New University of Michigan Tinnitus Discovery — Signal Timing

[Joey Lodes]

Agreed.

Tinearity is a white noise generator and is more unsightly than the Widex hearing aids I have which are already generating sounds (and which do nothing for my tinnitus).

The Auricle device is designed to actually lower the volume of your tinnitus. Just waiting patiently for its release.

 

[Earman]

I agree about the Tinearity being a white noise generator and I understand that most people here would not buy one. Thanks for your thoughts.

Looking forward to Auricle being released. It seems very promising. I hope it can help everyone with tinnitus to a better life!

 

[SarahMLFlemmer]

Come on Auricle!

 

[SilverFox]

I get the same feeling as from the earlier treatment threads on Tinnitus Talk. First it was 3 months, then a year, now it's 2-3 years... The replies provided in the Q&A were non-answers. The trials only tested people with somatic tinnitus, and the efficacy in non-somatic cases is unknown, as I understand. It is also not known whether the device is ready for mass production. And it seems to be targeting USA only for now.

While it would be life-saving to have such a treatment available, somehow I don't have a lot of hope that this will happen anytime soon.

 

[Fightthearmy]

To this day Hubert Lim talks about Lenire like it's a miracle invention. I wonder if they really expect to compete with Auricle. Could they be that delusional?

Give Hubert Lim a Nobel Prize.

Give Ross O'Neill more money.

 

[slc]

What do you think about Tinearity from the company Duearity compared to Auricle? Tinearity was recently FDA-approved and sales started in the USA. Is Auricle better?

As already mentioned, Tinearity is a type of white noise generator that works through bone conduction as opposed to a sound generator tube inserted into the ear canal. It avoids irritating the ear canal. It is used in conjunction with TRT (Tinnitus Retraining Therapy), which is meant to habituate the person to tinnitus. In my view habituation is achievable if the tinnitus is mild to moderate (only heard in quiet or less noisy environments). Some folks do habituate to louder tinnitus.

Auricle is a whole different ball of wax in that sound and electrical stimulation adapted to the patient are used to retrain the brain. Studies of the Auricle device were double-blinded with a control group. I have no idea what kind of studies Tinearity conducts. They probably just had to show their device was safe as there are many, many maskers already on the market. Dr. Shore's studies show an actual lowering of the decibel level with the Auricle device.

The Tinearity G1 consists of two small audio components that attach to adapters that are then attached behind the ears. Via the sound components, white noise is generated directly into the ears via the skull bone, leaving the ear canals free. In treatment, we recommend listening to white noise 6-8 hours per day for 6–24 months. The battery in the Tinearity G1 lasts up to 8 hours before it needs to be charged.

• Tinearity G1 can be used for treatment of tinnitus (e.g. as the sound source within TRT) and partly as a masker to mask the tinnitus sound
• The fact that the ear canals are kept free also means that Tinerarity G1 can be used for a longer period without irritating the ear canal.
• It is estimated that approximately 70-80 percent of those who suffer or are bothered from tinnitus are helped by TRT.

 

[Joeseph Stope]

Come on Auricle!

Careful!!!

Curb your enthusiasm. Remember, we are in this for the long term.

.......................................................

 

[SarahMLFlemmer]

Careful!!!

Curb your enthusiasm. Remember, we are in this for the long term.

.......................................................

I don't even have somatic tinnitus and treatments with all of my other ailments have pretty much failed me but I am *trying* to be as optimistic as I can be. Sometimes I go a little overboard because I'm just ready for the misery to end!

I remain cautiously optimistic

Unless you're talking about the timing. That, I actually remain highly optimistic that it'll be on the market sooner, rather than later

 

[dd314]

I'd be really interested to see if a multi-tonal approach could work. I have a tone at 8 kHz, 10.5 kHz and then somewhere around 12 kHz. Each day it changes for which is my dominant tone. I know previously Dr. Shore has said everybody has multiple tones so just to pick the most intrusive.

But if the study device was set at one tone and the treatment went 'tone-zap-tone-zap-tone-zap' I wonder if, using my tones, '8 kHz tone - zap - 10.5 kHz tone - zap- 12 kHz tone - zap' would produce a more drastic reduction as you're targeting all tinnitus tones? I wonder if they've looked into that.

I wonder if the auditory stimulus could be a broadband sound that incorporates various frequencies. I'm thinking I'll just have a full on symphony as mine.

 

[Jonno02]

Not quite there yet, but I feel like we're at risk of this thread becoming an echo chamber of negativity.

Susan Shore never said this would launch in 3 weeks, 3 months, 6 months etc. That's all speculation of members on here.

They've managed to show a reduction in tinnitus in 2 separate studies now. Yes, I know it's 6 dB and I know it doesn't work for everybody and I know there are further questions around the device and I know... you get the point. But if that 6 dB reduction in tinnitus is real, that's mind blowing to me. The first actual reduction in tinnitus in humans. Ever. For some people, as shown with 2 people in the first study, it's potentially even a cure. Even 1 dB shows a genuine pathway that tinnitus can be reduced!

And they've achieved this with minimal funding in a University lab. When gen 1 of this machine launches and really serious cash flow begins to come in, just imagine the studies and improvements they'll be able to make. They'll develop into an established company with R&D and regulatory experts to accelerate future revisions.

 

[ErikaS]

Not quite there yet, but I feel like we're at risk of this thread becoming an echo chamber of negativity.

Susan Shore never said this would launch in 3 weeks, 3 months, 6 months etc. That's all speculation of members on here.

They've managed to show a reduction in tinnitus in 2 separate studies now. Yes, I know it's 6 dB and I know it doesn't work for everybody and I know there are further questions around the device and I know... you get the point. But if that 6 dB reduction in tinnitus is real, that's mind blowing to me. The first actual reduction in tinnitus in humans. Ever. For some people, as shown with 2 people in the first study, it's potentially even a cure. Even 1 dB shows a genuine pathway that tinnitus can be reduced!

And they've achieved this with minimal funding in a University lab. When gen 1 of this machine launches and really serious cash flow begins to come in, just imagine the studies and improvements they'll be able to make. They'll develop into an established company with R&D and regulatory experts to accelerate future revisions.

I think what is also something important to remember and include with many of those points is the fact that they stated some participants shared that after they stopped using the device at 6 weeks, they continued to see/hear improvement. That is neuroplasticity at work and doing its job, so I for one am optimistic that continued use of the device past 6 weeks could very well yield more improvements.

I want the device tomorrow, but I am really trying to ride the patience and optimistic train with you, @Jonno02!

 

[SarahMLFlemmer]

I want the device tomorrow, but I am really trying to ride the patience and optimistic train with you, @Jonno02!

I want it yesterday.

 

[Stayinghopeful]

"Good things take time" and if that quote is anything to go by, then the Shore device is going to be GREAT!

I've got a spot on my leg left to get her portrait tattooed on me. I'll even let her select the photo she wants of her on me.

 

[Anuar Lukios]

Indeed, more and more often we read speculations and negative theories on this thread... then I remember that those who write are often ordinary people with no qualifications or expertise in this field.

I have the feeling that most of them haven't even read (or understood) the interview with Susan Shore... otherwise, we would be talking about:

- "In those who cannot modulate, we assume those connections are still there but perhaps not as strong. The preclinical (animal model) studies indicate that projections from somatosensory centers to the cochlear nucleus are present in 100% of animals tested."

- "So yes, the tinnitus signal originates in the cochlear nucleus. More central centers may modify the signal that they receive from the cochlear nucleus, including descending pathways."

- "We don't know that the guinea pigs had somatic tinnitus per se. We do know that somatosensory stimulation could modify auditory signals in all of the guinea pigs. Thus, we chose those who could modulate their tinnitus as our first test group as this was the group showing evidence of somatosensory innervation to the auditory system."

- "It is possible that the treatment could help those who cannot modulate because the preclinical (animal) studies show that after cochlear damage, all animals show somatosensory reinnervation of the cochlear nucleus. We have not yet tested those subjects."​

All these things are surprising statements to speculate and talk about... instead, I keep seeing the same senseless questions that Dr. Shore has already answered.

 

[Cmspgran]

I wonder if the auditory stimulus could be a broadband sound that incorporates various frequencies. I'm thinking I'll just have a full on symphony as mine.

She made a reference to this in her answer to a question on something along multiple tones and stated that tinnitus is in a frequency band. I get the impression what she means is, the audio stimulus will be a frequency range and not a case of you've got to match 'the perfect tone' to get it to work.

 

[RunningMan]

They've managed to show a reduction in tinnitus in 2 separate studies now. Yes, I know it's 6 dB and I know it doesn't work for everybody and I know there are further questions around the device and I know... you get the point. But if that 6 dB reduction in tinnitus is real, that's mind blowing to me. The first actual reduction in tinnitus in humans.

The "per protocol" (PP) group through the 12th week of the study, at the end of the washout period, experienced an average 10.9 dB reduction in tinnitus loudness. Susan Shore also referenced that figure in the Q&A. Also in the Q&A, 6 dB reduction is what she referred to as "half as loud".

That 6 dB is close to the difference in reduction between the control and active group at the end of the washout period - looks to be about 5 dB difference in reduction.

First study for comparison:

 

[Jonno02]

The "per protocol" (PP) group through the 12th week of the study, at the end of the washout period, experienced an average 10.9 dB reduction in tinnitus loudness. Susan Shore also referenced that figure in the Q&A. Also in the Q&A, 6 dB reduction is what she referred to as "half as loud".

That 6 dB is close to the difference in reduction between the control and active group at the end of the washout period - looks to be about 5 dB difference in reduction.

View attachment 56055

First study for comparison:

View attachment 56056

Right you are! Even better.

 

[Anuar Lukios]

The "per protocol" (PP) group through the 12th week of the study, at the end of the washout period, experienced an average 10.9 dB reduction in tinnitus loudness. Susan Shore also referenced that figure in the Q&A. Also in the Q&A, 6 dB reduction is what she referred to as "half as loud".

That 6 dB is close to the difference in reduction between the control and active group at the end of the washout period - looks to be about 5 dB difference in reduction.

View attachment 56055

First study for comparison:

View attachment 56056

Yes, but I would like to remind everyone that a "10.9 dB reduction in 12 weeks" doesn't simply mean a "10.9 dB reduction and stop".

I specify this because many seem to want to convey this idea... It doesn't even make sense to say "It's little," it would have been little (actually not) if it had stopped at 10.9 dB.

As Dr. Shore has also stated:

It's possible that longer times beyond 6 weeks may be even more effective.

And honestly, until proven otherwise, I prefer to trust a neuroscientist with decades of experience rather than my or your thoughts. Despite Dr. Shore's words, there are occasional complaints about the reduction in volume.

"With this diet, you will lose 6kg in 6 weeks" doesn't mean "With this diet, you will lose 6kg, and that's it," are we all in agreement on this?

 

[RunningMan]

Yes, but I would like to remind everyone that a "10.9 dB reduction in 12 weeks" doesn't simply mean a "10.9 dB reduction and stop".

I specify this because many seem to want to convey this idea... It doesn't even make sense to say "It's little," it would have been little (actually not) if it had stopped at 10.9 dB.

And honestly, until proven otherwise, I prefer to trust a neuroscientist with decades of experience rather than my or your thoughts. Despite Dr. Shore's words, there are occasional complaints about the reduction in volume.

10.9 dB reduction is an average based on the PP group that received the active treatment first. Some will be more, some will be less. In fact, 7 of the original 99 study participants got worse tinnitus during the study, so they are not part of the PP group data. And of those 99 study participants, only 53% of those receiving the active treatment had clinically significant improvement at week 6 vs. 20% of those in the control group. That's a 33 percentage point difference between active and control.

Dr. Shore said "it's possible" and "may", so she is being very conservative with that response of further reduction in tinnitus, as she should since it hasn't been tested. So, it's not a matter of "trusting" as she's not claiming or even speculating that there will be further improvement, only that it's possible, which means it's possible there won't be.

So, it's good to be optimistic, but keep expectations in check.

 

[Anuar Lukios]

10.9 dB reduction is an average based on the PP group that received the active treatment first. Some will be more, some will be less. In fact, 7 of the original 99 study participants got worse tinnitus during the study, so they are not part of the PP group data. And of those 99 study participants, only 53% of those receiving the active treatment had clinically significant improvement at week 6 vs. 20% of those in the control group. That's a 33 percentage point difference between active and control.

Dr. Shore said "it's possible" and "may", so she is being very conservative with that response of further reduction in tinnitus, as she should since it hasn't been tested. So, it's not a matter of "trusting" as she's not claiming or even speculating that there will be further improvement, only that it's possible, which means it's possible there won't be.

So, it's good to be optimistic, but keep expectations in check.

Is there a difference between being cautiously optimistic and questioning every response given by Dr. Shore. If she has said it's possible, she must have her reasons to believe it's possible... of course, I don't expect miracles.

For accuracy and precision, it should also be noted that the deteriorations are due to:

Only one patient experienced a worsening of tinnitus, probably associated with the use of the device during active treatment. Other cases of worsening were related to instances of noise overexposure during the study (e.g., attending a rock concert). These returned within one standard deviation from the baseline.

I'm writing this mainly because there was some alarmism a few pages back in the thread.

It's important that the thread returns to a more positive tone and focuses on the most interesting aspects that Dr. Shore revealed in the interview. Continuously repeating that the device may not come out or may disappoint us serves no purpose.

This is important because thousands of people who suffer from this condition rely on what they read on this forum, so let's get back on the right track.

 

[slc]

10.9 dB reduction is an average based on the PP group that received the active treatment first. Some will be more, some will be less. In fact, 7 of the original 99 study participants got worse tinnitus during the study, so they are not part of the PP group data. And of those 99 study participants, only 53% of those receiving the active treatment had clinically significant improvement at week 6 vs. 20% of those in the control group. That's a 33 percentage point difference between active and control.

Dr. Shore said "it's possible" and "may", so she is being very conservative with that response of further reduction in tinnitus, as she should since it hasn't been tested. So, it's not a matter of "trusting" as she's not claiming or even speculating that there will be further improvement, only that it's possible, which means it's possible there won't be.

So, it's good to be optimistic, but keep expectations in check.

Out of the 7 study participants who discontinued participation and whose tinnitus worsened, 4 were first in the control treatment group and 3 were first in the active treatment group. I'm not sure how how many weeks of the auditory-only or active treatment they received before dropping out.

 

[eagerUser]

Out of the 7 study participants who discontinued participation and whose tinnitus worsened, 4 were first in the control treatment group and 3 were first in the active treatment group. I'm not sure how how many weeks of the auditory-only or active treatment they received before dropping out.

View attachment 56057

I remember Dr. Shore said one of the participants who had his/her tinnitus worse attended a concert and that has nothing to do with the device.

 

[DeanD]

I remember Dr. Shore said one of the participants who had his/her tinnitus worse attended a concert and that has nothing to do with the device.

Went to a concert?! You do start to wonder just how bad these test case studies were!

 

[dd314]

10.9 dB reduction would be wonderful. For those of you that don't know, it's approximately the difference between standing 10-feet from a noise and standing 40-feet from a noise (or metres). The difference is night and day.

 

[Anuar Lukios]

And anyway, Dr. Shore's device represents a revolution in any case.

If truly 15% of the world's population suffers from tinnitus (1.2 billion out of 8 billion), and of those, 70% have somatic tinnitus (840,000,000), and 53% of them are "cured" (445,200,000), how can one complain about such results in the face of nearly half a billion treatable people?

All of this excluding the fact that:

• Improvements are possible even for those with non-somatic tinnitus.
• Further improvements are possible after the 12th week.
• All of this from the first generation of devices released.

I know many of us may think, "I'm probably part of that 47% that doesn't improve, so it's better to keep expectations low," but let's try to be positive.

 

[eagerUser]

I have a quick question: if you can't be positive, why are you trying to make others feel negative? How does it help to be cautiously optimistic?

Went to a concert?! You do start to wonder just how bad these test case studies were!

And why?

After all, it's not Dr. Shore's fault that the person attended a (rock?) concert.

 

[Anuar Lukios]

I have a quick question: if you can't be positive, why are you trying to make others feel negative? How does it help to be cautiously optimistic?

You've perfectly understood how some users behave on this forum, my friend.

 

[Utdmad89]

I have a quick question: if you can't be positive, why are you trying to make others feel negative? How does it help to be cautiously optimistic?

And why?

After all, it's not Dr. Shore's fault that the person attended a (rock?) concert.

100%, no one has the right to tell you what your expectations should be.

 

[Jeggie3]

In reading the paper, a couple of reasons to be optimistic with respect to the worry about "non-responders":

1. The mean response is not yet plateaued at 6 weeks so presumably with further treatment more people may fall into the "clinically significant" category.

2. I'm assuming that with this trial there was no way to modify the protocol once started unlike what would in a clinical setting if there is no response after several weeks.

 

[Jason Cohen]

I've been wondering if the device not working/not working as well for some people is from their tinnitus frequencies not being matched properly. I think I remember reading something in the animal study that they treated their tinnitus at the 8 kHz range, but it did nothing for their tinnitus outside of 8 kHz. If this is the case, I'd imagine that you could continue working with the audiologist to figure out the correct frequencies if the results aren't good at first.