New University of Michigan Tinnitus Discovery — Signal Timing

Yeah, that was the Q&A from the recent webinar, not the original Tinnitus Hub Q&A discussed here. I was also referring to that in my posts, so hopefully, I will see a significant and meaningful reduction for severe tinnitus beyond the average reduction shown in the study.

 

I don’t believe for a second that Dr. Shore hasn’t known the answer to this. She must have a few of these devices, and I’m sure friends and family would have benefitted from using the device behind closed doors. Surely, she knows someone with intrusive tinnitus. For all we know, treatment for longer than six weeks could have cured people, but she can’t say.

 

I imagine there may be diminishing returns at some point, but hopefully, I'm wrong.

 

Also, it feels like the hyperactivity could objectively be observed continuing to diminish, even if just anecdotally, on a single test animal. A curious researcher would have tried that, even if it's not documented somewhere.

 

How is someone coming along every week to say there is no news helpful in any way? It's stating the obvious. Many people want this thread to stop needlessly going round and round; every notification raises hopes and then dashes them.

How is me getting pain from noise and not being able to use the device funny to you? You are another idiot troll who contributes nothing; this is exactly what this site needs.

@Bob3382, this wasn't meant to get at you or try to silence you. Please, if you find actual new news about the device, post immediately. "No news" isn't really useful information. Sorry if it came across as confrontational; it wasn't meant to.

I also have loudness hyperacusis, but that has improved a lot. My noxacusis, on the other hand, hasn't and is seriously debilitating. I'd love for my severe tinnitus to go, but at the risk of getting severe or catastrophic levels of noxacusis, I don't think I could even bring myself to test the device.

 

I agree with most of your posts; however, 10.9 dB is the mean. Some had fewer reductions, and some had more. If I remember correctly, there was a scatter graph way back in this thread showing the variation. Generally, you don't want too many at each end, as they can skew the results.

 

Right, it sounds like you are saying the same thing I did. 10.9 dB was the average (mean average) with some getting more reduction and some less rather than an individual max of 10.9 dB reduction. That's what I mean about the charts showing the average, and that is why you can't assume 10.9 dB is the maximum reduction for any individual, as someone might think is implied by another post that said "up to 10.9 dB."

Here's the scatter chart:

 

As of 2020, I have a reserve of $10,000 set aside for Dr. Shore's device. So far, it doesn't seem that Auricle is interested in it. It's a business model to think about.

 

My guess is that it will cost around what Lenire does. Good on you for saving that much for it, though!

 

This shows the wide range of responses to the treatment. Some did not respond to the treatment at all, some only slightly, some well, and some superbly.

This is to be expected, as in all diseases, one size rarely fits all!

 

Do we know if the patients whose tinnitus did not reduce after the treatment could modulate it using neck and jaw movements?

I can't remember, but I think the study did include this type of patient.

I'm asking because it's possible that symptom reduction worked better in people who could modulate/enhance/aggravate their tinnitus via the somatosensory pathways (trigeminal, dorsal).

 

I live in Ireland but plan to fly to America to pay over the odds to any audiologist who will treat me. I will happily pay double the price for the device.

 

I always save money for contingencies, so I have about that much, but I also have a home equity line of credit, and if it costs more than I have in savings, I will pull the money out in a heartbeat.

Several people here are well-versed in clinical studies and statistical analysis of such studies, and they have conclusively shown the reliability of what has been completed. It will not cure anyone, but it will help a great majority of people. I, for one, want to thank the people (@RunningMan for one) who have taken the time to read the study and can understand it. I read the documentation but got lost in the details. But overall, it is the only truly promising thing on the horizon.

 

Everyone in the trial should have been somatic. It was an inclusion criterion for the trial.

 

All participants had somatosensory tinnitus.

The study design was good, and the results are promising. I disagree it's the only promising one on the horizon. Preliminary preclinical results from the Extracochlear studies look magnitudes better. Read the Research News threads on it.

 

Here's hoping!

What's crazy is that you're basically paying for the research/support/etc., whereas the actual cost of a device with the potential to save billions in productivity/sick leave/appointments/additional healthcare/support resources costs is probably what to produce... $10? $15? What a time to be alive

 

To meet eligibility, the study said, "Must be able to modulate their tinnitus with a somatic maneuver." There's a long list of those maneuvers in the supplemental document, which also says, "Reduction in TFI Significantly Correlates With Number of Somatic Maneuvers Eliciting Any Change in Tinnitus During Active Treatment"

 

It’ll be interesting to see how it plays out with insurance plans as well. My guess is that most, if not all, of it will be out of pocket. I would also expect it to be similar to Lenire in pricing except I’d feel happier with my purchase.

 

Does this mean that the more somatic your tinnitus is, the better the chance of the treatment working?

 

Why are there so many dots on the chart? I thought with 99 trial participants, I would only see 99 dots, but the chart looks like way more than 99.

And are we saying anything above the horizontal line is an increase in tinnitus volume? If so, I see purple dots (active treatment), and there are a lot of purple dots above the line, so that’s a lot of worsenings, but the trial results didn’t mention a lot of worsenings.

On that same note, there are some purple dots below the horizontal line, but to the right of the vertical line, it feels like a decrease in volume but an increase in THI score, which feels old.

Finally, if each mark on the y-axis for loudness is worth 6 decibels, some purple dots are approaching 8, so are we saying that’s 8 multiplied by 6, so a 48-decibel reduction? I’m sure I’m reading this all wrong!

I appreciate any answers!

 

Because the chart shows multiple measurements for each participant over time, allowing researchers to track changes and trends accurately. However, it doesn't specify which dots are related or indicate the stages at which improvements occurred, making it difficult to discern which measurements showed the greatest improvement.

Despite this limitation, the chart provides a good bird's-eye view of the changes in tinnitus loudness and TFI scores & holds promise for the treatment going forward.

 

The worsening cases, for the most part, are not significant. Perception of tinnitus varies daily, and many people have different perceptions of it. Likely, the treatment was just ineffective for them. If you take 100 people and treat none of them, some will report worse scores a few months later when retested.

The dots probably reflect both arms of the study for both groups. We look for a correlation, which is towards a decrease.

 

That scatter chart was from the PP group, so 56 were included in it. The ITT chart is also in the supplemental document.

Here's one that has the TFI results for each participant in PP for each phase and specifies that it is for only 1 arm of the study. It doesn't show loudness reduction since it correlates TFI reduction to somatic maneuvers. TFI reduction of at least 13 is considered clinically significant:

 

Thanks for posting this. But I am a little confused. It appears that the people with the lower maneuver counts had the larger decrease in TFI.

I guess I don't know what a maneuver count is, but knowing nothing, I would assume the higher the number, the more movement affected the tinnitus.

I hope that it is more effective for those with lots of ways to modulate their tinnitus because I can modulate my tinnitus with all kinds of face and jaw maneuvers.

 

Exactly. I wondered the same thing and was waiting to see if anyone would notice/mention that. It seems backward from what I would have expected, so maybe it's an error in the chart. That would be another good question for Susan Shore.

 

Right? I'm sure most who read that were like SHIT, I can only do it with my jaw or scrunching my face. Wait, does this one count? This one? Hmm, this one? Maybe this is good!

I think, realistically, this is probably a useless correlation.

 

Considering standard inflation and the fact that the Auricle device claims to be an improvement over Lenire's product, I think it will be closer to the $4-5k range.

I doubt insurance will touch it.

The bigger question is if they plan on having some return or buyback policy for those. It doesn't help. It doesn't make a lot of sense to have potentially half their products gathering dust on shelves when they can be returned/refurbished.

Lenire is non-refundable. If it doesn't work, you're out $3k.

 

David Martel has been tinkering with TinnTester on Github again. He has uploaded some docs and made a few tweaks to the code.

Also, Auricle has hired a grad student part time, so that would be the first known non-executive (Pearson, Shore and Martel being CEO, CSO, and VP of R&D, respectively). From his LinkedIn profile: "Developing ISO 60601 compliant mechanical design and supporting documentation for take-home tinnitus treatment device. Utilizing 3D printing and CNC routing to design and fabricate parts for ambient sound rejection and improved EMI testing."

Take it as you will, but I don't think the device is coming to the hearing aids dealer near you any time soon.

 

Hopefully they do. I'd be surprised if they didn’t considering it could potentially ruin the image of the company and possibly Dr. Shore herself.

 

Why do you think this signals a delay, causing a longer wait?