New University of Michigan Tinnitus Discovery — Signal Timing

Has anyone seen any info on how Dr. Shore's treatment will be offered?

I read somewhere that she hopes “eventually” to offer home-usage devices but have not seen anything about where the treatment will be available before that. I’m sure they will be very expensive but I’ll sell all my children and cats to be able to buy one... well maybe just the children...

 

I'd go with the incompetence explanation over patent avoidance.

 

But the other thing with Dr. Shore’s device is that it isn’t administered through the tongue so who knows if the same timings would apply.

 

Capitalism at its best.

 

It probably would enable it to get it out to us quicker, however the issue is that the device has still not passed through clinical trials. This means that even if the device is effective, it couldn't be used for regular use anyway. Although it is unfortunate and doesn't assist anyone now, it will certainly have a benefit in the future with people.

 

The truthful thing is that although this is an example of capitalism and capitalistic business practices, it is inevitably going to yield the best outcome. If Dr. Shore hypothetically merged her device into another device like Lenire, then there can be the possibility that not only would she lose the benefit from what she has spent years working on but she would also possibly lose control over treatment which would mean that she is effectively facing the distinct possibility of not actually also being able to release the device that she wants to. This therefore may mean that her signal timings in another device like Lenire would provide to be inferior in some way.

 

This bushy cell thing is new. Wonder how that was determined. Good to see more independent confirmation that the issue lies in inflammation/synapse damage somewhere between the cochlea and the auditory nerve. Does this information change anything about which current or upcoming medications/supplements/lifestyles might be most effective?

 

Along with the delay in Dr. Shore's work due to COVID-19, I have been concerned about any additional delays in tailoring her device for market.

When approached, Dr. Shore has stated that they are developing the commercial version of their device before the end of the trial. Her words were 'we are working on it'.

I believe she has filed for patents in Europe and Australia, which may have been approved?

The plan is to release it worldwide, but I'm unsure if it has been approved internationally yet.

 

Interesting. My understanding is that commercialisation will be handled by a dedicated department not directly connected to her lab. Maybe it's time to approach them to see if we can glean a little more information?

 

Sorry if this has been asked and answered before, but was the ability to somatically modulate your tinnitus a prerequisite for Lim's device in the same way it is for Shore's?

 

Each country has different patent laws. I just wonder if the concern is helping people get better, or make a profit.

 

I don't get the vibe she's hungry for profit. She's old school academic, wanting to do it by the book.

I wouldn't mind if she became rich from her work.

Susan Shore on Bimodal Stimulation for...

 

I do. On principle. I don’t think anyone in the medical field should profit off of discovery.

That is my personal opinion.

So since I have a device which functions similarly, I should patent and then sell each one for thousands of dollars.

My feeling is that UoM has the rough equivalent of the cure for cancer. However, unlike cancer, the principles that seem to make this work as UoM has documented on their website, have been long established. I'm not sure what the problem and hold up is with the FDA... I do see that the FDA hasn't approved their device... but it is somewhere working its way through the approval process.

It is great work, but I think it is being delayed out of this hope that patent protection in key countries will prevent it from getting cloned. However, it is going to be difficult to prevent this from being cloned by the Chinese because all we are talking about is an embedded chip, with some circuitry that times a biphasic shock wave with a sine wave. There are different timings that seem to work, so it would be literally impossible to patent everything. I would opine that the longer the delays, the greater the risk of someone coming out with a homeopathic product that achieves the same results, using different methods. Homeopathic products do not require FDA approval. TENS units are already being sold. As it stands right now (and I'm not selling, advertising, etc... so please don't hate on me), you can build a "wave generator" and pair it with a TENS device, and produce the same effect.

I do give kudos to Prof. Shore for answering email... it is possible she is frustrated because she has had the solution in her hands for a long time:

"The Neural Bases and Neuroengineering of...

My hope, and prayer, is that Prof. Shore gets her device out there before homeopathic devices flood the market. My line of business is web development and listing services... so this is out of my core focus. I built one because I'm damn tired of dealing with this, and based on how suicidal people can be (I once told my wife I was going to end my life), I don't think this should be delayed further.

And after all the concern about saving lives from COVID-19... well, what about ours. Prof. Shore needs to get the device out, take full credit for curing the world of tinnitus, before other competing homeopathic products enter the market. The component cost is around $25, and PCB costs around $45 made out of China. Programming and firmware development are pretty straightforward, and because I'm retired, have chosen to use some of my money on this, I know the ins and outs of how to produce a device - and without seeing the UoM device, component cost, and complexity is not that great. So let's hurry up, and get this thing out so that it can be professionally done. I've been working on mine for 18 months with an embedded engineering company, and once you know which components to use, it's not that hard. Figuring out the ins and outs IS hard, expensive, and long work.

 

Also something for consideration in light of Prof. Shore's phenomenal work.

Patent protection typically goes into effect when the patent is applied for, but takes many years to go permanent in many countries.

The device is designed to be used each day, which means users need to take it home. After the FDA approves, a company will need to start developing a production plan to get devices in the hands of licensed audiologists or ENTs , which will take time. I think that's what Prof. Shore means when she says "working on it". They probably have a design, but it still needs to go through some type of safety testing (unless they have already done so and the company just needs to flip a switch to start rolling production out). If they source in the United States... the costs are much more expensive... sourcing to China, Shenzhen, has significant cost advantages, but the risk of copying (which will eventually happen) goes up. Then again, China can reverse engineer. I think this is 3 to 5 years out from production... at least getting to the point where we can get treatment. With FDA focused like a laser beam on COVID-19, and the government already experiencing funding shortfalls... I don't think this is going to happen any time soon. Personally, I'm not waiting for the hopes that the moon, sun, and stars will align. Through no fault of UoM, I'm sure if they had their way, it would be out now... but COVID-19... yeah. So I'm not prepared to wait 3, 5, or 10 years... that's all I'm saying just so someone has their day in the sun. I know it's not, but medical research should be done solely to make a difference and improve the lives of others... not for glory or profit. It is not illegal to review medical research and develop treatment/devices accordingly based on one's own understanding of the research. Homeopathic approaches do NOT require FDA approval.

Just some things to think about as everyone, like me, is excited about. But it could be a long long time for this to get out. No one cares, besides us, about curing tinnitus.

 

You have made your own device? Does it work?

 

Posted under the DIY thread.

DIY Bimodal Stimulation Device

 

Stumbled upon this while going through recent research papers. Turns out last November, Susan Shore co-founded a for-profit company called Auricle, Inc. based out of San Francisco. A Google search came up with an Option Agreement between UoMich and Auricle, Inc.

Taken from the Background section of the Agreement:

"Susan Shore, PhD, a Professor in the Department of Otolaryngology-Head and Neck Surgery, and David Martel, Graduate Student Research Assistant in the Department of Otolaryngology-Head and Neck Surgery, are partial owners of a for-profit company called Auricle Inc. (the “Company”). The Company was formed recently to commercialize a device to treat tinnitus and desires to option from the University of Michigan the University’s rights associated with the following technology:

UM OTT File No. 5507, entitled: “Tailored Auditory - Somatosensory Stimulation to Treat Tinnitus” (Inventors: Seth Koehler, David Martel, Susan Shore)"
​

Seems like she'll be taking an active role in the commercialization of her device.

Hopefully she's working on this concurrently with their Phase 2 clinical trial to minimize delays in getting the device out to the market.

 

The train is moving guys, but slowly.

Hang on!

 

Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts

What do you all think about this study completion date?

 

It states January, 2023.

Then they analyze results.

Add one year.

Could be available in 2024-2025.

Then if it's another Lenire...

 

Does anyone remember what the original completion date was?

I know before this COVID-19 business she had been quoted on wanting to get the commercial ball rolling on this much sooner.

 

There appears to be specific and limited criteria as to whom is able to partake in the trial. Thus it would it interesting if Dr. Shore could tell us whether this device is limited to those who fit into the current criteria laid out in the trial or whether the device will be able to be used by a broader group of people.

 

Frustrating to say the least. They've been increasing the participant number by 100 every year. I get that more results means (hopefully) more concrete efficacy but is it really worth pushing this thing out another couple of years? I do wonder if Dr. Shore will retire before this thing ends up getting released.

 

To tommyd87:

Your prognostication is excruciatingly but pointedly accurate.

ajc also insightfully commented "Then if it's another Lenire"; my suspicions are
fully aroused that the reason for these endless extensions is because this has already been determined to be as disappointing as Lenire (but these painfully evident results have been withheld or obfuscated.)

If this shows such potential then why have only two small research groups throughout the entire World been in active development?

I just finished the book "Billion Dollar Loser", and the author Reeves Wiedeman describes how Venture Capital Consortiums are constantly on the lookout for promising new innovations. Why haven't at least several such Consortiums financed competitive ventures for developing similar devices?

I am also nearly convinced that given these endless delays there will be a Law of Diminishing Returns regarding improvements such that these efforts will eventually be quietly terminated.

For the sake of hope let's predict that effective drugs are available before 2024, let alone 2025.

 

2077. We'll get it around the same time as that game.

 

Is the new eligibility criteria more stringent? I notice 'mild' hearing loss up to 6 kHz, which would immediately preclude me and no doubt many others here. Also no relaxation on time since tinnitus onset:

• Preferably onset of tinnitus less than one year ago, but present for at least 6 months. Tinnitus should be bothersome.

 

To UKBloke:

This eligibility criteria has been narrowed to a truly absurd degree, especially regarding:

1) The time window of more than 6 months but less than 1 year;
2) No greater than mild or moderate hearing loss;
3) Unilateral tinnitus only preferred;
4) "Certain medications" will exclude a prospective client;
5) Your tinnitus must be reduced by clenching the jaw;
6) No various associated aural debilitating conditions.

What is the true negligible percentage of tinnitus sufferers who can actually conform to all of these requirements?

When in 2024 or 2025 this device is available, and these are ultimately determined to be standard requirements, it will not avail or benefit any of our 32,000 or so current Tinnitus Talk subscribers. At the very least, we will have had tinnitus for far too long.

 

The only way we will know whether we are able to use this device or not is if Dr. Shore comes out and states that this criteria is only for the trial and that the treatment it offers is actually much broader and also states what this is.

It is appearing more and more like Dr. Shore is conducting her work in a very similar way to Hough Ear Institute. Like Hough Ear Institute who have been very very vague about things like why they need to do the proof of concept study and why they need funding for their pill from the public, Dr. Shore has not explained to what extent this device can treat people positively.

Pretty much one thing I would agree with Hough Ear Institute on is that treating the underlying aspects of tinnitus is going to be the thing that has a positive outcome on it and while Dr. Shore’s device will help, it is probably only going to help a limited number of people.

 

This is the weirdest criterion for me. Who the hell can quiet their tinnitus by poking around their jaw?

 

I can, just slightly, and can increase it with chin tucks.

FX-322, OTO-413, SPI-1005 and RL-81 are going to beat Dr. Shore's device anyways.

Likely if Dr. Shore's device does work, it will be there to clean up what's left.