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...
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.
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.
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.
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.
You're welcome.
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.
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.
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.
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.
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.
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.
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 so agree with this.
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.
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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