New University of Michigan Tinnitus Discovery — Signal Timing

400 participants.

 

Yes, but the completed trial, the only one we have results for, and the one that we (or at least I) are basing our assessment of the potential likelihood of being a successful treatment had only 20 participants. The new trial may show that that treatment is effective, or it may show that the very small initial trial was a statistical anomaly.

One other thing about the initial trial is that it involved a sham stage and a treatment stage. As the treatment involved electrical impulses and auditory stimulation, how did the trial avoid the placebo effect (a very strong effect for those afflicted with tinnitus)? This isn't explained in their publication, but the answer according to @linearb is that they toned down the electrical stimulation so that it was no longer noticeable. If there is a possibility that this toning down was not completely effective, there is a potential for a placebo effect.

Yes, I think we are on the same page.

I said:

"Most tinnitus is somatic tinnitus I believe"

You said the CEO reported:

- The majority (anywhere between 60-80%) of tinnitus sufferers have somatic tinnitus and actually a lot of people don’t realize they have somatic tinnitus until they are shown or instructed how to do the proper somatic maneuvers.

 

How did Auricle show reductions in the actual tinnitus noise level? My question is how did they measure that?

 

So with your paragraph starting with "one other thing," are you saying Dr. Shore's device looks promising or not?

 

I think they used some kind of tinnitus matching software. It is explained in the paper.

 

Yes. This is from the paper:

“Change in Tinnitus matching loudness score (mean of weekly assessments for 4 weeks) from baseline tinnitus matching loudness score, for treatment and sham groups. Subjects are guided through a self-directed computerized assessment software that estimates how loud (in decibels) they perceive their tinnitus to be (TinnTester). This measure was performed at baseline, as well as time points following active, washout, or sham periods.”​

This is from a summary article of the 20 original test patients from the 4 week trial:

“Overall, the loudness of phantom sounds decreased only after the actual, or bimodal, treatment, but not the sham treatment of sound only. For some, the decrease was around 12 decibels, about the equivalent of making it half as loud. Two participants said their tinnitus disappeared.”​

 

Late to the party here, how many of the participants in the 20-person trial didn't respond at all?

 

I wonder if Dr. Shore's treatment device works for other causes of tinnitus apart from noise induced, like inner ear diseases, otosclerosis, vestibulopathy, Meniere's etc etc. But maybe it's too early to know.

 

Is this a device that you would be able to use at home on your own or would you need to go to the office of an ENT or audiologist for this treatment? My audiologist indicates that you would need to receive this treatment at a professional office.

It surprises me that Susan Shore indicates that 2/3 of cases are somatic. It sounds like she wants to make some changes to the device to treat other types of tinnitus. I have certainly not conducted my own studies but it seems that somatic cases would comprise a much more minor group of tinnitus sufferers. It also concerns me that this device may not be effective for non-somatic cases.

 

Actually Lenire made my tinnitus about half as loud and less intrusive. So if Dr. Shore's device is any better, it will be our gate out of this hell.

 

Sounds great.

Do you still use Lenire?

 

You can read for yourself here:

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

(I think at a high level about 50% of people get about a 50% reduction).

 

Are you sure, that Lenire did that magic or did you just adapt, habituate etc.

 

350 hamsters and 50 humans?

 

And what's the logic behind this statement?

 

The true mean is what it is.

Any trial with any number of participants will find a trial mean. The greater the number of participants involved will find a trial mean closer to the true mean with a smaller confidence interval.

The true mean is the actual efficacy of the device. trials don’t change the true mean, they are just helping us discover the true mean that is currently unknown to us.

Trials don’t change reality, they just help us discover what reality is.

 

Hence a smaller trial is less likely to reveal what that reality is, which really should be common-sense to all concerned.

 

You can use it at home.

But for setting up the device you will need to see a professional of some kind (audiologist?)

I hope we will know more details in 2022!

 

I also had some improvements. I went from several sounds down to two. I have some good days now whilst pre-Lenire I didn't even have a good minute.

I'm hopeful this new device from Dr. Shore will help, personally I don't give a hoot what it costs.

 

Are we of the understanding that Susan Shore’s device may provide relief for all types of tinnitus, including non-somatic tinnitus?

 

I don't think it has been established one way or the other. Somatic patients were selected for her study because they were the patient population that could definitely impact their tinnitus through physically moving the nerves she is targeting.

It is an open question whether those that can't change their tinnitus through head and neck movements would be benefited by her device. I would be agnostic on whether it would benefit non-somatic tinnitus sufferers.

 

Since you used the word "may", I believe your statement is strictly correct, but what's more likely is that it will help with some types of tinnitus, including tinnitus that isn't considered somatic but works off of similar mechanisms. I wouldn't say "all", though. Certain types of tinnitus aren't related to the mechanisms that her device targets, so I wouldn't expect those to be affected by the device.

 

I recall Susan Shore referencing that somatic cases are 2/3rds of all tinnitus cases. I would think that somatic cases are a much smaller number of cases.

 

Somatic tinnitus just means that you can temporarily change your tinnitus loudness or pitch by making some neck and/or jaw movements. I've read from multiple sources that 60-80% of all who experience tinnitus can do that and so they have somatic tinnitus.

 

Yeah I believe it’s likely hearing damage that can be altered like you stated.

 

Does anyone know if Dr. Shore has applied for FDA Fast Track approval?

 

Can someone please summarize the status of Dr. Shore's device, results of trials, and next milestones/target dates?

 

Once the device is on the market that should bring some of the answers. If Lenire did it, why not Susan Shore?

 

Results not available till April 2022.

Shore is commercialising her device via Auricle.

I've emailed her about FDA approval and fast tracking. Waiting for reply.

 

Send an email to the CEO.