New University of Michigan Tinnitus Discovery — Signal Timing

[MiaVIL]

Oh, so the device treats each ear individually? That's not good news for people with hearing loss like me. I was hoping my hearing ear would be enough.

Dr. Shore talks about this in her Q&A here. All you really need is one good ear to hear the stimuli.

 

[dj_newark]

Hiding the most important information such as when will the device be available and when are they going to submit for FDA approval is a huge red flag.

It's completely standard for medical and medical device companies not to discuss FDA approval or device availability before release. Stop being paranoid.

 

[IYIiKe]

All causes of hearing loss lead to the same pathological changes causing tinnitus, i.e., noise, Aspirin, Cisplatin, and infections.

Wasn't there a caveat that if the method of action damaged the greater CNS, then that might be a different/more difficult subtype?

 

[kingsfan]

Oh, so the device treats each ear individually? That's not good news for people with hearing loss like me. I was hoping my hearing ear would be enough.

Her tinnitus resolved (not sure if entirely, but it got better) in both ears after treating just one.

 

[marqualler]

Wasn't there a caveat that if the method of action damaged the greater CNS, then that might be a different/more difficult subtype?

It sounded like Dr. Shore didn't 100% know the answer to whether or not that would matter. Still, she was (similarly to her other Q&As) very confident that the actual mechanism of targeting the dorsal cochlear nerve with stimulation + audio stimulation resulted in a change in the actual tinnitus activity. I'm sure I paraphrase the actual science, but this was my takeaway. It did not seem that different subtypes/methods of tinnitus inducement mattered much to the actual treatment. All guinea pigs in the animal study were induced by noise and had the same overall trajectory.

 

[Bob3382]

I agree. It was a great webinar. She did a great job walking through the mechanism of the studies and explaining specifically why they are targeting the nerve they are targeting. I'm really glad I got to watch it. I can't remember the specific questions that were asked, and a lot of them were sort of already answered in the Tinnitus Hub Q&A (which got a shoutout in HHF's wrap-up email), but there was an interesting anecdote she shared about an audiologist who got to "try" the device herself with tinnitus in both ears and after using it and targeting only one ear with the treatment, her tinnitus resolved (not sure if entirely but got better) in both ears.

I'm curious to see if @Hazel has seen any discussion, formal or informal, about Susan Shore's research / the device itself at the TRI 2024.

Just the fact that Dr. Shore shared an anecdote about the device is telling to me. She would probably not be giving anecdotes if they had decided to abandon FDA approval, marketing, distribution, etc.

Admittedly, I am new to this discussion. I have had tinnitus only about three months, but what it has done to me, emotionally and physically, has been so devastating that I am sure thousands are going to jump on it the moment it is introduced. I have tried sound therapy, and like she said, it does not seem to make any difference at all. I've changed my diet and added some vitamin supplements such as Zinc, B12, and Magnesium. But no changes.

There are so many hawkers out there it is hard to wade through them.

After spending 20 years in the scientific community, Dr. Shore published two studies, which appear to meet the criteria for validity; she does not seem to be a hawker like Jastreboff, or whatever his name is.

 

[Dkellz]

This all sounds great, but it's troubling that the device that helped completely 'resolve' an ENT's tinnitus is sitting on a shelf somewhere, gathering dust.

As stated before, the trials began a decade ago; the device still uses the same software and hardware as it did back then (correct me if I'm wrong).

There are people here with catastrophic levels of tinnitus. It seems politics and money are keeping this device from being launched, which will be difficult for people to understand, especially given the lack of open communication from anyone in Auricle about the next steps.

I agree with the user @MiaVIL; there are absolutely red flags here.

 

[dd314]

The more I learn about this device, the more optimistic I get that it does actually work.

The only thing I'm still apprehensive about is the tone matching. Many people here have crazy broadband sounds that would be challenging to match correctly. Personally, I've had sounds that are like if you put diamonds, glitter and live cicadas into a blender.

 

[Cmspgran]

The only thing I'm still apprehensive about is the tone matching. Many people here have crazy broadband sounds that would be challenging to match correctly. Personally, I've had sounds that are like if you put diamonds, glitter and live cicadas into a blender.

It was @linearb, who was in the original trial, who said it was just a wide-band tone and all of his tinnitus tones lowered in volume synchronously.

From everything I've read, I don't think it's going to be a case of trying to match the perfect tinnitus tone. It'll either be a wide-band noise for those with multiple-pitched tones or a narrow-band noise for those with one or two tones in a similar frequency range.

 

[Muggumbo]

The only thing I'm still apprehensive about is the tone matching. Many people here have crazy broadband sounds that would be challenging to match correctly. Personally, I've had sounds that are like if you put diamonds, glitter and live cicadas into a blender.

I understand that they just need to get it in the same ballpark. I think it was also mentioned that some people in the trial had more than one tone.

Hell, there's no way they could have the guinea pigs tell them what their tinnitus sounded like.

 

[Nick47]

The only thing I'm still apprehensive about is the tone matching

Did they match the tones to what the animals heard?

 

[prowlinacage]

I'm still blown away that Dr. Shore shared information outside of the trial data—that an audiologist with tinnitus tried the device, and it worked for them.

 

[RunningMan]

The only thing I'm still apprehensive about is the tone matching. Many people here have crazy broadband sounds that would be challenging to match correctly. Personally, I've had sounds that are like if you put diamonds, glitter and live cicadas into a blender.

This was addressed in the Q&A:

 

[Hazel]

I agree. It was a great webinar. She did a great job walking through the mechanism of the studies and explaining specifically why they are targeting the nerve they are targeting. I'm really glad I got to watch it. I can't remember the specific questions that were asked, and a lot of them were sort of already answered in the Tinnitus Hub Q&A (which got a shoutout in HHF's wrap-up email), but there was an interesting anecdote she shared about an audiologist who got to "try" the device herself with tinnitus in both ears and after using it and targeting only one ear with the treatment, her tinnitus resolved (not sure if entirely but got better) in both ears.

I'm curious to see if @Hazel has seen any discussion, formal or informal, about Susan Shore's research / the device itself at the TRI 2024.

As you will all have probably guessed, no one from Auricle was present at the TRI conference in Vancouver. This is clearly part of their continued radio silence on the topic of coming to market.

There were some oblique references to her work in other presentations on bimodal stimulation, among others by Sven Vanneste, who is also working on a somewhat similar (?) device, but nothing much otherwise. These people all have their own areas of interest and aren't necessarily holding their breath until there's actually something new to discuss.

Lenire was heavily promoted at the conference, with some audiologists presenting results from their clinic, which seemed strangely much more positive than the experiences I tend to hear of...

 

[Nick47]

These people all have their own areas of interest and aren't necessarily holding their breath until there's actually something new to discuss.

So still no collaboration then?

 

[AverageJoe12]

As you will all have probably guessed, no one from Auricle was present at the TRI conference in Vancouver. This is clearly part of their continued radio silence on the topic of coming to market.

There were some oblique references to her work in other presentations on bimodal stimulation, among others by Sven Vanneste, who is also working on a somewhat similar (?) device, but nothing much otherwise. These people all have their own areas of interest and aren't necessarily holding their breath until there's actually something new to discuss.

Lenire was heavily promoted at the conference, with some audiologists presenting results from their clinic, which seemed strangely much more positive than the experiences I tend to hear of...

Thanks so much @Hazel. Were there any interesting/compelling presentations on hyperacusis?

 

[Nick47]

Thanks so much @Hazel. Were there any interesting/compelling presentations on hyperacusis?

There's a separate thread on TRI2024:

→ Tinnitus Research Initiative (TRI) 2024 Conference

 

[SarahMLFlemmer]

I'm still blown away that Dr. Shore shared information outside of the trial data—that an audiologist with tinnitus tried the device, and it worked for them.

Where did you hear this?

 

[RunningMan]

Where did you hear this?

That's from the webinar, in response to the question regarding having a different frequency of tinnitus in each ear and only treating one ear. She mentioned an audiologist who treated one ear and that it removed or reduced the tinnitus in the other ear, too. But she said she didn't know about another frequency and that it would need to be investigated.

 

[Nick47]

Where did you hear this?

The webinar was actually really interesting. It explained things I was not aware of like dendrites that come off the fusiform cells and link to the somatosensory nerves and auditory nerves.

She differentiated her device from other bimodal devices, calling it bisensory, with the key being the timing between electrical stimulation and sound.

 

[Daphne91]

Guys, it's coming home as the Brits would say

 

[Nick47]

Guys, it's coming home as the Brits would say

"Everyone seems to know the score; they've seen it all before..."

 

[Utdmad89]

Guys, it's coming home as the Brits would say

I think it's only the English that say this.

 

[BadNeighbors]

It seems politics and money are keeping this device from being launched, which will be difficult for people to understand, especially given the lack of open communication from anyone in Auricle about the next steps.

Who is benefitting from the device not being released? Big Audiology doesn't want Auricle to succeed because they'll have too many customers. The US government likes paying over a billion in disability checks to veterans because no politician can think of any pork spending they'd rather spend that billion on. Team Blue and Team Red somehow benefit from veterans, blue-collar workers, musicians, and the rest of us dealing with this horrible affliction.

We all benefit from the FDA vetting drugs and medical devices. It sucks that the department could use another 1,000 scientists to move things along much faster, but this is what we have.

I hate that my ears screech at me all day long, but I prefer to be protected from grifters. We didn't experience the thalidomide disaster that Europe did because of the FDA. We've also been protected from countless worthless or harmful drugs over the years. The FDA isn't perfect, but it is a million times better than I could do. I don't have the medical training to thoroughly vet a medical study. And, even if I did, I can't keep a clear perspective when it is something so close to me and something I so desperately want to work on.

Also, without the FDA vetting things, it might reduce the incentive for real scientists to do solid research. Why do things correctly when your voice will be drowned out by 1,000 grifters selling to desperate people? Why invest in a drug/research when you can invest in a catchy sales pitch instead?

The University of Michigan developed MRIs, and after a few years, they rolled them out to the world. I'm hoping this doesn't take a few years to roll out, but I'm hopeful that U of Michigan, Dr. Shore, and Auricle can build a solid company and get this rolled out to audiologists worldwide.

I worry about its effectiveness on my tinnitus, but I have little worry about conspiracies preventing this from coming to market. We have to remember that Dr. Shore has always moved slowly and cautiously, and sadly, going from university testing machine to consumer product takes time.

 

[SarahMLFlemmer]

The webinar was actually really interesting. It explained things I was not aware of like dendrites that come off the fusiform cells and link to the somatosensory nerves and auditory nerves.

She differentiated her device from other bimodal devices, calling it bisensory, with the key being the timing between electrical stimulation and sound.

I was at the webinar, too, but I don't remember if she said it diminished the person's tinnitus or lowered it...

 

[InNeedOfHelp]

I still cannot understand why people are supporting the slow-paced release and the strategy of Auricle trying to launch the device themselves. Plenty of pharmaceuticals are approved within six months of finishing their Phase 3 trials. Consider the pain medication Suzetrigine (VX-548), which just completed its FDA submission five months after publishing Phase 3 results. Auricle selling the device's rights to big pharma would have been far more efficient. This is what happens with the majority of new molecules anyway. Companies like Pfizer, MSD, AstraZeneca, and Abbott hardly do any R&D themselves; they acquire startups.

Oh, and let's not forget Auricle stated that the US will be their target market, not Europe, Australia, etc. It will probably take several years to be able to get this device outside of the US.

 

[ajc]

I still cannot understand why people are supporting the slow-paced release and the strategy of Auricle trying to launch the device themselves. Plenty of pharmaceuticals are approved within six months of finishing their Phase 3 trials. Consider the pain medication Suzetrigine (VX-548), which just completed its FDA submission five months after publishing Phase 3 results. Auricle selling the device's rights to big pharma would have been far more efficient. This is what happens with the majority of new molecules anyway. Companies like Pfizer, MSD, AstraZeneca, and Abbott hardly do any R&D themselves; they acquire startups.

It's easy to be an armchair critic.

You don't know if Auricle has tried reaching out to big pharma. Maybe big pharma wasn't impressed enough, or for whatever else reason didn't want to touch it.

You don't know if big pharma has tried to reach out to Auricle. Maybe Auricle wasn't interested. Maybe the money offered was too little.

Maybe UMich's involvement with funding the work limits Auricle's options to sell the rights.

Maybe Auricle prefers to do it by themselves, maybe they have a vision where selling out doesn't meet their goals.

Since you seem to know better though, maybe you should offer Auricle your highly valuable insights that they must not have thought about before... Try to get a job there!

 

[Calapsodis]

I still cannot understand why people are supporting the slow-paced release and the strategy of Auricle trying to launch the device themselves.

Despite the device taking longer than we'd all like to come to market, I think we'd rather it get there methodically and safely instead of being rushed without a second thought. Plus, it's essentially the closest treatment option we have to look forward to right now, minus a few other ventures. Lenire was significantly less successful than anticipated. The Auricle device has the science and minds behind it. I understand the frustration - believe me - but I doubt that they're taking their sweet time for no good reason.

 

[Bhaveen]

I still cannot understand why people are supporting the slow-paced release and the strategy of Auricle trying to launch the device themselves. Plenty of pharmaceuticals are approved within six months of finishing their Phase 3 trials. Consider the pain medication Suzetrigine (VX-548), which just completed its FDA submission five months after publishing Phase 3 results. Auricle selling the device's rights to big pharma would have been far more efficient. This is what happens with the majority of new molecules anyway. Companies like Pfizer, MSD, AstraZeneca, and Abbott hardly do any R&D themselves; they acquire startups.

I assume that Dr. Shore wants to make the device as affordable as possible. If big pharma were involved, they would want to make it as expensive as possible to maximize their profits, which none of us want. I think we can only criticize Auricle if they receive FDA approval but then the rollout is super slow, as that is something they have some control over.

 

[withintention]

During the webinar, Dr. Shore shared that a 7-ms delay between the somatic and electrical stimulus would excite the neurons, whereas a 10-ms delay would depress them (depressing is what you want for tinnitus). I'm not sure I have those numbers exactly right, but they were in that range.

I was amazed at how just a little difference in timing could result in the exact opposite effect as intended. I can see why a device like Lenire might not have managed to get that timing exactly right. It gave me a lot more faith that the Auricle team has something that could work a lot better than Lenire seems to!