New University of Michigan Tinnitus Discovery — Signal Timing

[Markku]

@Markku, can I extend my general thanks, and I am sure that of many here. It is this kind of service and dedication not just from yourself but other members helping each other why I decided to finally make a donation. I would ask anyone intending on following to do the same, if you can.

Yes, I looked at other speakers on this list and some caught my interest.

These caught my interest:

• LePrell: Pharmacology of Tinnitus and Its Treatment
• Zeng: Safe and Effective Treatments for Tinnitus
• Dyhrfjeld-Johnsen: Drug Therapies for Sensorineural Hearing Loss
• Eagleman: Neosensory Science and Technology Overview - A Haptic Approach to Bimodal Stimulation for Tinnitus Management

I've excluded the bullshit CBT/sound therapy and sponsored hearing dispensers break out sessions.

Why not let us know what other speakers peak your interest.

Thanks so much for doing this Markku.

Thank you both

We'll use the Palm Springs Hearing Seminar December 2022: Coverage thread for updates. It will remain locked until the seminar finishes tomorrow (Sunday, December 3rd); Dr. Shore's presentation at 2-3 PM (PST) will be the last one, after which we'll provide live commentary on the Section V of the seminar, and then immediately after we'll unlock the thread for all of your comments (for discussions on Dr. Shore, you should of course use this thread.)

 

[Markku]

Dr. Shore just confirmed that she will show some of the results of the latest study tomorrow!

 

[CRGC]

Dr. Shore just confirmed that she will show some of the results of the latest study tomorrow!

Fantastic news! Did she seem optimistic when she mentioned that?

 

[Markku]

Fantastic news! Did she seem optimistic when she mentioned that?

I was taking notes at the time, but @Hazel was watching; Dr. Shore had a little smile when she said that she would present some results of the latest study tomorrow. Otherwise very professional, neutral expression all throughout.

 

[Bambam0]

@Markku, thanks for being there! Do you think you should tell her about my possible tattoo or no?

 

[Lurius]

@Markku, thanks for being there! Do you think you should tell her about my possible tattoo or no?

I'd pay good money to see her reaction to that xD

 

[CRGC]

@Markku, thanks for being there! Do you think you should tell her about my possible tattoo or no?

If by some miracle it turned out her device could treat hyperacusis as well, I'm joining you on the Susan Shore tattoo train.

 

[Manny]

@Markku and @Hazel, you are literally doing God's work. Thank you a million times over, and then some. You and this forum bring real support, hope and community to severe tinnitus sufferers all around the globe who are in search of and awaiting an actual cure.

On a separate note, and directly to the topic of this thread - I do hope Dr. Shore will talk about the control group/blinding in her trials, being that well-designed placebo control is so critical in the realm of tinnitus!

It seems that while the active groups/phases of the University of Michigan trials received both auditory and electrical stimulation, the control phases received auditory stimulation only*. Trial participants may or may not feel the [electrical] stimulation from the pads**.

Now, if a given participant was be able to feel the electrical stimulation during the active phase, but (of course) did not feel it during the control phase, would this not defeat the blinding for that participant?

I wonder if I am missing something.

———————

* Source:
- First trial: "A sham "treatment" using just sounds did not produce such effects." (emphasis mine), from here,
- Second trial (larger trial): carefully (?) implied -"During active treatment, the device will deliver electric somatosensory and auditory stimulation." (emphasis mine), from here.

** Source:
- First trial: I have no source.
- Second trial (larger trial): "When using the device, you will hear different tones of varying volumes from the ear phone and you may or may not feel the stimulation from the pads (this varies person to person). If you do feel something from the pads, it is usually a light tingling or pulling sensation.", from here (Page 3 / Item 3).

 

[PeterPan]

@Markku and @Hazel, you are literally doing God's work. Thank you a million times over, and then some. You and this forum bring real support, hope and community to severe tinnitus sufferers all around the globe who are in search of and awaiting an actual cure.

On a separate note, and directly to the topic of this thread - I do hope Dr. Shore will talk about the control group/blinding in her trials, being that well-designed placebo control is so critical in the realm of tinnitus!

It seems that while the active groups/phases of the University of Michigan trials received both auditory and electrical stimulation, the control phases received auditory stimulation only*. Trial participants may or may not feel the [electrical] stimulation from the pads**.

Now, if a given participant was be able to feel the electrical stimulation during the active phase, but (of course) did not feel it during the control phase, would this not defeat the blinding for that participant?

I wonder if I am missing something.

Hi Manny, I raised the same issue quite a few pages back. It seems like showing that this issue has been overcome in the trial protocol is critical, but it's not mentioned anywhere in the original paper. Maybe they are seeing results because some people are detecting (maybe even subconsciously) the electrical signal during the auditory and electrical phase...

If there is an opportunity, it would be interesting to get an answer from Dr. Shore on how she has ensured that trial participants can't tell the difference between the sham and non-sham treatments.

From your second source on the larger trial it seems like some participants CAN detect the electrical impulses some of the time. If participants were more likely to believe that the phase during which they could detect the electrical impulses was the one that was the non-sham (which sounds like a reasonable assumption), then we could very well be getting placebo effects...

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.

 

[Stayinghopeful]

Even a 50% sound reduction will make me hop on the Shore Tattoo train, I'll let Tinnitus Talk decide where her name or portrait goes on my body.

 

[Markku]

I do hope Dr. Shore will talk about the control group/blinding in her trials, being that well-designed placebo control is so critical in the realm of tinnitus!

It seems that while the active groups/phases of the University of Michigan trials received both auditory and electrical stimulation, the control phases received auditory stimulation only*. Trial participants may or may not feel the [electrical] stimulation from the pads**.

Now, if a given participant was be able to feel the electrical stimulation during the active phase, but (of course) did not feel it during the control phase, would this not defeat the blinding for that participant?

I wonder if I am missing something.

If there is an opportunity, it would be interesting to get an answer from Dr. Shore on how she has ensured that trial participants can't tell the difference between the sham and non-sham treatments.

There is an opportunity to ask questions at the end of each presentation. We will ask this for sure (based on yesterday, there's limited time and not all gets answered, but fingers crossed!)

 

[InNeedOfHelp]

There is an opportunity to ask questions at the end of each presentation. We will ask this for sure (based on yesterday, there's limited time and not all gets answered, but fingers crossed!)

I sincerely hope the hyperacusis question gets asked too in the Q&A. Hyperacusis Handicap Index is not part of the measurement so I guess there is only anecdotal evidence it will work.

Thanks again for the efforts. 10 hours of livestream with bad ears must not be easy.

 

[Samwise_The_Loud]

Sounds somewhat promising! Thank you @Hazel and @Markku for the invaluable work you do to aid our cause!

 

[Nick47]

Thanks guys! This has been really engaging.

 

[prowlinacage]

The efficacy of the device appears derived, in part, from the precise timing between the sound and electrical stimulation. I'm guessing the sham portion of the trial likely altered that timing. The interval is so short (in milliseconds) that I doubt anyone would be able to notice the difference.

 

[be6z]

Some information on the Phase 2 results were mentioned in Dr Shore's presentation today (thanks @Hazel!) and there was a cumulative decrease in loudness of 6 dB by week 6 (50% reduction) and 12 dB by week 12 (75% reduction). I look forward to seeing the results in full.

As someone who has recently started suffering from tinnitus, this really gives me some hope that something may help if it doesn't go away.

 

[AfroSnowman]

• Cumulative decrease in loudness:
  • -6 dB by week 6 = 50% reduction
  • -12 dB by week 12 = 75% reduction

Obviously these would be life changing improvements.

2 questions:

1) Just to get my head around the math when she says -6 dB = 50% reduction, I should understand that to mean that 6 dB in noise is 50% of the total volume?

2) What percentage of folks experience improvements? What's the Standard Deviation?

 

[Nick47]

Well, it works!

 

[PeterPan]

Some information on the Phase 2 results were mentioned in Dr Shore's presentation today (thanks @Hazel!) and there was a cumulative decrease in loudness of 6 dB by week 6 (50% reduction) and 12 dB by week 12 (75% reduction). I look forward to seeing the results in full.

The duration of the treatment was 6 weeks, so I guess this means that after the end of the treatment there was, on average, a 50% reduction in loudness, and during the next 6 weeks (with no treatment) there was, on average, additional loudness reduction of 50% (i.e. 50% of the remaining 50%, to make a cumulative reduction of 75%)?

Either way, the results look very promising!!!

 

[Samwise_The_Loud]

To my mind this is fantastic news! Celebration!

 

[Nick47]

The duration of the treatment was 6 weeks, so I guess this means that after the end of the treatment there was, on average, a 50% reduction in loudness, and during the next 6 weeks (with no treatment) there was, on average, additional loudness reduction of 50%?

@PeterPan, this was my thinking. It was 6 weeks and I assumed the effect wore off after use? Or is this including the washouts. I don't know.

 

[Stanley Samwise]

Just knowing this worked and that this might not be the rest of my life gives me so much strength. Obviously there's still questions left but wow. Can barely believe it.

 

[@dam]

 

[dd314]

Did Dr. Shore only use "ringing" type narrowband sounds for these studies? How do we find the electrical cicadas frequency?

 

[UKBloke]

And that folks, is a living example of "within the next ten years"

 

[be6z]

• Cumulative decrease in loudness:
  • -6 dB by week 6 = 50% reduction
  • -12 dB by week 12 = 75% reduction

Obviously these would be life changing improvements.

2 questions:

1) Just to get my head around the math when she says -6 dB = 50% reduction, I should understand that to mean that 6 dB in noise is 50% of the total volume?

2) What percentage of folks experience improvements? What's the Standard Deviation?

That was my interpretation for #1 too but my main takeaway is a significant reduction in loudness. A question was asked to Dr. Shore "What about people with extremely bothersome tinnitus? Her view is that if we can reduce tinnitus loudness by 75% it should help the people who are most bothered."

I don't believe they provided more info on SD at the moment.

 

[Nick47]

And that folks, is a living example of "within the next ten years"

How do you feel about the results @UKBloke? You seemed sceptical but these results are slightly better than I thought...

 

[ma7555]

 

[TinnyCanMan]

This is what "it gets better" means.

 

[dj_newark]

These are my notes from Dr. Shore's presentation. For more comprehensive updates, see: Palm Springs Hearing Seminar December 2022: Coverage.

The device produces a 50% reduction in tinnitus volume after 6 weeks and 75% reduction after 12 weeks. Furthermore, there is no return to baseline after using the device longer. In the previous trial where the device was used for only 4 weeks, there was a return to baseline.

They will investigate using the device to treat non-somatic and other forms of tinnitus after it's been released. These results are only for somatic tinnitus sufferers (of which I am one).

A company's been formed, Auricle Inc, to market and sell the device. And they are in talks with the FDA to get the device approved. They have an FDA expert on the team helping them get the device approved. She would not give an estimate for the device to be released. Saying only that everything depends on FDA approval.

However, FDA approval for devices is not like approval for a medication. Devices are approved in 6 months or less unlike medications which take 10-15 years or longer.

This is everything I could have hoped for and then some!

I've asked Dr. Shore if her latest study was published. And this is what she had to say:

No, it will be submitted for publication next week. It will take up to 6 months.

"Up to 6 months" could mean that it could take less time of course, and that it probably won't be longer than that.

I could be wrong, but I believe that FDA approval may be dependent on that happening (at least in Dr. Shore's case). She's also stated in the past that they would have to publish their findings before they "move towards commercialization" (her words). So it's likely we have some more time to wait. However, what we've learned today was fantastic! And this process will keep moving forward, we'll have to muster as much patience as we can while this situation develops.