New University of Michigan Tinnitus Discovery — Signal Timing

[DeanD]

Unfortunately, and I hope I am wrong, but from what we have seen so far, it appears Auricle, Inc. may be more full of academic research types with old school views and values, rather than a dynamic team with aggressive marketing plans and an energetic buzz keen to take this to a national and global market, and start capitalizing on its success.

I get the impression there will be a slow, gradual soft launch. A few audiologists trained meticulously in a slow, painfully methodical way, and then they wait. Wait for the results, the case studies, the feedback before the next step in the overall plan, to expand.

With all the intricacies so far and painfully slow attention to detail, I can't see them leaving the training to chance of a few PDFs and walk-through videos.

This before the product is released nationwide, and if results look good, they look outside the North America borders in to Europe and beyond.

I think we all are very grateful to Dr. Shore for what she has achieved, and her persistence for a real treatment (unlike a certain TRT founder, who will remain nameless, but failed and gave up) - but, of course, we are all understandably very impatient.

It sometimes feels as if we need Lenire's aggressive drive and marketing mindset here - it's just they are touting the wrong product!

 

[Nick47]

People, don't forget a patent is running down with every day that passes. I'm sure it was granted a few years ago. That patent loses potential income with each passing day. Delays are not advantageous to any party. In addition, treatments are progressing through clinical trials and some will come to market, further squeezing the earning potential of Auricle.

Finally, the Chinese will be busy making their own devices as they care not for copyright infringements.

 

[BTaylor12]

Auricle is dropping the ball big time on raising boatloads of investment capital right now.

Unless of course, they aren't confident in one leg of this, such as FDA approval or product success, etc.

 

[ploughna]

It's been said before, but I'll say it again - the most expedient and lowest risk approach to take, IMHO, would be to simply license the IP to Neuromod and sit back to enjoy the revenue stream. However, at this point I'd be surprised if Neuromod had any interest as they seem to be enjoying tremendous success in their US rollout - if you follow them on LinkedIn, you'll see a continuous stream of updates from training and other promotional events across the country.

From an Auricle perspective, you remove the incredibly challenging fundraising requirements, design and manufacturing cost/risk, regulatory approval risk (for Neuromod, this would present as a new improved version of what's already been approved), team building (Engineering, Finance, Legal, Marketing, Sales, Biz dev., Regulatory, Quality, Logistics/Supply Chain). And most importantly, Neuromod have an established global customer base which is a huge deal - the time, cost and effort it's taken them to build this out cannot be underestimated and must be commended.

Unfortunately though, I'm not sure this approach fits the UoM commercialization model and the stakeholders may simply have too much vested in their work at this point to be seen to 'engage with the enemy' and 'give it away' even if that's not the case at all.

Just my $0.02. We shall see...

 

[spedgas]

I just re-read the Q&A with Dr. Shore. I took a second detailed read to realize how little information we got on the distribution progress and process. This is worse than waiting for the trial results to be published. After five years of tinnitus I finally had to break down and start an antidepressant yesterday in an attempt to keep myself alive. I was googling "exit bag" at 3 am with my wife lying next to me. I understand her not wanting to let info out or give timelines she probably doesn't have a clear picture of, but any information would be a glimpse of hope. Can't shake the fear this thing never sees a paying patient. Take my money, I'm ready.

 

[slc]

The company that "developed and manufactured" Dr. Shore's clinical trial device, in2being, has a Friday weekly call-in webinar that covers the following:

• News and updates from the FDA and the regulatory process
• In-depth med-tech regulatory and development education
• Interviews with med-tech community members
• Announcements regarding relevant events

I doubt they would answer specific questions about Auricle, but the Q&A might provide some insight into the FDA process. Their website says, "To join MedTech Crossroads live, just fill out the registration form, and we'll email you the details."

 

[JimmyStrong]

I had a conversation with a support worker from Tinnitus UK. He said he expects availability in the USA in about 2 years. With the rest of the world it will be longer as they need to build their client base in the USA first.

My reading into this is it will be a cash flow issue. They will only have cash for production of so many units initially, and will need to sell X amount of units in the USA before there is money to launch and supply elsewhere.

Fuck.

 

[Pixelito]

Are there any plausible reasons why the device wouldn't have been submitted to the FDA by now?

 

[Jonno02]

Are there any plausible reasons why the device wouldn't have been submitted to the FDA by now?

Lack of in-house regulatory experts to prepare their documentation into a submission ready format.

 

[Joey72]

Lack of in-house regulatory experts to prepare their documentation into a submission ready format.

Fuck X 2.

 

[ErikaS]

Lack of in-house regulatory experts to prepare their documentation into a submission ready format.

That would be so disappointing, not to mention embarrassing for them. They've had since 2019 to "prepare" that documentation and perfect it along the way. I am going to hope that this is not the case for their situation. Our community needs and deserves a true wave of hope and general timeline for treatment/intervention. We shouldn't have to literally beg for it or just be left in the dark continuously. People are literally killing themselves due to this condition. I'm so sick and tired for all of us.

 

[Nick47]

The joy of December 2022 has turned into despair. We've signed a contract for 250 million vaccines for a virus that doesn't yet exist in the UK. How can governments not expedite a tinnitus treatment where there is a clinically unmet need? What we have here are a group of great scientists attempting to launch a product at large scale. The reality and need for an experienced commercial entity is seemingly lacking. The patent continues to tick down and thousands in revenue are lost each day.

I was thinking yesterday we will see TU Delft or some De Ridder prototype hit the market before Dr. Shore's device.

 

[Joshyboy]

Lack of in-house regulatory experts to prepare their documentation into a submission ready format.

It's a shame they don't try to get this device out to the public sooner. It doesn't seem to be a top priority.

 

[Fightthearmy]

The joy of December 2022 has turned into despair. We've signed a contract for 250 million vaccines for a virus that doesn't yet exist in the UK. How can governments not expedite a tinnitus treatment where there is a clinically unmet need? What we have here are a group of great scientists attempting to launch a product at large scale. The reality and need for an experienced commercial entity is seemingly lacking. The patent continues to tick down and thousands in revenue are lost each day.

Maybe @Markku could obtain their take on this, without prying too much into their timeline.

 

[2noist]

I was thinking yesterday we will see TU Delft or some De Ridder prototype hit the market before Dr. Shore's device.

For the next year or two, it's just a waiting game. Nobody's getting their hands on any device in 2024 yet, that's for sure.

 

[Pixelito]

Fuck X 2.

6 months just to prepare documents is wild speculation.

Not saying this is wrong, but it's no more accurate than a prediction that the device will be ready for prescription by this time next year. For all we know, the device is close to approval by the FDA as we speak.

But I get why a lot of people are pessimistic.

 

[Jonno02]

6 months just to prepare documents is wild speculation.

Not saying this is wrong, but it's no more accurate than a prediction that the device will be ready for prescription by this time next year. For all we know, the device is close to approval by the FDA as we speak.

But I get why a lot of people are pessimistic.

It's not speculation nor my prediction. It was a response to someone asking what genuine reason could their be for no submission so far. I never said this was the case or that they hadn't submitted, but unless Auricle are working with an experienced third party, it's likely they lack the regulatory experience to make this super fast as they're scientific researchers and not RA experts.

 

[Karl Tallman]

The US Government spends a billion a year on US Veterans claims for tinnitus. The second the first human trial results looked promising, they should have been partnering up with UoM and providing funding for a 1000 person trial! If I was a veteran with severe quality of life diminishing tinnitus, I'd be teaming up through veteran associations and going into ballistic mode with my local senators and congressional leaders! Unbelievable incompetence in leadership at the US Veterans administration!

 

[SarahMLFlemmer]

6 months just to prepare documents is wild speculation.

Not saying this is wrong, but it's no more accurate than a prediction that the device will be ready for prescription by this time next year. For all we know, the device is close to approval by the FDA as we speak.

But I get why a lot of people are pessimistic.

It's not speculation nor my prediction. It was a response to someone asking what genuine reason could their be for no submission so far. I never said this was the case or that they hadn't submitted, but unless Auricle are working with an experienced third party, it's likely they lack the regulatory experience to make this super fast as they're scientific researchers and not RA experts.

I agree.

I'm sure Dr. Shore wants her money for her hard work that she has put into the device just as much as we want to put our hard earned money into whoever's hands that we gotta to get that said device. With how smart she is, I have no reason to doubt that she did things as accurately as she possibly could have, and that she is waiting patiently for the FDA process approval just like we are. Except, she's trying to earn money and help people and we're trying to give her our money and be helped. We're basically on the same team!

 

[gameover]

I agree.

I'm sure Dr. Shore wants her money for her hard work that she has put into the device just as much as we want to put our hard earned money into whoever's hands that we gotta to get that said device. With how smart she is, I have no reason to doubt that she did things as accurately as she possibly could have, and that she is waiting patiently for the FDA process approval just like we are. Except, she's trying to earn money and help people and we're trying to give her our money and be helped. We're basically on the same team!

Don't underestimate greed. I have no idea what's going on, but there are multiple parties involved, so I would not be so sure everyone is on the same team. Point is - waiting to gain a bigger share may be an acceptable strategy for one or more party. Pure speculation, we do not know what is going on, but Dr. Shore being so tight-lipped is worrisome. There is nothing that prevents them from saying "we submitted to FDA". If they are not saying it, I suspect (speculate) they have not.

There is also the possibility that they are all in sync and everybody is on the same team indeed (I hope so!). But maybe they have not attracted suitable (in their minds, or at all) investment to make it possible to move things along yet, including making submission to FDA. Especially in the new monetary regime, where money is more expensive. Hard to believe Lenire could attract investment, but they have a ready product (even if fraudulent), while Auricle evidently does not.

All speculation. But without concrete information that things are moving along, we have no reason to believe anything positive.

And the fact that http://auricle-inc.com still has no webpage has me concerned. Sure, web presence and marketing might not be a top priority, but it should be arguably a high one - to let the world know they are serious and they are coming with a killer product. So far - nothing there.

 

[ajc]

Pure speculation, we do not know what is going on, but Dr. Shore being so tight-lipped is worrisome. There is nothing that prevents them from saying "we submitted to FDA". If they are not saying it, I suspect (speculate) they have not.

Companies often announce the FDA submission (1, 2).

It not being submitted is the more likely of the options, hard as it is for us to accept.

 

[dj_newark]

The joy of December 2022 has turned into despair. We've signed a contract for 250 million vaccines for a virus that doesn't yet exist in the UK. How can governments not expedite a tinnitus treatment where there is a clinically unmet need? What we have here are a group of great scientists attempting to launch a product at large scale. The reality and need for an experienced commercial entity is seemingly lacking. The patent continues to tick down and thousands in revenue are lost each day.

I was thinking yesterday we will see TU Delft or some De Ridder prototype hit the market before Dr. Shore's device.

December 2022 wasn't even a year ago. It's too soon to give up hope. I looked at Dr. Shore's progress update from June and that reminded me that they are still working even if we don't see evidence of their progress. They have been making progress on this 20 years. They've been working on this every day and we've had the same level of visibility.

If you look at FDA device approvals for DeNovo, the ones that were submitted last November are just being approved now. If we assume, as I think we should, that Auricle submitted their device in December, that means we have a good chance of it being approved next month.

FDA device submissions are public record. Yes, but the submitter can choose to keep it off the public record for several reasons such as if they feel that they are protecting trade secrets by doing so.

We are understandably impatient. But us having no visibility doesn't mean that progress isn't being made. Jon Pearson has over 20 years of FDA medical device experience that he's bringing to the table.

Patents last 20 years, I don't think that's relevant. Guys, chill. It's happening!

 

[StoneInFocus]

The US Government spends a billion a year on US Veterans claims for tinnitus. The second the first human trial results looked promising, they should have been partnering up with UoM and providing funding for a 1000 person trial! If I was a veteran with severe quality of life diminishing tinnitus, I'd be teaming up through veteran associations and going into ballistic mode with my local senators and congressional leaders! Unbelievable incompetence in leadership at the US Veterans administration!

You are out of your damn mind if you think the results of the last study warrant funding for a 1000 person trial.

 

[Fightthearmy]

December 2022 wasn't even a year ago. It's too soon to give up hope. I looked at Dr. Shore's progress update from June and that reminded me that they are still working even if we don't see evidence of their progress. They have been making progress on this 20 years. They've been working on this every day and we've had the same level of visibility.

If you look at FDA device approvals for DeNovo, the ones that were submitted last November are just being approved now.

DeNovo is different from compassionate care use? If that be not the case, it's fair to say that you've been served:

The terms and conditions for 'compassionate care use' per the FDA are extremely specific, and it is only granted for immediately life-threatening diseases where there are no cleared therapies. There is now at least one FDA-cleared device to treat the symptoms of tinnitus, so compassionate care use of other non-FDA cleared approaches is challenging. In addition, Auricle does not have manufactured devices and the requisite infrastructure to support device use outside of investigational research.

If we assume, as I think we should, that Auricle submitted their device in December, that means we have a good chance of it being approved next month.

What is the matter with you? I'm fairly confident there was a statement by Dr. Shore that they weren't going to submit their device to the FDA before publishing the paper, the one we got in May.

 

[dj_newark]

DeNovo is different from compassionate care use? If that be not the case, it's fair to say that you've been served:

What is the matter with you? I'm fairly confident there was a statement by Dr. Shore that they weren't going to submit their device to the FDA before publishing the paper, the one we got in May.

What's the matter with me? What's the matter with you?

DeNovo is not compassionate use. It is for a 'first of its kind' device. As I've stated previously, the FDA does not care if you're published or not, because they examine your evidence directly. Theoretically she could have resubmitted to the FDA as a 510(k) device once Lenire was approved in March. But knowing her, I don't think she would do that, because Lenire is only superficially similar to the Michigan device.

If she's said they wouldn't submit until she's published, I didn't see that. And it's not a requirement to be published to have your device approved by the FDA. She's well aware of the need to get the device out to the public, so it would surprise me if she waited until she published before submitting to the FDA.

 

[Pixelito]

It's not speculation nor my prediction. It was a response to someone asking what genuine reason could their be for no submission so far. I never said this was the case or that they hadn't submitted, but unless Auricle are working with an experienced third party, it's likely they lack the regulatory experience to make this super fast as they're scientific researchers and not RA experts.

Understood. I was the one who posted that question about the reason why it wouldn't have been submitted by now and I appreciate your response.

I was only reassuring @Joey72 who had a frustrated response to your explanation. I understand at this point people have little reason for optimism and want to prepare for the worst instead of the best-case scenarios.

Personally, I'm going to try to be an optimist until I have real facts that tell me otherwise.

 

[Fightthearmy]

What's the matter with me? What's the matter with you?

DeNovo is not compassionate use. It is for a 'first of its kind' device. As I've stated previously, the FDA does not care if you're published or not, because they examine your evidence directly. Theoretically she could have resubmitted to the FDA as a 510(k) device once Lenire was approved in March. But knowing her, I don't think she would do that, because Lenire is only superficially similar to the Michigan device.

There are numerous entries in this thread where concerns about the DeNovo status after Lenire are being raised, as you can ascertain by google searching this thread. As to their merit, I'm not the expert on that. Some random examples:

I'm afraid that, because Auricle took the De Novo route at FDA, things are unfortunately delayed as the device is no longer De Novo because Neuromod completed the route with Lenire. Auricle will be a Class II device

Do we know what pathway Dr. Shore's device is going through, 510(K) or De Novo, and if it changed after Lenire was approved? I saw the Lenire FDA approval document. They submitted for approval in August 2021, with it being granted in March 2023. 19 months seems very, very slow.
FDA: Product Classification - Combined acoustic and electrical external stimulation device for the relief of tinnitus

----------

If she's said they wouldn't submit until she's published, I didn't see that. And it's not a requirement to be published to have your device approved by the FDA. She's well aware of the need to get the device out to the public, so it would surprise me if she waited until she published before submitting to the FDA.

Regardless if it's a requirement or not, publishing a paper before submitting to the FDA is a course a company may choose to pursue. This thread is lengthy and I'm usually not taking memos, but her saying something along these lines rings familiar to me. If someone can corroborate this, that would be nice.

 

[Jonno02]

Understood. I was the one who posted that question about the reason why it wouldn't have been submitted by now and I appreciate your response.

I was only reassuring @Joey72 who had a frustrated response to your explanation. I understand at this point people have little reason for optimism and want to prepare for the worst instead of the best-case scenarios.

Personally, I'm going to try to be an optimist until I have real facts that tell me otherwise.

I'm very much with you on this, I fall into the optimist camp too. Unfortunately these things do take time and people do tend to get anxious when it looks like nothing is happening. We all have bad days with this bastard of a condition.

Susan Shore et al. were smart enough to research the root cause and a treatment for tinnitus when nobody else has. So I'm sure getting to market won't prove too much trouble.

 

[dj_newark]

Regardless if it's a requirement or not, publishing a paper before submitting to the FDA is a course a company may choose to pursue. This thread is lengthy and I'm usually not taking memos, but her saying something along these lines rings familiar to me. If someone can corroborate this, that would be nice.

Yes, they certainly may have waited until they were published before submitting the device to the FDA. All that I am pointing out is that it's not a requirement, and none of us knows whether she waited for publishing before submitting to the FDA. The only one with complete clarity on the subject is Dr. Shore herself. She has stated in emails that 'as reputable scientists' they will publish a paper, but I don't know that she's ever said that she will wait until publication before submitting to the FDA. I believe she understands the urgency of getting the device into the hands of sufferers, but she is also staunch academic so it could go either way. All we can do is wait to see what happens!

 

[Fightthearmy]

Yes, they certainly may have waited until they were published before submitting the device to the FDA. All that I am pointing out is that it's not a requirement, and none of us knows whether she waited for publishing before submitting to the FDA. The only one with complete clarity on the subject is Dr. Shore herself. She has stated in emails that 'as reputable scientists' they will publish a paper, but I don't know that she's ever said that she will wait until publication before submitting to the FDA. I believe she understands the urgency of getting the device into the hands of sufferers, but she is also staunch academic so it could go either way. All we can do is wait to see what happens!

I found numerous allusions floating around, including your own, but after a systematic and sustained effort to find the alleged quote I was referring to, I'm fairly convinced it doesn't exist in this thread. If it exists, perhaps it's from an interview around December-January. (It is nowhere to be found by searching for the word "interview".)

Some of the allusions:

No one is doubting Dr. Shore's integrity. What many people have noted is that she has continuously taken her sweet time on many occasions, such as insisting on publishing her Phase 2 study first instead of proceeding with the regulatory process.

I could be wrong, but I believe that FDA approval may be dependent on that happening (at least in Dr. Shore's case). She's also stated in the past that they would have to publish their findings before they "move towards commercialization" (her words). So it's likely we have some more time to wait. However, what we've learned today was fantastic! And this process will keep moving forward, we'll have to muster as much patience as we can while this situation develops.

Device approval by the FDA can take place anywhere from 3 to 8 months, and it's very infrequent that it takes longer than that. Maybe this is optimistic of me, but I think with Dr. Shore's methods it will sail through the FDA approval process. One of the biggest stop gaps for progress is that she is insisting on publishing her work before pursuing FDA approval or commercialization because that is what she views as required of her as a "reputable scientist".

There was a statement by Dr. Shore reminiscent of it, but I don't think it's the right one, nor am I sure if she meant publishing the December results or the peer review, and "first" and "second" can signify her stating facts as bulletin points rather than how affairs were to proceed in a given order.

Dr. Shore sent the following in late April 2022 (it was already discussed here), so we are in for a long wait:
...........
We understand the desire to know results as soon as possible, but the release of clinical-trial results is constrained. First, as reputable scientists, we will publish the findings in a relevant journal after proper peer review. Second, regulatory agencies (e.g., FDA, NIH) are careful in their reviews of novel therapies, as they should be, so all of us must be patient.