New University of Michigan Tinnitus Discovery — Signal Timing

If they made a thorough advertisement that an uncertified device can make tinnitus worse, I wouldn't buy it from China. Even if it cost one dollar.

 

Said the man who wanted to patent Dr. Shore's findings to himself.

 

Effectiveness of bimodal auditory and electrical stimulation in patients with tinnitus: A feasibility study

Some new anecdotal evidence on bimodal stimulation. No ground breaking tinnitus reductions but this statement is interesting:

And

And

It is modest evidence and no clinical significance, but what is interesting for us that there was impact on hyperacusis, modulational tinnitus did not impact the result, and there were people with increased tinnitus. This is not logged as an adverse event, which supports my thoughts on the Auricle device for the safety profile - the graph of that study showed that some people in the placebo arm did have an increase in tinnitus and increase in tinnitus is not an adverse event. Any sound treatment (WNGs, apps, Lenire, etc) have to be used carefully is my conclusion.

 

4 to 6 thousand? So it will be unaffordable for 90% of the population? Bad business strategy.

 

"Additional research is needed toward establishing the optimal treatment protocol, as well as selecting the most appropriate inclusion criteria."​

I hate such statements. Why can't they find proper protocols and target groups! Every time they say more research (which is too slow) must be done.

Hoping that Dr. Shore found the right protocol after so many years. 20 or what?

 

Absolutely correct - The only way to get this done right is to get it from a reputable ENT / Audiology Group that has your chart and data and has attended an InService lecture about precisely where and how to affix these electrodes, how long and what level of intensity per day should it be applied, what sound pitch is applicable to each client, etc.

Only a prize fool would purchase on the cheap a Chinese knockoff and try this on a do-it-yourself basis. My ENT Doctor warned me that any error in electrical stimulation that adversely affected the Trigeminal Nerve would result in pain that would dwarf even severe tinnitus (check this out on the Internet - it is even called "the suicide nerve.")

If this is ever released, a cost of $4000.00 - $6,000.00 is not unrealistic.

Recall that I signed on for that useless (and now defunct) Desyncra, which ran just over $6,000.00.

You are entirely correct about how such flagrant overcharging is self-defeating in that it so reduces the potential customer base.

I have no idea why this has long been the policy for hearing aids; the New York Times reported that only one sixth of those with hearing loss could afford hearing aids (but now with the new FDA approval for selling them over-the-counter without a prescription, watch how the price will be drastically reduced.)

Let's also remember that if the Shore Device is ever available, Medicare and the Health Insurance Carriers will probably not provide coverage for the typically given boilerplate reason (as with Desyncra) that this is "investigative and experimental".

 

Meaning the improvements wear off?

 

Less promising results in that Antwerp study, but there's clearly something to this. Of note is that they seem to have used higher TFI criteria ("moderate to severe") than the pending Michigan study ("A score of >17 points").

I'm hoping that the broader range in a hundred participants might at least reveal a more responsive subgroup.

 

The TENS device in this study is vastly different from the one that Dr. Shore is developing. I'd expect this study to have no bearing on the work they are doing at the University of Michigan.

Although, Dr. Shore has stated that they expect their device to work on somatic tinnitus patients, and are unsure of whether it would effect other subtypes of tinnitus such as non-somatic or TMJ based tinnitus. She does seem to think it could be further developed to treat other subtypes of the disorder once the work of getting it to be effective for somatic tinnitus is done.

 

Yes, but who cares?

I'll turn this thing into a backpack and carry it with me everywhere if it comes to it.

 

Why does that matter? I'll use this device every day for the rest of my life once I own it, if I'll need to.

 

Agree completely with @dj_newark, if it works, it doesn’t matter if the tinnitus comes back because you’ll use it again. Do we always have to look for negatives? We finally have progress in some areas of tinnitus/hearing loss with all of the clinical trials and treatments hopefully coming towards us within the next decade. I’m going to stay cautiously optimistic, but maybe we can all be a bit happier that any progress has been made at all.

We will get there. There’s a lot of money to be made in this, that’s why I’m optimistic. For now we all have to try to live our lives the best we can.

 

Anytime the results are inconsistent from what's been claimed earlier, it raises red-flags.

 

If you are talking about Shore's device, how is it inconsistent with earlier claims? Her study is built around the presumption that this has a limited time of effectiveness after last treatment.

 

If you are talking about Dr. Shore's device, where have the results been inconsistent their claims? She's never committed to results or what her device will or will not do. All she will say is "if the results from the trial are good, we will move towards commercialization". She makes no claims about the success of her device.

She has positive results from her trial in 2017. And she doesn't even comment about that!

You are reading negativity into a situation that doesn't exist.

 

There's money to be lost, too. That's why the statements by most researchers reflect neither trial results nor timelines.

 

Completely agreed with this. That's a big reason most researchers don't comment about the results of their trials or timelines.

 

By “within the next decade,” are you referencing between now and 2030?

 

Would be curious to know how much grant money was used. I don’t think any personal funds are at risk.

 

FDA Clears New Neurostimulation System for Chronic Pain

Let's hope the Auricle device is also bought by this pharma and neuromodulation giant to put it to market.

 

If Auricle works, they will become a giant too.

 

Wish I had a dime for every time I heard something is in the final stages of development, or would launch "in a year or so"? (M. Kilgard's VNS was one year away from launch, in 2019.) I believe Dr. Shore said many years ago that hers was nearly ready for the market.

 

Dr. Shore is working to improve the lives of tinnitus sufferers through science. The work she is doing is very different than what she communicates to the public. She is very careful about how she communicates. So when you say that the claims of what her device can do are different from the results, please back that up! Because I seriously doubt that those claims are there.

Except that Neuromod's trial data was BS. It was not a sham-controlled study and it was lazy science with an aim to commercialize the device. Lenire is built on bogus science and the results from consumer use show that.

Dr. Shore on the other hand is practicing real science based on 20 years of research. Her trials are both placebo controlled and the test population in the recently concluded trial is a lot larger.

When they publish their data in a scientific journal, one thing you can be sure of is that the conclusions will be HONEST and credible. If the results are not good (let's hope not) they will report that, and if they are good we all have cause for celebration.

 

People, including researchers like Dr. Susan Shore and M. Kilgard can be optimistic and just flat out wrong. No one has a crystal ball to predict the future. That doesn't mean that their work isn't real or that they aren't trying to deliver on what they are working on.

There's also setbacks that we may not know about such as a team or a project losing funding which is what I think happened in the case of MicroTransponder. Loss of funding today doesn't always mean a project will never be funded. Then there are things like the pandemic happening which set the Michigan trial back by a couple years. Delays happen, it's part of life.

More recent talk in email correspondence I've had with Dr. Shore has been less committal and trying to set the expectation that getting through submission to a scientific journal and through FDA approval will take a while. But she won't provide timelines. The truth is no one knows when their work will be realized, not even them.

I was a participant in the MicroTransponder trial back in 2014, think of how I feel about it not being available in 2022! That doesn't mean it won't be ever be available, things like this will always take time. Science is just slow. It's hard to wait when you're suffering, but what else can you do? Sucks but it's true!

 

It is surprising that the US Military is not involved in this matter, since there are so many veterans suffering from tinnitus. The Military should have an influence on speeding up the introduction of treatments for tinnitus sufferers...

 

It’s odd. I’m not aware of many military members or veterans that hang out on Tinnitus Talk.

 

We’re around...

 

I guess your cause of tinnitus tag was a giveaway.

 

The US military does have some interest in this stuff, I'm not sure we've got an active thread for it but this study is investigating the TNF-alpha approach for veterans. I imagine if anyone else brings something promising to market they'll be all over it, but it seems like they're mostly interested in things they could roll out immediately and in frontline hospitals.

 

Let's get Jon Stewart on it!