New University of Michigan Tinnitus Discovery — Signal Timing

[slc]

Now that the dust has settled a little further over these past few days, I would like to say that the thing that still p*sses me off perhaps the most about the way this whole situation has played out is the chart below (which I'm finding increasingly difficult to locate online - but maybe that's just me).

The moment UMich released this chart, and then announced that the device worked so well on the Treatment 1 arm that they needed to scrap the Treatment 2 arm, they got themselves clean out of having to answer why it was that those patients who received the sham on Treatment 1 experienced practically no benefit at all receiving the active treatment on the 2nd arm.

In fact, if anything, the chart shows that the loudness level began to tick back up at the end of the active treatment phase on those patients. I mean, it's literally the elephant in the room, and to date, Susan Shore has said nothing (to the best of my knowledge) to actually address this fact.

View attachment 62992

Is this chart from the initial 4-week trial? As I recall, and it's been a while since I've read the papers, the 4-week trial did not show lasting improvement, but the 6-week trial did. The stumbling block was that in the 6-week trial, the control placebo group did not show improvement when they then received the actual Auricle treatment.

Was this the compelling reason for not submitting for FDA approval, given the lasting improvement shown in the 6-week trial? I didn't attend the Shore seminar. Was there any mention of the reason the Auricle was not submitted? Was it entirely due to the placebo-first, Auricle-treatment-second group?

 

[withintention]

No, they said that the delay was primarily because the proof-of-concept device they used in the study was too complex. It involved software running on a computer and a few other computers, which meant that the computer and all its components needed to be approved by the FDA as "medical grade" (or something like that).

They are redesigning the device to be more monolithic so they can submit a single device to the FDA for a hopefully faster, less risky approval process.

 

[Nick47]

No, they said that the delay was primarily because the proof-of-concept device they used in the study was too complex.

Do you really believe it takes 7-8 years to consolidate the device? In the presentation, they included a further trial requirement.

 

[withintention]

Do you really believe it takes 7-8 years to consolidate the device? In the presentation, they included a further trial requirement.

I missed that. What did they say about another trial?

 

[UKBloke]

Is this chart from the initial 4-week trial?

It's the loudness chart from the 6-week pivotal crossover trial.

The stumbling block was that in the 6-week trial, the control placebo group did not show improvement when they then received the actual Auricle treatment.

That's one stumbling block with the 6-week crossover trial. Another one is that the control group also exhibited a placebo effect in Treatment 1. To the best of my knowledge, UMich hasn't publicly addressed that fact yet.

Was this the compelling reason for not submitting for FDA approval, given the lasting improvement shown in the 6-week trial?

Just on the loudness chart alone, I can see two compelling reasons for not submitting for FDA approval, and in fact, both of those reasons relate to the control:

1. The control exhibited a placebo effect in Treatment 1
2. Any claims about how well the active treatment appeared to perform in Treatment 1 (with residual effect crossing the washout period) cannot be validated because of point 1 above.

Was there any mention of the reason the Auricle was not submitted?

Not that I'm aware of.

 

[kingsfan]

I missed that. What did they say about another trial?

They're going to trial our patience

 

[Ken219]

They're going to trial our patience

I heard there are many complaints about Lenire device to the FDA. You think Dr. Shore's device will be better?

 

[Joey72]

They're going to trial our patience

Good one.

 

[kingsfan]

I heard there are many complaints about Lenire device to the FDA. You think Dr. Shore's device will be better?

I do, yes. My main hope is that it will be something that can keep our existing tinnitus at baseline should we get worse. Then we can go live our lives again without worrying about every little noise exposure. And no more GD earplugs.