New University of Michigan Tinnitus Discovery — Signal Timing

[ploughna]

I wouldn't be surprised if Auricle were leveraging the expertise of their development/manufacturing partner who also provides FDA approval support, in2being. It would make sense for Auricle to use in2being given their familiarity with the details of the device and experience with the process through their regulatory team.

 

[AnthonyMcDonald]

I wouldn't be surprised if Auricle were leveraging the expertise of their development/manufacturing partner who also provides FDA approval support, in2being. It would make sense for Auricle to use in2being given their familiarity with the details of the device and experience with the process through their regulatory team.

in2being is based in Michigan, though. Auricle is based in the Bay Area. There are plenty of large-scale medical device manufacturers there.

 

[RebelScum]

in2being is based in Michigan, though. Auricle is based in the Bay Area. There are plenty of large-scale medical device manufacturers there.

While that may be true, we do know that in2being made the devices used in the clinical trials.

On the linked website, it also says:

With the U-M tinnitus team, we provided the following services:

• Mechanical, electrical, and software design: Our team designed a next-generation tinnitus treatment device, producing detailed mechanical and electrical plans and a software operating system.
• Prototyping: In our laboratories, we built the designs into working prototypes that the client used in successful first-in-human clinical trials.
• QSR compliance: As part of the design process, we implemented design controls following the Food and Drug Administration's (FDA's) quality system regulation (QSR) and carried out verification and validation testing on the device.
• Regulatory guidance: As we do with every client, we advised the U-M team regarding potential regulatory pathways they could pursue to legally market the new device.
• Additional services: We provided project and vendor management and advised the client on start-up formation and fundraising.

That is possibly what @ploughna was referring to.

 

[Calapsodis]

Personally, I don't really mind what it's called. Even if it's "Susan Shore's Super Duper Tinnitus Remover," I'm still buying it.

 

[ErikaS]

I posted this before in this thread a ways back, but it understandably gets lost, and those who didn't see it don't know.

I called the FDA in the summer of 2023 twice. One call was with a woman, and the other was with a man. Both told me that no one at the FDA can disclose if/when a device, drug, etc., has been submitted for FDA approval. All they can tell you is if something has been approved. So, I wouldn't look too far into that above email response and whether the submission has happened or not. Because, like I said, two different people told me it's very much against their protocol to release that information.

 

[Ferna]

Would Auricle have submitted the device for FDA approval very soon after the trial was completed? Also, do people think the device can help hyperacusis?

 

[AnthonyMcDonald]

Would Auricle have submitted the device for FDA approval very soon after the trial was completed? Also, do people think the device can help hyperacusis?

Prepping for FDA submission can take a while. While there is no official confirmation, some DIY folk have said it had decreased their loudness hyperacusis.

 

[Ferna]

Prepping for FDA submission can take a while. While there is no official confirmation, some DIY folk have said it had decreased their loudness hyperacusis.

Dr. Shore's device could help with hyperacusis since the pathways share circuits and neurological processes. Also, when you think about it from a very bare, logical perspective, things that usually share high rates of occurrence can often be treated similarly. Depression and anxiety have difficult mechanisms, but they can be treated with the same medication/therapy, etc. since they are quite similar in certain ways.

Not to mention that something like 80%+ of people with hyperacusis have tinnitus in some form. My pain hyperacusis started about a month after I got tinnitus.

 

[IYIiKe]

Dr. Shore's device could help with hyperacusis since the pathways share circuits and neurological processes. Also, when you think about it from a very bare, logical perspective, things that usually share high rates of occurrence can often be treated similarly. Depression and anxiety have difficult mechanisms, but they can be treated with the same medication/therapy, etc. since they are quite similar in certain ways.

Not to mention that something like 80%+ of people with hyperacusis have tinnitus in some form. My pain hyperacusis started about a month after I got tinnitus.

I would just temper any expectations here. Dr. Shore herself said there should be no anticipation that the device can assist with hyperacusis as there are different mechanisms at play, as per her most recent video (it was a community-asked question).

While they might share some channels, Dr. Shore was pretty adamant that this treatment would not work for hyperacusis.

 

[AnthonyMcDonald]

I would just temper any expectations here. Dr. Shore herself said there should be no anticipation that the device can assist with hyperacusis as there are different mechanisms at play, as per her most recent video (it was a community-asked question).

While they might share some channels, Dr. Shore was pretty adamant that this treatment would not work for hyperacusis.

I don't remember Dr. Shore mentioning anywhere that it won't work for hyperacusis. Just like with the other questions (reactive tinnitus, etc.), she said something along the lines of "we haven't researched this," etc.

The patent also mentions that it could work for other conditions.

 

[Anuar Lukios]

For me, @AnthonyMcDonald remains one of the most rational people on Tinnitus Talk, even if his manners are sometimes a bit rough.

I fully understand the anxiety and frustration of the more severe cases, who have all my support, but let's try not to be repetitive, pessimistic, and conspiratorial.

I don't believe there is a logical reason for Dr. Shore to abandon everything after 20 years of studies and research. It's obvious that it's only a matter of time now, especially since the trials have also concluded.

It's already a huge achievement that we can use the device with peace of mind without the fear of it making things worse.

Of course, there remains the question: Will it work for me? If it works, how much will I improve? But let's leave these questions for the future.

We've been repeating the same things for months now.

 

[slc]

I can't be the only one outside of America who is thinking it's fucking years away for us. Our options are knock-offs or flying to America. If the device is provided through audiologists, a flight is a waste of time with no permanent US address, registration, etc.

Not necessarily a waste of time. The American medical system is a patchwork of for-profit and non-profit institutions, all strangled by an insane insurance system. That being said, you can pretty much make an appointment with an audiologist and pay out of pocket for hearing aids, for example. I would guess that Auricle would be similar. Distance is a big problem if the devices need to be adjusted unless they can be adjusted online.

 

[IYIiKe]

I don't remember Dr. Shore mentioning anywhere that it won't work for hyperacusis. Just like with the other questions (reactive tinnitus, etc.), she said something along the lines of "we haven't researched this," etc.

The patent also mentions that it could work for other conditions.

I think Dr. Shore was asked, "Could this work for hyperacusis?" and she responded that there are completely different mechanisms at play in hyperacusis than in tinnitus.

So, while the patent or other things might say the device might have alternative uses, it would be like clinging on to her saying that she didn't say they didn't test toothpaste as a cure for hyperacusis in the same way.

 

[Ferna]

Different mechanisms may be at play, but that doesn't mean those mechanisms are entirely separate or don't affect each other. Desensitizing the synapses responsible for tinnitus may also have a knock-on effect on hyperacusis. Everyone I know with some form of hyperacusis also has tinnitus; my hyperacusis occurred after I got tinnitus. The tinnitus-generating synapses perhaps have some connection with the hyperacusis network. When my ear pain is terrible, my tinnitus usually reacts to that. They can affect each other.

 

[tiniturk]

Honestly, in my humble opinion, we should nuke this whole thread until we get a significant update on the matter. I completely understand that people are wondering where the device is after such a long time, but the fact is that NO ONE HERE KNOWS. There is no point in wondering. Zero. I am a big supporter of acting like this device (and the development of it) does not exist. I'm sure there's light at the end of the tunnel, though.

 

[IYIiKe]

It's fair for people affected by tinnitus to be upset about the slow progress in research and treatment.

However, it's important to remind everyone that there is hope -- and more progress has been made in the past 20 years than in the previous 2000. It's reasonable to suggest that improvements in understanding will lead to better treatments. However, we must also acknowledge that tinnitus, especially in severe cases, represents a smaller subset of the population, which may not attract as much research talent and funding.

My opinion on responding here has fluctuated over time. I usually comment when I hear things that might promote false hope or are too aggressive because false hope has negatively impacted me regarding tinnitus. Misguided anger can lead to further hopelessness. When complaints turn into misdirected anger, I try to address it. Many people come here and don't post at all. While some might share the sentiment of "I hate that it's taking so long," extreme comments like "THE DEVICE IS A FAILURE BECAUSE I DON'T HAVE IT NOW OMG BURN IT ALL DOWN I HATE LIFE" can be harmful to those already struggling psychologically.

I choose to counter that sentiment with a cautiously optimistic yet realistic approach to timelines and outcomes.

For the past thirty years, the "gold standard" has been akin to telling someone without a limb or with chronic pain to "get used to it" or "think differently" about it or to bombard their ears with noise to counter the phantom sound. Any tangible option from a respected researcher is obviously wanted as soon as possible. According to some studies, it's also considered no better than a placebo.

There's also a video of the leader of TRT implying that people who don't get better from it are essentially bad people or malingerers. Depending on where you live, before you're even offered this expensive treatment (typically not covered by insurance), you might have to go through ineffective steroid treatments, countless useless exams, and potentially procedures that only deplete your bank account, resolve, and quality of relationships with loved ones. It's exhausting being your own advocate when most doctors admit they have no idea how to help you. We need to cut them some slack -- no one truly knows what's going on, and emerging research will likely take another 50 years to start helping the way most of us expect for other conditions.

Coupled with significant anxiety and distress from tinnitus, the recourse may involve medications with severe side effects, leading to desperation. I understand why people post here and vent their frustrations. I understand why they are upset with their healthcare systems and doctors.

This is the perfect place for that to happen instead of at home or work, as long as the dialogue remains constructive.

As a relatively recent sufferer, I can only imagine the frustration of seeing trials and research stall when the science and devices already exist but are delayed by business decisions. It's infuriating, but there's little anyone here can do about how the world works. Pretending that large pharmaceutical companies can be swayed to move faster is unrealistic.

There's reason to have hope. Yes, progress is slow. No, there's not much anyone can do to speed it up. Yes, it's frustrating not to get weekly updates, but that's standard business practice. The research is groundbreaking. It might not help everyone, but I don't see anything better coming in the near future for which to be hopeful.

 

[Muggumbo]

I think it's perfectly acceptable to yell and complain about Auricle taking so long. Still, it makes no logical sense to make inferences about the device's effectiveness based on them being slow.

 

[RebelScum]

I think it's perfectly acceptable to yell and complain about Auricle taking so long.

While you certainly can, what is the benefit of doing so here, where nobody can actually do anything about it? Just venting?

 

[Calapsodis]

While you certainly can, what is the benefit of doing so here, where nobody can actually do anything about it? Just venting?

Well, it is a support forum.

 

[Bart]

I don't mean to be a party pooper in any way, but it seems as if this device is again considered as some holy grail.

My audiologist and I are pretty skeptical; similar devices and research have been tried before with subpar results, and Auricle's complete media silence and updates are not boding well.

Regardless, I hope it works, but how many more years do we need to wait?

 

[Muggumbo]

While you certainly can, what is the benefit of doing so here, where nobody can actually do anything about it? Just venting?

Many see this device as their best bet and are frustrated at the lengthy process. It's only natural for people to voice their frustrations. Either way, we're stuck waiting till the whole process is completed.

My only concern is that people keep equating the company's ability to get the product approved and shipped with how effective the device will be. These two things have nothing to do with each other.

 

[IYIiKe]

I think it's perfectly acceptable to yell and complain about Auricle taking so long. Still, it makes no logical sense to make inferences about the device's effectiveness based on them being slow.

While you certainly can, what is the benefit of doing so here, where nobody can actually do anything about it? Just venting?

This is my sentiment. The only reason people are upset is because of the initial timeline provided that, to anyone's knowledge, may not even have been missed. Otherwise, as pointed out by folks with knowledge of FDA certification -- things are going about as fast as they go. There is also the expectation that the device will be given the Rolls Royce treatment for rollout. You're looking at a partnership with a university that is obviously concerned with intellectual property rolling out a commercial product (something they rarely do.) Sure, they've gotten help, but it's not like Auricle is Johnson & Johnson. Timelines are different than a purely commercial interest. I understand it may be venting for some folks, which is fine -- but from my personal experience, when I get pissed, it just amps up and comes out in other parts of my life. Worse, folks here hoping to find glimmers of hope or discussing the potential positives see folks poo-pooing the companies involved and some outright claiming the device won't/doesn't work. Some even try contacting involved people on LinkedIn/Facebook to get updates, which Tinnitus Talk should honestly moderate and discourage.

 

[Fightthearmy]

For the past thirty years, the "gold standard" has been akin to telling someone without a limb or with chronic pain to "get used to it" or "think differently" about it or to bombard their ears with noise to counter the phantom sound. Any tangible option from a respected researcher is obviously wanted as soon as possible. According to some studies, it's also considered no better than a placebo.

I suppose you mean bombarding their ears with noise to counter the phantom sound, which is considered no better than a placebo because the parsing of your text doesn't correspond to that.

There's also a video of the leader of TRT implying that people who don't get better from it are essentially bad people or malingerers. Depending on where you live, before you're even offered this expensive treatment (typically not covered by insurance), you might have to go through ineffective steroid treatments, countless useless exams, and potentially procedures that only deplete your bank account, resolve, and quality of relationships with loved ones. It's exhausting being your own advocate when most doctors admit they have no idea how to help you. We need to cut them some slack -- no one truly knows what's going on, and emerging research will likely take another 50 years to start helping the way most of us expect for other conditions.

As objectionable as I find TRT, Jastreboff has never said that. To his credit, he also advocates CBT, which is considered at least marginally effective, unlike TRT.

 

[Ferna]

I don't mean to be a party pooper in any way, but it seems as if this device is again considered as some holy grail.

My audiologist and I are pretty skeptical; similar devices and research have been tried before with subpar results, and Auricle's complete media silence and updates are not boding well.

Regardless, I hope it works, but how many more years do we need to wait?

I understand the skepticism since, so far, nothing has really done much to help.

However, compared to other treatments like this, It is grounded in 'basic science' and actually has a relatively high-quality set of studies to back it up. The radio silence is probably out of respect for the FDA submission process and her reputation as a scientist.

 

[IYIiKe]

I suppose you mean bombarding their ears with noise to counter the phantom sound, which is considered no better than a placebo because the parsing of your text doesn't correspond to that.

As objectionable as I find TRT, Jastreboff has never said that. To his credit, he also advocates CBT, which is considered at least marginally effective, unlike TRT.

He does here at 6 minutes. There is a presumption that you're a malefactor or have an ulterior motive if his nonsense treatment doesn't work.

 

[Dkellz]

I understand your sentiments here & I also support rationality; however, there are 212 pages here of repetition. I do not in any way discourage anyone here from speaking their mind - or pushing for answers. In nearly all 212 pages here, you will find a question of hope, a frustration, a push - the quest for some truth or direction from an extremely sensitive and scared group of unsupported people. Regardless of how 'severe' your tinnitus is, you are absolutely within your right to search for an answer.

This thread is on a tinnitus forum, and with Auricle's extreme silence and secrecy, it is quite literally the only resource for the Michigan Device on the planet—Auricle has no website, social media, communications, press releases, public relations, or visible brand strategy; silence here is deafening. So please continue your repetition if it makes you feel better. If reaching out for answers helps you in the wait, then continue to do so. Speak your mind.

 

[Bart]

I understand the skepticism since, so far, nothing has really done much to help.

However, compared to other treatments like this, It is grounded in 'basic science' and actually has a relatively high-quality set of studies to back it up. The radio silence is probably out of respect for the FDA submission process and her reputation as a scientist.

I certainly hope so.

I am talking about the media silence regarding the fact that no professional has ever heard about this so-called device or Susan Shore in general, at least here in Belgium.

My audiologist asked me to link her to Susan Shore's research. She was not convinced about this "groundbreaking science." She talked about Lenire, which took a similar approach and was a complete failure. The same is true for brain stimulation: There are many expectations but very little to show for it.

But it might be a step in the right direction nonetheless.

 

[MiaVIL]

I certainly hope so.

I am talking about the media silence regarding the fact that no professional has ever heard about this so-called device or Susan Shore in general, at least here in Belgium.

My audiologist asked me to link her to Susan Shore's research. She was not convinced about this "groundbreaking science." She talked about Lenire, which took a similar approach and was a complete failure. The same is true for brain stimulation: There are many expectations but very little to show for it.

But it might be a step in the right direction nonetheless.

Lenire and Dr. Shore's device are two totally different treatments. The studies were done very differently as well.

 

[annV]

I am talking about the media silence regarding the fact that no professional has ever heard about this so-called device or Susan Shore in general, at least here in Belgium.

My audiologist asked me to link her to Susan Shore's research. She was not convinced about this "groundbreaking science." She talked about Lenire, which took a similar approach and was a complete failure. The same is true for brain stimulation: There are many expectations but very little to show for it.

Honestly that tells more about your audiologist than anything else. Your audiologist is happy dispensing 6000 EUR/USD hearing aids and 3000 EUR/USD white noise generators. If she was curious about tinnitus research and wanted to stay up to date, she would know about Susan Shore.

The fact that your audiologist compares the ScumScamLenire with Susan Shore's device is enough evidence to consider your audiologist irrelevant, and hopefully eventually AI will replace her.

 

[Nick47]

hopefully eventually AI will replace her.

Yes, Ann. Lol...