New University of Michigan Tinnitus Discovery — Signal Timing

[dj_newark]

Only participants with somatic tinnitus were tested. Thus the efficacy for the general case is unknown.

That was probably the easiest group for her to test. That doesn't mean it won't work for other kinds. More testing will be needed after it's been released!

 

[InNeedOfHelp]

Please cite an FDA source that agrees this (and I assume Lenire?) are equivalent substitutes.

Fits like a glove to Auricle.

Trade/Device Name: Lenire
Regulation Number: 21 CFR 874.3410
Regulation Name: Combined acoustic and electrical external stimulation device for the relief of tinnitus
Regulatory Class: Class II
Product Code: QVN

You don't make 'pre-arrangements'. It's one thing being in a development/design-phase of a project, moving to market-ready is a completely separate thing. You don't get everything I spoke about ready only for your development phase to fail and show no clinical improvement. For a multi-national established company, they can have things like suppliers ready for the go-ahead and the funding to inject into a huge launch. For a novel technology and a start-up company, that's just not possible.

From: https://innovation.medicine.umich.edu/portfolio_post/shore/

"Regulatory Pathway: Presubmission to FDA complete with feedback for path forward for DeNovo device"

She does not owe you, me or anybody else here a thing. She is not our friend. She is a researcher creating a product. I think people here forget that sometimes. This is a for-profit venture.

Yup.

She is entirely right, you do not speculate on FDA (or any other regulator) approval. If she said "we're going to submit on X month" and it then turned out to be "X+3 months" because of additional work, people would be going mad with speculation as to why there was a delay. Best not to say anything.

But she did say. Publicly in the article above. But not to us, and we asked her, many times, and Jon Pearson, and through the Tinnitus Talk Podcast.

It's her research and she's entitled to handle it any way she sees fit, regardless if that harms you or I by delaying the launch. What happens if a corporation buys the rights and then decides not to launch?

She is entitled to. I'm entitled to rant too. I have to wait an additional 3 years to start living again.

Think you've won your own trophy for "biggest BS in this thread." You state "CE approval" like you're conforming to electrical standards for a plug. You understand that the EU (and specific country entities within) have regulators/notified bodies exactly like the FDA? And you must confirm to strict regulations (EUMDR). Gaining EU approval has exactly the same hurdles as US approval. For a company with such limited resources, it makes sense to target one region right now. As much as I'd like them to launch in Europe at the same time, it's not gonna happen.

Lenire has no European body approval as far as I'm aware. Only CE which is as freely available as a pack of tissues. This is why Dr. De Ridder can experiment with all kinds of modulation in Belgium.

I'm not saying this has been well managed or has the right people working on it, I have zero information on their project management. I'm just saying that for a new company with a novel treatment, gaining regulatory approval from the FDA is a tremendous feat.

You damn right.

I didn't mean to offend you but clearly some frustration from my end for the way this is managed.

 

[R0B]

I'm excited to try this out when it comes out but I also have to be cautious. I am trying to find out any information about any adverse effects or tinnitus getting worse for those that participated in the clinical trial but I'm having trouble reading through the ClinicalTrial.gov results page.

I'm looking at the bottom section titled "Other (Not Including Serious) Adverse Events."

I'm having trouble reading these results. There are several columns, "Post enrolment...", "Active", etc.

How do I make sense of this table? I am especially interested in the row titled "Worsened Tinnitus."

If I am understanding this right, then in the middle of the trial up to 4 people reported their tinnitus got worse and if I look at the last column, it went down to 0 - meaning the worsening was temporary during the trial.

Is that a good summary of this section?

 

[Muggumbo]

That was probably the easiest group for her to test. That doesn't mean it won't work for other kinds. More testing will be needed after it's been released!

Where was this stated? I'm just curious because I'm hoping it would work for acoustic trauma as well.

 

[Jonno02]

Fits like a glove to Auricle.

Trade/Device Name: Lenire
Regulation Number: 21 CFR 874.3410
Regulation Name: Combined acoustic and electrical external stimulation device for the relief of tinnitus
Regulatory Class: Class II
Product Code: QVN

That's for the FDA to decide. They have similar modalities, but perhaps different enough to warranty separating them, i.e. different nerves. (I hope not, by the way).

From: https://innovation.medicine.umich.edu/portfolio_post/shore/

"Regulatory Pathway: Presubmission to FDA complete with feedback for path forward for DeNovo device"

This can be as simple as contacting the FDA to let them know a submission is coming and if they agree with the chosen pathway, it doesn't really relate to getting to market.

Yup.

But she did say. Publicly in the article above. But not to us, and we asked her, many times, and Jon Pearson, and through the Tinnitus Talk Podcast.

Fair point. Maybe they were told/decided to reign in the commenting at some point.

She is entitled to. I'm entitled to rant too. I have to wait an additional 3 years to start living again.

You absolutely are.

Lenire has no European body approval as far as I'm aware. Only CE which is as freely available as a pack of tissues. This is why Dr. De Ridder can experiment with all kinds of modulation in Belgium.

Taken from their declaration of conformity, Lenire was approved and granted CE mark by BSI NL (notified body number 2797) and was subject to inspection under Medical Device Directives, Radio Equipment Directives and Restriction of the Use of Certain Hazardous Substances Directive. They already had a compliant QMS system as required under MDD that was ISO 13485 compliant.

Just to clarify, BSI are a notified body within the EU that have the authorisation to grant market access for medical devices for which there is no designated standard. This is what the USA would call a regulator; the FDA.

Obtaining CE marking for a medical device in the EU is the same level of scrutiny/work as being granted approval by the FDA in the USA.

You damn right.

I didn't mean to offend you but clearly some frustration from my end for the way this is managed.

You didn't mate, I completely understand the frustration. My posts probably come across a bit dismissive but what I'm really trying to achieve is letting people know this stuff is slow. Just so they don't panic about how long it's taking and begin to think there's something seriously wrong behind the scenes.

 

[RunningMan]

If I am understanding this right, then in the middle of the trial up to 4 people reported their tinnitus got worse and if I look at the last column, it went down to 0 - meaning the worsening was temporary during the trial.

In the Q&A:

Only one patient experienced tinnitus worsening possibly associated with using the device during active treatment. Other instances of worsening were related to noise overexposure events during the trial (eg. attending a rock concert).

These returned to within one std. deviation of baseline.

 

[Gb3]

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

 

[nrep]

Where was this stated? I'm just curious because I'm hoping it would work for acoustic trauma as well.

If it doesn't, then the device is useless.

 

[Gb3]

Where was this stated? I'm just curious because I'm hoping it would work for acoustic trauma as well.

The reason they tested people with somatic tinnitus was because they could prove a connection with the dorsal cochlear nucleus I believe.

 

[dj_newark]

Where was this stated? I'm just curious because I'm hoping it would work for acoustic trauma as well.

At the Palm Springs Hearing Seminar from last year I believe.

The reason for the tinnitus starting (acoustic trauma in your case) shouldn't matter because as Dr. Shore states:

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.

Somatic tinnitus refers to the ability to modulate your sound with head and neck movements, not to how you got the condition!

 

[Nick47]

Do we know if it will be submitted as a 510(k)? If so, it could be cleared in 90 days.

 

[Jim Vasilakis]

The delay pattern is quite simple. Dr. Shore isn't bothered by her tinnitus. It's hard to feel urgency when the condition you have doesn't affect you. If a cancer researcher has someone in his family with cancer, won't he push the research even faster from his end.

Dr. Shore is meticulous but the truth is that it's hard to relate to people who struggle with tinnitus when you don't.

 

[ajc]

The delay pattern is quite simple. Dr. Shore isn't bothered by her tinnitus. It's hard to feel urgency when the condition you have doesn't affect you. If a cancer researcher has someone in his family with cancer, won't he push the research even faster from his end.

Dr. Shore is meticulous but the truth is that it's hard to relate to people who struggle with tinnitus when you don't.

Complete BS. She could have chosen a more prestigious field for her research, but decided to dedicate her career to paltry tinnitus that nobody cares about.

It's so obvious she cares about the science to a degree where she doesn't want to rush and make mistakes.

She even used to reply to tinnitus sufferers' emails, until it became completely unmanageable.

Cut her some fucking slack, you have no clue how much urgency she feels (I bet it's a lot).

 

[Jim Vasilakis]

Complete BS. She could have chosen a more prestigious field for her research, but decided to dedicate her career to paltry tinnitus that nobody cares about.

It's so obvious she cares about the science to a degree where she doesn't want to rush and make mistakes.

She even used to reply to tinnitus sufferers' emails, until it became completely unmanageable.

Cut her some fucking slack, you have no clue how much urgency she feels (I bet it's a lot).

You didn't understand what I wrote. I never said she doesn't care about tinnitus patients. Of course she does. But the lack of urgency is mainly IMO because she isn't personally bothered by it so there is a dissonance between her care about tinnitus patients and and an intimate feeling of disruption that the condition causes.

I'm eternally grateful to her for her work and I hope it eliminates my mild tinnitus forever. But a person who has habituated just doesn't have the same urgency as someone who has his life ruined. IMO of course.

 

[Muggumbo]

Do we know if it will be submitted as a 510k? If so, it could be cleared in 90 days.

Do we know how Lenire did theirs? Because it's a non invasive device that interfaces with the user in a similar way (even though Lenire seems to suck). Maybe they'll use Lenire as an outline on how to get approval.

 

[dj_newark]

Do we know if it will be submitted as a 510(k)? If so, it could be cleared in 90 days.

I think a 510(k) submission will be likely but far as I know we have no confirmation of that. Superficially (very superficially) it could be considered similar enough to Lenire to get the 510(k) distinction.

 

[Joey72]

Do we know how Lenire did theirs? Because it's a non invasive device that interfaces with the user in a similar way (even though Lenire seems to suck). Maybe they'll use Lenire as an outline on how to get approval.

Or will the FDA go hard on Dr. Shore's device because Lenire turned out to be harmful to some...

 

[slc]

Do we know how Lenire did theirs? Because it's a non invasive device that interfaces with the user in a similar way (even though Lenire seems to suck). Maybe they'll use Lenire as an outline on how to get approval.

I'm not aware of the specifics of Auricle's application other that what has already been posted. We do know details of Lenire's application and the FDA response. They were considered as De Novo (anew), and the device/treatment was then categorized as "QVN - Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus."

Whether or not the FDA accepts that Auricle is similar to a pre-existing approved device/treatment and therefore eligible for approval under the 510(k) process, rather than applying De Novo, is up to the FDA.

 

[Muggumbo]

Or will the FDA go hard on Dr. Shore's device because Lenire turned out to be harmful to some...

I sure hope not. At least Dr. Shore's device seems to have a lot more evidence behind it and the FDA haven't pulled approval from Lenire yet.

 

[BadNeighbors]

This Scientific American article is from July and clearly states, "Shore now wants to move the new method quickly through the approval process and then onto the market."

I feel the two biggest issues here are: 1) none of us know what it takes to move something like this from academic prototype to mass produced commercial treatment, 2) all of us want this thing to be in our doctor's office yesterday.

I wonder if U of Michigan's Innovation Office has a PDF that lays out a generic timeline for a medical device to go from prototype to commercial treatment. I feel this office has more power in this than many of us realize as the university seems to hold the title to the patent, not Dr. Shore.

Also, another U of Michigan device, LASIK, was cleared by the FDA in 1999 and introduced to the market in 2001. Dr. Shore's device isn't as complex or scary as LASIK, but it is an example of the time it takes to get things done.

I don't think any of us can expect things to be done overnight, but hopefully the results are worth the wait.

 

[lymebite]

While I realize it's apples and oranges, in the new biography of Elon Musk by Walter Isaacson published a couple months ago, it says Neuralink got FDA approval in just 4 weeks.

See the quote from the book, and more information at the CNN link.

To me, the Neuralink brain implant seems much more invasive and complicated than the Susan Shore device. So it seems possible FDA approval can come quickly if the applicant is highly motivated and moving swiftly to apply.

Neuralink, Elon Musk's brain implant startup, set to start human trials

 

[UHPTS]

I'm excited to try this out when it comes out but I also have to be cautious. I am trying to find out any information about any adverse effects or tinnitus getting worse for those that participated in the clinical trial but I'm having trouble reading through the ClinicalTrial.gov results page.

I'm looking at the bottom section titled "Other (Not Including Serious) Adverse Events."

I'm having trouble reading these results. There are several columns, "Post enrolment...", "Active", etc.

How do I make sense of this table? I am especially interested in the row titled "Worsened Tinnitus."

If I am understanding this right, then in the middle of the trial up to 4 people reported their tinnitus got worse and if I look at the last column, it went down to 0 - meaning the worsening was temporary during the trial.

Is that a good summary of this section?

You Pandorians are weird species.

 

[BadNeighbors]

While I realize it's apples and oranges, in the new biography of Elon Musk by Walter Isaacson published a couple months ago, it says Neuralink got FDA approval in just 4 weeks.

See the quote from the book, and more information at the CNN link.

To me, the Neuralink brain implant seems much more invasive and complicated than the Susan Shore device. So it seems possible FDA approval can come quickly if the applicant is highly motivated and moving swiftly to apply.

Neuralink, Elon Musk's brain implant startup, set to start human trials

View attachment 56134

This quote appears to be Musk marketing more than him telling the real story.

Neuralink was rejected for human trials by the FDA in 2022 and only got the ability to do human trials on a limited number of people in 2023. This is much longer than 4 weeks and, sadly, different than commercial release.

However, I don't think the FDA is going to be the real speed bump we need to get over. Based on very limited knowledge (i.e. what has been mentioned in this thread), I don't think the FDA is really going to slow this down too much. Instead, I think the business side of things will be harder and I hope U of Michigan has their foot on the gas to get Dr. Shore set up to get this produced and distributed.

• Elon Musk's Neuralink wins FDA approval for human study of brain implants
• U.S. regulators rejected Elon Musk's bid to test brain chips in humans, citing safety risks
• FDA Rejected Musk's Bid To Test Brain Chip Implants In Humans, Report Says

 

[Muggumbo]

This quote appears to be Musk marketing more than him telling the real story.

Neuralink was rejected for human trials by the FDA in 2022 and only got the ability to do human trials on a limited number of people in 2023. This is much longer than 4 weeks and, sadly, different than commercial release.

However, I don't think the FDA is going to be the real speed bump we need to get over. Based on very limited knowledge (i.e. what has been mentioned in this thread), I don't think the FDA is really going to slow this down too much. Instead, I think the business side of things will be harder and I hope U of Michigan has their foot on the gas to get Dr. Shore set up to get this produced and distributed.

• Elon Musk's Neuralink wins FDA approval for human study of brain implants
• U.S. regulators rejected Elon Musk's bid to test brain chips in humans, citing safety risks
• FDA Rejected Musk's Bid To Test Brain Chip Implants In Humans, Report Says

Honestly, the business side of things is probably why they don't have their foot on the gas with an FDA submission. I think pretty soon we'll be seeing people on Tinnitus Talk cheering at an FDA approval, then going after Auricle for not having the device available.

Auricle will need to produce these things with a high level of quality to ensure they work. They will also need to partner with clinics and train them on how to properly configure the device. People are probably going to be hammering down the doors of the clinics that get it first, so just getting an appointment will probably be hard.

Hopefully they are hard at work on this aspect so it goes as smoothly as possible. The FDA will probably just be a bump in the road since the study is pretty solid and the device is simple and non-invasive.

 

[InNeedOfHelp]

While I realize it's apples and oranges, in the new biography of Elon Musk by Walter Isaacson published a couple months ago, it says Neuralink got FDA approval in just 4 weeks.

See the quote from the book, and more information at the CNN link.

To me, the Neuralink brain implant seems much more invasive and complicated than the Susan Shore device. So it seems possible FDA approval can come quickly if the applicant is highly motivated and moving swiftly to apply.

Neuralink, Elon Musk's brain implant startup, set to start human trials

View attachment 56134

That is approval to trial. Not approval to market.

 

[Muggumbo]

Maybe somebody could answer this for me.

I've been combing over the Q&A with Dr. Shore and she noted that the electrical stimulation was set at just above the individual's threshold for the study.

Would a higher level of electrical stimulation possibly provide better results? I'm sure plenty of people here would let them crank the device up to 10 if it meant it worked better.

 

[Jonno02]

Maybe somebody could answer this for me.

I've been combing over the Q&A with Dr. Shore and she noted that the electrical stimulation was set at just above the individual's threshold for the study.

Would a higher level of electrical stimulation possibly provide better results? I'm sure plenty of people here would let them crank the device up to 10 if it meant it worked better.

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.

 

[Muggumbo]

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.

According to the Q&A, the placebo group definitely seems to be the reason it was adjusted so low.

I also agree that the electrical stimulus seems to be the main component of the treatment. I can't wait for this thing to get released into the world and see what comes of it. The possibility of a Gen 2 device as well as treatments that can coincide with use of the device are exciting as well.

 

[Joshyboy]

Honestly, the business side of things is probably why they don't have their foot on the gas with an FDA submission. I think pretty soon we'll be seeing people on Tinnitus Talk cheering at an FDA approval, then going after Auricle for not having the device available.

Auricle will need to produce these things with a high level of quality to ensure they work. They will also need to partner with clinics and train them on how to properly configure the device. People are probably going to be hammering down the doors of the clinics that get it first, so just getting an appointment will probably be hard.

Hopefully they are hard at work on this aspect so it goes as smoothly as possible. The FDA will probably just be a bump in the road since the study is pretty solid and the device is simple and non-invasive.

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.

 

[Joey Lodes]

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.

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.