New University of Michigan Tinnitus Discovery — Signal Timing

[Emao]

Has anyone had Auricle get back to them regarding investing? We did not receive a response. We would meet the criteria to invest.

Do you mean they hadn't contacted you to start the verification process?

 

[Watasha]

Yes, it's something we've talked about. An endowment would be a great way to create steady, long-term funding for research. The challenge is that it only really makes sense once there's a big enough starting amount. For example, a $1 million fund earning around 4 to 5 percent per year would generate about $40,000 to $50,000 annually for research. With smaller amounts, the yearly return just isn't enough to make a real impact. For now, we're focused on growing our donor base, but once we reach that level, it's definitely something we'd like to set up.

Help us find that big initial donor

Hah! I wish I did know that initial donor, I'll work on that... And that's awesome. I love hearing it. There's a famous movie line here in the states..."If you build it, he will come." I believe that the existence of an endowment could help secure its funding, and it also provides a convenient "consumer choice" option (I wouldn't worry too much about cannibalization between the two).

Tinnitus Quest, in my opinion, is what everyone has been waiting for. It has demonstrated accountability, transparency, and a clear vision and mechanism for advancing tinnitus research. You never know when someone out there catches wind of it and wants to leave a lasting legacy that will endure and see this mission through. The future is hopeful.

 

[DimLeb]

Auricle can't accept money from just anyone. The FDA could view that as pre-marketing, which is not something a company wants to risk.

If you're an accredited investor, you can invest in them. The minimum investment is $50,000. Go for it now.

Auricle. Treating tinnitus. At its source.

auricleinc.com

How is that? Doesn't every company out there, even medical ones like the Hough Ear Institute, ask for donations? Even the University of Michigan itself keeps sending me emails asking for donations after I gave just 10 euros on the page they had for Susan Shore.

 

[Nick47]

Has anyone had Auricle get back to them regarding investing

The minimum investment is $50k, I think. It's not something the average tinnitus patient could invest in, and there's no guarantee it will show positive results in another trial.

 

[Joeseph Stope]

It becomes clear that we need an objective tinnitus test to measure its existence and loudness. As long as we do not have that, it will remain too difficult, if not impossible, for anyone to develop a treatment that can reliably pass clinical trials.

I had hoped the Shore device would work and become available soon, but now I am not even sure about the first one.

Duh… I thought the Bionic Lab Institute of Australia, in Adelaide, I think, had already taken care of that. There's a lengthy thread about it here. Is there some kind of "Chinese wall" between the various researchers or what?

FYI:

The Bionics Institute Claim They Have Found a Way of Objectively Measuring Tinnitus

Dr Mehrnaz Shoushtarian claims she has found a way to objectively measure tinnitus severity and whether a person has tinnitus or not via fNIRS (functional near-infrared spectroscopy). I’ve read a few articles on this already. I’ll link two below: Technology lets clinicians objectively detect...

www.tinnitustalk.com

 

[Hazel]

Hah! I wish I did know that initial donor, I'll work on that... And that's awesome. I love hearing it. There's a famous movie line here in the states..."If you build it, he will come." I believe that the existence of an endowment could help secure its funding, and it also provides a convenient "consumer choice" option (I wouldn't worry too much about cannibalization between the two).

Tinnitus Quest, in my opinion, is what everyone has been waiting for. It has demonstrated accountability, transparency, and a clear vision and mechanism for advancing tinnitus research. You never know when someone out there catches wind of it and wants to leave a lasting legacy that will endure and see this mission through. The future is hopeful.

Thank you for your kind words, love it!

I am doubtful, though, on the "build it and they will come" quote. Maybe I misunderstand what you're saying, but the HUGE challenge we face is reaching a) as many people as possible, which takes major marketing efforts, and b) reaching the right people who can significantly propel the cause forward. Simply offering an endowment option will not make a difference unless we continue to make gargantuan efforts to reach a wide audience.

We recently reached the milestone of 10k followers on Instagram, which may not sound like much, but it's more than any of the other tinnitus and hearing charities. That took 1000s of hours of work to accomplish (no exaggeration).

Sorry, I don't mean to berate you at all, I just want people to understand how big the mountain is that we're trying to climb. It's the same reaction I always have when people (for the millionth time) tell us, why don't you "just" get a celebrity on board.

So please everyone, do think about who you might know in your network that could help connect us to some major donors! (Probably should be posting this in the Tinnitus Quest thread, haha.)

For the record, though, I too am hopeful that we will pull this off!

 

[cjbhab]

The minimum investment is $50k, I think. It's not something the average tinnitus patient could invest in, and there's no guarantee it will show positive results in another trial.

A good reason why they should probably respond to those who do inquire. It is definitely a high-risk investment.

 

[Hotrock]

Auricle can't accept money from just anyone. The FDA could view that as pre-marketing, which is not something a company wants to risk.

If you're an accredited investor, you can invest in them. The minimum investment is $50,000. Go for it now.

Auricle. Treating tinnitus. At its source.

auricleinc.com

With all due respect, and just to clarify, the FDA doesn't control private fundraising or investment. They only regulate the marketing and sale of unapproved devices. So, a company can accept funding from investors before approval; it's only public promotion or selling that's restricted. It's easy to see why people confuse the two.

I would gladly invest or donate a large sum, far more than $50k, if I believed it would help or speed up progress. My question is whether they actually need the money, or if there are other underlying reasons why it's taking so long to reach the market. Why haven't there been any recent trials? Are they concerned it won't perform well again?

Also, the device itself is relatively simple in both concept and components, which could make it vulnerable to imitation once released. Perhaps part of the delay has to do with ensuring proper copyright protection and a solid market strategy before rollout. Still, I hope the main focus remains on bringing relief to those who are suffering, rather than getting caught up in red tape or commercial interests.

Further trials were mentioned in the presentation and again at the end during the investors' pitch. The point is that the data from Phase 2 did not show a clear benefit. The second group did not experience improvement from the treatment compared to the sound-only (placebo) phase.

Of all the posts I've seen, only @UKBloke hasn't buried his head in the sand. If I presented the same Phase 2 results, but for a different condition such as depression, would you look at them and call them positive, and therefore wave them through for approval?

Just to clarify the Phase 2 trial results: the bisensory treatment (auditory and somatosensory) produced significant improvements in TFI scores and tinnitus loudness. The sound-only phase didn't show any meaningful benefit, so the positive effects are specifically linked to the bisensory approach.

It's definitely good to evaluate the results critically, but the published data support that bisensory stimulation was effective compared to sound-only treatment. So, in answer to your question, yes, I would approve it based on the trial data.

 

[annV]

With all due respect, and just to clarify, the FDA doesn't control private fundraising or investment. They only regulate the marketing and sale of unapproved devices. So, a company can accept funding from investors before approval; it's only public promotion or selling that's restricted. It's easy to see why people confuse the two.

I would gladly invest or donate a large sum, far more than $50k, if I believed it would help or speed up progress. My question is whether they actually need the money, or if there are other underlying reasons why it's taking so long to reach the market. Why haven't there been any recent trials? Are they concerned it won't perform well again?

With all due respect, you're mostly wrong.

You're right, the FDA doesn't regulate who a company can raise money from, only how the device is marketed. So, private fundraising from accredited investors is fine, but public crowdfunding that promotes or pre-sells an unapproved device would likely violate FDA rules on pre-approval marketing. Auricle does not want to take that risk. This is why they only take money from accredited investors.

If you have access to such large wads of cash (I assume you would then meet the accredited investor requirement), why not reach out to them and make an investment offer? They would probably share more information with a potential investor than a random forum user. To me, it sounds like you're just one person in a long line of people who like to run their mouth.

While you're at it, give some of your cash to Tinnitus Quest. I dare you!!!