New University of Michigan Tinnitus Discovery — Signal Timing

[Stayinghopeful]

It seems Auricle will be a superior device to Lenire, but Neuromod seems light-years ahead as an established company vs. Auricle.

Neuromod had to be, it was the only way they could possibly make any money. If Lenire had come out after Dr. Shore's device, I doubt nowhere near as many people would take a chance on it.

 

[gameover]

At the pace it is going, she may kick the bucket before the device is out.

This was in a bad taste and I regret posting this. I hope she stays in a good health, and God bless her for working on a relief for us. I hope it comes as soon as possible.

 

[Nick47]

doubt international people would need stay in the US for the whole 12 week treatment cycle.

@@dam, it was 6 weeks.

 

[awake 44]

I doubt international people would need stay in the US for the whole 12 week treatment cycle.

Yeah... I guess it will be set up along with some interview and you will be free to go. I'm just wondering if any tweaks in the software will be needed (due to the tinnitus parameters changing), and if we will be able to solve that remotely. If that is the case, I'm all good. I've never been to the US and A. I will give myself double present: silence plus holiday of a lifetime.

 

[awake 44]

This was in a bad taste and I regret posting this. I hope she stays in a good health, and God bless her for working on a relief for us. I hope it comes as soon as possible.

It was in bad taste indeed. Dr. Shore is our only hope, she is dedicated to us and we owe her our highest respect. Good on you for your apologizing for your mistake.

 

[cjbhab]

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.

Why would you need to reside in the USA for the whole duration of the treatment? Are they seeing you every week? Even if this is the case, I'll make it happen.

 

[Fightthearmy]

Why would you need to reside in the USA for the whole duration of the treatment? Are they seeing you every week? Even if this is the case, I'll make it happen.

Depends, will the thingamajig be yours to keep right from the launch, or will the treatment be administered exclusively at clinics in the early stages?

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!

My worst fear is it's gonna be this timeline:

FDA approval --> US launch --> Paperwork --> Aaaaand then, some paperwork --> Overseas launch.

 

[Ryan Scott]

It was in bad taste indeed. Dr. Shore is our only hope, she is dedicated to us and we owe her our highest respect. Good on you for your apologizing for your mistake.

If her device works, I will probably give her 20% of my salary every Christmas to show my gratitude.

#InSusanWeTrust

 

[dj_newark]

@@dam, it was 6 weeks.

Yes, the treatment lasted 6 weeks. But I fail to see why the confusion on here is so pervasive that the treatment period will be the same as the trial period. Trials have to have defined beginnings and ends as part of their nature. Once you own the device, you will use it as long as you want.

 

[AnthonyMcDonald]

Susan Shore tattoo? Hell yes.

 

[EDDTEKK]

The next Tinnitus Research Initiative conference will be in Dublin on 6-9 June.

Does anybody know if Dr. Susan Shore will present her latest results there? Will anybody from Tinnitus Talk attend this conference?

It's very frustrating that there are no news about the progress or results in detail on the web. I need hope to stay alive.

 

[Markku]

The next Tinnitus Research Initiative conference will be in Dublin on 6-9 June.

Does anybody know if Dr. Susan Shore will present her latest results there? Will anybody from Tinnitus Talk attend this conference?

We'll be there.

I don't think Dr. Shore will (I'm not 100% sure though), at least she's not listed as having a slot for a presentation. From our previous experience, not many US-based researchers attend TRI conferences, it's mostly EU folks there.

 

[Damocles]

 

[Jonno02]

Yes, the treatment lasted 6 weeks. But I fail to see why the confusion on here is so pervasive that the treatment period will be the same as the trial period. Trials have to have defined beginnings and ends as part of their nature. Once you own the device, you will use it as long as you want.

This is something I'm interested in too.

I don't think any of us here would moan at strapping this to our head for 30 minutes a day for the rest of our lives for relief from tinnitus anyway, but I wonder if either of these are realistic:

1. Like with medication/antibiotics, you start off on a high dose (using the device every day) for 6-12 weeks. Once the tinnitus calms down, you go onto a lower maintenance 'dose' and maybe use it twice/three times a week just to keep everything ticking over.

2. If the fusiform cells can become permanently hyperactive, and for the sake of this point we'll assume that's because they receive less input from hair cells dying, then should the opposite also be presumably true? The device after several months of use may permanently calm these cells down and, once you reach near-silence, you can stop using the device? If further damage occurred to your ears and the tinnitus rears its head again, you'd just repeat your treatment cycle.

Susan Shore's team may not even know the answers and the day 1 adopters may be involved in follow-up studies to determine the above, maybe not of so much interest for private use as once you own the device, you own it. But maybe for people that are undergoing chemotherapy that can induce tinnitus? Hospitals may have some of these devices on hand that people can check in/check out during their treatment to keep tinnitus away.

This along with the frequencies being user changeable are at the top of my 'I'd love to know' list.

 

[Cbush]

We'll be there.

I don't think Dr. Shore will (I'm not 100% sure though), at least she's not listed as having a slot for a presentation. From our previous experience, not many US-based researchers attend TRI conferences, it's mostly EU folks there.

Hi @Markku, when do you believe the device will be available to we peons, and do you know if it will truly work to help us or not?

 

[@dam]

Susan Shore's team may not even know the answers and the day 1 adopters may be involved in follow-up studies to determine the above

Once this treatment comes out, I'm going to ask the Bionics Institute if they want to do a pre-treatment scan. Then I'll fly to the United States, do the 12 weeks of treatment and go back down to Melbourne for a post-treatment scan. It would make concrete evidence if they can visibly see the brain changes.

 

[Joeseph Stope]

This is something I'm interested in too.

I don't think any of us here would moan at strapping this to our head for 30 minutes a day for the rest of our lives for relief from tinnitus anyway, but I wonder if either of these are realistic:

1. Like with medication/antibiotics, you start off on a high dose (using the device every day) for 6-12 weeks. Once the tinnitus calms down, you go onto a lower maintenance 'dose' and maybe use it twice/three times a week just to keep everything ticking over.

2. If the fusiform cells can become permanently hyperactive, and for the sake of this point we'll assume that's because they receive less input from hair cells dying, then should the opposite also be presumably true? The device after several months of use may permanently calm these cells down and, once you reach near-silence, you can stop using the device? If further damage occurred to your ears and the tinnitus rears its head again, you'd just repeat your treatment cycle.

Susan Shore's team may not even know the answers and the day 1 adopters may be involved in follow-up studies to determine the above, maybe not of so much interest for private use as once you own the device, you own it. But maybe for people that are undergoing chemotherapy that can induce tinnitus? Hospitals may have some of these devices on hand that people can check in/check out during their treatment to keep tinnitus away.

This along with the frequencies being user changeable are at the top of my 'I'd love to know' list.

Well how could they know the long-term results? That will pan out a year or two after it's been released. We are the guinea pigs, I guess... I'm up to taking the chance --- I benefitted somewhat from the TRT sound therapy back in the mid 90s.

We'll be there.

I don't think Dr. Shore will (I'm not 100% sure though), at least she's not listed as having a slot for a presentation. From our previous experience, not many US-based researchers attend TRI conferences, it's mostly EU folks there.

I would like to meet the team if I can get there.

 

[TinnyCanMan]

Gonna look like a cyborg with my iontophoresis machine and now this device, I'm so ready.

 

[dj_newark]

The next Tinnitus Research Initiative conference will be in Dublin on 6-9 June.

Does anybody know if Dr. Susan Shore will present her latest results there? Will anybody from Tinnitus Talk attend this conference?

It's very frustrating that there are no news about the progress or results in detail on the web. I need hope to stay alive.

I just asked Dr. Shore that question, and also asked if the conference in France this September will be streamed on the Internet the way that the Palm Springs Hearing Seminar conference was. And this is what she said:

Hello Tim,

I am not going to Dublin. I am not sure if the meeting in France will be streamed.

Best,
Susan Shore

 

[UKBloke]

Once this treatment comes out, I'm going to ask the Bionics Institute if they want to do a pre-treatment scan. Then I'll fly to the United States, do the 12 weeks of treatment and go back down to Melbourne for a post-treatment scan. It would make concrete evidence if they can visibly see the brain changes.

This would provide incredibly useful information for us if you could make that happen.

 

[dj_newark]

Once this treatment comes out, I'm going to ask the Bionics Institute if they want to do a pre-treatment scan. Then I'll fly to the United States, do the 12 weeks of treatment and go back down to Melbourne for a post-treatment scan. It would make concrete evidence if they can visibly see the brain changes.

You won't need to stay in America for 12 weeks. You'll buy the device and take it home and use it. That's it!

 

[Markku]

Hi @Markku, when do you believe the device will be available to we peons, and do you know if it will truly work to help us or not?

I don't like speculating. For all we know, there could be a delay for reason unbeknownst to us, or things could advance quicker than we thought. All these timeline speculations I've seen don't mean anything to me until we hear it straight from the horse's mouth.

Will it work? I will only say that I will eat my hat if it doesn't work better than Lenire. Speaking of Lenire, did you know that Neuromod recently asked us to update our Here's Why the Jury's Still Out on Lenire article, because it, in their words, misses context and information since their latest study's publication (which occurred after our article went out)? I replied and asked e.g., if they have yet conducted any studies with a control group, if they have noticed any improvement in tinnitus loudness, ... You know what? Never got a reply.

Our BS meter is on high alert after all these supposedly effective treatments that have failed us, but so far Dr. Shore's work has proven to be on another level. It's not without faults, some researcher contacts of ours have voiced some concerns, and I sometimes worry about this extremely positive vibe in this thread, setting the expectations so very high. I wouldn't personally be surprised if the real life results were going to be somewhere between Lenire and what we have been shown thus far.

We hope to interview Dr. Shore as soon as feasibly possible. @Hazel is ready to travel to Michigan and record it all on video, as well.

 

[Jonno02]

Well how could they know the long-term results?

Well, it's 20 years in the making with several concluded clinical trials, so I'm sure they have some idea.

 

[Hardwell]

We hope to interview Dr. Shore as soon as feasibly possible. @Hazel is ready to travel to Michigan and record it all on video, as well.

It's good to see you interacting with the forum again Markku Zuckerberg. Has Dr. Shore indicated she'd be up for an interview? I can only imagine she'll agree when there's something new she's allowed to talk about. Especially how she's insistent on how busy she is at present.

 

[Markku]

Has Dr. Shore indicated she'd be up for an interview? I can only imagine she'll agree when there's something new she's allowed to talk about. Especially how she's insistent on how busy she is at present.

Yes, but the exact time is to be determined, and your conclusion is correct

 

[AfroSnowman]

It's not without faults, some researcher contacts of ours have voiced some concerns, and I sometimes worry about this extremely positive vibe in this thread, setting the expectations so very high. I wouldn't personally be surprised if the real life results were going to be somewhere between Lenire and what we have been shown thus far.

 

[EDDTEKK]

I don't understand why Dr. Shore is not attending the TRI conference in Dublin. I think in 2019 she attended the TRI conference in Taipei, Taiwan. If she has breaking news, why doesn't she want to share it? Aren't they all searching for a tinnitus cure?

 

[Hazel]

I don't understand why Dr. Shore is not attending the TRI conference in Dublin. I think in 2019 she attended the TRI conference in Taipei, Taiwan. If she has breaking news, why doesn't she want to share it? Aren't they all searching for a tinnitus cure?

Indeed, she attended the TRI in Taipei. I interviewed her there:

​

I do not know whether she will attend TRI Dublin 2023, but looking at the preliminary program, like @Markku already mentioned, she is not one of the speakers.

I think the issue is she doesn't want to share the final results until they are 100% vetted by peer review. I have to say, personally, I agree with this approach. The worst outcome would be to raise hopes or expectations that later turn out to be unfounded because the results, upon closer scrutiny, do not hold up.

Having by now read many papers on clinical trial results, it's clear to me just how complicated it is to evaluate the effectiveness of a tinnitus treatment. You're dealing with a condition that has no objective measure, is highly susceptible to the placebo effect, and also very heteregeneous in nature. This is why we've seen so many clinical trial results published in the past that at first glance seemed like a breakthrough, but upon closer inspection were anything but.

My point is that I appreciate the dilligent approach; the aim of science should not be to ease the impatience of this community but rather to practice good science. That's just my opinion, for what it's worth

 

[Jonno02]

I think the issue is she doesn't want to share the final results until they are 100% vetted by peer review.

I heavily agree with this, but also when you've submitted to a regulatory authority, you do not attend conferences and talk about your devices/results. Sometimes less is more. You don't want to make a comment about something that isn't covered in any great detail within the submission and then the regulatory authority catch wind of your comments and come back and ask for more data, proof, tests etc., that delay their decision.

 

[dj_newark]

I heavily agree with this, but also when you've submitted to a regulatory authority, you do not attend conferences and talk about your devices/results. Sometimes less is more. You don't want to make a comment about something that isn't covered in any great detail within the submission and then the regulatory authority catch wind of your comments and come back and ask for more data, proof, tests etc., that delay their decision.

So let's hope that by the time she speaks in France in September, the device is FDA approved!