New University of Michigan Tinnitus Discovery — Signal Timing

I read in the Q and A that Dr. Shore could only attribute one case of worsening "possibly" to the treatment... I think in the other cases other stuff had happened.
Most of us here know pretty well that shit can go downhill on their own without any cause/reason, when you are just chilling around. And then try to investigate why, suspecting whatever happened to you the last few days. So, yeah...
 
I meant "available to us." Both doctors have ongoing trials at present. Of course, that is speculation on my part.
Yes, you are right. 3-6 years until it is available to us. They have made the chips and will be doing animal trials very soon, followed by human trials and becoming available to the public. And the best thing about it is they have experimented it on humans already so they know it works.

This is a conversation for another thread as it's not about Dr. Shore's device.

MOD NOTE: Further off-topic posts will be removed. Please continue in the relevant threads.
 
Does anyone work in device manufacturing? If so, for a device similar to this, what would the timeline from working prototype to mass production to distribution look like? Are there a ton of manufacturers waiting for contracts to develop stuff like this or is there a long waiting list? How can Dr. Shore (and her investors) be sure that a potential manufacturer is actually qualified to develop the device? I imagine a device like this must have a rather low tolerance for error. The tone probably has to be near perfect each time, the timing needs to be near perfect, and the strength of the shock would need to be near perfect as well, right?

Does anyone know how the devices in the trials were created? How are these prototype devices made for academics who might be smart, but aren't trained computer engineers?

I also wonder how long it will take to train all the audiologists to use the device. I wonder if this will be easy for them and will be just like any other tool they have in the clinic or if there will be a steep learning curve, which would create opportunities for mistakes.
 
Does anyone work in device manufacturing? If so, for a device similar to this, what would the timeline from working prototype to mass production to distribution look like?
Yes. Depends on what you're talking about. Prototype to mass production as a straight line or mass production after regulatory approval. Both can be answered with "how long is a piece of string." If you have contact-manufacturer agreements in place (including activities like mutual confidentiality agreements, supplier agreements, supplier audits complete etc) then it can be very swift. If you don't... well, each action will add on time.
Are there a ton of manufacturers waiting for contracts to develop stuff like this or is there a long waiting list? How can Dr. Shore (and her investors) be sure that a potential manufacturer is actually qualified to develop the device?
Yes, contract manufactures are extremely common. They're not developing anything, they're given a schematic and parts (or are included in the supply chain from specific suppliers chosen and approved by Auricle) and will assemble for a fee. Approval of a site like this will be done through supplier audits, questionnaires, ISO accreditation, current client list etc.
I imagine a device like this must have a rather low tolerance for error. The tone probably has to be near perfect each time, the timing needs to be near perfect, and the strength of the shock would need to be near perfect as well, right?
I'm sure Dr. Shore herself has said that the tone matching needs to be fairly close, but not perfect. Generating a specific Hz frequency with a fairly tight tolerance is not difficult. There are phone apps that can do this easily. Tone generation and timing, shock strength etc. will all be given an acceptable tolerance for the respective parts. How tight that tolerance is is up to Auricle. I imagine that whatever specifications the components that made their study devices are, is what they'll specify as the minimum acceptable +/- tolerance for manufacturing.
Does anyone know how the devices in the trials were created? How are these prototype devices made for academics who might be smart, but aren't trained computer engineers?
Can't speak for UoM, but when we have custom software developed, we work with a contract vendor that designs us our own software packages based on our user requirement specifications. This is not a difficult thing at all.
I also wonder how long it will take to train all the audiologists to use the device. I wonder if this will be easy for them and will be just like any other tool they have in the clinic or if there will be a steep learning curve, which would create opportunities for mistakes.
To my untrained eye, this device looks extremely simplistic. Don't take that the wrong way. Simplistic as in manufacturing and operation, but a very difficult thing to scientifically reach i.e. the background work they've done to prove the origin of tinnitus etc and come up with a treatment.
 
Yes. Depends on what you're talking about. Prototype to mass production as a straight line or mass production after regulatory approval. Both can be answered with "how long is a piece of string." If you have contact-manufacturer agreements in place (including activities like mutual confidentiality agreements, supplier agreements, supplier audits complete etc) then it can be very swift. If you don't... well, each action will add on time.

Yes, contract manufactures are extremely common. They're not developing anything, they're given a schematic and parts (or are included in the supply chain from specific suppliers chosen and approved by Auricle) and will assemble for a fee. Approval of a site like this will be done through supplier audits, questionnaires, ISO accreditation, current client list etc.

I'm sure Dr. Shore herself has said that the tone matching needs to be fairly close, but not perfect. Generating a specific Hz frequency with a fairly tight tolerance is not difficult. There are phone apps that can do this easily. Tone generation and timing, shock strength etc. will all be given an acceptable tolerance for the respective parts. How tight that tolerance is is up to Auricle. I imagine that whatever specifications the components that made their study devices are, is what they'll specify as the minimum acceptable +/- tolerance for manufacturing.

Can't speak for UoM, but when we have custom software developed, we work with a contract vendor that designs us our own software packages based on our user requirement specifications. This is not a difficult thing at all.

To my untrained eye, this device looks extremely simplistic. Don't take that the wrong way. Simplistic as in manufacturing and operation, but a very difficult thing to scientifically reach i.e. the background work they've done to prove the origin of tinnitus etc and come up with a treatment.
Thank you for breaking this down. I assume the Auricle team would at least carry some of these processes forward while the FDA does their thing? I understand they probably wouldn't make a large order or train distributors without approval, but at least know where that order would be sent? My fear is the FDA pulls some kind of stunt where they want another trial of data before approving. Would help if we knew it's at least in front of them.

Outside that I'm just trying to figure out if this darn thing will do anything for me.
 
It sounds more and more like 2025-2026... if at all.
Thank you for breaking this down. I assume the Auricle team would at least carry some of these processes forward while the FDA does their thing? I understand they probably wouldn't make a large order or train distributors without approval, but at least know where that order would be sent? My fear is the FDA pulls some kind of stunt where they want another trial of data before approving. Would help if we knew it's at least in front of them.

Outside that I'm just trying to figure out if this darn thing will do anything for me.
Besides whatever issues there may or not may be between inventors, University of Michigan and NIH, we need to keep in mind we are in quantitative tightening FED regime, which means money is not flowing easily and nearly for free like it was recently. OTOH, I hope this is viewed as a solid investment with relatively low risk - they will sell a ton if it hits the market. If Lenire is able to peddle their junk at four grand a pop, Auricle should have no problems at all, given the research behind the device. So I hope they will able to attract enough investment to get it off the ground at last.
 
I had a conversation with a support worker from Tinnitus UK. He said he expects availability in the USA in about 2 years. With the rest of the world it will be longer as they need to build their client base in the USA first.

My reading into this is it will be a cash flow issue. They will only have cash for production of so many units initially, and will need to sell X amount of units in the USA before there is money to launch and supply elsewhere.
 
I had a conversation with a support worker from Tinnitus UK. He said he expects availability in the USA in about 2 years. With the rest of the world it will be longer as they need to build their client base in the USA first.
LMAO "a support worker" from Tinnitus UK will have trouble knowing his ass from his elbow, let alone some keen unique insight into the workings of Auricle.
 
Thank you for breaking this down. I assume the Auricle team would at least carry some of these processes forward while the FDA does their thing? I understand they probably wouldn't make a large order or train distributors without approval, but at least know where that order would be sent? My fear is the FDA pulls some kind of stunt where they want another trial of data before approving. Would help if we knew it's at least in front of them.

Outside that I'm just trying to figure out if this darn thing will do anything for me.
You're welcome.

Depending on how the prototypes were developed, some of these may already be in place.

I have no knowledge of the data generated by UoM/Auricle during their trials and development, but I'd be quite surprised if the FDA asked for anything close to another study. I know many here were disappointed with the number of participants in the second study, but statistically speaking - the number of participants was more than satisfactory.

Whilst I can't offer any insight into how long this will take to hit market, I can hopefully offer some reassurance to those anxiously awaiting release. This device is not Class III, it does not contain any chemicals, it doesn't have a chemically processed production method, it doesn't contain any bio-active materials, it has no synthetic/animal derived raw materials, it's not implantable, it's not a life-prolonging device and so the approvals process should really be quite simplistic, relatively.

Any of the above would mean the submission process is a completely different beast. For example, the FDA may ask for residual chemical analysis, design of experiments to reduce residual load, biocompatibility studies, stringent raw material control, unwanted chemical interaction tests etc which generally always result in additional studies/investigations. As this isn't the case here, I don't really think Auricle will have any major problems with approval. Just the usual "please explain X,Y,Z in greater detail and provide evidence."

Take FMEA (failure mode and effect analysis) as our example here. This is one of several risk management techniques required by regulatory bodies. This looks as the question of "what if A,BC goes wrong?" You assign various risk factors depending on the failure mode you're assessing. I frequently take part in FMEAs whereby the possible outcome is fatal i.e. brain death, inhibited platelet aggregation leading to possible excessive bleeding, tissue rejection and necrosis - well beyond anything that's possible with this device. These must have risk strategies to identify the problems and solutions to fix it, as well as looking at possible occurrence rates. If your solutions to these problems are unsatisfactory, regulatory bodies will let you know or may even reject your submission. Going back to this device, the worst possible failure mode I can think of (again, I'm not an expert in this field) is the device going out of timing and thus the patient not getting the proper active treatment. Solution? Potential internal calibration prior to allowing the treatment to start as a go/no-go test. If the internal calibration/verification fails, the device will refuse to operate. The only risk to the patient here is that they may need to go a week or two without the treatment whilst their device is repaired. Annoying? Yes. Threat to life? No.

Speaking as a tinnitus sufferer, it doesn't fill me with any joy that we'll still be waiting a while for this to hit the market. As a scientist that deals with global regulatory bodies, it fills me with confidence there will be no catastrophic hurdles to overcome with approval.

I tend to waffle in these responses and probably bore a lot of people, but I think it'd be a disservice to my fellow sufferers that maybe are interested in it if I didn't try and impart some of my knowledge with the regulatory process.
 
I had a conversation with a support worker from Tinnitus UK. He said he expects availability in the USA in about 2 years. With the rest of the world it will be longer as they need to build their client base in the USA first.

My reading into this is it will be a cash flow issue. They will only have cash for production of so many units initially, and will need to sell X amount of units in the USA before there is money to launch and supply elsewhere.
Did your contact give any reason why two years?
 
I had a conversation with a support worker from Tinnitus UK. He said he expects availability in the USA in about 2 years. With the rest of the world it will be longer as they need to build their client base in the USA first.

My reading into this is it will be a cash flow issue. They will only have cash for production of so many units initially, and will need to sell X amount of units in the USA before there is money to launch and supply elsewhere.
After such estimates, I feel that Auricle's device is moving farther away, not closer. Each subsequent estimate gets longer and longer. If it goes on like this, year by year, without access to the device, it may well happen that some other device or drug will overtake Auricle. I personally wish for that. I don't want to be malicious. I'll gladly pay $10,000 to anyone who comes up with something that halves the loudness of my tinnitus. For me, it's about time, not sympathy for scientists. I truly suffer from the 12 kHz tinnitus sound.
 
After such estimates, I feel that Auricle's device is moving farther away, not closer. Each subsequent estimate gets longer and longer. If it goes on like this, year by year, without access to the device, it may well happen that some other device or drug will overtake Auricle. I personally wish for that. I don't want to be malicious. I'll gladly pay $10,000 to anyone who comes up with something that halves the loudness of my tinnitus. For me, it's about time, not sympathy for scientists. I truly suffer from the 12 kHz tinnitus sound.
But that is what all this is, estimates. No one here, literally no one, knows what they are talking about. Only Auricle and the FDA knows.
 
Did your contact give any reason why two years?
No reason given. I didn't push and accepted it as an educated guess. It ain't far off what many here expect, is it. Initially I thought USA next spring, with Europe end of next year.
it may well happen that some other device or drug will overtake Auricle
Yes, the Kv7.2/3 medications may be about to jump on the market.
 
Outside that I'm just trying to figure out if this darn thing will do anything for me.
You won't be able to figure it out until you get your hands on it in 2 or 3 years, but at least it looks like there's a 65% chance you'll experience a noticeable reduction in tinnitus.
 
Is there a legitimate concern this device never leaves the lab shelf? It's come this far. I can't imagine my disappointment if this dies before hitting the public.
Highly doubtful if it works as touted. The tinnitus market is an untapped revenue stream. Someone else would buy it up if Auricle couldn't get to market for some reason.

And people saying it'll be 20XX have just as much information as you do. I could say it'll be out in 3 months and that would hold as much validity as anybody else's guessing. People see someone else's guess and panic. It's just a guess. As said by @Utdmad89, literally nobody knows except Auricle and the FDA.
 
No reason given. I didn't push and accepted it as an educated guess. It ain't far off what many here expect, is it. Initially I thought USA next spring, with Europe end of next year.

Yes, the Kv7.2/3 medications may be about to jump on the market.
As time goes on, I honestly "daydream" about Dr. Shore's device less and think way more about the Kv7.2/3 medications. Even though I think taking the medication and doing the device at the same time could be amazing, I just feel the medication will be available first.
 
As time goes on, I honestly "daydream" about Dr. Shore's device less and think way more about the Kv7.2/3 medications. Even though I think taking the medication and doing the device at the same time could be amazing, I just feel the medication will be available first.
My doctor said she would help me investigate if the Kv7 modulators BHV-7000 and XEN1101 were available through FDA compassionate use.

I think Dr. Shore's device is actually doing the job of our underactive potassium channels. I don't necessarily think they will spring back into action after using her device. So, in other words, the Shore device will calm down the overactive neurons in the brainstem causing tinnitus. And we'd have to keep using the device to ward off the phantom sounds we hear. But when the Kv7 modulators come along, they could (potentially) restore the potassium channels to a healthy state. And, god willing, we wouldn't need to use the device anymore. If for some reason these drugs come out before the device, then this over 10-year-old thread and all the speculation in it could become irrelevant.

Of course I'm speculating too, but this is how important I think the potassium channels are in this equation. That said, if I had to use Dr. Shore's device every damn day of the rest of my life to keep the sound down to manageable levels, I'd be fine with that!
 
My doctor said she would help me investigate if the Kv7 modulators BHV-7000 and XEN1101 were available through FDA compassionate use.

I think Dr. Shore's device is actually doing the job of our underactive potassium channels. I don't necessarily think they will spring back into action after using her device. So, in other words, the Shore device will calm down the overactive neurons in the brainstem causing tinnitus. And we'd have to keep using the device to ward off the phantom sounds we hear. But when the Kv7 modulators come along, they could (potentially) restore the potassium channels to a healthy state. And, god willing, we wouldn't need to use the device anymore. If for some reason these drugs come out before the device, then this over 10-year-old thread and all the speculation in it could become irrelevant.

Of course I'm speculating too, but this is how important I think the potassium channels are in this equation. That said, if I had to use Dr. Shore's device every damn day of the rest of my life to keep the sound down to manageable levels, I'd be fine with that!
At this time, Biohaven has an Early Access Program and Xenon Pharmaceuticals does not. Xenon Pharmaceuticals has a page about it and why they do not have an active program at this time. They state that this policy could change/be revised at any time, but I think it's safe to say if they do not have an active program now, they probably won't due to the fact that they are in Phase 3 clinical trials.

Like I said before, the dream scenario for me would be taking the medication and using Dr. Shore's device at the same time.
 
As time goes on, I honestly "daydream" about Dr. Shore's device less and think way more about the Kv7.2/3 medications. Even though I think taking the medication and doing the device at the same time could be amazing, I just feel the medication will be available first.
The old rule of thumb: Don't fall in love with a house... or job... or pharmaceutical for that matter, till you've got to know it. You never know! Both might work.
 
At this time, Biohaven has an Early Access Program and Xenon Pharmaceuticals does not. Xenon Pharmaceuticals has a page about it and why they do not have an active program at this time. They state that this policy could change/be revised at any time, but I think it's safe to say if they do not have an active program now, they probably won't due to the fact that they are in Phase 3 clinical trials.

Like I said before, the dream scenario for me would be taking the medication and using Dr. Shore's device at the same time.
From what I have seen of Dr. De Ridder's videos, he said they used to give a single pill to HIV patients which extended their lives for five years before the virus evolved to evade the medicine. They added a second one that extended their lives for another five years. When they added four pills together, HIV patients lived for 40 years. He says we need to tackle tinnitus the same way to cure it. Since we can't do anything about hearing damage at the moment, we need to rewire the bad plasticity using all the methods available at the same time. This will include the potassium channel openers, the Shore device and neuromodulation, done long enough for the bad connections to be broken.
 
From what I have seen of Dr. De Ridder's videos, he said they used to give a single pill to HIV patients which extended their lives for five years before the virus evolved to evade the medicine. They added a second one that extended their lives for another five years. When they added four pills together, HIV patients lived for 40 years. He says we need to tackle tinnitus the same way to cure it. Since we can't do anything about hearing damage at the moment, we need to rewire the bad plasticity using all the methods available at the same time. This will include the potassium channel openers, the Shore device and neuromodulation, done long enough for the bad connections to be broken.
This is one of the best posts I've seen. Yes, we need to stop looking for the single "magic bullet." I know the lecture you are referring to. If Auricle provides some relief, great, but why stop there. Adding other treatments in may give a better, more sustainable clinical effect.

I'm really racked off with the waiting on Auricle though. With a clinically unmet need it seems cruel. Raising funds should not be an issue at all in this case!
 
This is one of the best posts I've seen. Yes, we need to stop looking for the single "magic bullet." I know the lecture you are referring to. If Auricle provides some relief, great, but why stop there. Adding other treatments in may give a better, more sustainable clinical effect.

I'm really racked off with the waiting on Auricle though. With a clinically unmet need it seems cruel. Raising funds should not be an issue at all in this case!
I so agree with this.

And from what I remember, Dr. Shore alluded to the fact that there is an existing FDA approved device to treat tinnitus, therefore that is one of the reasons they could not pursue a compassionate use pathway or whatever. Also known as Lenire, yeah, a device that worsens way more than helps. So because of a failed device that "technically" stands as a treatment, along with other reasons, we wait and wait and wait.
 
I'm really racked off with the waiting on Auricle though. With a clinically unmet need it seems cruel. Raising funds should not be an issue at all in this case!
Yeah, I don't understand the cloak and dagger behavior around the FDA stuff and the Auricle internal process for product launch. I know little about the process, but it makes me think there's some unknown hurdle here I'm not seeing. Would love to be a fly on the wall at Auricle HQ.
 
How many lives will be destroyed before Susan Shore gets this on the market. I honestly think there is something going on we don't know about. 2 years? C'mon man. Something is not right.
 
It hasn't even been six months since the study was published.
The FDA doesn't care if you're published or not. They examine your evidence directly. Although it is probably 'good form' and expected to be published. Theoretically, Dr. Shore could have submitted to the FDA to have her device approved back in December when her paper was sent to the journal to be published.
 

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