Dr. Shore literally answered this question. She hasn't said anything as it's company policy.
New University of Michigan Tinnitus Discovery — Signal Timing
- Thread starter Hudson
- Start date
MemberI don't know if Neuromod stated exactly when they submitted but they said they were waiting on FDA approval. They also opened up US headquarters anticipating approval.
She literally did not answer the question.
Somebody in biomedical engineering/business, help me out here.
What's the advantage of having a policy regarding not reporting when something is submitted for FDA approval? What's the upside for them?
What's the advantage of having a policy regarding not reporting when something is submitted for FDA approval? What's the upside for them?
- Dec 3, 2022
- 253
- Tinnitus Since
- 2012. Worsened 2022.
- Cause of Tinnitus
- Primarily loud music. Secondary - ETD + TMJ
Talking about submission is the exception to the rule. It's never a good idea to publicly announce you're waiting on approval from regulatory bodies, not a single one of them likes it. It makes it look like you've already assumed you're getting approval and the regulator is holding it up.
It's just 'not the done thing.'
Thank you. This does make sense when I think about it. And reading Dr. Shore's quote that @Utdmad89 posted above gives me some hope that they have started the process with the FDA as the quote talks about "engaging" with the FDA and used the words "in the midst of negotiations." This signals to me that something is happening with the FDA.
BobbieJay-1954
Member
All I can imagine is that Dr. Shore & co. want the rollout for this device to be as smooth as possible. If that means they can't tell us about the approval process timeline, then so be it. They definitely aren't twiddling their thumbs behind the curtain, especially after all the time and effort that's gone into her studies and the creation of this device. She knows that we're suffering out here, but there's only so much she can do on her end.
I get the same impression. When you follow the timeline of the product development, it would seem likely they have already submitted for approval. From my understanding, the FDA has allotted 10 months for review. This would indicate the product could be market-ready by roughly the end of 2024, or more realistically early 2025.
Being optimistic here of course.
I know the wait for Dr. Shore's tinnitus device can feel like forever, especially when it's something that could change our lives.
The FDA process is no joke, but that's a good thing – it means they're making sure it's the real deal. Hang tight, keep those fingers crossed, and let's remember we're all in this together.
There's a light at the end of this tunnel, and I'm hopeful it's going to be worth the wait. Sending everyone good vibes!
The FDA process is no joke, but that's a good thing – it means they're making sure it's the real deal. Hang tight, keep those fingers crossed, and let's remember we're all in this together.
There's a light at the end of this tunnel, and I'm hopeful it's going to be worth the wait. Sending everyone good vibes!
BS. Nothing "real deal" due to the process. They will merely say it's "safe". Safe my ass. Who knows, most likely should be. Antidepressants are "safe" and see what they do to people. Or the shitty COVID-19 vaccines (I took four jabs, I am not "antivaxer"). I despise the FDA. There is a value in a regulatory/approval body like this, but IMO treatments should be allowed to be offered without such bureaucracy as experimental if the patient agrees to the potential risk. Based on the data from Dr. Shore's device, I'd jump on the device yesterday. I don't need some assholes at FDA to declare it "safe".
I was never worried about the FDA approval. To me, the real question is the rollout and funding. The FDA won't take more than 6 months to approve it, it's a non invasive device and it hasn't shown any adverse effects.
The real question is, when it will become available after the approval?
The real question is, when it will become available after the approval?
- Sep 8, 2022
- 50
- Tinnitus Since
- 11/2020
- Cause of Tinnitus
- loud noise/construction
I had been a bit too scared to look at Dr. Shore's answers and I finally worked up the courage to look over her responses today. Overall, I'm alright with them. I would have loved for her to say, "The device will be shipped to your house tomorrow and extended use will for sure bring back your version of quiet once again," but this obviously wasn't the case.
However, I'm very happy to see that she said, "Our studies have shown no influence of tinnitus duration on treatment efficacy." The fact that waiting is unlikely to reduce the efficacy of the treatment is huge. I was terrified that anyone who has been suffering for more than 6 months or a year or 5 years would not be helped, but only those ones who got it yesterday could be helped.
In relation to the comments about her definition of the word quiet, I think we need to remember that she is an academic and her definitions are going to be far more precise than ours. Think of the word random, we all use this in everyday discussions, but I used to spend an entire class period teaching students why their definition of random wouldn't work when doing statistics. Bumping into a friend at the mall isn't "random" at all in the social sciences, even though we'd all say it was so random in everyday conversations.
Finally, our government is not a single entity. It is a whole host of institutions and individuals working towards various goals. Sometimes those goals overlap and sometimes they contradict one another. Some congress people want to see things we care about paid attention to and some do not for a whole host of reasons. Nearly 20 million people work for the federal, state, and local governments. This is 10x the size of Walmart's employee base. Some of these people and the institutions they work within are fighting hard for us, people with other illnesses, etc. Some aren't, some are apathetic, some are competing for that money to help those suffering in different ways, and some think the government shouldn't be involved at all and it should all private businesses doing whatever they want.
And, it is easy to criticize the institutions when we don't necessarily know how they work, why they work the way they do, and who/what is blocking the institutions of changing. If we want to know more about how the FDA and its processes actually work maybe we want to take this course, or read the assigned reading for this course, or this course.
I know we are all stressed, but there appears to be some light at the end of this tunnel. The tunnel is just a bit longer than any of us would like. We need to push through FDA approval, manufacturing, training of audiologists, shipping of the device, and so on. We are all suffering from a disease that doesn't have any real treatment yet. Being the first to be treated sucks as it requires a lot of waiting around, but at least we can see some light and will likely be treated at some point. Things are brighter than they were before she completed this study. I'm not sure if the device will work for me or any of us as individuals, but I'm hopeful... and the wait gives me some time to start saving for the treatment. Even if it was out tomorrow and it cost $5,000, I couldn't do it right away as I'd need some time to save up the money/borrow from family.
However, I'm very happy to see that she said, "Our studies have shown no influence of tinnitus duration on treatment efficacy." The fact that waiting is unlikely to reduce the efficacy of the treatment is huge. I was terrified that anyone who has been suffering for more than 6 months or a year or 5 years would not be helped, but only those ones who got it yesterday could be helped.
In relation to the comments about her definition of the word quiet, I think we need to remember that she is an academic and her definitions are going to be far more precise than ours. Think of the word random, we all use this in everyday discussions, but I used to spend an entire class period teaching students why their definition of random wouldn't work when doing statistics. Bumping into a friend at the mall isn't "random" at all in the social sciences, even though we'd all say it was so random in everyday conversations.
Finally, our government is not a single entity. It is a whole host of institutions and individuals working towards various goals. Sometimes those goals overlap and sometimes they contradict one another. Some congress people want to see things we care about paid attention to and some do not for a whole host of reasons. Nearly 20 million people work for the federal, state, and local governments. This is 10x the size of Walmart's employee base. Some of these people and the institutions they work within are fighting hard for us, people with other illnesses, etc. Some aren't, some are apathetic, some are competing for that money to help those suffering in different ways, and some think the government shouldn't be involved at all and it should all private businesses doing whatever they want.
And, it is easy to criticize the institutions when we don't necessarily know how they work, why they work the way they do, and who/what is blocking the institutions of changing. If we want to know more about how the FDA and its processes actually work maybe we want to take this course, or read the assigned reading for this course, or this course.
I know we are all stressed, but there appears to be some light at the end of this tunnel. The tunnel is just a bit longer than any of us would like. We need to push through FDA approval, manufacturing, training of audiologists, shipping of the device, and so on. We are all suffering from a disease that doesn't have any real treatment yet. Being the first to be treated sucks as it requires a lot of waiting around, but at least we can see some light and will likely be treated at some point. Things are brighter than they were before she completed this study. I'm not sure if the device will work for me or any of us as individuals, but I'm hopeful... and the wait gives me some time to start saving for the treatment. Even if it was out tomorrow and it cost $5,000, I couldn't do it right away as I'd need some time to save up the money/borrow from family.
- Jan 16, 2020
- 441
- Tinnitus Since
- 1992
- Cause of Tinnitus
- noise? infection? negative stress? other?
A barrow-load of folks here are in panic mode to get relief from tinnitus...
I can't say that I'm very much different except that the panic has subsided somewhat.
But we must remember that Dr. Shore is an academic and her aim and perhaps her life's work and passion is to develop a new idea.
If she can present the medical world with a procedure that will reduce hearing loss or reduce tinnitus by just 5%, this will be the first time in history that there's scratch in the armour of these apparently incurable afflictions.
It will give direction to the other scientists. And who knows, it might even trigger a cascade of research onto the subject
I can't say that I'm very much different except that the panic has subsided somewhat.
But we must remember that Dr. Shore is an academic and her aim and perhaps her life's work and passion is to develop a new idea.
If she can present the medical world with a procedure that will reduce hearing loss or reduce tinnitus by just 5%, this will be the first time in history that there's scratch in the armour of these apparently incurable afflictions.
It will give direction to the other scientists. And who knows, it might even trigger a cascade of research onto the subject
haha ear go eeee
Member
Especially if she's given praise and nominations for awards. Scientists might finally see tinnitus and hyperacusis as profitable areas if they have a chance at getting recognition.
- Dec 3, 2022
- 253
- Tinnitus Since
- 2012. Worsened 2022.
- Cause of Tinnitus
- Primarily loud music. Secondary - ETD + TMJ
I like to think of this as mk. 1 of this treatment type too. Look at any technology from aeroplanes to MRIs. The inception may be a little basic, but the progression, once the fundamental science and engineering is laid out and proven, becomes exponential.
This iteration may be a little rough around the edges, but if it works I think we'll see some serious refinements and an increased efficacy. And if this device is proven to work in the field, where there's money to be made, other companies will start to take notice.
If we assumed the device was submitted recently for approval, and the timeframe for that is 6-10 months, then say another 6 months for the rest of the process involving manufacturing, training, etc., could we dare to predict that roughly a year from now we could be getting ready to make appointments with our audiologists for the device?
Obviously, that's a very optimistic scenario. But in the worst-case scenario, by this time next year, we should at least have an idea about the release date.
Am I dreaming?
Obviously, that's a very optimistic scenario. But in the worst-case scenario, by this time next year, we should at least have an idea about the release date.
Am I dreaming?
- Dec 3, 2022
- 253
- Tinnitus Since
- 2012. Worsened 2022.
- Cause of Tinnitus
- Primarily loud music. Secondary - ETD + TMJ
Apologies if this comes across as an incoherent mumbo jumbo.
I was thinking about a few things earlier to do with this device. Once again, apologies if this has all been discussed before.
I'm sure I read somewhere that the electrical stimulation was set approximately in the region of the specific user's ability to feel it (if this is wrong, stop reading here
). This is obviously beneficial when you're running a placebo controlled study, as you don't want users to be able to immediately identify the active treatment because they can feel the little electrodes going bzzzt on their skin and none with the placebo.
With a weak electrical stimuli, electrode placement becomes absolutely critical as you may not be stimulating the target nerves enough with such a weak impulse. If the power of the electrode is increased, you may either increase the effectiveness of the treatment or stimulate the nerve even if your electrode placement isn't exact.
Most people don't like the feeling of electrical stimulation as it can somewhat feel similar to pins and needles at the treatment site and so some of the participants may have set their stimulation level quite low. I'm sure there's objective measurement data that Dr. Shore's team can/already have draw
a conclusion on with how specific respondents had their electrodes set up, i.e. can you group low respondents into a range of electrode power and perhaps those that had a greater response into another settings range. The fact the stimulation was removed in the sham suggests to me this is the most important part of the device.
I hope that when you sign up to buy the device you agree to sharing your setting and subsequent appointment data on how your tinnitus has reduced with Auricle so they can do some design of experiments level statistical analysis to target the most effective settings in future.
I was thinking about a few things earlier to do with this device. Once again, apologies if this has all been discussed before.
I'm sure I read somewhere that the electrical stimulation was set approximately in the region of the specific user's ability to feel it (if this is wrong, stop reading here
). This is obviously beneficial when you're running a placebo controlled study, as you don't want users to be able to immediately identify the active treatment because they can feel the little electrodes going bzzzt on their skin and none with the placebo.With a weak electrical stimuli, electrode placement becomes absolutely critical as you may not be stimulating the target nerves enough with such a weak impulse. If the power of the electrode is increased, you may either increase the effectiveness of the treatment or stimulate the nerve even if your electrode placement isn't exact.
Most people don't like the feeling of electrical stimulation as it can somewhat feel similar to pins and needles at the treatment site and so some of the participants may have set their stimulation level quite low. I'm sure there's objective measurement data that Dr. Shore's team can/already have draw
a conclusion on with how specific respondents had their electrodes set up, i.e. can you group low respondents into a range of electrode power and perhaps those that had a greater response into another settings range. The fact the stimulation was removed in the sham suggests to me this is the most important part of the device.I hope that when you sign up to buy the device you agree to sharing your setting and subsequent appointment data on how your tinnitus has reduced with Auricle so they can do some design of experiments level statistical analysis to target the most effective settings in future.
BobbieJay-1954
Member
I was pretty curious about the electrodes as well. Not so much their placement but rather the strength of the electrical signal. I feel like maybe some people didn't benefit to the fullest potential during the trials and a stronger signal could have helped them reach it? I'm sure it's been discussed somewhere in here already but oh well.Apologies if this comes across as an incoherent mumbo jumbo.
I was thinking about a few things earlier to do with this device. Once again, apologies if this has all been discussed before.
I'm sure I read somewhere that the electrical stimulation was set approximately in the region of the specific user's ability to feel it (if this is wrong, stop reading here
With a weak electrical stimuli, electrode placement becomes absolutely critical as you may not be stimulating the target nerves enough with such a weak impulse. If the power of the electrode is increased, you may either increase the effectiveness of the treatment or stimulate the nerve even if your electrode placement isn't exact.
Most people don't like the feeling of electrical stimulation as it can somewhat feel similar to pins and needles at the treatment site and so some of the participants may have set their stimulation level quite low. I'm sure there's objective measurement data that Dr. Shore's team can/already have draw
I hope that when you sign up to buy the device you agree to sharing your setting and subsequent appointment data on how your tinnitus has reduced with Auricle so they can do some design of experiments level statistical analysis to target the most effective settings in future.
I've been zapped by enough gag pens and gum packs in my life that I wouldn't care as long as it helped lol. If I felt like I was being tortured - that's a different story.
hta
Member
- Jul 1, 2022
- 5
- Tinnitus Since
- 10/2019
- Cause of Tinnitus
- Fell Asleep with headphones, followed by acoustic trauma
I don't believe this is about the strength of the zap. It is about the timing between the zaps. The zaps themselves should not even be felt.I was pretty curious about the electrodes as well. Not so much their placement but rather the strength of the electrical signal. I feel like maybe some people didn't benefit to the fullest potential during the trials and a stronger signal could have helped them reach it? I'm sure it's been discussed somewhere in here already but oh well.
I've been zapped by enough gag pens and gum packs in my life that I wouldn't care as long as it helped lol. If I felt like I was being tortured - that's a different story.
BobbieJay-1954
Member
In the Q & A, Dr. Shore was asked:
To which Dr. Shore answered:Question said:
I would interpret this to mean the timing was critical, but the level of sound was probably not the determinant factor in whether treatment worked. That being said, I don't recall the study addressing "level of sound" and how or if it was linked to different outcomes.Dr. Shore said:
Perhaps Dr. Shore and team Auricle will follow those being treated to get information on:
- importance of level of treatment sound.
- whether longer treatment leads to greater reduction in tinnitus decibel level or loudness. (I'm keeping in mind the in-depth discussion on the meaning of decibel. I'm using the word in the sense of objective loudness.)
- whether additional treatment could help with a spike caused by an acoustic trauma...
We have had comments here from folks whom are involved with FDA/pharma in their professional lives and the 6 month time frame for this device to be potentially approved is very much realistic.
ENT/audiology training is most likely going to be online which will help to expedite the process.
Now, that being said, I see most delays caused by manufacturing:
1) It requires decent amount of investment (which in theory should not be a problem for Auricle, if the device gets FDA approval).
2) You have to somehow make this device to be able to be produced in high quantities really fast. I am not sure what the FDA regulations are for that but I would imagine this device's core component, "the motherboard," could be assembled/built in China and shipped to the USA for final box assembly and software uploaded to the unit for it to function. This way it should count as assembled in the USA and clear with FDA? Not sure, does anyone know if Lenire is assembled in the USA or China/elsewhere
In my mind Auricle would like to preserve their software from being easily copied so I would imagine they are going to take some sweet time on this matter as well.
Auricle has really (unfortunately) no reason to rush it like crazy. Tinnitus sufferers only multiply daily. They will only rush it if XEN1101/BHV-7000 show efficacy towards tinnitus, but this is all like 2-3 years away from us to try so that is that.
Perhaps they are already talking to investors who are doing their research towards possible profits and I hope they realize that:
There are about 40 million people in the USA with tinnitus and most of them would love to get rid of it.
If the device sold for MSRP of $1.5k, it would be $60B market in the USA alone. Worldwide you would probably push around $200B market.
Once there is something that works for tinnitus (especially technology that would allow to accurately measure it) - we will see an influx of investment in the R&D because the overall market for auditory conditions is way above $3T.
- Aug 21, 2014
- 5,049
- Tinnitus Since
- 1999
- Cause of Tinnitus
- karma
It's thorny and basically amounts to being an almost useless process at this point because while the FDA certainly has requirements and performs checks on hardware, they certainly do not audit software, source code, etc with any serious scrutiny. I have a myriad of contacts who do or have done stuff like write firmware for medical imaging devices, and have commented on how mildly terrifying it is that their uncaught bugs could lead to misdiagnosis or worse.
The Therac-25 would be a significant example of "or worse":
Wikipedia.org: Therac-25
Note: I'm not afraid of this tech (lol I've used it in the clinical trial, if you've been following the thread long enough), I'm just shining a light on an ugly truth which is that stuff like the software running pacemakers and brain stimulation devices gets a lot less scrutiny than other types of critical-deployment software. Also, all software is pretty terrible and the people who make it are usually stressed out and being asked to do too many things at once.
I'm amazed any time a computer does what I want it to, and I have "software engineer" in my title.
Same! It does, until it doesn't because something somewhere changed and the link was not anticipated or understood.
I have seen the "6 month" comment a few times. But that is 6 months once they have applied for FDA approval.
Have they actually applied? I haven't seen a definitive yes to that question.
I'm not sure the 6 month clock is ticking yet.
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