New University of Michigan Tinnitus Discovery — Signal Timing

[Jonno02]

From what I understood reading the study, it has more to do with the timing of the electrical impulses than its amplitude. Hope this helps.

I don't think they changed timing, but instead the intensity of the pulses:

Somatosensory stimulation (3 biphasic square-wave pulses; 150 microseconds per phase; 1 millisecond between onsets) was provided by 2 transcutaneous active electrodes. The current level was titrated to the participant's sensation threshold.

 

[AnthonyMcDonald]

Yes, a lot of work goes into the industrial design, packaging and marketing. You can't just sell that black box with wires. It should look as good as it works.

I don't care if it looks like Satan's asshole as long as it works lol. I think most people would agree. Lenire was all bang and no buck.

 

[Kleiner]

I asked this a few pages back.

This is something I'm really interested in. For me it's potentially one of the largest causes for any spread in the results.

I understand the need for adjusting the dB of the tones as some people will be super sensitive to noise and I wonder if the stimulation threshold thing was due to not wanting people to be able to feel the pulses so the placebo wouldn't be bias.

I'm simplifying it in my head to a stupid level probably, but it's kinda like a deep tissue massage. If person A gets a proper deep tissue massage they'll feel the benefit. If person B gets one too but says 'oh be gentle I don't like it that much' they won't get as much benefit as person A.

Although sound and stimulation work together here, I think the electrical stimulation is the majority of the treatment as playing tones in your ear alone doesn't make tinnitus go away. If you turn that electrical pulse down to such a level it's almost imperceptible, are you also toning down the effectiveness of the treatment? Is that like taking half a Paracetamol for a headache when you should be taking 2 full tablets?

This will all be answered by field data I'm sure. Auricle will have so much data to sift through when this hits the market that they'll be able to identify optimal parameters which means they may be able to achieve an effectiveness not seen in the study.

No, the stimulation is not more important than the sound. In fact, according to the papers, the stimulation part alone tends to temporarily worsen tinnitus.

To put it simply, this technology consists of stimulating neurons via somatic stimulation and sound, almost simultaneously, but with a slight delay of a few ms. The neurons hate it, and they tend to become desynchronized, which would weaken the connections between tinnitus-producing neurons.

 

[Jonno02]

No, the stimulation is not more important than the sound. In fact, according to the papers, the stimulation part alone tends to temporarily worsen tinnitus.

To put it simply, this technology consists of stimulating neurons via somatic stimulation and sound, almost simultaneously, but with a slight delay of a few ms. The neurons hate it, and they tend to become desynchronized, which would weaken the connections between tinnitus-producing neurons.

Thank you for the correction, that's really interesting!

Could you tell me where that's discussed as I'd like to educate myself on it.

 

[Kleiner]

Could you tell me where that's discussed as I'd like to educate myself on it.

If I recall correctly, in the patent.

 

[slc]

I asked this a few pages back.

This is something I'm really interested in. For me it's potentially one of the largest causes for any spread in the results.

I understand the need for adjusting the dB of the tones as some people will be super sensitive to noise and I wonder if the stimulation threshold thing was due to not wanting people to be able to feel the pulses so the placebo wouldn't be bias.

I'm simplifying it in my head to a stupid level probably, but it's kinda like a deep tissue massage. If person A gets a proper deep tissue massage they'll feel the benefit. If person B gets one too but says 'oh be gentle I don't like it that much' they won't get as much benefit as person A.

Although sound and stimulation work together here, I think the electrical stimulation is the majority of the treatment as playing tones in your ear alone doesn't make tinnitus go away. If you turn that electrical pulse down to such a level it's almost imperceptible, are you also toning down the effectiveness of the treatment? Is that like taking half a Paracetamol for a headache when you should be taking 2 full tablets?

This will all be answered by field data I'm sure. Auricle will have so much data to sift through when this hits the market that they'll be able to identify optimal parameters which means they may be able to achieve an effectiveness not seen in the study.

There are quite a few studies out there on use of electrical stimulation alone to treat tinnitus. Here is one meta-analysis that looks at electrical intensity. It's hard to draw any conclusions about Auricle, but this still may be of interest.

Our meta-analysis included 11 studies involving a total of 447 patients with tinnitus. The results showed that electrical stimulation significantly reduced THI scores [mean difference (MD) = −9.69; 95% confidence interval (CI) = −14.25, −5.13; p < 0.0001; I2 = 80%] and VAS scores between the two groups (VAS loudness scores, MD = −0.72; 95% CI = −1.20, −0.25; VAS distress scores, MD = −0.90; 95% CI = −1.17, −0.63). In addition, subgroup analysis showed that THI scores in electrical stimulation group of different stimulating areas and methods follow-up times, tinnitus duration and electrical current intensity were generally reduced, regardless of the acute or subacute tinnitus group or left temporoparietal area (LTA) group with no statistical significance between two groups.

The studies analyzed used electrical stimulation ranging from 2 to 30 mA (milli-amperes). Auricle is bimodal and obviously this chart does not include information about electrical combined with acoustic stimulation. Here, they looked at a number of variables including electrical intensity. Below is the chart given for electrical intensity (less than or equal to 2 mA versus greater than 2 mA).

I find it interesting that electrical stimulation alone generally showed a reduction of THI (Tinnitus Handicap Inventory) scores.

The researchers do state, "our results demonstrated that a higher current intensity may not improve the treatment effect."

One cool thing is that the electrical stimulation seemed to be effective with chronic (long term) tinnitus.

Here is a free link to the study I referred to above. It is called:

Electrical stimulation to treat tinnitus: a meta-analysis and systemic review of randomized controlled trials.

 

[Chriscom]

I can't believe no one saw this back in September?!?! This is good news but you can't tell by the comments.

Agreed on both points!

 

[Fields]

Due to a regression I'll be seeing an audiologist again, soon.

I'm curious to learn whether my audiologist is aware of Susan Shore/Auricle, and whether they'd be willing to adopt the treatment (in Europe, in the future).

As a fallback, I've been saving up money for a possible treatment abroad.

 

[DimLeb]

I'm curious to learn whether my audiologist is aware of Susan Shore/Auricle, and whether they'd be willing to adopt the treatment (in Europe, in the future).

As a fallback, I've been saving up money for a possible treatment abroad.

It's 99% certain that they won't have a clue who that is lol.

 

[Joey72]

Due to a regression I'll be seeing an audiologist again, soon.

I'm curious to learn whether my audiologist is aware of Susan Shore/Auricle, and whether they'd be willing to adopt the treatment (in Europe, in the future).

As a fallback, I've been saving up money for a possible treatment abroad.

They are stuck in the 50s (the 1850s).

 

[SarahMLFlemmer]

It's 99% certain that they won't have a clue who that is lol.

Stanford's audiologist didn't know who Dr. Shore was or what the device was, but she wrote it down I think. I was suprised.

 

[LGuapo]

Stanford's audiologist didn't know who Dr. Shore was or what the device was, but she wrote it down I think. I was suprised.

The Stanford audiologist I saw knew who Dr. Shore was.

 

[gameover]

My audiologist was very aware of Dr. Shore's device. Standout guy, I guess. Meanwhile he peddles Lenire, though he is smart enough to not offer it to me.

 

[Joey Lodes]

My ENT is now up to date on all tinnitus research, especially Dr. Shore's device.

Thanks to me. Lol.

 

[SarahMLFlemmer]

The Stanford audiologist I saw knew who Dr. Shore was.

I believe I saw Emily Price, not Christian Bourdon. Who did you see?

 

[Fields]

My ENT is now up to date on all tinnitus research, especially Dr. Shore's device.

Thanks to me. Lol.

Worst case, I'll inform my audiologist and signal my intentions to try this treatment as soon as it becomes publicly available.

Depending on how I'm feeling by then, I'll either make a trip to the US or wait until it becomes available in Europe.

Might as well inquire if they're knowledgeable about any of the processes that are required in order to get medical treatment abroad (referrals, insurance, etc).

 

[R0B]

Something I came across in my research that gives me hope regarding Dr. Shore's device:

The Michigan Tinnitus Device is indeed customized to each individual's tinnitus sound. This personalization is crucial for the effectiveness of the treatment. The device delivers sounds that are matched to the loudness and pitch of the phantom sounds each patient experiences. In other words, the auditory component of the therapy is tailored to the specific characteristics of the tinnitus perceived by the individual user.

 

[WillBeNimble]

Something I came across in my research that gives me hope regarding Dr. Shore's device:

Yeah, you have to be able to hear your tone. This makes me sad, because I know I can't hear mine anymore in either ear. So, I'm going to get left behind.

 

[SarahMLFlemmer]

Yeah, you have to be able to hear your tone. This makes me sad, because I know I can't hear mine anymore in either ear. So, I'm going to get left behind.

What do you mean by not being able to hear yours?

 

[Jonno02]

Yeah, you have to be able to hear your tone. This makes me sad, because I know I can't hear mine anymore in either ear. So, I'm going to get left behind.

Nobody knows this, not even Dr. Shore.

If your tone is 8 kHz and you can't hear over 6 kHz, nobody knows what setting your tone at 6 kHz will achieve. 50, 75, 95% effectiveness? Who knows? Don't rule it out just yet.

 

[chinup]

Yeah, you have to be able to hear your tone. This makes me sad, because I know I can't hear mine anymore in either ear. So, I'm going to get left behind.

If you can perceive the tinnitus, you can "hear" your tone, right? It's not an actual sound so I'm not sure why being deaf in the range of the tone would make a difference.

My understanding is they match the device to whatever tone you're perceiving. So whatever sound you perceive that brought you to Tinnitus Talk is the sound they are talking about.

 

[Jammer]

Yeah, you have to be able to hear your tone. This makes me sad, because I know I can't hear mine anymore in either ear. So, I'm going to get left behind.

I'm in the same boat. My tinnitus lives in my head at 11 kHz to 12 kHz and my hearing now tops out at 6 kHz.

 

[RunningMan]

If you can perceive the tinnitus, you can "hear" your tone, right? It's not an actual sound so I'm not sure why being deaf in the range of the tone would make a difference.

My understanding is they match the device to whatever tone you're perceiving. So whatever sound you perceive that brought you to Tinnitus Talk is the sound they are talking about.

No. Deafness in those frequencies can definitely make a difference as per the Q&A. Being able to perceive a tinnitus tone is not the same thing as being able to hear that tone from the Shore device. For the Shore device to work, you need to be able to hear the tones with your ears as emitted from the device.

From the Q&A:

What if you have bilateral severe to profound hearing loss in the same frequency as your tinnitus? Will it impact the treatment?

At present, bilateral severe to profound hearing loss would preclude use of the device as the signal needs to be heard to be effective. The study only included up to moderate hearing loss.

 

[AfroSnowman]

Nobody knows this, not even Dr. Shore.

If your tone is 8 kHz and you can't hear over 6 kHz, nobody knows what setting your tone at 6 kHz will achieve. 50, 75, 95% effectiveness? Who knows? Don't rule it out just yet.

Agreed, in discussions about multiple/fluctuating tone tinnitus, I thought Dr. Shore stated that she just matched the dominant tone and it impacted the tinnitus as a whole; the timed stimulation seems to be the critical factor more than an exact tinnitus match.

How far off the tinnitus tone it can be and still be effective is the question. Maybe it really doesn't matter, as long as you have timed stimulation of the auditory nerve it will chill out the overactive cells.

 

[Nick47]

I have not commented on this thread much recently but if all goes well, I estimate approval will be before July 2024. What we don't know is if Auricle has the resources to hit the ground running so the treatment is available in the 2nd half of 2024. I have some doubts, but I expect to see the first USA members here receiving the treatment in 2024.

I don't think the results will be as spectacular as the trial results, they rarely are. There will be super responders and many saying it's doing something, I'm sure.

So the rest of the world will be staring into the window of the USA bubble.

A few comments on the hearing. You will need no more than moderate hearing loss, at least in one ear, to hear the tones. This is critical in conjunction with the electrical stimulation and the timing between the two sensory inputs.

 

[R0B]

I have not commented on this thread much recently but if all goes well, I estimate approval will be before July 2024. What we don't know is if Auricle has the resources to hit the ground running so the treatment is available in the 2nd half of 2024. I have some doubts, but I expect to see the first USA members here receiving the treatment in 2024.

I don't think the results will be as spectacular as the trial results, they rarely are. There will be super responders and many saying it's doing something, I'm sure.

So the rest of the world will be staring into the window of the USA bubble.

A few comments on the hearing. You will need no more than moderate hearing loss, at least in one ear, to hear the tones. This is critical in conjunction with the electrical stimulation and the timing between the two sensory inputs.

I like the sound of that timeline. I wonder what makes you think approval will take place in July 2024?

 

[chinup]

No. Deafness in those frequencies can definitely make a difference as per the Q&A. Being able to perceive a tinnitus tone is not the same thing as being able to hear that tone from the Shore device. For the Shore device to work, you need to be able to hear the tones with your ears as emitted from the device.

That actually makes total sense now that I think about it. If you can't hear the device's tone at all, it probably won't work properly, regardless of what tinnitus tone you're hearing. Similar to residual inhibition.

Not sure what I was thinking but you're absolutely right.

 

[Nick47]

I like the sound of that timeline. I wonder what makes you think approval will take place in July 2024?

It normally takes 90 days for a 510(k) FDA approval.

 

[Jonno02]

That actually makes total sense now that I think about it. If you can't hear the device's tone at all, it probably won't work properly, regardless of what tinnitus tone you're hearing. Similar to residual inhibition.

Not sure what I was thinking but you're absolutely right.

My residual inhibition works at any tone frequency. My 9.5 kHz tinnitus disappears even if I play a 400 Hz tone. I don't think there will be a definitive answer to this question until individuals get their hands on the device.

 

[DimLeb]

My residual inhibition works at any tone frequency. My 9.5 kHz tinnitus disappears even if I play a 400 Hz tone. I don't think there will be a definitive answer to this question until individuals get their hands on the device.

This more or less happens with me as well, at least for my tonal sounds which can't be modulated with jaw/neck movements. And meanwhile, residual inhibition doesn't work at all for my white noise tone which CAN be modulated by clenching my jaw/stetching my neck.

What a freaking mess tinnitus is.