New University of Michigan Tinnitus Discovery — Signal Timing

At 150 miles you could actually move closer fairly easily. I don’t even know if I consider 50 miles to be a hardcore move or anything.

And the way I got a response was by clicking the “I’m interested” button on that newsletter link posted above. I tried emailing both Susan Shore and her assistant tech directly with no response.

 

That's an utterly ridiculous stipulation.

 

Yep. Funny how politicians can move last-minute to compete strategically (think Hillary Clinton moving to NY) but people suffering from medical problems can't move to be part of a trial.

 

“The IRB is charged with the responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human participants. The IRB is concerned with protecting the welfare, rights, and privacy of human subjects. “

Thank you so much for protecting me against possibly getting treatment for the worsening severity of my symptoms. I’m extremely appreciative wth is wrong with their IRB

 

I'm not a researcher but I can imagine why they so stipulate, with the baseline being the desire to remove as many interfering variables as possible including (I think it was mentioned in this thread) people experiencing stress due to relocation. Many would be away from friends, in unfamiliar surroundings, hoping against hope it will help after all that effort.... Given the emotional connection between tinnitus and our psychological reaction to it--at least in many cases--I don't think that's nuts. I also expect they don't want to deal with folks disappointed with receiving placebos after the additional expense and effort of a move.

I say this as someone with moderate to significant tinnitus and by that I mean, probably at a point where I can cope with it most of the time, compared to our friends on this board who are much more painfully afflicted. So I get where y'all are coming from.

 

Nah, I don't think so. I was involved in the Phase-I as a "travel patient", I was the only person who did this, and I think it caused them to sort of evaluate that process.

There are two other good reasons that they have this policy:
* they have become so inundated with queries as a result of published research and medical papers, that they now have a large pool of interested local potential test subjects
* someone who is so desperate that they are willing to literally uproot their life and actually move, is not going to be a good test subject, because when you get yourself that personally invested in the research, you desperately want it to work. I had some amount of grappling with this, "I am super personally invested in this because I've spent thousands on travel", but the money wasn't much of a worry to me at that time, and I wasn't living there. I also don't think that I was desperate enough at that time to actually move to Ann Arbor full time, and if I had been... I would have been an even worse test subject.

Their concern right now is data aggregation sufficient to clear FDA hurdles for marketing. Trying to accommodate severely anxious or highly distressed patients who are willing to relocate just for the potential to maybe get relief for a few weeks only.... that's just peripheral distraction to the base goal of "prove this works ASAP, sell it so we can get these into peoples' hands, provide long term relief, and be profitable".

Frankly, my own experience as their only travel patient, might have something to do with why that exclusion exists; I think we both learned some things from that process. As far as I know I was either the literal best or one of the best responders to the treatment; the degree to which I was personally and financially invested in it, casts a small shadow on that.

Oddly this did not stop them from contacting me prior to the start of the Phase-II to ask if I wanted in.

 

You didn't want in? I'm thinking because you didn't want to move again, right?

 

Really good point given the placebo effect.

 

Isn’t Dr. Shore’s study closed for new patients now?

I got a reply from a local ENT...
“Thank you for contacting re the OTO-313 study. Can you tell me something about your tinnitus. Start date, severity, one-sided or bilateral, any associated hearing loss, intermittent or constant, etc.”

 

I didn't move the first time; I flew in and out constantly for the study. I would do it so that I'd fly in Thursday, be seen, stay at an AirBnB through Tuesday, be seen in the morning, fly back to DC area in the afternoon. Then, do the next thing a week from Thursday.

I didn't want to do that again because:
* Between phase-I and phase-II we switched from "dual income, no kids, live right next to major airport" to "single income, have a kid, live in the woods an hour from a regional airport"
* I already did the trial. I believe this tech will work on me if it ever reaches market. It was interesting to be a lab rat, and it was super cool to get to spend so much time in Ann Arbor because it's a really interesting and fun city and I actually considered moving there as a result. But, I probably spent ten thousand dollars between travel, accommodations and doing stuff while I was there (I made something like 8 of these trips?). That's sort of a one and done for me.

 

@linearb

Forgive me as I'm sure you've answered this already, but how was your response to this trial? What happened along the way, and more importantly, why didn't it last? Probably a hard question to answer. Did your tinnitus go away fully? Did it just come back out of the blue or slowly?

 

@linearb
So the treatment didn't work for you?

 

Looking for reasons to keep up hope today, so if you don't mind sharing how effective/how much relief did you get when you used it?

 

I'd acknowledge your respective arguments @Chriscom and @linearb, if we were still in the early stages of this research, but we're not. We're at the final gate prior to bringing this machine out into the public after nearly twenty long years. At least as a first generation device.

This phase two for a medical device, is the equivalent of a phase three for a drug. It's the time when you open it up to anyone with 'the condition' to prove it definitively works, with the only relevant conditions being the nature of one's tinnitus and hearing ability. Providing you make yourself available for all testing requirements, where you live or how far you travelled to get to the testing site, should not be pertinent to the devices efficacy.

If desperation for Dr. Shore's device to work for you, will unnaturally influence test results at this late stage, then surely no one should travel outside of their town to buy it, if it becomes available, lest your desperation renders it useless. Then one will simply have to wait till it arrives in your city so you can calmly walk or Uber to the treatment centre to maximise effectiveness, apparently stress free.

If that all sounds like a bizarre scenario, it's because it is! No matter where you come from to get your hands on this machine, you'll well and truly be invested in it.

I have faith in Dr. Shore's integrity, though she's really dragged her feet in moving from stage to stage, but I must admit, it really plants niggling seeds of doubt in my mind when I see such silly limits placed on participants at this final stage. Why do it? She doesn't need to fiddle with the goal posts. This thing either works or it doesn't. I just wish she'd hurry the hell up!

 

I may have misinterpreted something along the way, but wasn't there chatter that she was having a hard time filling the slots? My stance is you can be as picky as you want up to the point where the process has slowed to a crawl because of it.

 

I didn’t see an open link to apply... I didn’t see it on the .gov website... Is it still there?

 

https://umhealthresearch.org/index.html#studies/HUM00143675

 

On the trial website, it says that it won’t be completed until 2023. Why is there talk about it potentially being released commercially earlier?

 

She has recently said she hope's for results in mid 2020 and possibly even commercializing later the same year.

She has actually been saying she hopes for 2020 commercialization for some time now, but she doesn't promise it.

The overall study might be to further refine the device even if it does commercialize, or maybe she set that time as a just in case kind of thing. Either way, when I last emailed her, she said the results appear cumulative, so the more benefit the longer someone uses it. It could be that she has been seeing enough good results that she believes she won't need to wait until that time to be able to commercialize the device as the FDA could already be looking at it.

 

@ChrisBoyMonkey man, I hope she releases it in 2020.

 

(From FX-322 thread)

She’s testing patients with unilateral tinnitus only, correct? Someone on here said that unilateral cases are “very uncommon” so I’m sure one of these statements is wrong. I’m curious since I have unilateral/central tinnitus but definitely none isolated in my right ear.

 

Yes unilateral is preferred for her trial but I don't think bilateral excludes someone.

 

Sorry, as I recall you have unilateral tinnitus, i.e. predominately in one ear, yes?

 

Yes. Only thing is I'm currently nowhere near Michigan lol

 

I know dude... you are in Cali. Hope your ear pain goes. Maybe when they put on the numbing cream they were too forceful? Take it easy...

 

True unilateral is pretty rare, especially as it becomes chronic.

 

Shoooot, I thought unilateral was quite common, and as the perception of tinnitus becomes “chronic”, it shifts to the center and feels more “balanced”.

Do you have one ear that’s better, or did you back in the day?

 

Thanks man, it's not that bad. When it was bad it was only for a few seconds but I haven't really felt it since.

 

Dr. Shore was originally interested in somatic cases, no? I’m beginning to believe there’s a significant somatic component to my central tinnitus tone because it ramps up when I press on the back of my head/neck, and once my neck has reclined. Is her device thought to alleviate these cases as well?

 

Yes that's an inclusion criteria for her trial. She's not sure if it works for those whose aren't somatic yet.