New University of Michigan Tinnitus Discovery — Signal Timing

[acufenero]

Chill, people. Asking Dr Shore about trial availability in Europe was a highly relevant question. I for one am glad that it was asked.

He asked her when the device could be available in Europe, not when an European trial would start, if any. That is indeed a stupid question since she and her team have said several dozens of times in all kind of news pieces, interviews and videos that the device is years away from being finished. You still want to keep her busy answering the same stupid questions over and over again? You still want to flood this thread by calling her egocentric or unprofessional, as it has already happened before? Then go for it!

 

[Jiri]

He asked her when the device could be available in Europe, not when an European trial would start, if any. That is indeed a stupid question since she and her team have said several dozens of times in all kind of news pieces, interviews and videos that the device is years away from being finished. You still want to keep her busy answering the same stupid questions over and over again? You still want to flood this thread by calling her egocentric or unprofessional, as it has already happened before? Then go for it!

Look here, I can ask anybody at any time whatever I so desire. You are absolutely in no position to tell me any otherwise. Several people on here have already found my question helpful. To ask that q. was important to me too.

Just for your info, I'm a postgrad student at Uni of London and I'm in touch with other academics via email on a weekly basis. The way it works is you ask a straight question, then you wait for a reply and you usually get a straight answer back. Just like in this case. Nothing less, nothing more.

Again, especially for you - if she was way too busy with doing something else she wouldn't have responded so quickly. I worded my question in a concise manner.

As a matter of fact, I didn't even have to post it on here nor inform anybody of me sending her an email anyway. I of course did post it because I believed someone else might find it useful.

I'm done arguing. This has gone off topic now.

 

[Joe Bananas]

Keep bombing her with stupid questions rather than letting her do her f job. No wonder she'll blow it all before she completes the device. Then of course you'll call her egocentric!

If you consider that to be a stupid question then here are my bad news for you: You are the egocentric one.
Any information about this is priceless. If someone here is able to reach Susan that is a more valuable move than keeping especulating.
"One year and a half" sounds like a sentence which could give hope to lots of people suffering, so it worths the e-mail.
Anyway I guess for Susan, as a researcher, to answer e-mails is a big part of her job.

 

[crd3]

1 and a half years until they're done with trials??? Dang, I did not realize it was so far along the pipeline. Really feeling good about this.

 

[MickV]

1 year and half for MAYBE it will be in the market. DEPENDS on the second trial and FDA Approval.

 

[threefirefour]

1 year and half for MAYBE it will be in the market. DEPENDS on the second trial and FDA Approval.

That's a really good timeframe IMO.

 

[Paulmanlike]

Any long term sufferers here who have been scammed in the past will appreciate, professional, well made, lengthy trials to get accurate results. And as the guy said in the interview the more precise animal studies are done the higher the likelihood outcome of good results for humans.

If you can't wait that long, go to the tinnitus clinic and pay £5,000 for a Levo or a desyncra that's about as flaky as a custard slice whether it work or not. No thanks - professional, lengthy trails first, always.

 

[Jiri]

Any long term sufferers here who have been scammed in the past will appreciate, professional, well made, lengthy trials to get accurate results. And as the guy said in the interview the more precise animal studies are done the higher the likelihood outcome of good results for humans.

Absolutely. If you watched the video on the first page Prof. Shore says "we're excited about this device because it's not something we just cooked up but it's based on fifteen years of research showing how these two different sensory systems are interacting when producing tinnitus." This was back in 2013. Now it's 2018. They have spent quite some time now working on it with some promising results already - both on animal subjects and humans. It's not some hocus pocus. That's a professor of the department of otolaryngology - head and neck surgery collaborating with biomedical engineers. I'm very excited about their upcoming trial this fall. Then if it gets the FDA approval it could be ready by 2020. That's 7 years since the video and if I'm not mistaken before a drug hits the market it takes approx. 5 - 10 years too (if all goes well). This is a professional approach - no worries there.

Keep updated here: http://ns.umich.edu/new/multimedia/...ptoms-in-test-aimed-at-condition-s-root-cause

 

[RonnieCarzatto]

Nobody should be writing anything negative on this particular thread. This could be a major step forward and there is important work being done that we should all be extremely grateful for.

 

[Ambassador]

It's a medical device, not a drug so the process can be much shorter than drug approval. But before anything comes to market, they need to attract a medical device manufacturer who is going to be interested in manufacturing a commercial product. Who knows how long that will take. Maybe they need to get on the "Shark Tank" and get some financial backing.

 

[threefirefour]

Nobody should be writing anything negative on this particular thread. This could be a major step forward and there is important work being done that we should all be extremely grateful for.

There's nothing wrong with playing devil's advocate. Maybe saying that it will absolutely fail without a shadow of a doubt is bad, but realistic criticism is good.

It's a medical device, not a drug so the process can be much shorter than drug approval. But before anything comes to market, they need to attract a medical device manufacturer who is going to be interested in manufacturing a commercial product. Who knows how long that will take. Maybe they need to get on the "Shark Tank" and get some financial backing.

I heard one of the sharks have tinnitus so that's actually a pretty good idea.

 

[Ambassador]

There's nothing wrong with playing devil's advocate. Maybe saying that it will absolutely fail without a shadow of a doubt is bad, but realistic criticism is good.

I heard one of the sharks have tinnitus so that's actually a pretty good idea.

I just looked it up, Daymond John has tinnitus and hearing loss. He's wearing Starkey Halo hearing aids but he's not an investor.

 

[threefirefour]

I just looked it up, Daymond John has tinnitus and hearing loss. He's wearing Starkey Halo hearing aids but he's not an investor.

Interesting. On his wiki it says he's appeared on the show as an investor.

 

[GregCA]

Interesting. On his wiki it says he's appeared on the show as an investor.

He is a regular investor there.

 

[threefirefour]

He is a regular investor there.

Thanks. I've seen him but I don't watch much. I'm replying to someone who said he's not an investor.

 

[RonnieCarzatto]

There's nothing wrong with playing devil's advocate. Maybe saying that it will absolutely fail without a shadow of a doubt is bad, but realistic criticism is good.

I heard one of the sharks have tinnitus so that's actually a pretty good idea.

Oh I just meant more the dumb "you shouldn't ask these questions" stuff. I absolutely agree with you about playing Devil's advocate no argument from me there.

 

[Ambassador]

He's a regular on Shark Tank. He's a spokesman for Sharkey hearing aids but not an investor in Sharkey. I sent him Dr. Shore's contact information hoping to interest him in providing some funding for her device.

 

[threefirefour]

He's a regular on Shark Tank. He's a spokesman for Sharkey hearing aids but not an investor in Sharkey. I sent him Dr. Shore's contact information hoping to interest him in providing some funding for her device.

That's a pretty great idea! I think he's probably too busy to get it though. Since we know Dr. Shore keeps in contact with us, we should give her the idea.

 

[Markku]

Why Susan Shore's team don't take part of this year's TRI conference in Regensburg Germany? With such new insights it would be great to share and discuss with the rest of tinnitus researchers... what do you think?

Could be lots of reasons; scheduling issues, not invited, travel cost, etc. Let's not get hung up over this little issue and stay focused on topic at hand.

Actually she is coming to TRI 2018 in Regensburg in March, possibly "only" for a day due to having other commitments, but still, will be attending.

So surely she'll have discussions with other researchers even if no keynotes or such.

 

[hans799]

About finding investment: I think it will go very easily. Not only are there hundreds of millions of sufferers around the globe (~10% of a global population of 7.6 billion), but there are also concentrated groups with serious purchasing power. For example, tinnitus is the #1 complaint for which the US Veterans' Administration pays disability benefits, to the tune of about a billion of dollars a year.

Just imagine that you're an investor and the following elevator pitch is given to you: 1. here's this serious medical condition, 2. it has no treatment, 3. we found a treatment and proved that it works with more than a decade of science and clinical trials on humans, 4. it is not a drug, but a device, much easier to manufacture and with much less regulatory oversight, 5. there are major concentrations of patients to whom we can sell immediately.

In a business climate where there's so much money sloshing around that even the "Uber for organic vegan craft pizzas" startup ideas get hefty sums.

The main problem Dr Shore will have with potential investors is to crowd control the queue forming up in front of her office.

 

[Paulmanlike]

About finding investment: I think it will go very easily. Not only are there hundreds of millions of sufferers around the globe (~10% of a global population of 7.6 billion), but there are also concentrated groups with serious purchasing power. For example, tinnitus is the #1 complaint for which the US Veterans' Administration pays disability benefits, to the tune of about a billion of dollars a year.

Just imagine that you're an investor and the following elevator pitch is given to you: 1. here's this serious medical condition, 2. it has no treatment, 3. we found a treatment and proved that it works with more than a decade of science and clinical trials on humans, 4. it is not a drug, but a device, much easier to manufacture and with much less regulatory oversight, 5. there are major concentrations of patients to whom we can sell immediately.

In a business climate where there's so much money sloshing around that even the "Uber for organic vegan craft pizzas" startup ideas get hefty sums.

The main problem Dr Shore will have with potential investors is to crowd control the queue forming up in front of her office.

Without a doubt tinnitus treatment is a potential lucrative investment. The only drawback is risk - it's getting the timing right (a bit like Susan Shores signal timing haha). If a company even developed a treatment (temporary) for chronic tinnitus or a cure for acute tinnitus it would still be highly lucrative imo.

If anybody is feeling bad about having tinnitus, turn something into a positive and buy some stocks into treating your own medical condition - i always looked at Auris stocks (EARS) but it's a good job I didn't, still, who knows where these companies will go in the future.

 

[Adriel93]

When I clench my jaw my T gets louder, so I do have somatic T, but I also have reactive T. I wonder if this will also help with that

 

[threefirefour]

When I clench my jaw my T gets louder, so I do have somatic T, but I also have reactive T. I wonder if this will also help with that

Depends. If you have something like TMD or SCM issues, then you do have somatic. if it's hearing loss or brain based, and you can modulate it by manipulating your body, then you have Somasensory tinnitus. Somasensory is treatable with this device.

 

[drivera2592]

Does anyone know how long the trial will last? I live in California, but I've saved enough money to move to Ann Arbor to try her device for a year if I have to.

 

[threefirefour]

This is promising, but it is important to keep in mind what is actually in the paper.

First, the average reductions in TFI in the active treatment and active washout phases are 7.51 and 6.71 points, respectively. These were both significantly different from 0, but they are both much less than 13 which is the cutoff for clinical significance. Additionally, the mean reduction during the sham phase is about 2 points, and the sham washout has a mean reduction of a bit less than 2. Thus, the effect of the treatment itself (active - sham) is about 5.5 to 4.7 points - not large. Either way, on average the treatment has a statistically significant but clinically insignificant effect on the TFI.

Second, 10 of the 20 subjects did have a clinically meaningful reduction of at least 13 points during the active treatment. This is good. However, we don't know what reductions these individuals had during the sham phase. In fact, 4 participants had clinically significant reductions during the sham phase, and 2 participants had clinically significant reductions during BOTH phases. The authors do say that the two who experienced reductions during both phases experienced larger reductions during the active phase, but they don't provide the information so that the reader can understand the differences. It would have been useful to see individual level data. This would be possible with only 20 subjects, and it would allow the reader to see the degree to which individuals who saw improvement in the active phase also saw improvement in the sham phase. (Ideally you would like to see responses during the active phase and no response during the sham phase for each person. Assuming they are correct that the sham is truly a sham, it acts like a placebo so if you see a reduction in TFI or loudness during the sham period this is due to the placebo effect. That's why you need to subtract out the effect of the placebo in order to determine the effect of the treatment.)

Third, assuming the treatment truly does have a clinically significant reduction for a significant proportion of people who are treated, it would be useful to know ahead of time who might benefit. In this case, there were no demographic differences between the people who improved significantly and those that didn't. This may be due to the very small sample. Assuming the results persist in a larger sample, perhaps observable differences will observe.

Fourth, there is a reduction in loudness during the treatment of about 8 dB. Unlike the reduction in TFI, this effect becomes smaller during the active washout. Thus, it appears that any sustained reduction in perceived loudness requires continued use of the device. However, the 8 dB reduction isn't all due to the treatment. The effect during sham treatment is a reduction in loudness of about 3.5 dB or so (hard to say exactly from the figure). Thus the net reduction due to the treatment is about 4.5 dB. (In Figure 6C, it's interesting that there is a similar relationship from sham to sham washout that there is between the active and active washout.)

Fifth, 2 people did report the elimination of tinnitus "toward the end of the active treatment period" though there is no information the durability of that result.

So there are promising results here, but they aren't earth-shattering. It's important to remember this is a small study with some promising results. We won't really know more until they do a larger study which is or will soon be underway.

This is interesting but I have a question. What were the original results? Are these much better?

And how much is a "point" in dB?

 

[Aaron123]

What were the original results? Are these much better?

Not sure what you mean regarding "original" results.

And how much is a "point" in dB?

There's no relationship. The TFI (Tinnitus Functional Index) is a questionnaire that measures the impact of tinnitus on various aspects of life. They did, however, measure changes in perceived loudness in dB.

 

[threefirefour]

Not sure what you mean regarding "original" results.

There was a trial before this one. I think linearb was part of that one.

There's no relationship. The TFI (Tinnitus Functional Index) is a questionnaire that measures the impact of tinnitus on various aspects of life. They did, however, measure changes in perceived loudness in dB.

Oh I thought that TFI was actually important. Definitely glad they focused somewhat on dB. Thanks this reply was extremely helpful I'll be sure to read the full paper on my own.

 

[Jiri]

The only thing I'm worried about (apart from the device actually being able to do its job) is the final price of the product. I hope it won't be priced anywhere near as riduculous as Acoustic CR® Neuromodulation (£4495) *rip off

 

[MickV]

The only thing I'm worried about (apart from the device actually being able to do its job) is the final price of the product. I hope it won't be priced anywhere near as ridiculous as Acoustic CR® Neuromodulation (£4495) *rip off

Let's see if it even works!!! She said that in the first trial two people said their tinnitus went away. However, after two weeks it got back! I think we have long way to go before even think about marketing this device.

 

[Stakovic]

The only thing I'm worried about (apart from the device actually being able to do its job) is the final price of the product. I hope it won't be priced anywhere near as ridiculous as Acoustic CR® Neuromodulation (£4495) *rip off

If really this device will help us, £4495 is nothing