New University of Michigan Tinnitus Discovery — Signal Timing

[Nick47]

I used the pathsurveyor.com that they mentioned in the video.

Here is the timeline for Lenire.

Couldn't find Dr. Shore's.

De Novo approvals seem to take 18-24 months.

510k (if that's the route) can take as little as a month, with an average of 121 days.

Thing is, has it been submitted?

Then of course only 3% of the world live in the USA, so for the rest of us, we may as well switch off.

 

[AfroSnowman]

One thing I am not sure yet of (and maybe no one is?) is if Dr. Shore's device is targeted to somatic tinnitus only, or not.

The pre-clinical trials have been conducted on animals with somatic tinnitus; not sure about the clinical trials, though.

Does this mean that the device will work only for somatic tinnitus sufferers or not? Being my tinnitus is noise induced and not changing with any jaw/head/neck movement at all, this would be disheartening.

But I think I also read somewhere that experimenting on somatic tinnitus cases was just easier, probably because it is the easiest way to identify tinnitus in a non-human entity? I cannot find the source though.

The study was only on those with somatic tinnitus, but I believe that her theory is that it should work on non-somatic as well.

 

[slc]

I used the pathsurveyor.com that they mentioned in the video.

Here is the timeline for Lenire.

Couldn't find Dr. Shore's.

De Novo approvals seem to take 18-24 months.

510k (if that's the route) can take as little as a month, with an average of 121 days.

Thing is, has it been submitted?

Then of course only 3% of the world live in the USA, so for the rest of us, we may as well switch off.

Thanks @Nick47 for looking this up. The pathsurveyor.com link to the Lenire FDA letter shows the application was submitted August 18, 2021 and the letter of approval was dated March 06, 2023.

A search using Lenire's product code, "QVN - Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus," did not bring up any information.

And as you say, we don't know if Auricle has been submitted. I also couldn't find Dr. Shore's device. I searched for Auricle and also Medtech in the De Novo category.

 

[dd314]

Maybe they're not much more confident than the Lenire people.

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?

 

[SarahMLFlemmer]

One thing I am not sure yet of (and maybe no one is?) is if Dr. Shore's device is targeted to somatic tinnitus only, or not.

The pre-clinical trials have been conducted on animals with somatic tinnitus; not sure about the clinical trials, though.

Does this mean that the device will work only for somatic tinnitus sufferers or not? Being my tinnitus is noise induced and not changing with any jaw/head/neck movement at all, this would be disheartening.

But I think I also read somewhere that experimenting on somatic tinnitus cases was just easier, probably because it is the easiest way to identify tinnitus in a non-human entity? I cannot find the source though.

I have non-somatic tinnitus too.

The only time that my tinnitus adds a tune ("shhh" and sometimes morse code) is when I open my mouth in front of either; a fan or the shower.

Other than that, my tinnitus doesn't change at all.

I've read in the Q & A that it *could* work for non-somatic tinnitus. We just have to wait and see.

How can you know a lab animal has somatic tinnitus?

I've wondered the same thing!

 

[Tiles]

We cannot look for similarities between probably the most complicated medical device (MRI) and Auricle. For me, personally, nothing can explain why Auricle's commercialization can take so long.

Another factor is the level of incidental support that's available to the manufacturer. In the 70s, businesses still used manual typewriters and carbon paper. Today we carry around supercomputers and can order from job shops all over the world.

No doubt the secret sauce in the Michigan Device takes some specialized tech to implement, but I have a wristwatch that can take my EKG.

 

[Ed Fleck]

I had a conversation with a support worker from Tinnitus UK. He said he expects availability in the USA in about 2 years. With the rest of the world it will be longer as they need to build their client base in the USA first.

My reading into this is it will be a cash flow issue. They will only have cash for production of so many units initially, and will need to sell X amount of units in the USA before there is money to launch and supply elsewhere.

My feeling is that the Tinnitus UK "support" member knows nothing.

I know that effective October 1, 2023, the CDRH of the FDA - which has jurisdiction over medical devices such as Auricle - enacted rules that any submissions pursuant to 510 (k) must be submitted electronically to speed up approval. Auricle is similar enough to the Lenire device (although Auricle actually works) that it can be submitted as a 510 (k) submission. FDA rules require a decision within 90 days of submission.

Although the FDA is not allowed to confirm or deny whether a submission has been made, the woman at the FDA confirmed on the phone yesterday that all 510 (k) submissions must be decided within 90 days.

I messaged Auricle on LinkedIn quoting the new electronic submission rule of the CDRH for 510 (k) submissions, and Auricle liked my post. That was several days before October 1. I do not know if it has been submitted as a 510 (k) submission already or will be but why would Auricle like my post. They know Biohaven and Xenon Pharmaceuticals are in Phase 3 trials to cure epilepsy with their potassium channel openers that could cure epilepsy and, if trials are successful, can be used off-label for tinnitus. If I was Susan Shore and worked on this device for 20 years, I would want to get it to market as soon as possible An electronic 501 (k) submission makes the most sense.

This is what I know and, while I'm not a Tinnitus UK support member (whatever that is), I believe that the Shore device will be available in the spring of 2024 in the US and that will be the end of Lenire.

 

[Fightthearmy]

Then of course only 3% of the world live in the USA, so for the rest of us, we may as well switch off.

You could buy plane tickets.

 

[Jonno02]

I was having a daydream about this earlier (again). I am a believer that Dr. Shore's device works as per the study data but is maybe just in its infancy. A lot of the tweaks will come from field data.

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.

 

[ErikaS]

I was having a daydream about this earlier (again). I am a believer that Dr. Shore's device works as per the study data but is maybe just in its infancy. A lot of the tweaks will come from field data.

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 remember asking @linearb specifically about this because he had multiple sounds. He shared that ALL of his tinnitus sounds/frequencies decreased as he used the device. Like it settled as a whole, not just one sound or frequency. I think it comes down to how the general hyperexcitability of the fusiform cells in the DCN is being targeted and calmed with this treatment, and as you target that, to get an overall calming effect would be likely. I understand there's the sound stimulating that's important, but I just wanted to reiterate what he shared when I asked him about this many pages back in this thread.

 

[Onguacchiat]

Here are the answers to some of the questions that were asked previously in the thread, including how can you know a lab animal has somatic tinnitus. They're taken directly from the Q&A.

Can the treatment help if the patient cannot modulate their tinnitus by jaw/neck/head/other movements? If not, are there plans for a treatment that helps these patients?

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.

---

What are the contraindications (medications, conditions) for using the device?

The device is intended for tinnitus patients that are able to modulate their tinnitus with a somatic maneuver. They also must be able to hear the auditory stimulus, so persons with mild to moderate hearing loss will generally be fine.

---

Do you believe that all forms of subjective tinnitus (excluding those caused by mechanical issues) are generated in the dorsal cochlear nucleus (DCN)?

All signals must be processed by the cochlear nucleus (including the dorsal cochlear nucleus) before ascending to the rest of the auditory system. Thus, the tinnitus signal that fusiform cells produce is passed along to the rest of the brain. 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.

---

How did you know in the animal studies that the guinea pigs had somatic tinnitus?

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.

The device has NOT been tested on non-somatic tinnitus cases (neither in the animal tests nor in the human trials). They just don't know if it can help in such cases. The reason being that they could only use guinea pigs that react to somatosensory stimulation - it is explained in the last Q&A in the list above, but honestly I am not a fan of that and other answers. To me they seem short and vague but, at the same time, very specific medical terms are used. I'd rather have a long scientific explanation or a short and simple one that people without a medicine degree can understand, not a mix of these two approaches... but that might be only me.

Anyways, that's the reason for testing only "somatic" guinea pigs, but what about the human trials? Why did they not test patients with non-somatic tinnitus? The only answer seems to be that, as someone else already said, most tinnitus sufferers can modulate it in some way, making the non-somatic sufferers a smaller demographic (thus with less priority and representation in the trials).

So, most of you can modulate their tinnitus with some movement? Even those of you who got tinnitus from acoustic trauma? I guess it just surprises me because I was quite convinced of the opposite until now.

 

[gameover]

So, most of you can modulate their tinnitus with some movement? Even those of you who got tinnitus from acoustic trauma?

My tinnitus is 100% caused by acoustic trauma (maybe made worse by lingering sinus infection I had at the time).

Jaw movement does not quite modulate my regular sound, but turns on another sound that is completely absent when my jaw is closed. It is possible I had some of that before but it was so faint I may not have noticed.

 

[dj_newark]

Thanks @Nick47 for looking this up. The pathsurveyor.com link to the Lenire FDA letter shows the application was submitted August 18, 2021 and the letter of approval was dated March 06, 2023.

A search using Lenire's product code, "QVN - Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus," did not bring up any information.

And as you say, we don't know if Auricle has been submitted. I also couldn't find Dr. Shore's device. I searched for Auricle and also Medtech in the De Novo category.

The reason that Lenire took so long is that the FDA asked them to do another trial. That won't be the case for Dr. Shore. And of course Neuromod used their trial as a marketing opportunity by conveniently deciding to not use a placebo for their trials!

 

[Jonno02]

I remember asking @linearb specifically about this because he had multiple sounds. He shared that ALL of his tinnitus sounds/frequencies decreased as he used the device. Like it settled as a whole, not just one sound or frequency. I think it comes down to how the general hyperexcitability of the fusiform cells in the DCN is being targeted and calmed with this treatment, and as you target that, to get an overall calming effect would be likely. I understand there's the sound stimulating that's important, but I just wanted to reiterate what he shared when I asked him about this many pages back in this thread.

That's great news.

But I still wonder if you'd see on average a greater than 6 dB reduction within the same timeframe (for all tones) if you were to target all frequencies.

 

[SarahMLFlemmer]

Here are the answers to some of the questions that were asked previously in the thread, including how can you know a lab animal has somatic tinnitus. They're taken directly from the Q&A.

The device has NOT been tested on non-somatic tinnitus cases (neither in the animal tests nor in the human trials). They just don't know if it can help in such cases. The reason being that they could only use guinea pigs that react to somatosensory stimulation - it is explained in the last Q&A in the list above, but honestly I am not a fan of that and other answers. To me they seem short and vague but, at the same time, very specific medical terms are used. I'd rather have a long scientific explanation or a short and simple one that people without a medicine degree can understand, not a mix of these two approaches... but that might be only me.

Anyways, that's the reason for testing only "somatic" guinea pigs, but what about the human trials? Why did they not test patients with non-somatic tinnitus? The only answer seems to be that, as someone else already said, most tinnitus sufferers can modulate it in some way, making the non-somatic sufferers a smaller demographic (thus with less priority and representation in the trials).

So, most of you can modulate their tinnitus with some movement? Even those of you who got tinnitus from acoustic trauma? I guess it just surprises me because I was quite convinced of the opposite until now.

Thank you for sharing this! My tinnitus was medicine induced and is not really somatic; only in front of a fan or shower, when I open my mouth, I hear "shhh," but other than that, no change.

I see yours was noise induced, can you modulate yours?

 

[El BUZZ]

So, most of you can modulate their tinnitus with some movement? Even those of you who got tinnitus from acoustic trauma? I guess it just surprises me because I was quite convinced of the opposite until now.

I remember stretching my neck before swimming and noticing I could "hear" a high-pitched tone as I twisted my head around. This was exactly three weeks prior to my onset, eight years ago. I thought it had to be really tough to deal with the condition and just three weeks later... BAM! Maybe I was able to hear that tone while stretching just because my hearing was already messed but not enough to have tinnitus.

 

[Onguacchiat]

Thank you for sharing this! My tinnitus was medicine induced and is not really somatic; only in front of a fan or shower, when I open my mouth, I hear "shhh," but other than that, no change.

I see yours was noise induced, can you modulate yours?

Nope, I cannot modulate my tinnitus with jaw/neck movements, but when I sneeze or yawn it seems to get a bit louder; that might be more of a perception induced by my fear of making it worse, though, rather than an actual somatic reaction, because I try my best not to stress my ears, and after I sneeze/yawn I become very aware of my tinnitus.

On top of it, I have pulsatile tinnitus, which sounds like the wings of a bird flapping and it is synchronized with my heartbeat. I am pretty sure that this one is not related to the other, because I had it before the onset of noise-induced tinnitus (heavy metal concert). Interestingly enough, though, about 1 month after the onset of the noise-induced tinnitus, the pulsatile one started to present itself more often - before, I only had it when lying down at night and after smoking, now it's always here during the first half of the day.

The pulsating one is somatic: the more I lean forward, the more the "flapping wings" frequency increases, to the point that, when I am facing the ground, it is a constant hissing that sounds more like wind.

Although the pulsatile tinnitus is somatic, it is most likely not treatable by the Susan Shore device because a) in the Q&A they explicitly say it is not made for this type of tinnitus, and b) apparently, it is not an auditory/neurologic condition like other types of tinnitus, but it is related to blood pressure / circulatory conditions that I might need to figure out at some point.

Also, to be honest, the pulsatile tinnitus doesn't annoy me that much, I have had it for years and it never let me down.. the real annoyance is the noise-induced, high pitched ringing, because it is harder to tolerate, and because it seems like it's reactive to sounds and music (even when it's not loud) which in my case took its toll on my career as music producer.

I am also not sure if what you describe, with the "SHH" when you open your mouth in front of fan/shower, is not somatic. Reading around the internet and some answers here, it seems like the definition of somatic is still pretty vague and 'open', and even when only subtle modulations (like yours) are possible, then the Tinnitus should still be considered somatic, so there is hope!

 

[RocketJSquirrel]

So, most of you can modulate their tinnitus with some movement? Even those of you who got tinnitus from acoustic trauma? I guess it just surprises me because I was quite convinced of the opposite until now.

I'm not sure. If I clench my jaw, my tinnitus gets louder. It returns to its usual level when I un-clench. This is the only action I can take to modify the sound; nothing else makes it change. Does this indicate somatic tinnitus?

 

[Jonno02]

I'm not sure. If I clench my jaw, my tinnitus gets louder. It returns to its usual level when I un-clench. This is the only action I can take to modify the sound; nothing else makes it change. Does this indicate somatic tinnitus?

Yep.

 

[Fightthearmy]

The reason that Lenire took so long is that the FDA asked them to do another trial. That won't be the case for Dr. Shore. And of course Neuromod used their trial as a marketing opportunity by conveniently deciding to not use a placebo for their trials!

Really? Who knows! We can expect more incompetence and corruption from regulators who are loose enough to approve Lenire.

 

[dj_newark]

Really? Who knows! We can expect more incompetence and corruption from regulators who are loose enough to approve Lenire.

I think that Dr. Shore's trials were really well run especially when we compare them to the Lenire trials. I think there's almost no chance of FDA asking for another trial, because she was really meticulous. But you're right, who knows? No one has a crystal ball to predict the future.

 

[Joey Lodes]

Let's hope this device is available by the end of 2024.

I thank everyone who contributes to this thread as it really does help keep my hope alive. Thank you, sincerely.

 

[LostinTX]

Here are the answers to some of the questions that were asked previously in the thread, including how can you know a lab animal has somatic tinnitus. They're taken directly from the Q&A.

The device has NOT been tested on non-somatic tinnitus cases (neither in the animal tests nor in the human trials). They just don't know if it can help in such cases.

LOL. Did you think the Guinea pigs had somatic tinnitus? Hello Mr. Guinea pig, can you modulate your tinnitus with your neck?

There is no way to tell if a Guinea pig has somatic tinnitus and there is no way to tell if a human has somatic tinnitus as you're taking their word for it. There is no test to see if someone 100% has tinnitus that's somatic.

I see hope in her study as the Guinea pigs 100% DID NOT have somatic tinnitus lol.

 

[Nick47]

LOL. Did you think the Guinea pigs had somatic tinnitus? Hello Mr. Guinea pig, can you modulate your tinnitus with your neck?

Now now.

 

[SarahMLFlemmer]

LOL. Did you think the Guinea pigs had somatic tinnitus? Hello Mr. Guinea pig, can you modulate your tinnitus with your neck?

There is no way to tell if a Guinea pig has somatic tinnitus and there is no way to tell if a human has somatic tinnitus as you're taking their word for it. There is no test to see if someone 100% has tinnitus that's somatic.

I see hope in her study as the Guinea pigs 100% DID NOT have somatic tinnitus lol.

In the trials, did all Guinea pigs and human patients have noise-induced tinnitus? I forgot.

 

[dd314]

In the trials, did all Guinea pigs and human patients have noise-induced tinnitus? I forgot.

There were only 3 requirements for the last trial:

1. have had bothersome tinnitus for at least 6 months
   
   
2. have no more than a mild hearing loss (better than 40dB)
   
   
3. live within 100 miles of Ann Arbor, MI

That's what was explicitly required when they were recruiting for it 3 years ago. I'm guessing they also screened for somatic tinnitus but I don't know. But the guinea pigs were all noise-induced. I remember reading how she blasted them with 100 dB for 3 hours or something like that.

 

[Onguacchiat]

LOL. Did you think the Guinea pigs had somatic tinnitus? Hello Mr. Guinea pig, can you modulate your tinnitus with your neck?

There is no way to tell if a Guinea pig has somatic tinnitus and there is no way to tell if a human has somatic tinnitus as you're taking their word for it. There is no test to see if someone 100% has tinnitus that's somatic.

I see hope in her study as the Guinea pigs 100% DID NOT have somatic tinnitus lol.

This question was in the Q&A so I think it was a legit doubt. No one's a researcher here and there are almost no stupid questions, although some people here (and everywhere else) talk like they were.

I also am hopeful. We just don't know yet who the device will work for. Only hope and speculation are possible at this point.

 

[Earman]

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?

 

[Nick47]

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?

I don't know what to say buddy. There is a Tinearity thread if you search.

How are the two devices even theoretically comparable in Mechanism of Action?

 

[sergerold]

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?

Tinearity looks like a glorified white noise generator.