MemberTrue, it's the only promising thing. Yet, the pace at which it has been coming is excruciatingly slow, to a point it is hard to believe it will ever come.
New University of Michigan Tinnitus Discovery — Signal Timing
- Thread starter Hudson
- Start date
Please don't tell me that you think that Lenire can get market approval from the FDA and that the Auricle device by Susan Shore (backed by 20 years of research and much stronger science) won't?
AnthonyMcDonald
Member
If Lenire's BS not working ass could get approval, there's no way in hell almighty that Shore won't lol.
It's not what I think, it's what has actually happened.
Lenire is approved. Auricle/Shore is not.
I hope like everyone it gets approved quickly, but they could be doing much more to raise start-up funds.
I think she's been working with the FDA for approval for her device since her data was ready to be published in December. If that's the case, then it does make sense that her device isn't approved yet. She likely submitted it to the FDA as a De Novo device, but when Lenire got that classification and was approved, then she likely had to re-submit as a 510(k) which goes a lot quicker. So I'm hoping it will be approved soon!
awake 44
Member
- Nov 22, 2022
- 46
- Tinnitus Since
- 02/2022
- Cause of Tinnitus
- Years of playing in heavy metal band.
I love your optimism. I'm also one of the funny fellas here. However, it slowly starts to scare me, that there is totally no business infrastructure on Auricle's side. FDA is one animal. They need to have contracts with OEM factories and sales structures. How can they be working on that, if they do not even have a website? Maybe they treat the FDA approval as the starting point? What's your take on that?
- Jul 16, 2019
- 89
- Tinnitus Since
- 10/2018
- Cause of Tinnitus
- Unknow. Maybe stress?
Do you think the FDA is investigating the manufacturing and distribution potential of the device? That would be strange. Either the device is safe for humans or it is not. How the owner handles it should not be of any interest to the FDA. Or?
Totally no business infrastructure? She's said that they have an FDA expert already working with Auricle that's a full time member of the staff. She'd mentioned that at the Palm Springs Hearing Conference. So Susan Shore and John Pearson aren't their only employees. There could be more for all we know!
You could be right, and they could be focusing on getting the device through the FDA right now. And the business infrastructure could be in the future plans. Problem is we have absolutely NO visibility into what's going on. I don't know how to check for such things, maybe someone more expert at that could do this, but is it possible that the infrastructure exists but that we don't know about it?
Our main problem from our perspective is visibility. From our point of view nothing is happening. From the standpoint of her and her team, they are working as fast as they can to get things done. However, it's easy to think nothing is happening, because we can't see what's going on. This entire thread is almost (not quite) entirely speculation because we can't see what's going on.
SarahMLFlemmer
Member
- Feb 2, 2023
- 190
- 37
- Tinnitus Since
- 11/20/2022
- Cause of Tinnitus
- Accutane (withdrawl)
I do not have somatic tinnitus, but...
Out of curiosity, to everyone currently on this thread that is eagerly waiting on Dr. Shore's device, do all of you have somatic tinnitus or no?
If you do not have somatic tinnitus, are you still hoping to at least try it when it finally gets approved?
Out of curiosity, to everyone currently on this thread that is eagerly waiting on Dr. Shore's device, do all of you have somatic tinnitus or no?
If you do not have somatic tinnitus, are you still hoping to at least try it when it finally gets approved?
I have somatic tinnitus, fortunately. I am sorry that you are saying you don't. However, let's not assume it won't work for you. It's only been tried in clinical trials for those with somatic tinnitus. Presumably because she'd thought that would be the easiest kind to treat. That doesn't mean that once it's released to the public that it won't work with other kinds as well. We'll have to wait and see. She did say that there will be additional studies of the device after it's released to increase its effectiveness. She's also said that she will work on more precisely identifying other subtypes of tinnitus and that she'll get it to work for other kinds of tinnitus, including non-somatic. The only way we'll know is by waiting until the device is a reality for the rest of us.
My question as well.
Is your somatic tinnitus tonal or a hiss/buzz? I can modify my hissing tinnitus with my jaw, but none of my three sinus tones.
No, it's mostly the sounds of train wheels screeching on the tracks at extremely high volume. It's awful.
Has Dr. Shore indicated when she plans to retire? According to Spokeo, she is 72 years old.
Many people keep working well into their 80s, sometimes even 90s, but I think that's more the exception than the rule.
Many people keep working well into their 80s, sometimes even 90s, but I think that's more the exception than the rule.
It's been 5 months since the December presentation. She really wasn't kidding about the publication taking up to 6 months.
- Dec 3, 2022
- 253
- Tinnitus Since
- 2012. Worsened 2022.
- Cause of Tinnitus
- Primarily loud music. Secondary - ETD + TMJ
I'm going through a particularly frustrating period with this, but I am fortunate enough to not have it as bad as many on here.
What we need to remember though is even if they had a fancy website with loads of information about the device, they cannot comment on a pre-market submission. In any capacity. I'd love transparency and some updates, but it's just not possible at this stage.
Of course there are concerns about production of the device. But Susan Shore's team have developed, on paper from what we've seen anyway, the first actual tangible treatment for this condition. So I'm sure they can sort out manufacturing of the device, be that through working with the companies that created the prototypes and study devices or by licensing this out to an established medical device manufacturer. It's a PCB, some electrodes and basically an MP3 player, it's not some crazy new technology that no manufacturer can make yet.
After 20 years or so of R&D, I'm sure those with investments in this want a return and the team behind the device want to see it come to fruition. Each day that passes for us living with this condition is hell and that manifests as frustration as we're not seeing any movement with this. But that doesn't mean it's not happening.
I repeatedly check this sub forum many times a day to see if there are any new posts on this thread, and hope it's somebody posting a link to the publication, but no luck yet, obviously. The device has made it through R&D and multiple well designed clinical trials but the ultimate test will be once we get our hands on it.
We're on the home stretch now, we just need to keep going that little bit longer. As many of the old timers here have said recently, this is the last man standing from a lineup of potential treatments spanning many years back. I have been guilty of negative postings in here, but we're so close so let's try and keep good vibes flowing.
Of course your suffering is subjective so feel free to also tell me to shut up
What we need to remember though is even if they had a fancy website with loads of information about the device, they cannot comment on a pre-market submission. In any capacity. I'd love transparency and some updates, but it's just not possible at this stage.
Of course there are concerns about production of the device. But Susan Shore's team have developed, on paper from what we've seen anyway, the first actual tangible treatment for this condition. So I'm sure they can sort out manufacturing of the device, be that through working with the companies that created the prototypes and study devices or by licensing this out to an established medical device manufacturer. It's a PCB, some electrodes and basically an MP3 player, it's not some crazy new technology that no manufacturer can make yet.
After 20 years or so of R&D, I'm sure those with investments in this want a return and the team behind the device want to see it come to fruition. Each day that passes for us living with this condition is hell and that manifests as frustration as we're not seeing any movement with this. But that doesn't mean it's not happening.
I repeatedly check this sub forum many times a day to see if there are any new posts on this thread, and hope it's somebody posting a link to the publication, but no luck yet, obviously. The device has made it through R&D and multiple well designed clinical trials but the ultimate test will be once we get our hands on it.
We're on the home stretch now, we just need to keep going that little bit longer. As many of the old timers here have said recently, this is the last man standing from a lineup of potential treatments spanning many years back. I have been guilty of negative postings in here, but we're so close so let's try and keep good vibes flowing.
Of course your suffering is subjective so feel free to also tell me to shut up
- Jul 8, 2019
- 1,161
- Tinnitus Since
- 1991
- Cause of Tinnitus
- Loud Music / family history
Who are 'we'? Practically, this won't be accessible to most non-Americans for ages, not with their current infrastructure. I don't suppose there are too many foreigners who can afford to reside on US terrain for the whole duration of the treatment, on top of covering for the flight and then the treatment itself. It's such a long stay that the majority of Europeans, even, would be paying that loan for the rest of their lives.
- Jan 16, 2020
- 441
- Tinnitus Since
- 1992
- Cause of Tinnitus
- noise? infection? negative stress? other?
Duh... Oxymoron alert here.
Like, how could a one-trick-pony company be light-years ahead if their product was second best?
If Dr. Shore's device works best, surely the capital-rich medical device firms or biopharma companies will swoop in and purchase the rights or license?
SarahMLFlemmer
Member
- Feb 2, 2023
- 190
- 37
- Tinnitus Since
- 11/20/2022
- Cause of Tinnitus
- Accutane (withdrawl)
If the device becomes available in the US, then it's a matter of time till it's available abroad. It's a non-invasive treatment.
- Dec 3, 2022
- 253
- Tinnitus Since
- 2012. Worsened 2022.
- Cause of Tinnitus
- Primarily loud music. Secondary - ETD + TMJ
Tinnitus sufferers.
You're right, it will be available to Americans first as they developed it. But after a U.S. launch I'm sure they will roll it out elsewhere.
You can sit in an echo chamber of negativity, or you can choose to be optimistic that there may be a serious treatment on the horizon. Your call.
This is the result of taxpayer funded research, right? So why doesn't that automatically mean that it will be available to the public for an affordable price?
From this page, they have filed patents in other countries, besides the US, and they are pursuing more patents worldwide.
It was patented in the US in 2016. That tells me that they are planning on rolling the device out to the rest of the world, to as many places as they can, as fast as the local regulatory agencies (equivalents to the FDA) will allow!
AfroSnowman
Member
- Jul 23, 2019
- 1,075
- Tinnitus Since
- 04/2019
- Cause of Tinnitus
- Nonnatural energy source
Lenire wasn't very useful, but I flew in, got fitted, stayed for a couple of days and flew out. I think it will probably be the same for this device. Though it will cost a pretty penny for the flight, I don't think you would need to worry about putting yourself up for 6 weeks.
I doubt international people would need stay in the US for the whole 12 week treatment cycle.
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