New University of Michigan Tinnitus Discovery — Signal Timing

[Cyborg]

Anyway, @Markku previously mentioned that the timelines discussed here on Tinnitus Talk for the potential launch of Susan Shore's device are unrealistic.

I don't think the device will be available on the market before 2030, and it likely won't be accessible outside the United States before 2035...

I'd say (hope) that that's maybe a bit pessimistic.

 

[From9to<1]

Ah, yes, having a notoriously anti-scientific figure who once suggested injecting bleach as a solution for COVID-19 will undoubtedly speed up approvals for safe treatments, right?

YouTube and Google are already overrun with snake oil salesmen touting tinnitus "cures." Do you really want to open the door to more manipulation and make these scams legal if the FDA can no longer protect consumers?

Also, companies pay a fee whenever they submit or notify the FDA about a product for any reason. This doesn't mean they own the FDA or control its employees. In fact, if someone has previously worked for a company, they cannot participate in reviewing that company's submissions.

The real reason many conservatives hate the FDA is because it approved Mifepristone, giving women a choice regarding unwanted pregnancies. If we think Lenire's business practices are questionable, just wait to see what kind of products could hit the market if the FDA's authority is weakened.

You DO know he never actually said that, right? He was rather uneducated on the subject and was rambling in his musings. But liberals jumped on a quick, abridged version—much like how most rumors start. Liberals, being liberals, tend to believe what other liberals say without fact-checking. His actual, literal words were:

A question that probably some of you are thinking of if you're totally into that world, which I find to be very interesting. So, supposedly we hit the body with a tremendous, whether it's ultraviolet or just very powerful light. And I think you said that hasn't been checked, but you're going to test it. And then I said, supposing you brought the light inside the body, which you can do either through the skin or in some other way. And I think you said you're going to test that, too. Sounds interesting, right?

And then I see the disinfectant, where it knocks it out in one minute. And is there a way we can do something like that, by injection inside or almost a cleaning, because you see it gets in the lungs and it does a tremendous number on the lungs, so it'd be interesting to check that, so that you're going to have to use medical doctors with, but it sounds interesting to me. So, we'll see, but the whole concept of the light, the way it kills it in one minute. That's pretty powerful.

And before you say, "That's essentially the same thing"—no, it's not.

Saying "something like that" is not saying "that."

 

[ZFire]

Yes, Trump wants Americans to have access to treatments and medicines that can help us. Despite what the liberal media says, he is focused on what is best for the people!

No. Immunity from the judicial process is the priority. You fell for the con.

 

[Jonno02]

You DO know he never actually said that, right? He was rather uneducated on the subject and was rambling in his musings. But liberals jumped on a quick, abridged version—much like how most rumors start. Liberals, being liberals, tend to believe what other liberals say without fact-checking. His actual, literal words were:

And before you say, "That's essentially the same thing"—no, it's not.

Saying "something like that" is not saying "that."

From that whole post about reducing the FDA's protectorate remit and opening people like us up to conmen, your whole stance is, "I must protect Trump." Oh, apologies, he said, "inject disinfectant," which is worlds apart from injecting bleach. I'm relieved the medical doctors didn't listen to him either way.

I'm glad we both agree he's uneducated on subjects he interjects himself into and rambles.

 

[IYIiKe]

Hi everyone. I've been having a rough few days. I know things have been left a bit up in the air, but are there any upcoming studies aimed at advancing this research? Like many of you, I'm genuinely excited about potential treatments that address the physiological basis of tinnitus rather than framing it solely as a psychological issue.

If dorsal cochlear nucleus (DCN) modulation is just the first of many pathways involved in the perception of tinnitus, wouldn't more animal studies help identify other potentially non-invasive options? So far, all I've found are some basic animal studies focusing on DCN lesioning. Is this because the upstream auditory networks are challenging to pinpoint and vary individually?

 

[Alberte]

It is taking so long...

 

[Nick47]

Hi everyone. I've been having a rough few days. I know things have been left a bit up in the air, but are there any upcoming studies aimed at advancing this research? Like many of you, I'm genuinely excited about potential treatments that address the physiological basis of tinnitus rather than framing it solely as a psychological issue.

If dorsal cochlear nucleus (DCN) modulation is just the first of many pathways involved in the perception of tinnitus, wouldn't more animal studies help identify other potentially non-invasive options? So far, all I've found are some basic animal studies focusing on DCN lesioning. Is this because the upstream auditory networks are challenging to pinpoint and vary individually?

@IYIiKe, sorry to hear that your condition has intensified. I tagged you in the Eglumegad thread to keep this discussion on topic.

 

[earear]

last year's Q&A

Hi @Markku, is there a link to last year's Q&A, please? Thank you.

 

[Josh59]

We've been anticipating Dr. Shore's protocol for several months, or even years, now. However, there's something I don't understand: why isn't there scientific research being conducted on Dr. Shore's theories, particularly the localization of tinnitus in the DCN?

 

[IYIiKe]

We've been anticipating Dr. Shore's protocol for several months, or even years, now. However, there's something I don't understand: why isn't there scientific research being conducted on Dr. Shore's theories, particularly the localization of tinnitus in the DCN?

Could DTI Unlock the Mystery of Subjective Tinnitus: It's Time for Parameters That Go A Little Out of the Routine - PubMed

In this study, it was aimed to assess the microstructural changes in the main central auditory pathway in cases with subjective tinnitus. In total, 101 subjects (52 cases with bilateral subjective non-pulsatile tinnitus and 49 healthy cases as the control group) were included in the study...

pubmed.ncbi.nlm.nih.gov

I mean, there is. If you look at any tinnitus research, it's likely to cite Dr. Shore et al. from numerous studies. However, the tools for treatment aren't well defined, and even if researchers agree on certain points, there's little that can be done until better tools are developed and sufficient funding exists to explore or apply potential treatments in studies.

Here are more (recent) studies that implicate the DCN and/or other parts of the brain since the JAMA/Dr. Shore article:

Transcriptional profile changes caused by noise-induced tinnitus in the cochlear nucleus and inferior colliculus of the rat - PubMed

Our findings reveal gene expression alterations in neuronal excitability within the DCN and IC when comparing the tinnitus group to the non-tinnitus group at the transcriptome level. Additionally, the enriched signaling pathways related to changes in synaptic plasticity in the differentially...

pubmed.ncbi.nlm.nih.gov

Photobiomodulation therapy in improvement of harmful neural plasticity in sodium salicylate-induced tinnitus - PubMed

Tinnitus is a common annoying symptom without effective and accepted treatment. In this controlled experimental study, photobiomodulation therapy (PBMT), which uses light to modulate and repair target tissue, was used to treat sodium salicylate (SS)-induced tinnitus in a rat animal model. Here...

pubmed.ncbi.nlm.nih.gov

Effectiveness of bimodal stimulation of the auditory-somatosensory system in the treatment of tonal tinnitus - PubMed

Our study showed that bimodal stimulation is a better intervention option compared to unimodal stimulation. Bimodal stimulation may be an effective intervention method for some subjects with tinnitus, especially people with hearing loss who have tonal tinnitus.

pubmed.ncbi.nlm.nih.gov

 

[slc]

After reading the above post, I searched for Susan Shore's publications. It turns out that Auricle is not the final outcome of her research—she continues to be actively involved in tinnitus studies.

I came across a 2024 article titled "From Hidden Hearing Loss to Supranormal Auditory Processing by Neurotrophin 3-Mediated Modulation of Inner Hair Cell Synapse Density." Dr. Shore's roles in the study included "Conceptualization, Funding Acquisition, Methodology, Supervision, and Writing – Review & Editing."

The article is quite dense, but it describes work with mice using sophisticated techniques to modulate inner hair cell synapse density. This, in turn, appears to affect the startle reflex and excessive gain in auditory processing. It seems like a very different approach from that of Auricle, although it is likely tangentially related, as they are exploring mechanisms that—if I understand correctly—could eventually help reduce tinnitus in humans.

 

[Fields]

After reading the above post, I searched for Susan Shore's publications. It turns out that Auricle is not the final outcome of her research—she continues to be actively involved in tinnitus studies.

I came across a 2024 article titled "From Hidden Hearing Loss to Supranormal Auditory Processing by Neurotrophin 3-Mediated Modulation of Inner Hair Cell Synapse Density." Dr. Shore's roles in the study included "Conceptualization, Funding Acquisition, Methodology, Supervision, and Writing – Review & Editing."

The article is quite dense, but it describes work with mice using sophisticated techniques to modulate inner hair cell synapse density. This, in turn, appears to affect the startle reflex and excessive gain in auditory processing. It seems like a very different approach from that of Auricle, although it is likely tangentially related, as they are exploring mechanisms that—if I understand correctly—could eventually help reduce tinnitus in humans.

It's interesting to read that Dr. Shore is also in some way involved in researching Neurotrophin-3. Several companies and researchers seem to be focusing on it lately, including the French company Cilcare.

 

[IYIiKe]

In academia, it is not hard to gain credit on a paper, especially if you are well-recognized and your name alone lends legitimacy and respect to a publication. I see Dr. Shore's involvement more as advisory rather than something she is deeply pursuing. Given her expertise and academic background, it is not surprising that the College of London reached out to her.

There does, however, seem to be a growing focus on cochlear synapse repair and growth as a future target for treatment. I believe Mass Eye and Ear is also exploring a similar direction. This focus is somewhat concerning, as previous trials in this area were unsuccessful. Still, who knows—maybe one of these years, we'll get lucky.

 

[slc]

In academia, it is not hard to gain credit on a paper, especially if you are well-recognized and your name alone lends legitimacy and respect to a publication. I see Dr. Shore's involvement more as advisory rather than something she is deeply pursuing. Given her expertise and academic background, it is not surprising that the College of London reached out to her.

There does, however, seem to be a growing focus on cochlear synapse repair and growth as a future target for treatment. I believe Mass Eye and Ear is also exploring a similar direction. This focus is somewhat concerning, as previous trials in this area were unsuccessful. Still, who knows—maybe one of these years, we'll get lucky.

Not to detract from your insight; you made a valid point.

Authors David Martel and Calvin Wu, two of the co-authors of From Hidden Hearing Loss to Supranormal Auditory Processing by Neurotrophin 3-Mediated Modulation of Inner Hair Cell Synapse Density, have been part of Dr. Shore's University of Michigan laboratory. David Martel is also a co-author, along with Dr. Shore, of Reversing Synchronized Brain Circuits Using Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts: A Randomized Clinical Trial. Additionally, both Martel and Wu have collaborated with her on this study.

Indeed, as you've indicated, it appears that Dr. Shore has likely been involved, probably in an advisory capacity, as you suggest. I assume she finds neurotrophin intriguing, at least in terms of its potential for understanding or perhaps even treating tinnitus.

 

[antonio77]

Tinnitus is a problem of the nervous system, making it complex and difficult to treat. Comparatively, issues like hematological, bone, or muscular problems are often easier to address. However, I believe that just as technology has enabled people with spinal cord damage (and nerve damage) to walk again without their nervous system fully healing, something similar could be developed for tinnitus.

There could be a way to confuse the brain into canceling out the signal caused by tinnitus without affecting hearing. Of course, this is purely speculative, but it seems plausible.

 

[Cyborg]

I don't want to fuel speculation, but I recently came across a domain name, auricle.fr, which appears to be linked to Auricle Inc. It was created around the end of September 2024. This caught me off guard, as they previously claimed to be focusing on the U.S. market first.

Is there any particular reason they might be connected to France?

 

[Cmspgran]

I don't want to fuel speculation, but I recently came across a domain name, auricle.fr, which appears to be linked to Auricle Inc. It was created around the end of September 2024. This caught me off guard, as they previously claimed to be focusing on the U.S. market first.

Is there any particular reason they might be connected to France?

There's zero information on the WHOIS as to who has registered it, so I wouldn't get too speculative...

 

[Gb3]

They have a domain on their LinkedIn account.

This is probably someone who bought the domain with the intention of trying to sell it later.

 

[slc]

Auricle.fr, according to WHOIS, lists IONOS SE (formerly 1&1 Internet SARL) as the registrar. Here is the WHOIS, which is available to the general public.

This is part of the WHOIS listing, but as to who registered the site, we're in the dark:

nic-hdl: UIS153-FRNIC
type: ORGANIZATION
contact: 1&1 Internet SARL
address: 1&1 Internet SARL
address: 7, place de la Gare. [looks like a generic office building.]
address: 57200 Sarreguemines
country: FR
phone: +33.970808911
fax-no: +33.387959974

nic-hdl: ANO00-FRNIC
type: PERSON
contact: Ano Nymous
registrar: IONOS SE
anonymous: YES
remarks: -------------- WARNING --------------
remarks: While the registrar knows him/her,
remarks: this person chose to restrict access
remarks: to his/her personal data. So PLEASE,
remarks: don't send emails to Ano Nymous. This
remarks: address is bogus and there is no hope
remarks: of a reply.
remarks: -------------- WARNING --------------
obsoleted: NO
eppstatus: associated
eppstatus: active
eligstatus: not identified
reachstatus: not identified
source: FRNIC

I agree with the above post. Someone purchased the domain name, perhaps to sell it later.

 

[Cyborg]

It might be, indeed. The LinkedIn user appears to be active in posts related to Susan Shore.

 

[GlennS]

2026 seems realistic.

I'd have to look back in this thread, but I'm pretty sure we've been in this position before where someone posts a prediction 1-2 years off, which just comes and goes and then lather-rinse-repeat.

This thread has become a graveyard of wishful thinking.

As far as the FDA, ultimately, I don't think the problem of this thing coming out rests in the government. It's Susan Shore's slow-walking approach. It becomes harder and harder to rationalize it as each precious year dissolves, and excuses (like COVID-19) are no longer valid.

 

[IYIiKe]

I'd have to look back in this thread, but I'm pretty sure we've been in this position before where someone posts a prediction 1-2 years off, which just comes and goes and then lather-rinse-repeat.

This thread has become a graveyard of wishful thinking.

As far as the FDA, ultimately, I don't think the problem of this thing coming out rests in the government. It's Susan Shore's slow-walking approach. It becomes harder and harder to rationalize it as each precious year dissolves, and excuses (like COVID-19) are no longer valid.

View attachment 58425

Anyone making predictions before, during, or shortly after the projected (not actual) start of the FDA submission process was already engaging in wishful thinking. Susan Shore has no involvement in the business side or the approval process. At most, she might advise on FDA comments during the back-and-forth process. Yet, the community here seems to expect a university-partnered, seed-funded startup to operate like a Fortune 500 company. The CEO has already stated that the expectations and timelines people have put forward regarding this process and the subsequent rollout were unrealistic, but that hasn't stopped the speculation.

To be blunt, while people have shared future dates in this thread, those estimates were inaccurate from the start, showing little understanding of the FDA process or how slow it is to scale from three full-time employees to a hundred. Starting a company from scratch involves tens of thousands of moving parts. Realistically, I would be surprised if this product is available anywhere outside major U.S. population centers before the end of 2026, at the earliest.

 

[cjbhab]

The CEO has already stated that the expectations and timelines people have put forward regarding this process and the subsequent rollout were unrealistic, but that hasn't stopped the speculation.

An easy way to end the speculation would be for the CEO to announce a conservative target date. What harm could that do?

When someone withholds information, it usually means the news isn't good. If it were good news, they'd likely be shouting it from the rooftops to let everyone know.

Unfortunately, I believe we are still 5 to 7 years away.

 

[Davek]

So, Susan Shore's device turned out to be a disappointment? It was all hype—very disappointing.

 

[Kam75]

Unfortunately, I believe we are still 5 to 7 years away.

Unfortunately, I agree. This aligns with what I said earlier: if 2026 is unrealistic, I don't think the device will be available in the U.S. before 2030, and likely not before 2035 in other countries.

I really hope I'm wrong because my tinnitus keeps getting worse, and I'm only 33 years old.

No medications help me sleep anymore. I live completely isolated in my room, waiting for death.

I don't know how I'll manage to survive until the device finally launches. We don't even know if it will work for non-somatic tinnitus. We don't even know if it will actually make it to market.

So many unanswered questions.

 

[IYIiKe]

So, Susan Shore's device turned out to be a disappointment? It was all hype—very disappointing.

The simple answer is usually the correct one: they have no way of knowing or predicting a specific date because the FDA certification process is arduous and unpredictable.

Think about it. Why would a CEO offer a deadline they know is unreliable? Even if they provided a conservative, arbitrary date, the same people complaining about the lack of a timeline would likely criticize it for not being fast enough.

Some individuals on this forum have even contacted the few people associated with Auricle through their private Facebook accounts to harass them about the device. Do you think the company wants to invite more of that behavior?

There's no "win" for the company in providing more information than necessary, and right now, the necessary information is none.

 

[@dam]

Let's just hope no one goes crazy on the CEO like they did with the United Healthcare CEO.

 

[Fields]

So, Susan Shore's device turned out to be a disappointment? It was all hype—very disappointing.

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

 

[Joeseph Stope]

Let's just hope no one goes crazy on the CEO like they did with the United Healthcare CEO.

I realize you were trying to introduce some humor. However, with some of the folks on here, just the odd one, mind you, I hope they do not take it the wrong way or do anything rash.

We need every tinnitus researcher to have a long and productive career.

 

[Cmspgran]

I truly believe that if Auricle cannot market it, a bigger player will step in. If it works as advertised, there is serious money to be made. If their funding model collapses, a larger company will likely swoop in. As others have mentioned, Neuromod could be a leading contender, ironic as that might be.

They are not just going to hide it away when a company is willing to offer millions for the patent.