New University of Michigan Tinnitus Discovery — Signal Timing

https://clinicaltrials.gov/ct2/show/NCT03621735

Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : January 2023

So a long way off!

 

Oh yikes! Here's to hoping the Lenire device works.

 

I may be wrong, but I think that none of the other two bimodal projects will come out on the market before 2025.

 

How sadly ironic that my previous facetious comments about how the Glaciers formed the Great Lakes in less time than it is taking for certain research institutions to release an effective treatment is actually accurate.

As annV indicated, let's anticipate that the combined technology that created Lenire will be sufficient as a treatment.

 

With the number of companies working on hearing restoration and tinnitus treatments, Dr. Susan Shore might find herself to be completely irrelevant by then. Unless she's got something up her sleeve it seems Neuromod has already beat her to the punch anyway.

 

I emailed Dr. Shore about this trial, hoping to maybe get in. She said that they plan to begin commercialization next year.

Just thought I would pass this along.

 

I thought that was the timeline they were operating on. If that's the case they have a good shot at competing with Neuromod. If I had to choose between the the two I would rather plunk down the $3000 on Shore's device.

 

Do you know if that means as in having a clinic for patients up and running next year (I doubt it...), or just some sort of step towards commercialization?

 

From what I've read in the past they want to bring it to market in 2020.

 

Whoooaaaaaaaaa that's crazy good news. Awesome find!

 

Sadly there is no information about the effectiveness of this device in cases of non-somatic tinnitus. I asked her some time ago and she answered "We don't know, but it might work".

 

P.T. Barnum
“The public appears disposed to be amused even when they are conscious of being deceived.”
"There's a sucker born every minute"

 

The way I read it was that she planned on it being on the market next year. But I could be wrong.

I never asked her when she thought her device would be on the market, she added that in to her response on her own. So I hope this is promising news.

 

they have consistently said they're targeting 2020-2022 for first commercialization, pending FDA approval and completion of parts of the Phase-II.

Current phase-II will not complete until later than that but I was told early on that would not necessarily be an impediment to market.

 

Makes sense. Thank you!

 

This is interesting news. I have always been hoping that Susan would get the credit she deserves for all her work.

My hope was always to go with her device, but it seems to be moving slow. I am still going to keep my appointment with Neuromod. I will be curious how she gets FDA approval without finishing the trials. I do know that they are less stringent on medical devices versus drugs.

 

There seems to be so much conflicting information regarding commercialization of their device. Some people say that they talked with her and she said commercialization will start next year, others based on trial information say as late as 2023.

 

Are you able to post her email reply to you?

 

Sure.

"We are currently running a trial. If you live within 100 miles of Ann
Arbor you may be eligible. We hope to begin commercialization next year.

I can't comment on Lenire as they haven't published any controlled
clinical trials.

Best wishes,

Susan Shore"

 

I have a good feeling about this.

 

Next year, I thought it was 2023??? I think I would be a good candidate for this method given I have no hearing loss...

 

Hey! Could you PM me? I tried to PM you but it wouldn't let me.

 

Do we know if anyone from Tinnitus Talk is taking part in the trial?

@Markku

 

Susan Shore e-mailed me back yesterday and she said her audiologist will contact me next week to see if I am eligible. I am pregnant so I hope that doesn't exclude me.

 

Interesting that she said, "within 100 miles", and not "within 100 miles or willing to travel". I did the latter, it was a nice excuse to spend a bunch of weeks in Ann Arbor which is a pretty cool little city.

 

Things are going to become expensive for me, first Lenire, then Susan Shore's device... mmmhhh decisions.

 

I got a similar email.

 

At least it is two remedies that might be able to relieve you from hell - and not stupid moronic stuff like ear candles

 

Shore's device has been used on 20 patients with only somatic tinnitus... (and claiming, it so seems, to be on the market next year based on 20 people??)

Neuromod's device has been used on over 500 people with rigorous clinical trials and been submitted for peer review

I would seriously want to see the evidence before parting with a couple thousand... I know what desperation does to one suffering but there’s nothing worse than buying things to be disappointed you’ve been conned (not saying it’s a con - but more trials are needed to build an evidence base and likelihood of it working).

 

Agreed, you would think that something that is priced at 2500 EUR would be supported by published clinical evidence. Granted, we have seen much worse in the past, with expensive treatments having zero or very little evidence. At least Neuromod seems to have done a lot of work, even if they started commercialisation before the review publication. I still believe that asking people to pay 2500 EUR before you publish the evidence only works because people are desperate for relief, and I perfectly understand that, but in an ideal world Neuromod would have published the review before the commercialisation. Oh well, in an ideal world there would be no tinnitus.