New University of Michigan Tinnitus Discovery — Signal Timing

With the publication pending and expected soon, it's time to think of questions you would like to see answered in the paper. A chance to critique, criticise and question, much in the way we did with Lenire (very well) and Frequency Therapeutics/Otonomy (not so well) over the last couple of years.

So what questions/information would you pay particular interest to? Remember this is a publication and not a speculative piece, so expecting information on non somatic cases or reactive tinnitus is not going to be included.

For me:

1. How many were originally recruited and how many dropped out?
2. What were the reasons for dropouts?
3. How many side effects were they and what were they?
4. I want to see results from both groups, so those that received the treatment first and those that received the sham first. I don't think the preliminary findings had this?
5. The validity of the TinnTester as a recognised test.
6. Were there variations in efficacy based on chronicity of tinnitus?
7. Information on standard deviations, outliers for super responders and non responders.
8. Was information on comorbidities, like depression and anxiety, taken into account/randomised as this can affect particularly the THI scores?
9. Directions for future studies and/or research based on the findings?

Anything else critical?

 

The wide gap between decrease in loudness and TFI? (Is that because the average person with tinnitus is not greatly bothered by it?)

 

Critical for me is to know the length of time since tinnitus onset for each participant in the study.

 

Yes, I was sort of circumventing that at point 8.

 

I've wondered for a while if this is due to that level of tinnitus becoming their 'new normal'. I'll try explain.

If you have tinnitus at a level of 10 (on a scale of 1-10) and you're incredibly bothered by it, so you use this device. After a few months your level is now a 5. But that decline has been so gradual, it's not like a light switch where the tinnitus is turned off, so the reduction is on a gradient giving you time to acclimatise to it each day. You're hyper focussed on it as you're wanting to determine if the treatment is working.

When you reach the level 5, you're obviously going to be incredibly happy. But now that level 5 is your normal. You're still bothered by it, focussed on it and wanting it to reduce further. So it still bothers you. Yes, it's much more manageable than the level 10, but it's still there.

Not a great explanation. But it's like anything in life that eventually goes from abnormal to your normal. I'll try a few other short examples:

Salary. Oh a nice pay increase with a promotion. After 6 months, the salary has become normal so you're looking forward to your next increase.

Drive a fast car? For the first few months it'll feel really powerful. Then it becomes normal to you and doesn't feel so fast anymore.

It's like looking a photograph of a family member you live with from 15 years ago. They'll look so young in the photo, but you haven't noticed them age in real-time as you see them everyday and the daily aging progress is so slow. I reckon the tinnitus reduction day to day will be like this, but after half a year or treatment if you try and look back pre-treatment, you might then realise how much it's worked (or not).

Had the study gone on for months and months, and if possible to reach near total elimination of the tinnitus, would those scores show a vast improvement? Guess we'll find out in the near year or two...

 

In my opinion, for people with truly 100/10 tinnitus, not some hyper-focus OCD mental issues BS, any reduction would be phenomenal.

P.S. I think there is no reason why the improvements wouldn't continue/why you can't do it longer.

 

I certainly know if I could reduce this Morse code like buzz tone in my right ear by 25%-50%, then that would be close enough to a cure for me.

 

Susan Shore officially retired, as per last week, from the University of Michigan and will have Regent status.

(Source: PDF)

I guess this implies teaching and research.

 

Is it good or bad news?

 

Yes. It means that she will receive money from the retirement system, but will continue to work. This is a common situation in the scientific field. I couldn't imagine her leaving for good when the device is not FDA approved. It is the fruit of her life. I guess she will stop working and properly retire after it is approved and available in the market. Further developments might be done by her students. But I really hope she will be with us for the first part.

Please do not use retirement announcements to spread negativity.

 

Where am I spreading negativity? I'm stating the facts and basically saying the same thing as you. She will stop teaching and stop researching physically at the lab. Indeed this is very common. She will for sure still be involved in the background as an advisor. I guess she wanted her retirement to align with her FDA approval and the paper publication too. Who knows.

I'm just keeping people informed. Nothing more, nothing less.

 

Sorry. I did not mean that you are spreading negativity. I would like to direct that at people who will find this information disturbing and panic as a result.

 

Putting on the positive hat: She is so confident in the results from her study she now wants to focus primarily on her role of CSO of a company with a new blockbuster treatment.

 

It could also mean she's freeing up time to focus more on Auricle Inc.

 

To be fair, if I was about to become a multi millionaire from the launch of this device, I’d be sitting on a beach with a few cocktails rather than stuck in a lab.

 

Some of you savvy observers of this should attempt to pin University of Michigan down about:

1) Will a new team of researchers continue where Dr. Shore left off?

2) When on Earth is my Audiology Group going to call me about having this available? (Please recall that our Chicago Tribune on 01/2018 had an article in their Health and Wellness
Section about how this would soon be ready for distribution; come on, that was nearly 5 1/2 goddamn years ago).

 

Ain't going to lie, my heart skipped a beat for a second.

 

You bring this up repeatedly, but news outlets are in the business of getting clicks, not reporting news. Unless you have a direct quote in there from Shore's lab saying they were readying for distribution 5.5 years ago, I think your gripe is with your with your local rag doing misleading articles and not Shore making misleading claims. Heck everything we hear from her is incredibly constrained and conservative.

 

I'm sad that Dr. Shore did not release additional information for the tinnitus community, to clarify her plans. Now all we can do is speculate.

 

It is inexcusably irresponsible on your part to assume that whatever was published (in such a universally respected paper as the Tribune) is by definition in the business of getting "clicks", a "local rag", et. al.

Did it ever occur to you that during that time (as it does now) the Tribune had a very responsible, multilevel vetting process for all of their articles before they are granted allowance for publication?

In spite of your tone of such childish rancor, I can reassure you that such an article would not have been allowed without being thoroughly sourced and validated (I have known people who worked in this capacity for the paper).

My problem, capt'n, is that I will soon be 69 and I do not have that many years left to be kept waiting, year after year after year.

When the f**k is this ever going to be made available? You will get a mea culpa from me only when you answer this question (and why shouldn't you want to for your own benefit?)

 

That would be brilliant, but unfortunately that is only speculation. I hope @Hazel and @Markku will be able to ask Dr. Shore for clarification about her plans. Right now, the news of her retiring might be causing anxiety for thousands of people. I would be very grateful if someone clears this up.

 

Further to this, I reached out to a former PhD student of Dr. Shore's today (who was involved in an earlier trial).

Here are her speculations:

 

I concur. I see posts along the lines of “You’re a bunch of whiny whiners, there’s nothing you can do, so just don’t let it bother you.” But since mine started a few months ago, it’s gone from a 6 (as loud as great-grandpa watching Bonanza on TV and I went to Urgent Care) to an 8 (I woke up thinking a smoke alarm was ringing and went to the ER) but also all the possible 5-and-lesses. Including a few ones and zeros. One of the first posts I read said “Mine’s so loud only the shower or something louder can drown it out” and I thought “Oh no: I totally hear mine during showers.”

The idea that there might be a proper medical intervention that results in even minor improvements is so tantalizing.

 

I'd like to know how the device will work on/target tinnitus types that are not as easily identifiable as pure tones? For example sounds that are hissing, screeching, or rumbling.

 

I don't think the type of sound makes any difference. I don't think they even assessed the type of sound looking at the inclusion and exclusion criteria. So the upshot being, I don't expect anything in the discussion part of the paper on this, maybe acknowledging noise versus pure tone is the nearest you will get.

 

My brother is a professor at a university and while they don't do research, most of his free time is consumed with grading work, developing the curriculum for his classes, advising students, and planning for the next semester. If this will allow Dr. Shore to be free from those responsibilities to focus on Auricle or whatnot, I'm all for it.

 

You are the best. I had an anxiety attack after seeing the news of Dr. Shore retiring, but this made my day.

 

I don't get it?

 

Just take it as an endorsement that I believe, in the worst case scenario, this is going to provide us all with some much needed relief.