New University of Michigan Tinnitus Discovery — Signal Timing

[BadNeighbors]

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.

Great work with the updates.

"Furthermore, there is no return to baseline after using the device longer." This is unbelievable and something I didn't think was even possible. I hope this is true, I hope it works for all of us, and I hope the device doesn't lose any quality when it is mass produced.

And, I hope Dr. Shore and everyone else who worked on this ends up being a millionaire many times over. I hope whoever at the National Institute of Health wrote her a check to support her research gets promoted. And, I hope more Americans see the value of the NIH and the research it funds.

In 2012, the VA paid out $1.5 billion in disability compensation to over 971,000 veterans for tinnitus alone. If this works, it will save the US Government a huge sum of money each year and directly benefit so many vets (in addition to musician, concert goers, and so on).

Finally, I don't plan on getting a tattoo, but assuming that this works and the device isn't like $100K or something, I'll buy two and donate a device to someone who couldn't afford one on their own.

 

[Leeroy]

I really hope it works on reducing multi-tonal tinnitus...

 

[Stayinghopeful]

I think what's further encouraging is Dr. Shore will probably keep perfecting and improving the device which will potentially further enhance results and help a wider variety of sufferers in the future too.

It just feels really good to hear after the let downs we have had this year (Otonomy etc.)

 

[InNeedOfHelp]

I need some help understanding: -12 dB reduction should correlate to a much much higher TFI reduction. For example, when someone has a 40 dB tinnitus and the loudness is roughly halved/quartered (perception of 50% reduction lays between 3-6 dB).

How come someone's TFI will only drop from e.g., 80 to 65-60? Which keeps it in the severe very intrusive range? Don't you think such a dB drop would make someone very optimistic mentally would will result in TFI drop from severe to medium? Especially after years of torture? I don't get it. Very important to know. 15-20 TFI is barely significant. Lenire's initial ones were higher than that. It makes me worry.

• What was the average TFI before starting?
• Did people completely get cured of their tinnitus?
• Did any people worsen?
• Do you still get tinnitus spikes or can you finally live your live again despite a high TFI?
• What happens if you use the device longer?
• What will be the usage protocol? Do you stop after 6 weeks?

Many unanswered questions. Like I said before, I feel the Phase 2 protocol should have been split in subgroups (6 week, 8 week, and 10 week durations), and hyperacusis should have been measured etc.

 

[awake 44]

@Hazel, @Markku, you are a gift from God. If you will be interviewing Susan, I think the hottest question would be multi-tonal tinnitus. I imagine that in such a case you would have to have separate treatments for every tone/frequency you have. This is the logical conclusion after hearing the fact, that you have to match the frequency of the treatment with the frequency of your tinnitus. I might be talking bullshit tough...

 

[AnthonyMcDonald]

Holy shit. This is it. I'm getting a tattoo.

 

[ZFire]

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

I hope that's the case too. The statistics tell us that 86% of people with hyperacusis have tinnitus and conversely, 40% of people with tinnitus have hyperacusis. There is a strong relationship between hyperacusis and tinnitus even though the underlying relationship is still unknown.

If the odds are good that someone with hyperacusis will have tinnitus to accompany it too, then surely it's possible in some of these cases that both conditions share the same underlying cause to which Dr. Shore's device would be able to treat. I'd imagine both conditions would see improvements simultaneously then. This is of course assuming Dr. Shore's device works really well on tinnitus (which looks really promising at the moment).

Here's hoping...

 

[Lurius]

I'm happy about this, but I'm curious what it's going to cost, how long will it take before it gets to Europe and how long will it take before the non-somatic version goes into production. I'm sort of expecting 2025, at least, for that, so I might have to be really patient. Then again, it's also entirely possible the somatic version is going to work for me. I won't jump on the wagon immediately this time like I did with Lenire. I'll wait it out for a bit to see more results from people who have tried it. But it's much better news than I anticipated.

 

[UKBloke]

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

I think the news coming out at around the ten year anniversary of this thread is interesting to say the least. In a good way.

As for the actual data - really the only two aspects of it that I was ever interested in were: reduction levels and chronicity of those in the trial inclusion criteria. I haven't been too bothered about sample sizes etc.

I did speak personally with Dr. Shore a few years ago on the point of chronicity. In her trials, as we know, time since tinnitus onset for each participant was > 6 months but preferably less than 1 year. Again for the record, Neuromod's Lenire, Dr. Shore's close competitor at the time, had a much broader inclusion criteria with time since onset > 6 months and < 5 years.

We all know what happened with Lenire. Regardless of this, however, subsequent to my conversation with Dr. Shore I understood that a number of her trial participants had experienced tinnitus for much longer than one year. How much longer, I have no idea. Perhaps once the papers are released we'll be able to take a view.

People here are very well aware of my view that the average tinnitus patient will experience automatic central nervous system habituation within 2-3 years of onset. Applying treatment within this window of potential regression has always been problematic for me.

However, there have been many cases made on the forum for 'the science' testing within a criteria that can yield positive results, and then moving on from there. And I have to state that I do take that point and am happy with it.

In that respect then, regarding the reduction figures, I'm ecstatic. I've always said that if I can reduce my tinnitus to its 2017 levels I will consider that a cure. And I stand by that.

Regarding chronicity, pragmatism dictates that I remain on the fence until I can see more data.

With all that said, I don't want to pour water on the fire, however. Today, I genuinely believe Dr. Shore has made perhaps the most important medical advance in proper mechanical tinnitus treatment that I've seen since my onset in 1991. And that's fantastic news for everyone.

 

[Nick47]

So publication around April-May 2023 and 6 months for FDA approval would see commercialisation in about 1 year. This ties in from the video clip I posted here about 3 weeks ago.

Be great to get Dr. Shore on the Tinnitus Talk Podcast!

 

[Alue]

I hope that's the case too. The statistics tell us that 86% of people with hyperacusis have tinnitus and conversely, 40% of people with tinnitus have hyperacusis.

That seems really high. I don't believe it. Let's assume 32 percent of the population has tinnitus (as some figures show). That would mean 12.8% of the population has hyperacusis. Hyperacusis can be debilitating and is pretty rare, aside from forums like this where more severe sufferers congregate, most people have never even heard of it.

 

[Stanley Samwise]

So publication around April-May 2023 and 6 months for FDA approval would see commercialisation in about 1 year. This ties in from the video clip I posted here about 3 weeks ago.

Be great to get Dr. Shore on the Tinnitus Talk Podcast!

I assume FDA approval and preparing for publication is happening simultaneously? Although 1 year sounds about right.

 

[lusiol]

Despite the fact my tinntus isn't somatic, I cried a bit this morning when I saw this, is this THE day for tinnitus sufferers?

The results seems much better than I would have expected. I can't totally believe it somehow, I'm feeling weird.

I hope they will be able to bring the same results for all tinnitus types.

 

[Mathew Gould]

I think the news coming out at around the ten year anniversary of this thread is interesting to say the least. In a good way.

As for the actual data - really the only two aspects of it that I was ever interested in were: reduction levels and chronicity of those in the trial inclusion criteria. I haven't been too bothered about sample sizes etc.

I did speak personally with Dr. Shore a few years ago on the point of chronicity. In her trials, as we know, time since tinnitus onset for each participant was > 6 months but preferably less than 1 year. Again for the record, Neuromod's Lenire, Dr. Shore's close competitor at the time, had a much broader inclusion criteria with time since onset > 6 months and < 5 years.

We all know what happened with Lenire. Regardless of this, however, subsequent to my conversation with Dr. Shore I understood that a number of her trial participants had experienced tinnitus for much longer than one year. How much longer, I have no idea. Perhaps once the papers are released we'll be able to take a view.

People here are very well aware of my view that the average tinnitus patient will experience automatic central nervous system habituation within 2-3 years of onset. Applying treatment within this window of potential regression has always been problematic for me.

However, there have been many cases made on the forum for 'the science' testing within a criteria that can yield positive results, and then moving on from there. And I have to state that I do take that point and am happy with it.

In that respect then, regarding the reduction figures, I'm ecstatic. I've always said that if I can reduce my tinnitus to its 2017 levels I will consider that a cure. And I stand by that.

Regarding chronicity, pragmatism dictates that I remain on the fence until I can see more data.

With all that said, I don't want to pour water on the fire, however. Today, I genuinely believe Dr. Shore has made perhaps the most important medical advance in proper mechanical tinnitus treatment that I've seen since my onset in 1991. And that's fantastic news for everyone.

I wonder if it's going to help people like me who have good days and bad days of tinnitus. I'm having about 18 good days a month (days where it is not annoying) due to the fact that I recently removed trigger points in my neck.

 

[DimLeb]

That seems really high. I don't believe it. Let's assume 32 percent of the population has tinnitus (as some figures show). That would mean 12.8% of the population has hyperacusis. Hyperacusis can be debilitating and is pretty rare, aside from forums like this where more severe sufferers congregate, most people have never even heard of it.

I don't think 32% of population has tinnitus, more like 10-20% or even lower. If 1 out of 3 people had it, then the overall awareness would be much greater and it would be taken seriously. In my personal circle, for example, I know (and I asked about tinnitus) around 50 people and found out only 3 have tinnitus - me, my mother and my psychiatrist. Everyone else hadn't even heard of it...

Hyperacusis must have a very very low percentage, but there are many degrees of it and people might not know they actually have it. If you have tinnitus and you find some sounds uncomfortable, even mildly, that could very well be some kind of hyperacusis.

 

[dj_newark]

I really hope it works on reducing multi-tonal tinnitus...

I've asked Dr. Shore about this. She just responded by saying that "everyone has multiple tones". Meaning that yes, her treatment works for those with multiple tones!

 

[AnthonyMcDonald]

That seems really high. I don't believe it. Let's assume 32 percent of the population has tinnitus (as some figures show). That would mean 12.8% of the population has hyperacusis. Hyperacusis can be debilitating and is pretty rare, aside from forums like this where more severe sufferers congregate, most people have never even heard of it.

I'm not too sure about that. I'm friends with a lot of musicians, and most of my extended family are professional musicians. I'd say about >70% of them have hyperacusis, albeit in quite a mild form. I just don't think it's reported as often, people just say "I have sensitive hearing".

 

[Ben Winders]

I can't wait to throw all of our cacophony of combined tinnituses (is that a word) at Shore's device to see how well the device holds up 'in the wild'.

Our low frequency humming tinnitus that ramps up with high pitched noise like running water, our tinnitus that sounds like a ticking clock, our high piercing morse code tinnitus and whatever other shape or form tinnitus presents itself at in the wild.

One can only hope that Shore's research paper shows this vast spectrum and included some of those outliers in her research, not just "regular electric status shhhhhh" tinnitus that is probably most common.

I'm not a religious man, but I'm praying this is it, for many of us. First device that actually claims to calm down the cells that are causing this circus in our heads.

 

[LGuapo]

As I understand it, the audio component of this treatment is intended to be at the patient's perceived tinnitus frequency. But I wonder what that will mean for those of us with ultra high-pitched tinnitus. Has there been any mention of frequency range limitations of the treatment or even of the device?

Also, it seems for many people, including myself, the main tinnitus pitch is at the frequency where age-related hearing loss is occurring. This means that not only can I hardly hear real world (non-tinnitus) sounds that are at the same frequency as my main tinnitus pitch, but as I age this hearing loss will get worse and worse as the highest frequency I can hear gets lower and lower. So there is potentially a real need for a timely rollout of this treatment.

 

[Karen1979]

What I still can't get my head round (In a good way) is that the treatment stopped at six weeks and participants continued to get better! I would love to see the data from six months.

There's lots of details needed, like could you work on two tones at once (separate use), but I think this is where protocol designs are needed. All in all I'm very happy.

 

[Damocles]

I can't wait to throw all of our cacophony of combined tinnituses (is that a word) at Shore's device to see how well the device holds up 'in the wild'.

Eh?

Surely the millions and millions of tinnitus sufferers skipping around swinging chainsaws in the air and living happily you know about that the rest of us don't, won't even notice the difference the Shore device brings about.

Won't it just be us handful of looney cranks that frequent this forum, testing "how well the device holds up 'in the wild'"?

Hate to lower your expectations on the expected sample data, but it's your hypothesis I'm drawing from here, right?

 

[Nick47]

What I still can't get my head round (In a good way) is that the treatment stopped at six weeks and participants continued to get better! I would love to see the data from six months.

Yes, that's the first thing that struck me, there's a delayed effect. This effect seemed to last 30 weeks before diminishing.

I expect they will collect data after approval to get a better idea of efficacy and amend the protocols (duration of treatment, daily treatment time etc) of recommended use along the way.

Like you said previously, we are unlikely to see it in the NHS despite the clinically significant results. Someone will need to know how to test each patient's frequency, somatic location and set up the device. I would not attempt it myself so either way it will be a few thousand pounds through some private clinic. If it works then I will be more than happy to pay, but I would expect some sort of money-back guarantee or loan option offered, just in case it doesn't work. It looks like after 4-6 weeks you will know if you are a responder or not, so forking out £3,000 for a device you don't respond to and are stuck with is harsh.

 

[Nick47]

@Mentos, what did you think about Dr. Shore's Phase 2 results?

 

[Ben Winders]

Eh?

Won't it just be us handful of looney cranks that frequent this forum, testing "how well the device holds up 'in the wild'"?

Hence why I said "our". I was referring to all of us here on the forum. The people "in the wild" that are not too bothered by tinnitus (like our stone cutters) will never use Dr. Shore's device, obviously.

 

[Karen1979]

Yes, that's the first thing that struck me, there's a delayed effect. This effect seemed to last 30 weeks before diminishing.

I expect they will collect data after approval to get a better idea of efficacy and amend the protocols (duration of treatment, daily treatment time etc) of recommended use along the way.

Like you said previously, we are unlikely to see it in the NHS despite the clinically significant results. Someone will need to know how to test each patient's frequency, somatic location and set up the device. I would not attempt it myself so either way it will be a few thousand pounds through some private clinic. If it works then I will be more than happy to pay, but I would expect some sort of money-back guarantee or loan option offered, just in case it doesn't work. It looks like after 4-6 weeks you will know if you are a responder or not, so forking out £3,000 for a device you don't respond to and are stuck with is harsh.

I was thinking the hoops they would have to go through to get this commonplace in the NHS. First off, the BTA would have to support this/multiple studies, then NICE would have to include it in their recommendations, then like you said, the training of staff.

I agree with you; there needs to be a deposit kind of deal, if it doesn't work.

I can see this being picked up by the big clinics first. The Tinnitus Clinic comes to mind. I'm in Nottingham and I think it's based in Leicester so it would suit me.

I'm in a funny place with my tinnitus, I think overall I'm doing better. If in a year I'm still where I'm now, I'll definitely consider this. The funny thing is, when I read the results of the trial, I felt better. Talk about the "placebo effect".

 

[Nick47]

the BTA would have to support this/multiple studies, then NICE would have to include it in their recommendations,

Both of these can fcuk off as far as I'm concerned. They churn out nothing but psychobabble and mindfulness and need ripping up and throwing in the 1981 bin.

Where were the BTA reporting this today? They are supposed to be involved in bringing treatments.

 

[DimLeb]

Both of these can fcuk off as far as I'm concerned. They churn out nothing but psychobabble and mindfulness and need ripping up and throwing in the 1981 bin.

Where were the BTA reporting this today? They are supposed to be involved in bringing treatments.

That should be interesting, how all those crap organisations like BTA, ATA etc will react to this actual research advancement. Hopefully, they can't (and will not) bury Dr. Shore's device, as it goes against all the clown fiesta they promote - TRT, CBT and whatnot.

 

[UKBloke]

I'm in a funny place with my tinnitus, I think overall I'm doing better

You're very early in with it all. Believe me; you need to try and give it until around 2024 and then take a view. There's a very good chance you'll be just fine with your tinnitus (if it has persisted) by then. If not though, it's good to know that a robust treatment is there if needed. At this point, I have a feeling Dr. Shore has opened the flood gates and the technology will start to improve in leaps and bounds.

 

[UKBloke]

Also, it seems for many people, including myself, the main tinnitus pitch is at the frequency where age-related hearing loss is occurring. This means that not only can I hardly hear real world (non-tinnitus) sounds that are at the same frequency as my main tinnitus pitch, but as I age this hearing loss will get worse and worse as the highest frequency I can hear gets lower and lower. So there is potentially a real need for a timely rollout of this treatment.

This is an important point. What does your current audiogram look like? I have a circa -43 dB notch @ 4 kHz and would therefore have been excluded from using this device based on Dr. Shore's Phase 1 criteria. Thankfully, however, the team relaxed that particular criteria in Phase 2 and made it a max hearing loss of -50 dB.

 

[Gb3]

I have a feeling Dr. Shore has opened the flood gates and the technology will start to improve in leaps and bounds.

Very true. If her theory is right about the DCN, it's only a matter of time before someone can stimulate it directly and completely eliminate tinnitus!