get it; you're a naysayer. I think you're either still here because you do actually believe it will work but are just venting your frustration about the timeline in the wrong way, or you're taking pleasure in trying to repeatedly convince others it doesn't work.

There are a lot of very fragile people here. You only need to look at some of the recent profile postings, some that even mention this device, to know that. Realistically, this is our best option in the next few years. It has clinically proven to work twice and has been in development for a long time, so it is not a quick cash grab yet, and no offense intended with this word; a few laymen here are now saying there's obviously something wrong, and it doesn't work because it's not on the shelves yet. Zero data was provided, yet just because it's taking a while, you've decided it doesn't work while ignoring multiple posts about why a regulatory submission takes so long. And with many of the aforementioned fragile people waiting on this device, the continuous 'it doesn't work' posts while providing no evidence verge into irresponsible. Provide your data, and most people here will be happy to consider it if you've found a chink in the Auricle armor.

When it launches, if it doesn't work, rip it apart. I'm not sure how effective it'll be, but the data looks promising for a first generation of the treatment. But please stop the ridiculous posts about how it obviously doesn't work purely because it takes a while for regulatory approval while providing no actual analysis of how you've reached that conclusion. By pure chance, you might be correct, but posting it over and over in the same manner is becoming juvenile.

 

[ColinUK]

Yeah, even cynically, if this is a "scam" or doesn't work, why not release it and make some quick cash off the early adopters before the word spreads about how "it doesn't work"? The fact that this is not what they did tells me they believe in it enough to do everything "by the book." We may not like "the book," but it is what we have.

Unfortunately, "shouting from the rooftops" would do nothing to speed things along.

But what does "by the book" mean exactly? I mean, they have a working device or so they claim, but they don't have the capacity or funding to even start the processes outside the US, have no devices manufactured, and have no public information for possible investors; I'm sorry, but no.

If you had the investment and resources, you could pursue FDA regulation, regulation in the EU, and global regulation. If this was a working product, why wouldn't you have a published website with information to attract investment and funding to promote it?

Auricle consists of a couple of people sitting on their hands. It's just not good enough. I will believe it when I see it, but after 20 years of research and another 20 years or more to get an actual device out, I'm past caring by the book. This is the wrong book they have.

 

[RebelScum]

But what does "by the book" mean exactly? I mean, they have a working device or so they claim, but they don't have the capacity or funding to even start the processes outside the US, have no devices manufactured, and have no public information for possible investors; I'm sorry, but no.

Right now, it means they are awaiting FDA approval, which they have absolutely zero control over. They have said they are avoiding talking about the process for fear of saying something that may risk or delay the approval process. This doesn't mean they have or have not started the manufacturing process, but they certainly can't talk about it either way.

If you had the investment and resources, you could pursue FDA regulation, regulation in the EU, and global regulation. If this was a working product, why wouldn't you have a published website with information to attract investment and funding to promote it?

A website costs money. I'm fine with the decision to put as much of their resources as possible into getting the product approved and made. What exactly would be the benefit of a website? Maybe they don't have any information they want to put out there that isn't already out. Perhaps they don't feel that they need more investors or advertisements. Tinnitus Talk is full of people waiting who will jump at the chance to try it, so they probably think they have enough interest for at least the first manufacturing run.

Auricle consists of a couple of people sitting on their hands. It's just not good enough. I will believe it when I see it, but after 20 years of research and another 20 years or more to get an actual device out, I'm past caring by the book. This is the wrong book they have.

If they are waiting for FDA approval, they aren't necessarily "sitting on their hands." They may also be getting the manufacturing process underway but have decided not to discuss it publicly.

 

[Karl Tallman]

I've been following this thread for a couple of years now, but could someone tell me if there is positive proof that Auricle has actually submitted the medical device for FDA approval, or is that just speculation?

Unfortunately, it doesn't seem like there are any resources (databases) available online to show that a manufacturer has submitted a medical device to the FDA; only when it's actually approved does it become part of a public database.

 

[JeffToob]

I've never commented on this thread, but I have read up on the device and most of this thread's posts.

No one knows anything about this device and can only have opinions because there is no real-world application of the treatment to judge. That's absolute.

I hope everyone feels heard in this thread and no one's voice here is any more or less informed than the next person's.

This is a public forum. Anyone can say what they like, how they like it, and how often they feel the need to.

 

[RunningMan]

I've been following this thread for a couple of years now, but could someone tell me if there is positive proof that Auricle has actually submitted the medical device for FDA approval, or is that just speculation?

Unfortunately, it doesn't seem like there are any resources (databases) available online to show that a manufacturer has submitted a medical device to the FDA; only when it's actually approved does it become part of a public database.

Speculation like so many of the comments. See the last word from Auricle CEO here:

→ https://www.tinnitustalk.com/posts/705315/

 

[ColinUK]

A website costs money. I'm fine with the decision to put as much of their resources as possible into getting the product approved and made. .

If they don't have enough funding or resources to deploy a website, they are the wrong people. I am sorry, but I still don't understand why there is so much secrecy.

Is there any news available on Auricle anywhere, including financials, staffing, and investment partners?

What harm could come from them providing news about where they are at with their timelines and giving updates? Isn't it far more commonplace for companies to do this and have transparency?

What benefit do they get from being invisible, and if they understood their patients and potential customers, why do they not understand how much we would value some news and hope?

 

[RebelScum]

If they don't have enough funding or resources to deploy a website, they are the wrong people. I am sorry, but I still don't understand why there is so much secrecy.

Is there any news available on Auricle anywhere, including financials, staffing, and investment partners?

What harm could come from them providing news about where they are at with their timelines and giving updates? Isn't it far more commonplace for companies to do this and have transparency?

What benefit do they get from being invisible, and if they understood their patients and potential customers, why do they not understand how much we would value some news and hope?

I wouldn't want anyone other than Susan Shore working on this. She is not one of the "wrong people," in my opinion.

→ https://www.tinnitustalk.com/posts/705315/

Read that. That should explain the current silence, which has a side effect of not needing a website.

 

[Jonno02]

I've never commented on this thread, but I have read up on the device and most of this thread's posts.

No one knows anything about this device and can only have opinions because there is no real-world application of the treatment to judge. That's absolute.

I hope everyone feels heard in this thread and no one's voice here is any more or less informed than the next person's.

This is a public forum. Anyone can say what they like, how they like it, and how often they feel the need to.

Of course, they can. But don't get fragile and offended when someone asks you to back up your constant stream of 'opinion' with data on how you reached that opinion. If you can't, people are more than entitled to call you out.

And yes, nobody is more informed than anybody else when it comes to the device. That much is true. When it comes to the regulatory process, that opinion falls apart. I have tried, over several posts, to give insight into the regulatory process, but the same names totally ignore the information.

Apologies if this comes across as big-headed, but as someone who has been involved with dozens of Class II and III medical device launches and deals with the FDA on a near-weekly basis, I find it extremely grating when people ignore my posts and comments 'lol the delay means it doesn't work.'

For example, I have previously addressed every single one of @ColinUK's points above, yet they have been ignored - then that obviously means something is wrong with the device.

 

[Bhaveen]

Of course, they can. But don't get fragile and offended when someone asks you to back up your constant stream of 'opinion' with data on how you reached that opinion. If you can't, people are more than entitled to call you out.

And yes, nobody is more informed than anybody else when it comes to the device. That much is true. When it comes to the regulatory process, that opinion falls apart. I have tried, over several posts, to give insight into the regulatory process, but the same names totally ignore the information.

Apologies if this comes across as big-headed, but as someone who has been involved with dozens of Class II and III medical device launches and deals with the FDA on a near-weekly basis, I find it extremely grating when people ignore my posts and comments 'lol the delay means it doesn't work.'

For example, I have previously addressed every single one of @ColinUK's points above, yet they have been ignored - then that obviously means something is wrong with the device.

Do you think the sample size of Dr. Shore's Phase 2 trial was big enough for the FDA? I remember Lenire's trial having 300+ participants, and when I googled the question, it talked about 400+, but this, I think, was more for drugs.

I'm just asking due to your experience. Thanks.

 

[ColinUK]

I wouldn't want anyone other than Susan Shore working on this. She is not one of the "wrong people," in my opinion.

→ https://www.tinnitustalk.com/posts/705315/

Read that. That should explain the current silence, which has a side effect of not needing a website.

I have read that, and it still makes no sense. They are silent, so there is no speculation or disappointment. I don't really think that is working out. I would argue that their silence, lack of transparency, and zero communication are causing more speculation and disappointment.

IMO, if the company were more open, it would benefit everyone, including them and the community, and I still fail to see how it harms them in any way.

To me, how they are managing their product, company, and public relations is a shambles and again shows no relatability to the people struggling with this condition. Some news, some hope, can make a massive difference to people.

You can choose to have blind faith. I'll believe it when I see it, though at this rate, I doubt that will happen in my lifetime.

Anyway, I will end my comment here.

 

[Rhawnhurst]

I really can't blame Auricle for not telling us much more. I am sure that their attorneys are advising them against public comments since, at this stage, it doesn't help them get through the FDA and can only hurt them. It would have been prudent for them to have told us that from the get-go. We are all encouraged by their scientific approach. We can also assume that in a free enterprise system, and knowing the enormous market out there, they work as fast as humanly possible to complete the process, bring a cure to market before someone else does, and start making money.

The only part that concerns me is Dr. Shore leaving the mothership of Michigan. In her interview, which I saw somewhere, she hopes that their work will help future researchers. We all want their research and studies to work and be successful. But for now, all we can do is wait for the Eureka moment of an Auricle announcement and hope that maybe AI is helping others find a solution.

On another subject, clinical trials are also done to make money. I wonder if there is any chance that someone like the ATA could conduct a clinical trial to determine if Lenire is working.

 

[RebelScum]

I have read that, and it still makes no sense. They are silent, so there is no speculation or disappointment. I don't really think that is working out. I would argue that their silence, lack of transparency, and zero communication are causing more speculation and disappointment.

IMO, if the company were more open, it would benefit everyone, including them and the community, and I still fail to see how it harms them in any way.

To me, how they are managing their product, company, and public relations is a shambles and again shows no relatability to the people struggling with this condition. Some news, some hope, can make a massive difference to people.

You can choose to have blind faith. I'll believe it when I see it, though at this rate, I doubt that will happen in my lifetime.

Anyway, I will end my comment here.

I agree with this, mostly. Silence itself causes just as much if not more, speculation and disappointment than a bit more transparency.

That being said, they are evidently under the impression that any comment they make could negatively affect the FDA process.

As for the company's running, I agree that it is possible they may not be running it as efficiently as possible. It doesn't mean the product does or doesn't work. Just that the people running it are scientists, not "businessmen," which makes it more likely the product works, but yes, it might make the process take longer.

I wouldn't say I have "blind faith" per se. I also want to see how it works when it comes out. How long it's taking, what level of transparency we are entitled to, and whether it works or not are really three separate discussions. The third one we can only speculate on, but all data we have so far supports that it should be effective to some extent. Waiting to see how it's working for people after it comes out is actually very sensible.

 

[999]

Will Dr. Shore's device come out in the next few years?

I think so. Based on this year's web conference she gave, Dr. Shore explained the results of a study with 99 people who have tinnitus. The study found that, as a whole, there was a measurable and lasting reduction in perceived tinnitus. She stated that they had favorable results. The kind of data they collected would be exactly what the FDA would need to see.

It is possible that the FDA could fast-track Dr. Shore's device as a "De Novo" or novel treatment (the only other approved treatment is Lenire, but that is a good sign that the FDA may also approve this device, IMO.) With Lenire, their "first trial" results were published in 2020, and the FDA approved the device in 2023 as a De Novo treatment.

To try and be optimistic, I think there is a great chance it will be approved in the next few years. While I don't think it will "cure" tinnitus, I think it could make people's lives actually more bearable since the perceived noise volume is such a big factor in how distressing/bothersome it can be.

 

[Alberte]

Here is the answer I got from the FDA:

Thank you for contacting the Division of Industry and Consumer Education (DICE) at FDA's Center for Devices and Radiological Health (CDRH) DICE@fda.hhs.gov e-mail account.

In searching our database of FDA cleared and/or registered medical devices, I was unable to find a manufacturer or device with the name "Auricle." Therefore, you may want to check directly with the manufacturer to learn the current status of their device with the FDA.

You may be interested in the "Lenire" device the FDA cleared in 2023 for treatment of tinnitus. You can view that information at Device Classification Under Section 513(f)(2)(De Novo) (fda.gov)

If you have any further questions, feel free to write us back at dice@fda.hhs.gov I hope this information is helpful.

 

[MiaVIL]

Here is the answer I got from the FDA:

When did you send this? What did you ask them exactly?

 

[Nick47]

I can't be the only one outside of America who is thinking it's fucking years away for us. Our options are knock-offs or flying to America. If the device is provided through audiologists, a flight is a waste of time with no permanent US address, registration, etc.

 

[AnthonyMcDonald]

Here is the answer I got from the FDA:

So this means that the device's official name is not going to be "Auricle," lol.

It could also mean the manufacturer is different. Auricle is not a device manufacturing company. For more accurate information, we should search for common medical device manufacturers in the Bay Area.

 

[2noist]

So this means that the device's official name is not going to be "Auricle," lol.

It literally does not mean that.

"In searching our database of FDA cleared and/or registered medical devices, I was unable to find a manufacturer or device with the name "Auricle." Therefore, you may want to check directly with the manufacturer to learn the current status of their device with the FDA."

But Auricle could have submitted for FDA approval. FDA wouldn't share that information.

 

[Alberte]

I sent my question to FDA last Friday (28th June). Here is what I wrote:

Good morning.

I would like to know if a request for approval of a medical device treating tinnitus is in progress? The company's name is Auricle, located in San Francisco California.

Thank you.

 

[AnthonyMcDonald]

It literally does not mean that.

or device with the name "Auricle."

But yes, I agree that the FDA most likely would not disclose such information.

 

[Joeseph Stope]

Of course, they can. But don't get fragile and offended when someone asks you to back up your constant stream of 'opinion' with data on how you reached that opinion. If you can't, people are more than entitled to call you out.

And yes, nobody is more informed than anybody else when it comes to the device. That much is true. When it comes to the regulatory process, that opinion falls apart. I have tried, over several posts, to give insight into the regulatory process, but the same names totally ignore the information.

Apologies if this comes across as big-headed, but as someone who has been involved with dozens of Class II and III medical device launches and deals with the FDA on a near-weekly basis, I find it extremely grating when people ignore my posts and comments 'lol the delay means it doesn't work.'

For example, I have previously addressed every single one of @ColinUK's points above, yet they have been ignored - then that obviously means something is wrong with the device.

The fact that Auricle is keeping a low profile and not canvassing for funds or investors is, in my view, one indication that they are a serious company.

The history of high-publicity research start-ups funded on stock options seems to be in disrepute at the moment, which may or may not be a pity.