New University of Michigan Tinnitus Discovery — Signal Timing

[slc]

We won't know whether the device will be a success or a disappointment until it's either released or canceled.

The two studies were quite comprehensive. We know that Auricle shows promise in reducing the actual decibel level for a significant percentage of participants. However, it's important to note that these participants did not receive the placebo sound-only treatment first, which could influence the results. Based on the findings, I would expect that over 50% of people with tinnitus—particularly those able to manipulate sound through various facial movements—may experience relief in a clinical setting. That said, real-world outcomes might differ, as audiologists and patients may not adhere as strictly to the treatment protocols as the study participants did.

I don't fault Susan Shore. This was a university-funded study without major corporate backing. The FDA approval process, along with rolling out devices and training audiologists, will take time. Unlike a multinational drug company with billions—or even millions—of dollars at their disposal, they have limited resources.

 

[withintention]

There seems to be a lot of doom and gloom in this thread about Auricle failing to deliver the device. I just wanted to point out this post:

Check the attached screenshot. This is the job description for the new Auricle employee on LinkedIn. To me, this suggests they are working on a take-home device. Something else seems to be mentioned in the second paragraph, which I think might be related to radiation, but I'm not entirely sure.

From what I've read about the FDA approval process, I believe the device needs to be in its final form before submission. This makes sense, as the FDA needs to review the exact version of the product they are approving.

What worries me is if a new device necessitates a new clinical trial. However, it could just be something related to aesthetics, so hopefully, it's not a major issue. Whatever the case, I can't imagine they have submitted anything to the FDA yet if they are still working on a take-home device.

I recall someone on Tinnitus Talk having experience with medical device submissions, and perhaps they can shed some light on this situation.

View attachment 57157

From their LinkedIn activity, it appears they hired this person in August.

It seems very likely they decided to make some changes to the device, either before submitting it to the FDA or in response to FDA feedback. The references to "ambient sound rejection" and "improved EMI testing" suggest efforts to enhance either the device's efficacy or safety.

Alternatively, a more optimistic interpretation is that they hired this person to work on a future 2.0 version of the device.

That said, if they're actively hiring someone to improve the device, why all the negativity surrounding the company? Why do some people believe they've given up on the device, despite signals like this hiring decision and Susan Shore participating in a Q&A just a few months ago?

I'm feeling hopeful, but if there's a solid reason to doubt, I'd like to know. I don't want to rely on false hope.

 

[Vadimus]

If we set aside the FDA approval process, one thing can be stated with certainty:

In today's world, founding a company doesn't take much time; sometimes just days or even hours. Designing a finished device and developing the necessary software often takes weeks, and in some cases, just days. Scaling production for such a device can also be accomplished within weeks or even days. Creating a website and other marketing materials typically requires only days, and sometimes mere hours. Attracting serious investment has become routine, even for projects with far less potential or those that ultimately prove to be completely worthless. Establishing and maintaining communication with a target audience no longer demands significant money or effort. All of the above can be achieved with minimal resources if managed by someone even moderately capable.

In the case of the Susan Shore device, however, it is evident that an incompetent and unskilled individual is responsible for bringing this groundbreaking project to market. A mediocre person is at the helm of launching what could be one of the most significant medical innovations in history; an invention created by a truly brilliant and exceptional scientist. Sadly, such mismatches between talent and execution are not uncommon in life.

 

[IYIiKe]

It's a startup partnered with a university. It is what it is.

 

[Joeseph Stope]

If we set aside the FDA approval process, one thing can be stated with certainty:

In today's world, founding a company doesn't take much time; sometimes just days or even hours. Designing a finished device and developing the necessary software often takes weeks, and in some cases, just days. Scaling production for such a device can also be accomplished within weeks or even days. Creating a website and other marketing materials typically requires only days, and sometimes mere hours. Attracting serious investment has become routine, even for projects with far less potential or those that ultimately prove to be completely worthless. Establishing and maintaining communication with a target audience no longer demands significant money or effort. All of the above can be achieved with minimal resources if managed by someone even moderately capable.

In the case of the Susan Shore device, however, it is evident that an incompetent and unskilled individual is responsible for bringing this groundbreaking project to market. A mediocre person is at the helm of launching what could be one of the most significant medical innovations in history; an invention created by a truly brilliant and exceptional scientist. Sadly, such mismatches between talent and execution are not uncommon in life.

Oh dear!

 

[withintention]

If we set aside the FDA approval process, one thing can be stated with certainty:

In today's world, founding a company doesn't take much time; sometimes just days or even hours. Designing a finished device and developing the necessary software often takes weeks, and in some cases, just days. Scaling production for such a device can also be accomplished within weeks or even days. Creating a website and other marketing materials typically requires only days, and sometimes mere hours. Attracting serious investment has become routine, even for projects with far less potential or those that ultimately prove to be completely worthless. Establishing and maintaining communication with a target audience no longer demands significant money or effort. All of the above can be achieved with minimal resources if managed by someone even moderately capable.

In the case of the Susan Shore device, however, it is evident that an incompetent and unskilled individual is responsible for bringing this groundbreaking project to market. A mediocre person is at the helm of launching what could be one of the most significant medical innovations in history; an invention created by a truly brilliant and exceptional scientist. Sadly, such mismatches between talent and execution are not uncommon in life.

@Vadimus, what industry operates with those kinds of timelines? My career has been in Silicon Valley hardware and software startups, where the general rule of thumb is that it takes an average of ten years to go from Series A funding to an IPO. And that's for companies that don't have a regulatory approval step, like FDA approval.

 

[Vadimus]

@Vadimus, what industry operates with those kinds of timelines? My career has been in Silicon Valley hardware and software startups, where the general rule of thumb is that it takes an average of ten years to go from Series A funding to an IPO. And that's for companies that don't have a regulatory approval step, like FDA approval.

Which of the timelines I've listed do you have doubts about? Some of these tasks I can complete entirely on my own in just a few days. For example, I can build a website, write the content for it, create all the marketing materials, and set up the social media pages myself.

A programmer I know can write software of this complexity in just a couple of weeks, working solo, and it will not cost millions of dollars. Additionally, a Chinese factory can assemble a device using an existing circuit and create a modern design for housing the circuitry within a week. You might not be aware of this, but some individuals have already built similar devices themselves at home, and it didn't take them years. They are even testing these devices on themselves and reporting results.

I understand that every country and market has its own specific challenges and nuances, and I may be missing some of those details. However, I believe that with the right expertise and motivation, the process of bringing a device like this to market can be much faster—it certainly does not need to take years. The device and the accompanying software are not particularly complex.

To clarify, I am not referring to the FDA review and approval process here.

 

[withintention]

The timelines you mentioned seem accurate for an individual hobbyist, but that doesn't mean they would work for a privately funded company.

For example:

• Many people can build a website in days, but that doesn't mean they are ready to launch Reddit.
• Many people could build a heart-monitoring watch in weeks, but that doesn't mean they are ready to launch Garmin.

Beyond just product development, you need to build a marketing program, customer support team, and distribution system. In this case, you also need to develop training programs for the distributors. All of this takes a surprising amount of time if you want to scale nationally or internationally.

Hardware product development requires several certifications that are time-consuming (e.g., UL, CE Mark, etc.). Manufacturing tens or hundreds of thousands of units involves working iteratively over many cycles with your Chinese fabricator to achieve the quality and yield necessary for scaling.

I can't even begin to imagine the additional hurdles involved in launching a medical device, as I have never done it myself.

My point is that taking a company from seed funding to product launch typically takes years, not days or weeks. While building a prototype can be done in a short time frame, I have yet to see a company bring a commercial product to market at scale that quickly. If you know of any successful examples of commercial products brought to market so rapidly, I would be very interested to learn about them, as there may be exceptions I am not aware of.

 

[lolkas]

The timelines you mentioned seem accurate for an individual hobbyist, but that doesn't mean they would work for a privately funded company.

For example:

• Many people can build a website in days, but that doesn't mean they are ready to launch Reddit.
• Many people could build a heart-monitoring watch in weeks, but that doesn't mean they are ready to launch Garmin.

Beyond just product development, you need to build a marketing program, customer support team, and distribution system. In this case, you also need to develop training programs for the distributors. All of this takes a surprising amount of time if you want to scale nationally or internationally.

Hardware product development requires several certifications that are time-consuming (e.g., UL, CE Mark, etc.). Manufacturing tens or hundreds of thousands of units involves working iteratively over many cycles with your Chinese fabricator to achieve the quality and yield necessary for scaling.

I can't even begin to imagine the additional hurdles involved in launching a medical device, as I have never done it myself.

My point is that taking a company from seed funding to product launch typically takes years, not days or weeks. While building a prototype can be done in a short time frame, I have yet to see a company bring a commercial product to market at scale that quickly. If you know of any successful examples of commercial products brought to market so rapidly, I would be very interested to learn about them, as there may be exceptions I am not aware of.

I agree with many of your points and have some speculative thoughts of my own:

Could it be that they want to release the device in a way that prevents counterfeiting?

It is almost 2025, and creating devices with encrypted storage is not a challenge anymore, even on a large scale. This would ensure the device cannot be reverse-engineered from a code perspective. Additionally, encrypted communication could be implemented between the device and its "management app," allowing adjustments to be securely controlled by the provider.

In summary, I think the delays are partially due to concerns about counterfeiting, along with other logistical challenges. These likely include fabricating the device, developing training for providers, setting up a distribution chain, and navigating the regulatory landscape.

Still, I wish they would move faster. It feels absurd that, as humankind, we can send rockets into space, have them return to Earth, and even self-park, yet we still fail to deliver a product that, while it cannot restore hearing, could at least alleviate one of the most unbearable symptoms — tinnitus.

Sometimes I wonder if all it would take for this problem to be solved is for someone among the wealthiest 1% to experience hearing loss, tinnitus, or hyperacusis. Of course, I do not wish this torture on anyone, but it does make you think.

 

[Kleiner]

For those concerned about "counterfeits," consider this: preventing them has already been largely a failure for Auricle, and it's just another issue to add to the list.

The delays aren't caused by Auricle's efforts but rather by their lack of effort.

 

[withintention]

I think it's entirely possible Auricle could speed up the release of their product by spending more money on staff than they have. I'm not saying they are going the "speed of light." I'm just saying there is no reason to think they have given up on the device. They are just being frugal with their pre-release spend. There could be many reasons for that which have nothing to do with their faith in the device.

I think about that question you posed, @lolkas, a lot. As a startup guy, I rub shoulders with billionaires. I guarantee if one of them got tinnitus, we'd see hundreds of millions flowing into tinnitus research, and I think we'd have a lot better treatment options a lot sooner.

 

[Bob3382]

I think it's entirely possible Auricle could speed up the release of their product by spending more money on staff than they have. I'm not saying they are going the "speed of light." I'm just saying there is no reason to think they have given up on the device. They are just being frugal with their pre-release spend. There could be many reasons for that which have nothing to do with their faith in the device.

I think about that question you posed, @lolkas, a lot. As a startup guy, I rub shoulders with billionaires. I guarantee if one of them got tinnitus, we'd see hundreds of millions flowing into tinnitus research, and I think we'd have a lot better treatment options a lot sooner.

Speculation. That is just about all we have seen in this thread. I have been following this discussion closely, checking Auricle's updates, and reviewing the FDA's approved devices website weekly for almost a year. Person after person shares their take on why Auricle is not more forthcoming, why they remain silent, or why progress seems slow.

The general consensus, based on conversations that long-time forum members have had with Auricle, is that the company avoids announcing anything or providing timelines to prevent speculation from spiraling out of control. I understand their reasoning, but I do not like it.

For those with their own theories, more power to you. But the truth is, we just do not know, and we will not until something is publicly announced.