New University of Michigan Tinnitus Discovery — Signal Timing

[Mathew Gould]

My bet is that Lenire has a big competitive advantage. It now has a lot of data from patients, which allows them to improve and upgrade the device; this has happened in many industries.

I am still a big believer in Susan Shore, we supported her a lot with the STAT Madness and I will still support her, and I want to believe she is not launching the device until it perfectly works.

But I would also like to thank Lenire for launching the device, they have now a lot of feedback from patients and they can start an internal process to improve and upgrade their treatment in the following years.

If they both are reading this post, please don't stop trying to make our lives better!

Nothing ever "launched" or tried works the first time. Continuous improvement is more likely. She should just launch it, get results and then improve it.

 

[GlennS]

My bet is that Lenire has a big competitive advantage. It now has a lot of data from patients, which allows them to improve and upgrade the device; this has happened in many industries.

On the flipside, using paying customers to beta-test an unfinished product was bad PR, especially when you factor in those who have had negative reactions, some apparently permanent.

 

[GlennS]

From what I've read on the two devices / treatment methods I believe the Shore device will be the most effective.

Two? What about Minnesota?

 

[Christiaan]

Do you people think that it would be possible to hear silence again when using the Michigan device longterm? I thought I read somewhere that Susan Shore wants to test the idea in the next trial that long term use of her device might incrementally decrease the hyperactivity of the fusiform cells over time, which in turn could decrease tinnitus. I am living on a prayer here.

 

[F-u-T]

Do you people think that it would be possible to hear silence again when using the Michigan device longterm? I thought I read somewhere that Susan Shore wants to test the idea in the next trial that long term use of her device might incrementally decrease the hyperactivity of the fusiform cells over time, which in turn could decrease tinnitus. I am living on a prayer here.

Yes. I do think it is possible. If not silence then hopefully a big reduction that is easier to cope with.

 

[Piney]

Why does this device have a trial completion date years away? Is that an estimation? How much hearing do you have to have to use it?

 

[tommyd87]

Why does this device have a trial completion date years away? Is that an estimation? How much hearing do you have to have to use it?

This thing tends to have heaps of questions around it much like there was with Hough Ear Institute until they put out their video on the trial progress.

I'm pretty positive people have been questioning this device and also its progress probably for reasons like you have been and that there is no direct information forthcoming from those that are trying to make it.

I reckon it is a bit shaky and actually a medication will come first before this treatment does because of the vagueness and definite hold ups.

 

[gerhei]

Because we know she is never going to release it and when she does there will be no need for it since hearing regeneration medicine will be out by then to solve tinnitus.

Also tinnitus that is not caused by hearing loss?

 

[FGG]

This thing tends to have heaps of questions around it much like there was with Hough Ear Institute until they put out their video on the trial progress.

I'm pretty positive people have been questioning this device and also its progress probably for reasons like you have been and that there is no direct information forthcoming from those that are trying to make it.

I reckon it is a bit shaky and actually a medication will come first before this treatment does because of the vagueness and definite hold ups.

Medical devices have different trial requirements than drugs. I think the hold up on the trial is less the FDA and more investigating the treatment and how, when and for who it should be used.

This site has a good overview of drugs vs device trials:

https://premier-research.com/blog/perspectivesmedical-devices-vs-drug-trials/

Maybe you weren't alluding to the FDA here but using the video as an example of Hough explaining their particular delay.

 

[DebInAustralia]

So, skimming through this thread, does anyone know if Shore has indicated when her device will be released?

 

[Emgee]

So, skimming through this thread, does anyone know if Shore has indicated when her device will be released?

At the end of May, she indicated that they were in the midst of their second trial. She estimated it would be completed by early fall. I'm not sure if there are delays caused by COVID-19. Lastly, she could not estimate a timeframe to commercialization.

 

[Thuan]

At the end of May, she indicated that they were in the midst of their second trial. She estimated it would be completed by early fall. I'm not sure if there are delays caused by COVID-19. Lastly, she could not estimate a timeframe to commercialization.

What clinical phase is this supposed to be?

PS.
This thread was started in 2013...

 

[DebInAustralia]

At the end of May, she indicated that they were in the midst of their second trial. She estimated it would be completed by early fall. I'm not sure if there are delays caused by COVID-19. Lastly, she could not estimate a timeframe to commercialization.

Thanks Emgee.

Has she published her findings?

How many trials does the device need to pass through to get to market?

 

[F-u-T]

My guess is still a couple years away until we see any device available to purchase.

 

[GlennS]

What clinical phase is this supposed to be?

PS.
This thread was started in 2013...

How many trials does the device need to pass through to get to market?

She could have done a dozen by now if she wanted to.

 

[asey20]

Is the Susan Shore device the same as Lenire?

 

[WillBeNimble]

Is the Susan Shore device the same as Lenire?

No, Shore's device is more specific, from my understanding.

 

[DebInAustralia]

Is the Susan Shore device the same as Lenire?

No. They're not the same. I can't give you details. I know others here could. But, from what I have read, Shore teams sound therapy with carefully timed electrical stimulation to the trigeminal nerve with the placement of an electrode either on the cheek or neck, as opposed to Lenire, that involves sound therapy (that is not synchronised?) and placement of a mouth piece to deliver electrical impulses to activate the trigeminal nerve.

I have read about a poster's experience here who got trigeminal neuralgia during the Lenire trial (I hope they are OK now), and others who have experienced permanent spikes using Lenire.

I think I would be more comfortable using Shore's device if it is ever released to the market.

 

[BBakkers]

Not sure if this has been posted here already. I think it's from July this year. Nothing new, but it's some info.

https://www.ata.org/news/news/tune-atas-brand-new-podcast-dr-susan-shore

 

[Christiaan]

Not sure if this has been posted here already. I think it's from July this year. Nothing new, but it's some info.

https://www.ata.org/news/news/tune-atas-brand-new-podcast-dr-susan-shore

Thanks Bro And for those who are not energetic enough to sit out the whole podcast, here's the transcript.

 

[Christiaan]

Info about next trial:

 

[Adaś]

Not sure if this has been posted here already. I think it's from July this year. Nothing new, but it's some info.

https://www.ata.org/news/news/tune-atas-brand-new-podcast-dr-susan-shore

Looking there I read "In the fall, her team will begin the next phase of research, with the goal of replicating earlier results and gaining Food and Drug Administration approval for commercialization of the technique".

There's a transcript here: https://www.ata.org/sites/default/files/Podcast 7 Susan Shore Transcript.pdf

So I have listened to this podcast. Long story short, the next NIH funded trial is supposed to be concluded by the end of the next year, and depending on the outcome of this next trial that will look into e.g. long term effects of bi-modal stimulation therapy, they will decide whether to purse commercialization for this technique.

I guess we need to wait till (at least) end of the next year to know if this will work at all and if it has (any) chances of commercialization.

It is worth to listen to this podcast though. It is disappointing however that the hosts were so euphoric (nervously laughing) when Dr. Shore says the next trial is to be concluded end of next year. They were like "oh that so quick", even if she meant that as maybe... maybe they will start commercialization efforts if that trial goes well, without talking how long it would take to have it commercialized. It only shows how much we starve for some viable therapies and remedies for this condition.

 

[Watasha]

Not sure if this has been posted here already. I think it's from July this year. Nothing new, but it's some info.

https://www.ata.org/news/news/tune-atas-brand-new-podcast-dr-susan-shore

I don't think this one is new.

 

[ruud1boy]

I have read about a poster's experience here who got trigeminal neuralgia during the Lenire trial (I hope they are OK now), and others who have experienced permanent spikes using Lenire.

She wasn't part of the trial - she bought the device as a commercial patient. I feel pretty peed off that I've spunked the thick end of £3k on Lenire to no effect, but I'm thankful to say the least that I didn't experience any 'disimprovements'.

 

[Bambam0]

Not sure if this has been posted here already. I think it's from July this year. Nothing new, but it's some info.

https://www.ata.org/news/news/tune-atas-brand-new-podcast-dr-susan-shore

This podcast is from July 2018 y'all.

I emailed her a few months back and she said to expect news "later this year." Which would be in the next 4 months.

 

[BBakkers]

This podcast is from July 2018 y'all.

I emailed her a few months back and she said to expect news "later this year." Which would be in the next 4 months.

My bad then! Apologies. On google it said july 2020.

 

[Bambam0]

My bad then! Apologies. On google it said july 2020.

I just remember listening to that podcast a few years ago and confirmed by looking at the ATA podcast lineup. I'm just glad we're going to hear something soon!

 

[DebInAustralia]

I'm just glad we're going to hear something soon!

Hear something soon... as in commercialisation?

 

[DebInAustralia]

I emailed her a few months back and she said to expect news "later this year." Which would be in the next 4 months.

Even in the midst of COVID-19?

 

[Bambam0]

Even in the midst of COVID-19?

Yup! I asked her if there were any updates on Phase 2 trial and to quote her she said "should be updates later this year"

This was 5 weeks ago