New University of Michigan Tinnitus Discovery — Signal Timing

[BadNeighbors]

I wonder how long it will take from journal publication and FDA approval to market availability? How long does it take for Auricle to figure out to how to mass produce this device with little error? And, how long will it take Dr. Shore/her team to develop a program to train people to use the machine on us?

Also, which doctors will have priority? Will this be something that doctors in Beverly Hills get first? Will the VA doctors get priority? Will it simply be given to those ear doctors who request first? Or, will it be a lotto based system?

However, this is all based on the assumption that the device will benefit some of us. I think it is important to remember that the device might not work and it may not work for all of us. I'm hopeful, but I also don't want to pin all my hopes on this particular device. I am trying to remember that the device might not work and it might not work on me, despite being hopeful and having a bit of trust in Dr. Shore as she seems to be a legitimate scientist doing what scientists do best (slow and rigorous research).

 

[Jonno02]

I will fly to the end of the world.

My thoughts too. As soon as the (hopefully) positive feedback starts to appear on here, I'm getting on a plane.

In case anybody needs some perking up, here's some hopeful-Haiku's about the peace we may be experiencing soon.

Lenire's song incomplete
Susan Shore's device plays the tune
Tinnitus silenced soon

Lenire's sound a miss
Susan Shore's device strikes the mark
Tinnitus surrendered

Ringing ears no more
Susan Shore's device brings peace
Tinnitus conquered

We can live in hope, eh?

 

[Stayinghopeful]

I've left a space on the back of my leg for a tattoo portrait of Susan should the device be a success.

Still deciding if I want colour or go grey?

 

[JimmyStrong]

I really wish I was a guy with normal hearing and just tinnitus, because Dr. Shore's device looks promising, and this is the only thing we're going to have in the next 80+ years probably. Hopefully I will be able to accept the stigma against hearing aids and not feel insecure about them. I know we all have different life struggles, and this is my life struggle, but it hurts knowing that it could have been so easily prevented if I had just been more cautious.

Hopefully I will be able to experience silence from Dr. Shore's device and benefit from hearing aids.

 

[Nick47]

I really wish I was a guy with normal hearing and just tinnitus

"Just" ;-/

 

[Joey72]

I wonder how long it will take from journal publication and FDA approval to market availability? How long does it take for Auricle to figure out to how to mass produce this device with little error? And, how long will it take Dr. Shore/her team to develop a program to train people to use the machine on us?

Also, which doctors will have priority? Will this be something that doctors in Beverly Hills get first? Will the VA doctors get priority? Will it simply be given to those ear doctors who request first? Or, will it be a lotto based system?

However, this is all based on the assumption that the device will benefit some of us. I think it is important to remember that the device might not work and it may not work for all of us. I'm hopeful, but I also don't want to pin all my hopes on this particular device. I am trying to remember that the device might not work and it might not work on me, despite being hopeful and having a bit of trust in Dr. Shore as she seems to be a legitimate scientist doing what scientists do best (slow and rigorous research).

The VA doctors I've spoken to don't even know who Dr. Shore is. They just seem like they're way behind in research and development.

 

[Gb3]

Hopefully I will be able to accept the stigma against hearing aids and not feel insecure about them. I know we all have different life struggles, and this is my life struggle, but it hurts knowing that it could have been so easily prevented if I had just been more cautious.

I'm 40 and I wear a hearing aid. No one says anything, and who cares if they do. A lot of people wear ear wearables anyways.

 

[GregCA]

I'm 40 and I wear a hearing aid. No one says anything, and who cares if they do. A lot of people wear ear wearables anyways.

Same here. I was about the same age when I started wearing a hearing aid. It turns out that nobody notices it, actually (it's a "Behind The Ear" kind, so pretty inconspicuous). In close to 10 years, nobody has ever mentioned anything.

 

[Stayinghopeful]

I really wish I was a guy with normal hearing and just tinnitus, because Dr. Shore's device looks promising, and this is the only thing we're going to have in the next 80+ years probably. Hopefully I will be able to accept the stigma against hearing aids and not feel insecure about them.

It's 2023, the only stigma about hearing aids is the one you make up in your head. Literally no one cares if someone has hearing aids, just like no one cares if someone wears glasses.

 

[awake 44]

I've left a space on the back of my leg for a tattoo portrait of Susan should the device be a success.

Still deciding if I want colour or go grey?

I left some space on my forehead for this.

The VA doctors I've spoken to don't even know who Dr. Shore is. They just seem like they're way behind in research and development.

I've spoken with a shit ton of Doctors and Professors of Audiology. If they are not researchers themselves, they do not care about any research at all. They start to pay attention to a treatment only after it is registered as an official procedure. I'm used to being very verbally aggressive toward them. It is funny to see their "small child" mode, when they are realizing they are worthless ignorants. When I present Dr. Shore's facts and publications, they cannot find any words for defence.

 

[ColinUK]

To be fair, when I saw ENTs and audiologists, they said there was no treatment. I refused that and for years have spent countless hours trying to find solutions, but in the end, and as far as I can see, that statement is correct.

All the potential treatments we have got previously excited about have failed and so far Dr. Shore's device is just that - a potential treatment.

If it comes out and works, then I am sure ENTs and audiologists will change their advice, but I suppose expecting them to keep abreast of all the potential treatments is not realistic and also probably not healthy in giving false hope to patients.

I am sure they would love to be able to actually help us and have something to give us but, as of yet, that thing doesn't exist.

I hope Dr. Shore's device is a miracle but hope doesn't make it so.

 

[Jonno02]

I do think it's easy to confuse doctors for researchers.

I deal with surgeons a lot, some at the top of their game. They are most certainly not up to date with cutting edge or in-the-approval stage devices and technology. Specialists like ENTs only become aware of new treatments when their governing body, for example the NHS, send them on a course or they receive a bulletin for this 'new treatment we can now offer.'

It's apples and oranges. I don't expect the surgeons I talk to to be able to develop new medical devices, just as they don't expect me to be able to implant them.

 

[tiniturk]

I mean, I (kind of) don't blame ENT doctors who do not have any knowledge about Dr. Shore's device. Most of them don't have tinnitus themselves, why would they know? Yes, it's a POSSIBLE breakthrough in their field but a lot of treatments were treated as such and resulted in nothing. If the device proves to be working and it gets on the market, I'm sure they'll be the first to jump on top of it and spread it out to patients. Maybe I'm wrong, tho.

 

[ErikaS]

I think our anger towards these professionals truly comes from many of their reactions. At least that's what it was for me. I will never forget ENT #1, "I expect that hiss to go away in the next few weeks", ENT #2, "Your tinnitus should be gone in 3 months", and my favorite, a "top" Otologist in my area, "Nothing we can do, but here is some Zoloft, try to get yourself some therapy and see me in 3 months. I presume you'll be 30% better by then and 80% better in a year." They all said this based off of my "normal" audiogram up to 8 kHz. Little did they know or care to entertain my request to send me somewhere to check higher frequencies which is where the sudden hearing loss was. I know they cannot offer me a great treatment or cure, but it's the lack of empathy and/or going a step further in something that they can control or entertaining a point outside of their normal, routine boxes that could help the patient gain more insight and/or closure. Especially when your entire world just stopped and life as you know it is put on hold until further notice, and if you were like me, you worsened in the first 3-4 months as you kept being told, "Oh it will get better".

ENT #2 did agree to do shots in the right ear 4 months out to appease me, which I appreciated. But when I brought up "Susan Shore", he had no idea who she was. And that's okay, I guess, just goes to show that he or a loved one of his never had tinnitus or tinnitus bad enough to know her name. Jealous!

 

[Philip83]

@linearb, you might have talked about it before, but looking through your posts I couldn't find it; Do you have the cicada-hiss-style tinnitus sound and did this also improve during the trial? I'm curious how you would dial in the "tone" for that, as it's not really a tone.

I have pretty much no hearing/all tinnitus above 12 kHz.

 

[Watasha]

I mean, I (kind of) don't blame ENT doctors who do not have any knowledge about Dr. Shore's device. Most of them don't have tinnitus themselves, why would they know? Yes, it's a POSSIBLE breakthrough in their field but a lot of treatments were treated as such and resulted in nothing. If the device proves to be working and it gets on the market, I'm sure they'll be the first to jump on top of it and spread it out to patients. Maybe I'm wrong, tho.

I 100% agree with you what's to know for an ENT. There are hundreds of different conditions/symptoms for them to consider, why would they be spending their time studying unproven research for possible future treatments for one of the many conditions that they diagnose. I trust that when a viable treatment is available, if it's a good product (or even if it's not), sales people will be pushing these down ENTs' throats to get to market.

 

[Tomas80]

I 100% agree with you what's to know for an ENT. There are hundreds of different conditions/symptoms for them to consider, why would they be spending their time studying unproven research for possible future treatments for one of the many conditions that they diagnose. I trust that when a viable treatment is available, if it's a good product (or even if it's not), sales people will be pushing these down ENTs' throats to get to market.

Hopefully, while the FDA is reviewing the matter, Auricle will reach out to at least a few ENTs, so that for the most desperate people, the treatment is available as soon as possible. Every day is extremely difficult.

 

[DimLeb]

Hopefully, while the FDA is reviewing the matter, Auricle will reach out to at least a few ENTs, so that for the most desperate people, the treatment is available as soon as possible. Every day is extremely difficult.

I don't think that will be the case... Seeing how long every step of the process has taken already, things will move even slower to spread the device around the world. If Auricle's priority was to get the treatment to desperate people as soon as possible, then they would go for different markets like Europe, where things aren't so strict about medical devices.

 

[Jonno02]

I don't think that will be the case... Seeing how long every step of the process has taken already, things will move even slower to spread the device around the world. If Auricle's priority was to get the treatment to desperate people as soon as possible, then they would go for different markets like Europe, where things aren't so strict about medical devices.

Please don't spread mis-information. Europe's MDR are even more strict than the FDA. The FDA is just very political and prioritise American devices over RoW devices.

 

[Tomas80]

I don't think that will be the case... Seeing how long every step of the process has taken already, things will move even slower to spread the device around the world. If Auricle's priority was to get the treatment to desperate people as soon as possible, then they would go for different markets like Europe, where things aren't so strict about medical devices.

They have to start somewhere. They probably won't wait until 1,000 ENTs are ready to start all at once. Lenire also started first in its head office and gradually added doctors. It will be very similar with Auricle. They will start somewhere and gradually increase. Otherwise it would have no logic.

 

[blamingeverything]

Is the device necessarily not a direct-to-consumer thing? Sorry if this is covered previously.

 

[DebInAustralia]

Is the device necessarily not a direct-to-consumer thing? Sorry if this is covered previously.

It'll be rolled out via audiologists.

 

[DimLeb]

Please don't spread mis-information. Europe's MDR are even more strict than the FDA. The FDA is just very political and prioritise American devices over RoW devices.

I'm not really sure about the strictness of Europe's MDR, but they haven't even started the process of getting the device to Europe (as far as we know) and the 2nd trial ended years ago (2019?). If they wanted to get the device out fast, they would apply anywhere they could - meaning Europe, Asia, South Africa or whatever.

In Europe, there are already similar minimally invasive devices, like Lenire and Cleanhearing Sono, so I don't think it would be so hard to get it to the market. The device is literally a headphone that makes sound and small electrodes. The science behind it is huge (if it works), but in reality it's a really simple device.

It's starting to feel like a joke how long this device has taken to come out, given how largely unmet the need for it is.

 

[Nick47]

Is the device necessarily not a direct-to-consumer thing? Sorry if this is covered previously.

@blamingeverything, I think Dr. Shore was asked this and she said it would probably be distributed through audiologists and medical professionals first.

 

[Jonno02]

I'm not really sure about the strictness of Europe's MDR, but they haven't even started the process of getting the device to Europe (as far as we know) and the 2nd trial ended years ago (2019?). If they wanted to get the device out fast, they would apply anywhere they could - meaning Europe, Asia, South Africa or whatever.

I don't think they have the resources to do multiple submissions at once though. Wish they did, but that's probably the limiting factor.

 

[AnthonyMcDonald]

I don't think they have the resources to do multiple submissions at once though. Wish they did, but that's probably the limiting factor.

I'm sure they will be able to send them by mail and set up with telehealth. If not, I'm ready to bring them to Europe, I'm sure it's legal to do so.

 

[Nick47]

I'm sure they will be able to send them by mail and set up with telehealth. If not, I'm ready to bring them to Europe, I'm sure it's legal to do so.

I'm not sure, but maybe he meant financial resources i.e. for approval and accreditation for different governing bodies around the world?

Seems like it has been a long time since the Palm Springs Hearing Seminar. Where is the publication?

 

[gameover]

There is another company called Auricle - https://auricle.com/ - working on some implant. At least they have a webpage.

Dr. Shore's Auricle - https://auricleinc.com/ - can't even put up anything under that address. It really feels like some fringe, underfunded, over-researched, underdeveloped, hack.

 

[Utdmad89]

Dr. Shore's Auricle - https://auricleinc.com/ - can't even put up anything under that address. It really feels like some fringe, underfunded, over-researched, underdeveloped, hack.

Well, this hack is the only promising treatment at this point. Calm down and wait for the results to be published.

 

[BTaylor12]

There is another company called Auricle - https://auricle.com/ - working on some implant. At least they have a webpage.

Dr. Shore's Auricle - https://auricleinc.com/ - can't even put up anything under that address. It really feels like some fringe, underfunded, over-researched, underdeveloped, hack.

It would be so easy for them to raise start-up capital, which they need. But instead they're being very quiet and laying low. They should be using a number of different avenues to be raking in cash right now, so once approved, they hit the ground with feet running.

Only reason I could see for not actively raising capital is if they feel it may not get approval.