New University of Michigan Tinnitus Discovery — Signal Timing

[Athens]

I note that the first post about Dr. Shore's device was in 2013. Are we now talking about the device not being available until 2023-2024?

 

[EDDTEKK]

The Million Dollar question: which will work better, Dr. Shore's audio and neck stimulation, or vagus nerve stimulation (without surgery) paired with tones?

I note that the first post about Dr. Shore's device was in 2013. Are we now talking about the device not being available until 2023-2024?

Yes this is expected for US. For EU we have to wait probably another year or so after that

 

[Hottopic29]

I could imagine, if the device was showing good results, Dr. Shore would likely start manufacturing it before FDA approval.

 

[Athens]

I could imagine, if the device was showing good results, Dr. Shore would likely start manufacturing it before FDA approval.

I imagine that getting FDA approval for a non-invasive device is easier than a pill or other medication.

 

[Athens]

I will say though the thing that gets me more excited was the mean reduction of tinnitus loudness by ~8 dB. I've read arguments about whether that really would equate to a 50% reduction in loudness as it would for real sounds, but if I could get that kind of response it would make a real difference, maybe even enough of a difference to make the tinnitus more of a shrug event rather than a daily burden.

That was the exciting thing, right? That there was a true control and that only the real treatment during the treatment had the effect. Afterwards or during the sham treatment people reverted to baseline. I mean we'll see when this big study comes out (maybe the whole thing is a dud), because 20 people is a real small study, but I am optimistic that whatever was seen in this is differentiated from an habituation effect.

I will state that 8 dB through my above-the-ear sound generators is pretty loud. If you hold it just outside your ear canal, you cannot hear much, but 8 dB close to your eardrum and auditory system is clearly audible in a quiet room. I am not certain what 8 dB of tinnitus means, but it might be louder than you think. I think that a whisper might be 20 dB, but it is not being heard right up next to your eardrum and auditory system.

 

[AfroSnowman]

I will state that 8 dB through my above-the-ear sound generators is pretty loud. If you hold it just outside your ear canal, you cannot hear much, but 8 dB close to your eardrum and auditory system is clearly audible in a quiet room. I am not certain what 8 dB of tinnitus means, but it might be louder than you think. I think that a whisper might be 20 dB, but it is not being heard right up next to your eardrum and auditory system.

I believe dB is a logarithmic-ish scale. So a jump in sound from 10 dB to 20 dB roughly doubles (super soft whisper). It also doubles between 110 dB and 120 dB (super plane taking off loud). So for tinnitus lowering a 8 dB lowering will be roughly a halving of sound, be the original volume high or low.

 

[Padraigh Griffin]

Yes this is expected for US. For EU we have to wait probably another year or so after that

Is that certain? That would be a pity? How long does it take for FDA approved devices to gain approval in the EU? Do we have any precedent?

 

[InNeedOfHelp]

Is that certain? That would be a pity? How long does it take for FDA approved devices to gain approval in the EU? Do we have any precedent?

Not certain at all. Lenire only has CE which is a matter of weeks and is no roadblock at all. CE is worth absolutely nothing.

Theoretically Auricle can start rolling out in the EU as we speak.

FDA approval for medical devices is 3-6 month for US but we see Lenire already pending for 9 months now. Could be that the FDA is requesting additional data or is not happy with what they see.

It would be quite the thing if Auricle started rolling out in EU while awaiting the FDA approval.

Only way of really knowing is asking Jon Pearson what the global approach is.

 

[Christiaan]

Not certain at all. Lenire only has CE which is a matter of weeks and is no roadblock at all. CE is worth absolutely nothing.

Theoretically Auricle can start rolling out in the EU as we speak.

FDA approval for medical devices is 3-6 month for US but we see Lenire already pending for 9 months now. Could be that the FDA is requesting additional data or is not happy with what they see.

It would be quite the thing if Auricle started rolling out in EU while awaiting the FDA approval.

Only way of really knowing is asking Jon Pearson what the global approach is.

From what I gather in my exchange with Mr. Pearson (CEO of Auricle), it seems that Auricle will initially focus on the US market before moving on to Europe.

----------------------------------------------

Hello Christiaan,

Thank you for reaching out, and for your interest in Auricle.

The commercialization timeline and steps for FDA clearance and European CE mark approval are entirely separate, so obtaining an FDA clearance does not directly enhance CE mark approval. As a US-based company, our focus is initially on the American market, but we are hopeful of gaining regulatory clearances that enable us to offer the device globally to tinnitus sufferers. At present, we have not made public our regulatory clearance and commercialization timelines for any market. There are many challenges in bringing a novel therapy to market for indications that do not have predicate or existing therapies previously cleared, but we are doing the best that we can to move quickly.

We will add your name to the list of the many persons interested in hearing news, and will provide updates as soon as we are able.

Kind regards,
Jon

Jon Pearson
CEO & Co-founder
Auricle, Inc.

 

[InNeedOfHelp]

From what I gather in my exchange with Mr. Pearson (CEO of Auricle), it seems that Auricle will initially focus on the US market before moving on to Europe.

----------------------------------------------

Hello Christiaan,

Thank you for reaching out, and for your interest in Auricle.

The commercialization timeline and steps for FDA clearance and European CE mark approval are entirely separate, so obtaining an FDA clearance does not directly enhance CE mark approval. As a US-based company, our focus is initially on the American market, but we are hopeful of gaining regulatory clearances that enable us to offer the device globally to tinnitus sufferers. At present, we have not made public our regulatory clearance and commercialization timelines for any market. There are many challenges in bringing a novel therapy to market for indications that do not have predicate or existing therapies previously cleared, but we are doing the best that we can to move quickly.

We will add your name to the list of the many persons interested in hearing news, and will provide updates as soon as we are able.

Kind regards,
Jon

Jon Pearson
CEO & Co-founder
Auricle, Inc.

Makes sense. Thanks.

 

[Padraigh Griffin]

That's not good. Personally I don't think I can hold out that long here in the EU. Resilience fading again. Sounds like 24 months or more easily for EU.

 

[Uklawyer]

Couldn't we go to the US to get treatment (and bankrupt ourselves)?

 

[InNeedOfHelp]

That's not good. Personally I don't think I can hold out that long here in the EU. Resilience fading again. Sounds like 24 months or more easily for EU.

Dirk de Ridder and others will surely early adopt the device in EU. Keep the faith up. If it is the first FDA approved tinnitus treatment, I'm sure European tinnitus associations are going to help to move this treatment faster towards us.

 

[Padraigh Griffin]

Dirk de Ridder and others will surely early adopt the device in EU. Keep the faith up. If it is the first FDA approved tinnitus treatment, I'm sure European tinnitus associations are going to help to move this treatment faster towards us.

Unfortunately, when I spoke to De Ridder, he wasn't overly enthusiastic about this device. I've requested a Zoom with him again as soon as possible to see if he has anything new, but unlikely. I'm always trying to look on the bright side with regards to treatments and cures. I think within 5 years there will be both. Just don't know if I can last that long tbh.

 

[Padraigh Griffin]

Couldn't we go to the US to get treatment (and bankrupt ourselves)?

I'd row a boat across the Atlantic if this treatment ends up helping significantly.

I presume they would accept international patients? Why not? A paying customer is a paying customer.

Also, just wondering if trial participants will be allowed to freely discuss results/experiences online after the 'unblinding' date. It will be a while before they process the data, but surely we have participants on here within the 400 patient cohort.

 

[InNeedOfHelp]

Anyone else checking daily if the status changes to completed or am i the only one?

Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts

 

[Bambam0]

I just reread the results on Phase 1 and was reminded there were only 20 participants. This trial has an estimated 400. A 20x increase! No wonder there were delays. Managing that many participants is a chore.

Really excited to see these results! But tempering my expectations about time it will take to analyze and publish them.

 

[David S]

This trial has an estimated 400.

Interesting, how many of them have we been seeing here?

 

[Gb3]

Interesting, how many of them have we been seeing here?

No one has mentioned being in the trial. They were enrolled via invitation to the trial I believe.

 

[Hottopic29]

With 400 people taking part in the trial, that would mean they have already started manufacturing the devices, so it could roll out quicker... since they already produced 400 devices for the study.

 

[Padraigh Griffin]

With 400 people taking part in the trial, that would mean they have already started manufacturing the devices, so it could roll out quicker... since they already produced 400 devices for the study.

Honestly I don't think manufacturing will be an issue unless some of the chips are part of the 'chip shortage'.

It looks like a very basic device and the manufacturing should scale up very quickly. It is more distribution that I am worried about initially. If there is significant demand, what is their planned business model as regards to actually getting the customers into clinic and setting up the device. The parameters have to be set based on each individual's ability to modulate their tinnitus + presumably other factors. If it could be done via Zoom or video conference it would be great and less costly than having brick and mortar clinics. Perhaps rolling it out to audiologists is an option, but they would need training on setting up the device.

There is a lot to be worked out regarding commercialisation yet. As a potential customer in the EU, it looks like we will have to wait as international distribution would pose a challenge. Hence why I'd love a licensing deal with Lenire. Could be of benefit to both parties commercially. Lenire gets a product that actually works and Auricle gets to concentrate resources on the US, whilst having a royalty income stream from International Markets. Also will help to develop significant economies of scale a lot lot faster.

But... let's just get the results first. 3 days to 'unblinding'.

 

[Athens]

Honestly I don't think manufacturing will be an issue unless some of the chips are part of the 'chip shortage'.

It looks like a very basic device and the manufacturing should scale up very quickly. It is more distribution that I am worried about initially. If there is significant demand, what is their planned business model as regards to actually getting the customers into clinic and setting up the device. The parameters have to be set based on each individual's ability to modulate their tinnitus + presumably other factors. If it could be done via Zoom or video conference it would be great and less costly than having brick and mortar clinics. Perhaps rolling it out to audiologists is an option, but they would need training on setting up the device.

There is a lot to be worked out regarding commercialisation yet. As a potential customer in the EU, it looks like we will have to wait as international distribution would pose a challenge. Hence why I'd love a licensing deal with Lenire. Could be of benefit to both parties commercially. Lenire gets a product that actually works and Auricle gets to concentrate resources on the US, whilst having a royalty income stream from International Markets. Also will help to develop significant economies of scale a lot lot faster.

But... let's just get the results first. 3 days to 'unblinding'.

Is there an expectation that Susan Shore might informally release some preliminary results before they are formally published?

 

[Padraigh Griffin]

Is there an expectation that Susan Shore might informally release some preliminary results before they are formally published?

To be honest I don't know. Plus the 'unblinding' in two days is probably optimistic as Dr. Shore has a tendency to run late with the project. Hopefully news soon

 

[Hottopic29]

Is there an expectation that Susan Shore might informally release some preliminary results before they are formally published?

I'm sure she might mention it went very well (if it did) at one of the conventions soon without going into detail. If she doesn't mention anything, we might know it didn't go well.

 

[Bambam0]

She was supposed to be speaking at the STAT Conference tomorrow. If I remember correctly, @IntotheBlue03 is attending. But now I don't see her in the lineup! Maybe it's because the trial?!

 

[Gb3]

Is there an expectation that Susan Shore might informally release some preliminary results before they are formally published?

@Athens, I doubt it. She will let the official results speak for themselves.

 

[Athens]

To be honest I don't know. Plus the 'unblinding' in two days is probably optimistic as Dr. Shore has a tendency to run late with the project. Hopefully news soon

I agree on the running late part. The first post about this device is almost ten (10) years old.

 

[IntotheBlue03]

She was supposed to be speaking at the STAT Conference tomorrow. If I remember correctly, @IntotheBlue03 is attending. But now I don't see her in the lineup! Maybe it's because the trial?!

Unbelievable. That cost me a pretty penny too.

 

[AfroSnowman]

Unbelievable. That cost me a pretty penny too.

I'd try asking for a refund.

 

[Athens]

I'd try asking for a refund.

I assume that she was speaking on the subject of this device or was it some other topic?