New University of Michigan Tinnitus Discovery — Signal Timing

I'm inclined to think the name change was to make the title more informative and attractive. It is possibly the case that not everyone at the conference is familiar with the Michigan Tinnitus Device itself, so by including the technique used (bisensory stimulation) in the title instead may make the presentation more attractive to other researchers.

 

Let's hope you're right and that my well-founded pessimism is misplaced.

 

Gotcha! I feel the same way. Good thing Dr. Shore is on the case.

 

Just looks more like it went from working title to presentation title... and it seems less generic.

I asked someone who is a published PhD in statistics if it's odd to change a presentation title and they said yes. I read them the titles and they said it just sounds more precise now.

 

I guess why this worries me that there are two presentations now with essentially the same title.

Friday, December 2, 10-11 am: Shore - Altering Plasticity in a Brain-stem Circuit to Treat Tinnitus in Guinea Pigs and Humans

Saturday, December 3, 2-3 pm: Shore - Precisely-Timed Bisensory Stimulation to Treat Tinnitus

My doomsday thinking is that she will go in-depth on the technique with conclusion that the protocol needs further development, hence moving away from the focus of the device. But I'll not spoil the fun. 2 months to go. My timer to market for the first treatment is currently set on 14 months. Hoping for an FDA submission in February, an approval in September and initial device availability in December.

Lenire is launching aggressively in new EU countries almost on a weekly basis. Really rapid growth of the installed base.

I've been doubting many times to ask Jon Pearson of Auricle if/when the licensee is made known. I have done extensive e-digging but not a trace lol.

 

Changing the title of presentation could come from any number of places:

1) It could be that the people running the conference wanted the title changed for some reason.
2) It could be that the results were less solid than we had hoped.
3) It could be she had positive results and came up with an even better idea to reduce the volume even more.
4) It could be that there is some sort of naming issue going on with whoever is going to produce the device at scale.
5) It could be that her presentation is about the science behind her solution, not an infomercial about her device.

This change could be due to all sorts of things. Unless someone has heard from Dr. Shore directly or someone actually knows someone who was in the trial, I wouldn't stress out too much.

I know we are all on pins and needles as I imagine we are all praying that her device reduces the volume and she becomes a billionaire on December 3rd, but I don't think we have enough to work with here. We are just going to fill in the gaps with our own biases, hopes, or pessimism.

 

I think we are looking too deeply into it. It seems most plausible that there was simply not enough time to put the presentation in 1 hour, and that they didn't have time slots available to put it into 2 hour back to back. Dr. Shore, therefore, named the presentation according to what was being presented. The 1st hour she will discuss the science, the 2nd hour she will discuss the device. It is an extremely positive sign. They updated the clinical trial page with the test methodology around a week back, and now she is spending 2 hours to talk about her method and device.

 

I've noticed a lot of people on this thread fretting about the name change of one of Dr. Shore's seminars for the Palm Springs Audiology conference.

This is the exchange we had. I wrote:

And she responded with:

So I think you can all settle down on this now. There are no implications to the name change other than what she described! Dr. Shore has the final word.

I have no doubt at all that your pessimism is well placed! We've been let down countless times before! However, I have ultimate faith in what Dr. Shore is doing, and I believe it will help!

 

Your ultimate faith, frankly, just proves how gullible you are - it's a coping mechanism of yours, relief is coming, when the facts are not there. The first study showed 10 out of 20 patients improved, somewhat.

You making the leap that her device is gonna be all of our savior is just so misplaced. False hope is dangerous.

She's been working on this now for decades, so what is ABSOLUTELY SURE is that she's going to try to make the numbers look as good as possible. This is her life's work after all...

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

Important part (20 participants in the trial):

Mean overall TFI scores decreased from baseline of 29.2±2.6 to 22.9±1.8 units during the active treatment, but remained unchanged during sham treatment. Improvements in TFI scores were sustained beyond the active treatment and into the washout period, unlike the changes in loudness matching. As treatment order also had no significant effect on TFI scores (GLMM; P=0.819), both groups were pooled for statistical analysis. The mean TFI scores across the different study periods were significantly improved (i.e., reduced relative to baseline) for both active and active washout periods (but not sham periods) (7.33±0.956 TFI units; two-way ANOVA, F(3,1)=7.712, P=6.14e-5) indicating a diminished impact on daily life with mean reductions of 7.51 and 6.71 points, respectively. Eleven participants noted subjective changes in volume, pitch, or quality that resulted in their tinnitus becoming less “harsh” or “piercing” and more “mellow.” Even participants who did not experience a complete elimination of their tinnitus reported anecdotally that their tinnitus was noticeably less obtrusive and easier to ignore.

Ten of the 20 subjects had a clinically significant reduction of at least 13 points in their TFI scores during active treatment, which is considered clinically meaningful for this questionnaire. There were no demographic differences across subjects showing significant TFI changes compared to stable subjects. Four participants had clinically significant drops during the sham treatment, but two of these also showed significant decreases in TFI during the active treatment. Further, both participants reported that their tinnitus improved more during the active treatment. The two participants who stated that the sham treatment was more effective also had the shortest tinnitus duration (less than 1 year).​

 

I wouldn’t call @dj_newark’s hope false, the man has experienced first hand reduction of symptoms from a technique similar to the one investigated by Dr. Shore. Let’s hope for progress from the first trial to this one. It’s all we can do.

 

No need to be insulting about it. I actually did have a 15 dB reduction in volume from a technique that was similar in nature to what Dr. Shore is working on. That is what I am basing my hope on! And if my hope is a coping mechanism, then so be it! Thanks for crapping all over that. You must be a lot of fun at parties.

 

I would say, without a doubt, the improvement was significant. 50% it didn't work for. What is most important is the group was tiny. 20 people is very small.

We saw this type of improvement with OTO-313 in Phase 1 with some big responders.

That said, I think in all probability this will be 'better' and get through Phase 2.

The real world will not reflect the success of a trial of 100. Trials are set up to show the best results and then the best formula through SPSS is chosen to further show best results. So if 50% get a clinically significant improvement in the trial, given the heterogeneity in tinnitus cases, it WILL be lower in the population.

Now there may be surprises in that it works for 'some' people who didn't fit the inclusion criteria, however, overall real world data will still be lower.

It really comes down to how significantly and what percentage improved.

If it turns out 50% got clinically significant improvement, then real world you may look at a 3rd. However, just to have a treatment on the market that DOES work to some degree for a significant minority is a big step forward.

Now looking at my own case if I may:

• Bilateral tinnitus - modulated by yawning, turning head.
• Normal audiogram in left ear with a few 20 dB drops at 4 kHz/6 kHz/8 kHz.
• Right ear normal until severe drops at 4 kHz (80 dB), 6 kHz (90 dB), 8 kHz (90 dB).

The treatment 'may' only help with the left ear. It CANNOT help me with the right ear. That's just the sad fact here.

I do think any noise induced tinnitus could benefit, even those panicking about not being able to modulate, as it's still hyperactivity somewhere, It may just take some playing around with placement of electrodes.

My 3 cents.

 

Why don’t you think the device could help you with your right ear? I haven’t read anything about severity of hearing loss affecting the technique’s effectiveness.

 

Well as a part of Dr. Shore's treatment is sound stimulation in the ear, I can't see how it could help in the right ear with severe high frequency hearing loss. I think that's why they screened for no more than moderate hearing loss. I would be literally stunned if it did help both of my ears.

 

I wonder if being able to hear the sounds in your left ear will be enough to help your right.

 

The Phase 1 results are not very good, they are similar to 95% of other studies in which tinnitus patients simply give better values at the end of the study for various reasons (guilt, lack of understanding of pseudo-technology, getting used to it because of having only mild tinnitus).

There is nothing for us severely affected people with hearing loss. If Dr. Shore's device really had any effect, it would have gotten through here by some enthusiastic tester who can't keep quiet. So I'm muting this thread. Good luck to all of us.

 

If we have to treat one ear at a time, as long as it works - no problem!

 

They may just need to adjust the sounds to your hearing thresholds, just like a hearing aid. Just because they had certain parameters for the study doesn’t mean they won’t do that.

 

Your negativity will be dearly missed!

 

You are right. There are so many studies out there for treatments which have positive, statisitically significant results, but which are not adopted because in practice they don't work (if they did, we'd have a batch of treatments endorsed by our national health authorities, which we don't, and we'd have plenty of recommendations based on word-of-mouth, which we don't).

This treatment seems to be generating a lot of interest because it has come out of research based on animals, it has the backing of a respected university and ostensibly the research protocol has a superior design (i.e. it is supposed to eliminate placebo effects). Also there's been plenty of time to generate interest as there has been an extended period between publication of research and the release of a product (over a decade and counting).

I predict when/if this treatment becomes available, there will be a lot of excitement and hope, followed by slowly creeping disillusionment as reports come in from real users (although I would be VERY happy if I am wrong!).

 

Just a note, this is not how academia/academic research works.

First, Dr. Shore has already achieved a good amount of success as an academic. I can't fully understand her CV, since I'm not from her discipline, but I can say that she made it to full Professor at an R1 research institution, which is an accomplishment that few academics will ever achieve.

Second, SPSS is a relatively weak program compared to SAS or STATA and ANOVAs are undergraduate level stats in most social-science programs. While some academics--like those in any other profession--cut corners or massage data, it is rare and there are checks against it. And, unlike our high school chem/physics courses, success isn't limited to finding evidence to support our hypotheses, but instead, success is often defined as moving the field forward and learning something new. At her level in the creation of knowledge, not finding evidence to support a hypothesis is important.

Third, there could be some profit motivation that could influence her research, but other than creating a biased sample and influencing the respondents' answers about their tinnitus, I don't see too many opportunities for her to play with the data here. I'm too tired to look at her research, but are these double blind studies? If they are, these are the absolute best and least likely to allow the researchers (un)conscious actions to bias the results.

In terms of ANOVAs, it only takes a few YouTube videos to understand how to create/read these stats.

Two Way ANOVA - SPSS (part 1)

 

This is me being hopeful and thinking out loud.

If this device works, I wonder if it will be most likely to help those who experience temporary tinnitus relief from listening to crickets chirping or other similar noises.

I know Dr. Shore has discussed that being able to change the tone of tinnitus is related to the effectiveness of her device, but I wonder what other variables might correlate with this being an effective treatment IF it works.

 

I sure hope so. I have a ton of tinnitus tones, and only a couple are affected by stuff like chewing or clenching my jaw.

However, if I get my tinnitus app and play the same tone as any of my tinnitus tones, it disappears for about 10 seconds. Hopefully that’s a positive sign in the context of the Dr. Shore device given that it seems to involve some tone-matching; we shall see...

 

Just thought I'd jump on here with a random thought.

Assuming the trial results are good.

Dr. Shore's device will be very difficult for clinics to have as the user needs to use it daily. Logistically how would this work? It needs to be set up for the individual. I cannot see how they would afford one device for each person to take away, nor the time and resources for daily clinic visits.

I can only see it being a personal purchase like Lenire.

For instance, can you see the NHS managing Dr. Shore's device?

 

The study participants took the device home with them after it was calibrated.

 

@Gb3, I was thinking forward. How it would work in a clinical setting.

 

Is anyone jumping the gun here and paying the $100 USD for the Palm Springs Hearing Seminar? I'm assuming the actual presentations, as usual, will not be published afterwards, only in the enclosed/paywall website.

Besides Dr. Shore, there are presentations of Acousia Therapeutics too (Phase 1 results of an intratympanic Kv modulator with high potential) and others, so very valuable for the tinnitus crowd.

 

The same way.

 

@Markku, thanks.