New University of Michigan Tinnitus Discovery — Signal Timing

[Fields]

The bigger question is if they plan on having some return or buyback policy for those. It doesn't help. It doesn't make a lot of sense to have potentially half their products gathering dust on shelves when they can be returned/refurbished.

I doubt it, honestly. Such buyback policies come with a certain risk for the manufacturer that impacts profitability.

An alternative business model would be to lease the device through an affiliated audiologist or treatment center. They buy the machines and then rent them out to you. If treatment doesn't work, you return them. This could possibly save you some money.

In the worst-case scenario, you could try selling it on the second-hand market. Hopefully, affiliated audiologists will still adjust your settings, even if you didn't buy it through Auricle or them directly.

But anyway, this is all speculation. We have no idea what kind of business models Auricle is contemplating. I know Dr. Shore gave an estimated $3000-4000 range for the device, but this doesn't tell us whether they'll actually be selling it outright.

 

[Bob3382]

I doubt it, honestly. Such buyback policies come with a certain risk for the manufacturer that impacts profitability.

An alternative business model would be to lease the device through an affiliated audiologist or treatment center. They buy the machines and then rent them out to you. If treatment doesn't work, you return them. This could possibly save you some money.

In the worst-case scenario, you could try selling it on the second-hand market. Hopefully, affiliated audiologists will still adjust your settings, even if you didn't buy it through Auricle or them directly.

But anyway, this is all speculation. We have no idea what kind of business models Auricle is contemplating. I know Dr. Shore gave an estimated $3000-4000 range for the device, but this doesn't tell us whether they'll actually be selling it outright.

$3,000-$4,000 is not that much. Considering how much tinnitus impacts my life, the device is worth every penny I can find. If it were $10,000, I would not blink once.

I have been in the insurance business for years and have worked for America's largest health insurance company. Medical devices, especially new ones, are extremely hard to get covered.

 

[MiaVIL]

Take it as you will, but I don't think the device is coming to the hearing aids dealer near you any time soon.

Why is that?

 

[Utdmad89]

$3,000-$4,000 is not that much. Considering how much tinnitus impacts my life, the device is worth every penny I can find. If it were $10,000, I would not blink once.

I have been in the insurance business for years and have worked for America's largest health insurance company. Medical devices, especially new ones, are extremely hard to get covered.

You're lucky you have access to those kinds of funds.

 

[RunningMan]

$3,000-$4,000 is not that much.

To many people, that's like a million dollars, especially if they have severe tinnitus and are debilitated to the point of not being able to work and unable to get disability due to all the hoops you have to jump through and delays getting it. I'm not talking about me, but some people have talked about being homeless or having to live with others to get by.

Why do you think this signals a delay, causing a longer wait?

@gameover is correct, but not because of what he posted. I was optimistic, but I am pushing my prediction off at least an additional full year for when the device will actually be available through any audiologists. Better late than never.

 

[Muggumbo]

I remember Dr. Shore insinuating that payment plans could also be available for the device if you can't afford the lump sum.

 

[Fields]

I remember Dr. Shore insinuating that payment plans could also be available for the device if you can't afford the lump sum.

I'd imagine some people in the community might also be willing to pay it forward and share their devices if reconfiguring the settings isn't too much of a hassle.

I'm lucky to have the option of flying out to the US if everything pans out; not everyone does. I'd certainly look into helping others out once I feel I've benefitted enough.

I fear calibrations will have to be done through official channels, though.

 

[Calapsodis]

I remember Dr. Shore insinuating that payment plans could also be available for the device if you can't afford the lump sum.

I'm almost positive that will come to light. Few people are ready to drop a few grand on anything anytime soon.

This is from Dr. Shore's Q&A if it helps;

Whether or not insurance providers offer therapy coverage will be dependent on the individual provider. In the US, because there is no established standard of care for tinnitus treatment and therefore no CPT ('Current Procedural Therapy') codes for reimbursement, it will require a multi-year effort for providers to offer reimbursement. There are many established and possible financing models, however, that should contribute to making the therapy accessible to most.

 

[Bob3382]

You're lucky you have access to those kinds of funds.

It has taken long years of not spending, putting money into savings, and a wife who helps me keep our budget tight. But God has also blessed me with employment that I can do from home and managers who understand tinnitus. The VP of my department has tinnitus and has made it clear that this is a debilitating affliction. That makes a big difference.

 

[IYIiKe]

Expecting everyone to have access to a new medical device that insurance doesn't cover is a bit silly.

Realistically, those of us who are able/willing to pay to travel and receive treatment will subsidize later widespread use, provided it shows sustained clinical effectiveness. Likely, you would see NIH/VFA in the U.S. subsidize the device for military service members, sort of how they are/have with Lenire. Eventually, insurance will not be able to deny its effectiveness, and it will work its way into major insurance carriers, etc. Even then, there might be hoops a patient might have to go through by working with a PCP, an ENT, and a Neurologist to justify insurance paying for the device. You're talking about developments years after the device has been released.

But yeah, the expectation that a private company will give their IP away is like expecting Coke to let everyone sell their soda and give the recipe away; it's just not how the world works.

 

[RebelScum]

I'd imagine some people in the community might also be willing to pay it forward and share their devices if reconfiguring the settings isn't too much of a hassle.

One potential problem would be if the device works, but you have to keep using it to maintain the benefits, then people won't want to quit using the device and pass it on to others. I think @linearb, who was in the first clinical trial, said his tinnitus returned to its old baseline a few days after he stopped using it. However, the first clinical trial was only four weeks long, and the second was six weeks.

Did the second clinical trial show benefits remaining during the washout period?

 

[Utdmad89]

It has taken long years of not spending, putting money into savings, and a wife who helps me keep our budget tight. But God has also blessed me with employment that I can do from home and managers who understand tinnitus. The VP of my department has tinnitus and has made it clear that this is a debilitating affliction. That makes a big difference.

At least you have been able to do these things. My family lives hand to mouth, I can't work, and I have a small child. I wonder why some are so-called blessed and others are completely ignored.

 

[gameover]

Why is that?

Educated guess. If they have a student working part-time on something that sounds like a key part of the device, it suggests they have not submitted it to the FDA yet. I don't know anything beyond that, so it is a speculation.

 

[RunningMan]

Did the second clinical trial show benefits remaining during the washout period?

Yes, there was a further benefit in loudness reduction during washout. And for TFI, it was still lower AFTER the washout period. Susan Shore stated in a recent webinar that you might have to still use it occasionally.

 

[UHPTS]

Also, Auricle has hired a grad student part time, so that would be the first known non-executive (Pearson, Shore and Martel being CEO, CSO, and VP of R&D, respectively). From his LinkedIn profile:

"Developing ISO 60601 compliant mechanical design and supporting documentation for take-home tinnitus treatment device. Utilizing 3D printing and CNC routing to design and fabricate parts for ambient sound rejection and improved EMI testing."

June 2024 - unbelievable.

 

[Jonno02]

June 2024 - unbelievable.

I'm not quite sure I understand this. Can someone please explain?

When the company I work for submits a new product to regulators that we know/expect will get approval, we generally start to hire new engineers and scientists to look after that specific product. This could be to continuously improve the science behind it to produce Gen2, streamline and maximize the efficiency of the manufacturing processes, etc.

 

[gameover]

I'm not quite sure I understand this. Can someone please explain?

When the company I work for submits a new product to regulators that we know/expect will get approval, we generally start to hire new engineers and scientists to look after that specific product. This could be to continuously improve the science behind it to produce Gen2, streamline and maximize the efficiency of the manufacturing processes, etc.

That would be an optimistic explanation, but if you are a startup that has not really generated one single dollar in revenue, would you be working on "Gen2" already?

They either realized they were not ready, or perhaps - at best - submitted to the FDA, and the FDA sent it back requesting changes/improvements, so they hired the guy to help address those requests.

I think they are still deep in the weeds.

 

[Muggumbo]

I'm not quite sure I understand this. Can someone please explain?

When the company I work for submits a new product to regulators that we know/expect will get approval, we generally start to hire new engineers and scientists to look after that specific product. This could be to continuously improve the science behind it to produce Gen2, streamline and maximize the efficiency of the manufacturing processes, etc.

It's hard to say. All people can do is speculate about Auricle's lack of communication. I definitely understand that they don't want to mention anything regarding the FDA, but I don't feel there's a need for total radio silence. I said this in the past, but I think the FDA approval is the least of everybody's worries. The real question is how fast they can roll the device out after the approval.

 

[UHPTS]

Jon Pearson started Auricle Inc. almost five years ago. There is no official website for Auricle, and the only thing I could trace about Auricle is a three-year-old video on YouTube.

In the video, he brags about people investing in the company. I wonder how much he raised if they could only hire part-time students to do a job that should probably have been done a year ago. Also, this type of work can be / should be outsourced to a company with experience. There are many out there who could do the job quickly.

 

[Jonno02]

That would be an optimistic explanation, but if you are a startup that has not really generated one single dollar in revenue, would you be working on "Gen2" already?

I can't speak for Auricle specifically, but yes, you would. You can't change ANY manufacturing processes or specifications after you submit. Technically, any changes or improvements post-submission would either be Gen 1.1 or 2.0, depending on how large a jump it is.

So, whilst your regulatory experts deal with submission, your development team doesn't sit on their hands. They start looking at areas that could be better; continuous improvement.

In 2018, I was part of a Class III submission. We hadn't even submitted it, and we're already full speed ahead on the device/material that would supersede this product that wasn't even on the market yet.

As I said, I can't speak for Auricle's situation here. But it's hardly unusual.

 

[Utdmad89]

Let's go round again!

 

[MiaVIL]

I can't speak for Auricle specifically, but yes, you would. You can't change ANY manufacturing processes or specifications after you submit. Technically, any changes or improvements post-submission would either be Gen 1.1 or 2.0, depending on how large a jump it is.

So, whilst your regulatory experts deal with submission, your development team doesn't sit on their hands. They start looking at areas that could be better; continuous improvement.

In 2018, I was part of a Class III submission. We hadn't even submitted it, and we're already full speed ahead on the device/material that would supersede this product that wasn't even on the market yet.

As I said, I can't speak for Auricle's situation here. But it's hardly unusual.

This is handy information. I mean, I would rather wait and get a possible new and improved 2.0 Susan Shore Device that could be a lot more effective (even for non-somatic cases) than maybe the earlier version, which was less effective. Maybe it's been submitted, and as you said, they are looking to expand with more treatments!

 

[Muggumbo]

This is handy information. I mean, I would rather wait and get a possible new and improved 2.0 Susan Shore Device that could be a lot more effective (even for non-somatic cases) than maybe the earlier version, which was less effective. Maybe it's been submitted, and as you said, they are looking to expand with more treatments!

You would likely be waiting a very long time for something like that. More studies are required to make it more effective. Improvements they make quickly would most likely be "quality of life" improvements that would make the device more comfortable or easier to use.

 

[gameover]

I can't speak for Auricle specifically, but yes, you would. You can't change ANY manufacturing processes or specifications after you submit. Technically, any changes or improvements post-submission would either be Gen 1.1 or 2.0, depending on how large a jump it is.

So, whilst your regulatory experts deal with submission, your development team doesn't sit on their hands. They start looking at areas that could be better; continuous improvement.

In 2018, I was part of a Class III submission. We hadn't even submitted it, and we're already full speed ahead on the device/material that would supersede this product that wasn't even on the market yet.

As I said, I can't speak for Auricle's situation here. But it's hardly unusual.

You are looking from the perspective of a large corporation flush with money. I think these rules do not quite apply to a small-time show like Auricle. Of course, there is a remote possibility they submitted and are working on improvements, but I am doubtful about it. Their pace and track record do not suggest that.

You would likely be waiting a very long time for something like that. More studies are required to make it more effective. Improvements they make quickly would most likely be "quality of life" improvements that would make the device more comfortable or easier to use.

Or cheaper to manufacture, most likely.

 

[MiaVIL]

You would likely be waiting a very long time for something like that. More studies are required to make it more effective. Improvements they make quickly would most likely be "quality of life" improvements that would make the device more comfortable or easier to use.

Yeah, I have given up much hope that the device will see the light of day.

 

[UHPTS]

The University of Michigan invested $14M+ into the research and gave all the findings to Auricle? Auricle is looking for investors. What will the university gain? Whose money was behind the clinical trials? I don't understand how this works.

If they don't want to talk about FDA approval, OK, but why can't they say what the relationship between the University of Michigan and Auricle is, and what the mission and goals are?

 

[gameover]

The University of Michigan invested $14M+ into the research and gave all the findings to Auricle?

What is the source of this information? What period does it apply to?

 

[UHPTS]

What is the source of this information? What period does it apply to?

It's stated in many articles over the internet, including the video I shared in one of my previous posts.

 

[AfroSnowman]

It's stated in many articles over the internet, including the video I shared in one of my previous posts.

View attachment 57086

I'd imagine that most of the 14 million in grants probably came from sources other than UoM, such as NSF, the Defense Department, NIH, etc.

 

[gameover]

It's stated in many articles over the internet, including the video I shared in one of my previous posts.

View attachment 57086

Yeah, it's a decent amount of money with little practical impact so far—a sad state of affairs.

I wish Auricle considered selling the device in a country without regulatory obstacles while they work on approval/clearance in the US. That would be a real goodwill gesture for suffering people. Panama would be inconvenient, but I bet people would gladly do it if the alternative were waiting however many years. I guess it would create an appearance of working around the system. But that is silly. FDA has no jurisdiction abroad.

So sad. People needed help years ago.