New University of Michigan Tinnitus Discovery — Signal Timing

[dj_newark]

I thought they were trying to get approval at least since early December?

Her paper was submitted to be published in early December. I don't know if publishing in journal is a requirement for FDA approval, but I think for Dr. Shore at least it probably is. The paper will be published in a journal sometime this year, then after that I think the device will be approved by the FDA in six months or less.

These are educated guesses, so don't hold me to that. No one really knows how long the publishing process will be, or even how long the FDA approval process will be, not even her, because there are a lot of variables that are out of her control. For example, her paper being published could happen sooner than we expect or it could take a long time, if there are a lot of reviewers challenging her work.

 

[Nick47]

This paper is from 2005, of which the author cites Dr. Shore (1992) amongst many others:

Contralateral Effects and Binaural Interactions in Dorsal Cochlear Nucleus

The main focus is on contralateral modulation of the DCN (inhibitory or excitatory) using tones and broadband sound. It also discusses descending pathways. Whilst not specifically addressing tinnitus as a subject, it does provide a more holistic idea of how the hearing system works together. It also mentions broadband noise being more inhibitory than tonal.

 

[KoolKat]

This paper is from 2005, of which the author cites Dr. Shore (1992) amongst many others:

Contralateral Effects and Binaural Interactions in Dorsal Cochlear Nucleus

The main focus is on contralateral modulation of the DCN (inhibitory or excitatory) using tones and broadband sound. It also discusses descending pathways. Whilst not specifically addressing tinnitus as a subject, it does provide a more holistic idea of how the hearing system works together. It also mentions broadband noise being more inhibitory than tonal.

This at the very least reassures me and I'm sure you guys too, that Dr. Shore is at least committed to this and isn't in this to simply get rich. She could have very easily been like those phonies who promote TRT & other BS products and called it a career. But no, she kept pushing. That's why whether it works or not, KNOCK ON WOOD, we can't hold any grudges as she's probably one of the very few trying to help us. Which is sad in itself. I'm sure the brain has been mapped out so by now you would think they can pinpoint what does what.

Lastly, I wonder if Dr. Shore had had powerful financial backing early on, would tinnitus have been solved back in the 1990s?

 

[Jonno02]

Lastly, I wonder if Dr. Shore had had powerful financial backing early on, would tinnitus have been solved back in the 1990s?

Probably.

In my experience, and I find this quite sad, is that most large companies with the financial capability to do it, don't want to inject the cash into research. They'd rather wait until some tiny start-up or government/university funded research house has a breakthrough, then then simply buy them out.

Cheaper, less risk and near instant rewards for them.

 

[Discretion]

Does anyone have a rough idea when the Phase 2 results will be published? I feel like that will give us a real idea of how well this device works.

 

[2noist]

Does anyone have a rough idea when the Phase 2 results will be published? I feel like that will give us a real idea of how well this device works.

You are the first to ask this. Sometime in 2023.

 

[Nick47]

Does anyone have a rough idea when the Phase 2 results will be published? I feel like that will give us a real idea of how well this device works.

@Discretion, I'm going for middle of May - beginning of June.

 

[dj_newark]

@Discretion, I'm going for middle of May - beginning of June.

That would be great! However, when Dr. Shore said it would be six months (from the beginning of December), please remember that was only an estimate. When I emailed her recently saying that I hope the results will be published when she speaks at the conference in France this September, she only said "I hope so too!". Meaning that even she doesn't know.

That being said, let's hope you're right! Having the results by mid May - beginning of June would be phenomenal!

 

[Joeseph Stope]

So can we estimate Dr. Shore's device will be available at the same time of the study results being published, or three, six months after?

And of course you will need an ENT or audiologist's supervision, I assume?

 

[Utdmad89]

That would be great! However, when Dr. Shore said it would be six months (from the beginning of December), please remember that was only an estimate. When I emailed her recently saying that I hope the results will be published when she speaks at the conference in France this September, she only said "I hope so too!". Meaning that even she doesn't know.

That being said, let's hope you're right! Having the results by mid May - beginning of June would be phenomenal!

I just don't get why it has to be dragged out. If it works, then get it out. Why the peer review?

 

[dj_newark]

I just don't get why it has to be dragged out. If it works, then get it out. Why the peer review?

She probably considers it part of her job as a scientist and a necessary part of the scientific process to publish. I think it helps with FDA approval but I don't know if it's necessary.

From the mass communication she sent out last summer it was said:

We understand the desire to know results as soon as possible, but the release of clinical trial results is constrained. First, as reputable scientists, we will publish the findings in a relevant journal after proper peer review. Second, regulatory agencies (e.g., FDA, NIH) are careful in their reviews of novel therapies, as they should be, so all of us must be patient.

 

[AfroSnowman]

I just don't get why it has to be dragged out. If it works, then get it out. Why the peer review?

Science.

 

[Nick47]

For all we know, the FDA approval process may have started a long time ago. If the published study is not an integral part of it, that is.

 

[Jonno02]

I think it helps with FDA approval but I don't know if it's necessary.

Not a factor. The FDA don't care if you've published, they'll have their own auditors go over your data regardless.

 

[awake 44]

For all we know, the FDA approval process may have started a long time ago. If the published study is not an integral part of it, that is.

A totally valid point. I did not find any information saying a published study is necessary for FDA approval. If the device becomes available before the study publication, I'm taking my shot. I'd rather have my brain fried like beacon, than live with this mother***ker longer than necessary.

 

[Utdmad89]

For all we know, the FDA approval process may have started a long time ago. If the published study is not an integral part of it, that is.

Has anyone asked Dr. Shore about this?

 

[dj_newark]

For all we know, the FDA approval process may have started a long time ago. If the published study is not an integral part of it, that is.

They have. They've started the 'presubmission' process with the FDA years ago. This article is from 2017 and talks about that:

Overall Commercialization

• Commercialization Strategy: Form a company; create a patient-paid model with consumer financing
• Intellectual Property: Patents have been granted in the US, Canada, Europe, and Japan and additional patents are being explored
• Regulatory Pathway: Presubmission to FDA complete with feedback for path forward for DeNovo device
• Product Launch Strategy: To be determined by licensee

I think the the paper for the latest trial has to be published before the FDA will grant final approval. Approval for devices doesn't take long compared to medicines. It takes months, not years. I am not an FDA expert, but that seems reasonable to think.

 

[BTaylor12]

So can we estimate Dr. Shore's device will be available at the same time of the study results being published, or three, six months after?

And of course you will need an ENT or audiologist's supervision, I assume?

Boy, I don't know. The device being approved and available are very different things. Where are all the thousands of devices right now? Not produced I assume. Who is producing them and how long will it take?

 

[dj_newark]

Not a factor. The FDA don't care if you've published, they'll have their own auditors go over your data regardless.

Thanks for clearing that up. That's actually good news! I wonder if the FDA process is further along than we thought. However, Dr. Shore hasn't been responding to my emails lately, so I doubt asking her would do us any good.

 

[AfroSnowman]

Boy, I don't know. The device being approved and available are very different things. Where are all the thousands of devices right now? Not produced I assume. Who is producing them and how long will it take?

I think the the bigger hold up will be in the development of distribution networks; I assume these will be distributed via audiologists. There are a couple of chains but for all the rest they will have to sign on to distribute Auricle individually. I'd be pricing in the cost of a plane ticket to buy one of these in the first year or so that they are available.

 

[DimLeb]

This I-don't-know-how-many-years-long waiting game is like being a musician, having written the best song ever that will skyrocket your career and then waiting until you get 95 years old to release it.

With a breakthrough like this, she could go to other markets like Europe and just release it. We all know that it's possible, since far "smaller" guys have done it.

 

[Utdmad89]

The device being approved and available are very different things. Where are all the thousands of devices right now? Not produced I assume. Who is producing them and how long will it take?

This is a good point. Makes me think that it could be a couple of years still. And that's only in the USA, everywhere else could be even longer.

 

[JimmyStrong]

Where are all the thousands of devices right now? Not produced I assume. Who is producing them and how long will it take?

That's a good question.

 

[Jonno02]

I assume these will be distributed via audiologists.

How is Lenire controlled? I actually hope it's just a straight up purchase. The majority of audiologists, and ENTs especially, don't give a hoot about tinnitus.

 

[Nick47]

The actual production costs of the device should not be that much. The device needs to be tested and calibrated properly due to the specific timings needed.

Having said that, the upfront costs to produce a high volume may be significant. Then the cost of getting regulatory approval.

On the other end, from a commercial point of view, time is ticking on the patent too.

 

[dj_newark]

The actual production costs of the device should not be that much. The device needs to be tested and calibrated properly due to the specific timings needed.

Having said that, the upfront costs to produce a high volume may be significant. Then the cost of getting regulatory approval.

On the other end, from a commercial point of view, time is ticking on the patent too.

Patents generally last 20 years in the US. I think the device was patented back in 2017.

 

[AfroSnowman]

How is Lenire controlled? I actually hope it's just a straight up purchase. The majority of audiologists, and ENTs especially, don't give a hoot about tinnitus.

Audiologists, Lenire headquarters, or other brain oriented medical practices I believe.

 

[Joeseph Stope]

The actual production costs of the device should not be that much. The device needs to be tested and calibrated properly due to the specific timings needed.

Having said that, the upfront costs to produce a high volume may be significant. Then the cost of getting regulatory approval.

On the other end, from a commercial point of view, time is ticking on the patent too.

If I have understood correctly, the actual therapy lasts a few weeks, or a month or two. Correct me if I have got this wrong. But this would imply that there will be a lively second-hand market for the device.

The big costs will be with the calibration and the ENT supervision.

Having said this, I hope that Dr. Shore and the University of Michigan come out of this with big bucks for their patient and diligent work. If it works, now that would be a milestone.

 

[Sironketchup]

Actually this thing it what keeps me going at the moment.

I'm totally sleep deprived and all I can think is "make it one more year until the Shore device comes out!".

 

[Nick47]

therapy lasts a few weeks, or a month or two.

6 weeks.