New University of Michigan Tinnitus Discovery — Signal Timing

[Athens]

I still wonder if we could listen to the audio through a speaker? Maybe headphones or earbuds aren't required.

The prototype appears to show earbuds.

 

[Jerad]

The prototype appears to show earbuds.

Yeah, which is even worse than headphones. So I really hope those buds aren't crucial to the treatment's success... because I dunno if my fragile ears can handle them. :-(

 

[ZFire]

For Susan Shore's device, is anyone else concerned about how it uses earbuds or headphones?

@GoatSheep made a thread regarding this concern. I would take a wait and see approach. Assuming this device works for tinnitus, some people with hyperacusis like myself are going to take a chance with it and once the user reviews are out, that could make your decision easier.

 

[Bjjwal]

So I hate to be the one beating a dead horse here, but do we even know if Susan Shore has been un-blinded to the test results yet or will we just know "sometime in April?"

I would ask Dr. Shore herself, but I'm afraid doing so will delay the commercialization timeline by another 10 years.

 

[Gb3]

So I hate to be the one beating a dead horse here, but do we even know if Susan Shore has been un-blinded to the test results yet or will we just know "sometime in April?"

I would ask Dr. Shore herself, but I'm afraid doing so will delay the commercialization timeline by another 10 years.

We just have to be patient guys. Just relax.

 

[AfroSnowman]

We just have to be patient guys. Just relax.

To quote the late great Tom Petty, waiting is the hardest part.

 

[Athens]

To quote the late great Tom Petty, waiting is the hardest part.

If she waits until the results are formally published in a peer reviewed publication, this might be a very long wait. This may have been asked before but have any folks who are part of this forum referenced their experience with this study? I am not certain if they have agreed to keep this confidential until a certain time period. I would think that we must have some folks here since there are four hundred (400) people in this study.

 

[Gb3]

If she waits until the results are formally published in a peer reviewed publication, this might be a very long wait. This may have been asked before but have any folks who are part of this forum referenced their experience with this study? I am not certain if they have agreed to keep this confidential until a certain time period. I would think that we must have some folks here since there are four hundred (400) people in this study.

I'm pretty sure they were all close residents to Michigan University.

 

[AfroSnowman]

If she waits until the results are formally published in a peer reviewed publication, this might be a very long wait. This may have been asked before but have any folks who are part of this forum referenced their experience with this study? I am not certain if they have agreed to keep this confidential until a certain time period. I would think that we must have some folks here since there are four hundred (400) people in this study.

From listening to interviews with her, I doubt that she will wait for a published peer review paper to come out. It sure sounded to me like she wanted to aggressively (for an academic) bring this to market if the results from this study are as good or better than her first. My guess is once the results are in she will pull a lever and the commercial side of the process will start and be run (design, production, FDA approval) by Auricle while in parallel she goes about her academic work. I can't see why one would wait on the other.

 

[InNeedOfHelp]

From listening to interviews with her, I doubt that she will wait for a published peer review paper to come out. It sure sounded to me like she wanted to aggressively (for an academic) bring this to market if the results from this study are as good or better than her first. My guess is once the results are in she will pull a lever and the commercial side of the process will start and be run (design, production, FDA approval) by Auricle while in parallel she goes about her academic work. I can't see why one would wait on the other.

If the funding is backed up my an investor/pharmaceutical company, no way they would start placing orders with manufacturers unless it is approved I'd say. That's too much of a financial risk and money in advance. Once this leaves development phase, different forces are at play.

 

[Athens]

If the funding is backed up my an investor/pharmaceutical company, no way they would start placing orders with manufacturers unless it is approved I'd say. That's too much of a financial risk and money in advance. Once this leaves development phase, different forces are at play.

I agree. I doubt that they would start the manufacturing process until the results come back favorable and the FDA approves it.

 

[Padraigh Griffin]

I agree. I doubt that they would start the manufacturing process until the results come back favorable and the FDA approves it.

It's not manufacturing that will be a challenge (unless there's chip shortages). It seems a simple device and they will have an outsourcer primed to manufacture to spec if the trial is a success. What will be a challenge is creating a distribution network. That will not be easy.

 

[AfroSnowman]

It's not manufacturing that will be a challenge (unless there's chip shortages). It seems a simple device and they will have an outsourcer primed to manufacture to spec if the trial is a success. What will be a challenge is creating a distribution network. That will not be easy.

It will have to be done, it is a step, but assuming it has good results and FDA approval, it would just go out through audiologist offices like hearing aids do. IF it has good or better results than last time, I would think a lot of audiologists would want to get their hands on some.

 

[Athens]

It will have to be done, it is a step, but assuming it has good results and FDA approval, it would just go out through audiologist offices like hearing aids do. IF it has good or better results than last time, I would think a lot of audiologists would want to get their hands on some.

I recall that in the trial with twenty (20) people that two (2) people had their tinnitus vanish. What was the rate of success with the other eighteen (18) people? Was it 40% of the people who experienced a significant improvement? I have read some stories about it, but they were somewhat vague about the rate of success.

 

[Padraigh Griffin]

I recall that in the trial with twenty (20) people that two (2) people had their tinnitus vanish. What was the rate of success with the other eighteen (18) people? Was it 40% of the people who experienced a significant improvement? I have read some stories about it, but they were somewhat vague about the rate of success.

10 participants had a TFI reduction of 13 points or more. The mean starting TFI was 28 points.

Very limited data. This trial will provide far more comprehensive data.

 

[Toby1972]

10 participants had a TFI reduction of 13 points or more. The mean starting TFI was 28 points.

Very limited data. This trial will provide far more comprehensive data.

Low starting values allow much more improvement through habituation. In addition, all that is hardly meaningful without a placebo group. There are purely psychological effects of giving better values at the end of the study because you think hey someone wanted to help me, I'll help them too.

 

[Athens]

Low starting values allow much more improvement through habituation. In addition, all that is hardly meaningful without a placebo group. There are purely psychological effects of giving better values at the end of the study because you think hey someone wanted to help me, I'll help them too.

I thought that they had a placebo group in the first group with twenty people.

 

[InNeedOfHelp]

I briefly looked at Phase 1...

Actual Primary Completion Date: June 2016
Results First Posted: May 17, 2017
Publication: Sci Transl Med. 2018, Jan 3

It took 11 months for updating the results, and another 7 months for the paper.

There is a good chance that the researchers will see the results in a few days assuming the study closes anytime soon (all the results are already entered during the weekly readouts of course, only the last data points need to be entered). It's just a click on the button in a statistics program for graphs etc to roll out.

Generally, unfortunately, researchers are not willing to share anything before they either publish, submit or report something.

I hope @Hazel sets up a Tinnitus Talk Podcast for preliminary results way before... but I think we should stop focusing on preliminary results in the coming months.

 

[Padraigh Griffin]

I thought that they had a placebo group in the first group with twenty people.

They did. From what I remember, participants had time with the device and time with the sham treatment. I could be wrong.

 

[AfroSnowman]

Low starting values allow much more improvement through habituation. In addition, all that is hardly meaningful without a placebo group. There are purely psychological effects of giving better values at the end of the study because you think hey someone wanted to help me, I'll help them too.

TFI is really a measurement of habituation. The cool thing about the study was the measured drop in volume of the tinnitus. I think somewhere in the scale of ~8 dB reduction on average. That is the big deal.

 

[DimLeb]

I briefly looked at Phase 1...

Actual Primary Completion Date: June 2016
Results First Posted: May 17, 2017
Publication: Sci Transl Med. 2018, Jan 3

It took 11 months for updating the results, and another 7 months for the paper.

There is a good chance that the researchers will see the results in a few days assuming the study closes anytime soon (all the results are already entered during the weekly readouts of course, only the last data points need to be entered). It's just a click on the button in a statistics program for graphs etc to roll out.

Generally, unfortunately, researchers are not willing to share anything before they either publish, submit or report something.

I hope @Hazel sets up a Tinnitus Talk Podcast for preliminary results way before... but I think we should stop focusing on preliminary results in the coming months.

Happy 2024 then...

 

[Athens]

Happy 2024 then...

I just read an article again from September of 2021 that references that the device is based on $14 million in funding and is "nearly market ready."

 

[DimLeb]

I just read an article again from September of 2021 that references that the device is based on $14 million in funding and is "nearly market ready."

Yeah, I remember that too. I think it was around October that I read that it's nearly market ready from more than one source.

Let's hope stuff goes much faster than Phase 1, because if they took 1 year to make a paper with 20 people, I don't want to imagine how long they'll take for 400 people...

 

[Athens]

Yeah, I remember that too. I think it was around October that I read that it's nearly market ready from more than one source.

Let's hope stuff goes much faster than Phase 1, because if they took 1 year to make a paper with 20 people, I don't want to imagine how long they'll take for 400 people...

Maybe there will be more of a push based on all of that investment.

 

[Gb3]

Did the results come out yet?

 

[ajc]

Did the results come out yet?

Dude, are you trolling? Obviously not. Look below how Phase 1 data came out... study completion date June 2016 and results were first posted almost a year later in May 2017, and final publication in January 2018.

It's going to be a long wait. Prepare for that.

Actual Primary Completion Date: June 2016
Results First Posted: May 17, 2017
Publication: Sci Transl Med. 2018, Jan 3

 

[InNeedOfHelp]

For me it's the psychological feeling of moving this study to completed that will give me a boost, regardless of the results being available or not. Putting this on completed might just bring us one step closer to a treatment. I'm trying hard to hold back in emailing Jon Pearson/Susan Shore for an update on the closure of the study and timeline for the FDA approval or commercialization.

Would be great if they could share a tiny bit of insider knowledge to comfort our minds, like we have a big investor on board, or we already have some dealership/distributor network in contract, or we expect to submit to the FDA in month X... anything to keep us going strong!

 

[Bambam0]

I'm trying hard to hold back in emailing Jon Pearson/Susan Shore for an update on the closure of the study and timeline for the FDA approval or commercialization.

Would be great if they could share a tiny bit of insider knowledge to comfort our minds, like we have a big investor on board, or we already have some dealership/distributor network in contract, or we expect to submit to the FDA in month X... anything to keep us going strong!

Same here. But I just cannot imagine them taking their sweet time. Might not hurt to have just one person communicate with them on behalf of the forum. That way they're not getting bombarded.

 

[IntotheBlue03]

Can someone catch me up on where we are with this? Has nothing been unblinded/reported? I am having serious visual issues so reading through this stuff is no longer an option. Thanks.

 

[Jerad]

Can someone catch me up on where we are with this? Has nothing been unblinded/reported? I am having serious visual issues so reading through this stuff is no longer an option. Thanks.

I enlarged the response. Maybe that will help with the vision problems you're having. Sorry to hear of your suffering. I'm having a hard time, too.

So I agree with what @ajc said (quote below). It's probably going to be a long wait to see results. Seems this type of stuff always moves at a snail's pace unfortunately. Are you still interested in this treatment? Isn't your tinnitus under control now?

Look below how Phase 1 data came out... study completion date June 2016 and results were first posted almost a year later in May 2017, and final publication in January 2018. It's going to be a long wait. Prepare for that.