New University of Michigan Tinnitus Discovery — Signal Timing

I assume it was Dr. Susan Shore's 2017 trial that McMaster University in Canada was working with Michigan University, but I heard Dr. Larry Roberts passed away so not much went on with it...

 

I was going through her proposal and I have a few questions that some of you might know the answers to (it is hard to read these when I'm just hoping that this will work and it'll potentially work for me).

1) What exactly does "no greater than a mild hearing loss up to 6 kHz" mean for her study? Did those in the study need have perfect hearing below 6 kHz? What if the tinnitus is likely related to mild hearing loss at frequencies higher than 6 kHz?

2) Does our tinnitus need to ring, hiss, scream only at the 5 kHz level for this to work? It looks like she is testing specifically those whose tinnitus rings, hisses, screams, etc. at 5 kHz.

Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts

 

I'm pretty sure you have to be able to hear the audio tones for this to work, so no more than moderate hearing loss is a criteria to keep the data clean.

 

Generally that would mean that when you look at the audiogram, at no point before 6 kHz does the measured loss exceed something like 30 to 40 dBHL for 'mild' loss, and 40-55 dBHL for 'moderate' loss at around the tinnitus frequency. Thresholds vary, I'd have to double check what they defined it as.

Keep in mind that these were criteria for maximising the useful information in their research, it's not necessarily the threshold for treatment being viable.

EDIT:

The consent form specifies:

No greater than a moderate hearing loss at the tinnitus frequencies (≤55 dB HL) and no greater than a moderate hearing loss (≤50 dB HL) from 125 – 6000 Hz.​

 

Any old timers (I'm looking at you @linearb) know how long it took Dr. Shore to announce results after her first study closed?

 

For what it is worth, Dr. Shore’s prior paper was published in March 2018, whereas I believe the preceding study results came in May 2017. See below links.

Auditory-somatosensory bimodal stimulation desynchronizes brain circuitry to reduce tinnitus in guinea pigs and humans

Auditory-somatosensory Stimulation to Alleviate Tinnitus

 

10 months to publish the results of Phase 1. Ugh.

 

The study protocol has been posted today.

An interesting read to warm up for the finale on 3rd of December and has some more insights on using the device:

And also interesting to those asking about hyperacusis and listening to the device's sounds:

PDF: ClinicalTrials.gov - University of Michigan - Consent Document

 

”The position of the pads will be determined by the manner in which you can modulate your tinnitus.”

In other words, it doesn’t work if you can’t modulate the tinnitus?

 

"4.5 Am I allowed to share details about the study and my personal experience within the study to the public via Internet, tinnitus support groups, newsletters, etc.?

In a clinical trial there is potential for research participants to draw their own conclusions, based on their subjective experience, that may differ from the bigger picture (ie. biased). In an effort for all participants to be unbiased, we ask that you please refrain from sharing with the public (via Internet, tinnitus support groups, newsletters, etc.) your personal experience using the device and Section 4 of the Informed Consent. This is to ensure our results are valid. If we do find you are sharing this information, you will be asked to leave the study. After participating, we highly encourage you to remain quiet as it may affect the experience, and possibly the results, of participants still enrolled in the study."

 

In Shore we trust!

I think it only works if you can modulate your tinnitus.

Joke's on them, I have both kinds!

 

I wish I could just buy it and play with it. I know I can’t and I shouldn’t. But I still wish I could. Last year I purchased and tweaked a CPAP machine to my linking. Now I sleep way better in spite of the tinnitus. But that’s besides the point.

Fingers crossed for everyone! Seems like this is our last best hope for peace and quiet in the short term. In my case I can modulate the tinnitus just by yawning, so I hope it helps, even just a bit.

In Shore we trust!

 

I can modulate mine too, so fingers crossed.

If the results turn out to be positive, I'm curious to learn in what capacity this will be available in Europe.

 

As someone based in the UK, I'd be keen to understand too. To be honest I'd be willing to travel to the US if needed.

 

It's the only possible treatment in the short-medium term for sure. Nothing else per say is in trials for chronic tinnitus at the moment.

 

@Samwise_The_Loud, yes, I'm UK based too. It would be interesting to see if our NHS approve it and it makes its way into audiology appointments. Lenire has not made it into any clinics (not surprisingly) which tells you all you need to know.

If it gets into the NHS, they know it works, at least in a decent percentage and will serve as a good barometer for the rest of the world.

 

It is more than depressing, it is TERRIFYING to realize that Dr. Susan Shore's device seems to be our last hope to alleviate our tinnitus.

Indeed, almost all other treatments have failed or been abandoned.

If her device doesn't make all tinnitus sufferers better, we will probably have to continue to suffer and live in isolation until we die

 

I said short-medium term, not forever...

Probably looking at 10 years, although I maybe shouldn't say so as I saw this said 10 years ago on here.

 

Your comment basically sums it up. 50 years from now, we will have an effective and safe tinnitus treatment in about 5 to 10 years...

 

Dammit! Get it through through your thick skulls that Dr. Shore's treatment will likely be potent treatment for a broad swath of tinnitus sufferers that will be available to all somewhere in the next 1-3 years. It's not a cure, but it will almost certainly be life changing for the majority of us to have this technique alleviate our symptoms in a meaningful way.

 

The name of Dr. Shore's December presentation has changed.

From: Michigan Tinnitus Device: Improving treatment for patients with tinnitus

To: Shore - Precisely-Timed Bisensory Stimulation to Treat Tinnitus

I don't like that. The original name was really focused on the novel device. Now the name is more generic. We can only speculate on why they took their time to change something small as the name of the presentation. But apparently they found it relevant so we should find it relevant too.

 

Personally I’m trying not to read too much into it. It could just be that the first title was too narrow and that the second one reflects more the science behind it.

 

The very simple explanation for that is that the device will most definitely not be called the Michigan Tinnitus Device, and that the name isn’t finalised yet, which shows they’re already thinking about distribution.

 

Michigan Tinnitus Device is a terrible marketing name.

I’m probably reading into it too much but I think it’s interesting that it’s the final presentation of the seminar.

 

Read nothing into that. I actually also don't think she will go into detail on Phase 2 because she's prim and proper and the write up is not published.

I expect content on the animal trials, Phase 1 human trials and mechanisms of action.

 

I also like she was given the last slot on the last day. Clearly they know everyone is going to stay to see the unveiling of results.

You know (and I am super negative about the chances for real effective tinnitus treatments in the short to medium term), if her results are strongly positive, there will be a rush of researchers and companies to expand and improve the use of bimodal stimulation tech. What I mean to say is if this works, this will be the first word and not the last word, one that might see rapid increase in spending and research.

I'd be much more concerned if she had changed to Precisely-Timed Bisensory Stimulation Fails to Treat Tinnitus

 

The positive thing is that is says ”...to treat tinnitus”. It doesn’t say somatic tinnitus, so hopefully it will work for other causes too?

 

I've already addressed this. I've had an email exchange with Dr. Shore where she's confirmed that she will be presenting new information at the seminar on December 2-3.

You must have missed it so here it is again.

My email to her:

Her reply:

So in other words, she's not going to be talking about the old data from 2017. She'll be presenting based on the trial that recently concluded this year!

I don't know this for a fact of course, but what I HOPE this means is that she expects to be published by then. But really, who knows?

 

It is weird they would change it. Hopefully the results weren’t a bust.

 

@dj_newark, thanks. Yes, memory failed me. Early tinnitus dementia ;-/