New University of Michigan Tinnitus Discovery — Signal Timing

[DebInAustralia]

@Survivor234, I believe @Harder Calm provided an update that the trials and FDA application are delayed but that we could expect an update by mid 2022?

The commercialization process is being setup now I believe in the form of Susan's company Auricle.

Please feel free to correct me anyone who is more in the loop. Hoping that commercialization and completion of the trials in mid 2022 are on parallel tracks.

Susan Shore said the trial will finish by the end of April 2022.

 

[AfroSnowman]

Susan Shore said the trial will finish by the end of April 2022.

I wonder how long after we will get top line results.

 

[Survivor234]

Susan Shore said the trial will finish by the end of April 2022.

And, considering they have a mailing list for updates next summer, it's likely that commercialization is around that period as well.

 

[AfroSnowman]

And, considering they have a mailing list for updates next summer, it's likely that commercialization is around that period as well.

I believe they need to wait for FDA approval first.

 

[Survivor234]

I believe they need to wait for FDA approval first.

How long does that take?

 

[DebInAustralia]

I believe they need to wait for FDA approval first.

Would an FDA application have been submitted yet?

 

[IntotheBlue03]

Would an FDA application have been submitted yet?

@Harder Calm, hoping you might be able to advise from the update you provided regarding the FDA application being delayed?

 

[AfroSnowman]

Would an FDA application have been submitted yet?

I reached out to the CEO of Auricle a couple months back and he said:

"With regard to the commercialization schedule, the conclusion of Dr. Shore's confirmatory study will determine next steps with regulatory bodies, so we will have a better idea of where we stand mid 2022. Given that there are no FDA-cleared devices or drugs for the treatment of tinnitus, regulatory bodies—appropriately—have higher hurdles for safety and efficacy that must be satisfactorily demonstrated before clearance is awarded. As such, we don't make public comments concerning timing since it is premature to do so. But please know that Auricle was formed to gain clearance and commercialize Dr. Shore's device, so we are bringing talent and resources to this critical project. You'll certainly hear from us when we have relevant and public news to report!"​

So to me it looks like they are waiting for the results before getting FDA approval.

 

[Mentos]

I reached out to the CEO of Auricle a couple months back and he said:

"With regard to the commercialization schedule, the conclusion of Dr. Shore's confirmatory study will determine next steps with regulatory bodies, so we will have a better idea of where we stand mid 2022. Given that there are no FDA-cleared devices or drugs for the treatment of tinnitus, regulatory bodies—appropriately—have higher hurdles for safety and efficacy that must be satisfactorily demonstrated before clearance is awarded. As such, we don't make public comments concerning timing since it is premature to do so. But please know that Auricle was formed to gain clearance and commercialize Dr. Shore's device, so we are bringing talent and resources to this critical project. You'll certainly hear from us when we have relevant and public news to report!"​

So to me it looks like they are waiting for the results before getting FDA approval.

Perhaps mid 2022 for the estimate comes from the following timing:

- April/May end of study
- 3 months for FDA clearance which brings us to July/August

 

[mrbrightside614]

@linearb, sorry to ask more about your personal experience with this device, but is the sound they play through the airbud tailored from your tone-matching, or do they play "factory settings" type tones? I'm a little worried because I have a hard time tone-matching.

 

[AfroSnowman]

Perhaps mid 2022 for the estimate comes from the following timing:

- April/May end of study
- 3 months for FDA clearance which brings us to July/August

Man would that be sweet. I have no idea if 3 months or 10 months is more realistic but the thought that there will be something that can help being available in 2022 brings me joy.

All of this of course assumes that the clinical trial confirms the positive results and doesn't show any worsenings. As unpleasant as it is to think about, there is a real chance (not a likelihood but a chance) that this larger clinical trial comes in with a negative outcome. I want to hope but I can't allow myself to have unrestrained optimism after the disappointments of Lenire and FX-322. The latter of which really put me in a dark place for a week or two.

 

[Padraigh Griffin]

Just received this from Dr. Shore. Nothing new really.

"Our second human study will end next year, and 'Auricle' will pursue regulatory clearance and commercialization. The study is double-blind, so we will not know results until the conclusion. We will make news public as soon as we have anything to report."​

 

[Bruce NH USA]

The FDA is a strange animal---they certainly have proven that with COVID-19. I just hope that they don't drag their feet if the results of this study are convincing. Dr. Shore has been working on this for a decade---if the device is finally ready for Prime Time, let's see it!

 

[Xys87]

I find it very odd and dubious that those who wish to commercialize this device are also the ones evaluating its efficacy.... there is a conflict of interest.These people have a pressure of result because of the millions invested and also know that there will be a lot of money to earn (even if their device is not efficacious).

Just look at Lenire...

I find it hard to trust but I hope I'm wrong.

 

[Survivor234]

I find it very odd and dubious that those who wish to commercialize this device are also the ones evaluating its efficacy.... there is a conflict of interest.

They're interested in commercializing it precisely because it's effective. And commercialization hasn't even started yet (the company has just been founded).

And, in regards to tinnitus treatment, I am pretty sure that efficacy is what tinnitus sufferers are interested in. Lenire has failed because it did not provide the adequate treatment that tinnitus sufferers were looking for.

Combined with the prohibitively high cost, it's something most tinnitus sufferers don't really care for. As a result, Lenire isn't making much money, even in its home area of Europe, as a form of tinnitus treatment.

I would say, in comparison to Lenire, Susan Shore's device is significantly more likely to actually do something in reducing or eliminating tinnitus. And I think it'll only get better at doing that in the future.

 

[Padraigh Griffin]

Neuromod's Lenire trial was a joke of a trial. No sham control. Basically if you told people eating an apple a day (and had 'science' papers/research) would improve their tinnitus by an average of 12 pts on the TFI it would improve their tinnitus by 12 pts. That is the average placebo result in other trials. Basically they are marketing a placebo effect device. They should be in court like Theranos Elizabeth Holmes. Bunch of jokers.

Susan Shore's device is compared to sham and is double blinded. It is a well designed clinical trial and her device actually targets a supposed physiological cause of tinnitus in the DCN.

Ask Neuromod what physiological cause it targets. Zilch, zero, none. Just a habituation device that is no more effective than placebo.

I do hope that Dr. Shore's device works and works well. Not just a 12 pt plus reduction in TFI that is deemed clinically significant.

For many of us a TFI reduction of 12 pts is minuscule.

All will be revealed in 2022. I'm more 'excited' about potassium channel modulators like XEN1101 targeting the hyperexcitability in the DCN myself. Hopefully without the side effects of Trobalt.

 

[IntotheBlue03]

Hey Folks,

Once again calling on those who are better versed in the technical aspects of Dr. Shore's work.

Is it the case that the frequency of tinnitus or hearing loss will be irrelevant with how her device works? I had watched the Tinnitus Hub 2019 interview and if I understand correctly, the focus is on the DCN.

Curious if that means that the device should still be effective for users who have high frequency hearing loss past 8 kHz or normal audiograms (as I do)? I believe we are termed the "hidden hearing loss" subgroup of tinnitus sufferers.

 

[DebInAustralia]

Hey Folks,

Once again calling on those who are better versed in the technical aspects of Dr. Shore's work.

Is it the case that the frequency of tinnitus or hearing loss will be irrelevant with how her device works? I had watched the Tinnitus Hub 2019 interview and if I understand correctly, the focus is on the DCN.

Curious if that means that the device should still be effective for users who have high frequency hearing loss past 8 kHz or normal audiograms (as I do)? I believe we are termed the "hidden hearing loss" subgroup of tinnitus sufferers.

I don't think the frequency or your hearing loss is relevant.

Dr. Shore is addressing the hyperactivity of fusiform cells in the DCN as a result of auditory damage; even if it is hidden as in your case.

 

[IntotheBlue03]

@linearb, sorry to ask more about your personal experience with this device, but is the sound they play through the airbud tailored from your tone-matching, or do they play "factory settings" type tones? I'm a little worried because I have a hard time tone-matching.

Excellent question and my concern as well in case anyone has any details around this.

 

[DimLeb]

@IntotheBlue03, that's a good question since a lot of people may have a hard time tone matching due to multi-tones or just straight up complex sounds in their tinnitus (like broadband hums, tones masking each other etc etc).

Personally I, being a sound engineer/designer, can't fully replicate my sounds, so I imagine, people without sound-spectrum experience will face even more technical difficulty.

 

[prowlinacage]

@linearb, sorry to ask more about your personal experience with this device, but is the sound they play through the airbud tailored from your tone-matching, or do they play "factory settings" type tones? I'm a little worried because I have a hard time tone-matching.

Specially timed signals ease tinnitus symptoms in test aimed at condition's root cause

"The U-M device delivers sounds matched to the loudness and pitch of the phantom sounds that each patient hears."

 

[mrbrightside614]

@linearb, sorry to ask more about your personal experience with this device, but is the sound they play through the airbud tailored from your tone-matching, or do they play "factory settings" type tones? I'm a little worried because I have a hard time tone-matching.

Sorry but I'm doing this @linearb and also want to ask how long the relief lasted? I'm hoping it can reduce my tinnitus for at least 8 hours for a normal night's rest.

 

[IntotheBlue03]

Sorry but I'm doing this @linearb and also want to ask how long the relief lasted? I'm hoping it can reduce my tinnitus for at least 8 hours for a normal night's rest.

So I've resorted to screenshotting since I'm not that familiar with all the areas of Tinnitus Talk but here is a poster referencing 50+ weeks after a course of 3 month treatment. Can anyone verify this?

 

[GoatSheep]

Sorry but I'm doing this @linearb and also want to ask how long the relief lasted? I'm hoping it can reduce my tinnitus for at least 8 hours for a normal night's rest.

If you click on the number of replies for a thread on the right hand side on desktop (not sure about mobile, not on my phone currently) it breaks down the replies in a thread to the individual poster. You can then choose @linearb and browse through some of his early posts in the thread. Just letting you know in case you aren't aware.

 

[Survivor234]

What if you don't know the exact frequency of your tinnitus so that you can signal time? How long does it take to reduce tinnitus?

 

[IntotheBlue03]

@Survivor234, others can chime in but I can imagine once this comes to market that it will be pushed to audiologist clinics where there will be pitch matching but here's to hoping they make it more self intuitive in the way of apps etc as well.

 

[mrbrightside614]

So I've resorted to screenshotting since I'm not that familiar with all the areas of Tinnitus Talk but here is a poster referencing 50+ weeks after a course of 3 month treatment. Can anyone verify this?

View attachment 48405

Pretty highly speculative and mostly in regards to Lenire, not Shore unfortunately.

If you click on the number of replies for a thread on the right hand side on desktop (not sure about mobile, not on my phone currently) it breaks down the replies in a thread to the individual poster. You can then choose @linearb and browse through some of his early posts in the thread. Just letting you know in case you aren't aware.

Thanks, but I only use Tinnitus Talk on my phone so I have to resort to good ol' stalking his recent posts that were in this thread lol.

 

[Watasha]

Just received this from Dr. Shore. Nothing new really.

"Our second human study will end next year, and 'Auricle' will pursue regulatory clearance and commercialization. The study is double-blind, so we will not know results until the conclusion. We will make news public as soon as we have anything to report."​

Next year as in 2023?

 

[GoatSheep]

Pretty highly speculative and mostly in regards to Lenire, not Shore unfortunately.

Thanks, but I only use Tinnitus Talk on my phone so I have to resort to good ol' stalking his recent posts that were in this thread lol.

If you are using mobile the link to all responses is still there.

Just click the hyperlink of replies.

Then just click on his replies of 91 link. I'd probably open it in a separate window to keep it open and then open his individual responses you wish to read in a new window/windows.

Newest replies first. Oldest replies on the second page of the responses. I've read through those early replies before. IMO the information you seek is there.

 

[IntotheBlue03]

Just posting an email response I received that was fielded from Dr. Shore to one of her lab clinicians:

Inquiry:
Hi Dr. Shore,

Is it the case that the frequency of tinnitus, level of hearing loss or even the cause of tinnitus (somatic or other) will be irrelevant with how your device works? I had watched the Tinnitus Hub 2019 interview and if I understand correctly, the focus is on the DCN.

Curious if that means that the device should still be effective for users who have high frequency hearing loss past 8 kHz or normal audiograms (as I do)? I believe we are termed the "hidden hearing loss" subgroup of tinnitus sufferers. In addition I believe your device targets somatic related tinnitus as well?

Response:
Hi Ashley

Thanks for your interest in our research, Dr. Shore forwarded your email on to the clinical lab team. For our current study, each person's treatment spectrum is based on the their individual perception of their tinnitus- most people tend to have high pitched ringing, but not everyone, so our device accounts for differences the pitch of each person's tinnitus. In terms of degree of hearing loss, we have limited our research study participants to those with no greater than a moderate hearing loss (55 dB HL). Many people with tinnitus have more significant hearing loss than that, but for the purposes of testing our device we limited it to moderate hearing loss levels. It's common for people to experience tinnitus when they have hearing loss, but not everyone who has tinnitus has hearing loss, some have completely normal hearing. Like you mentioned, a normal audiogram tests up to 8 kHz; for our study we test ultra-high frequencies (up to 16 kHz) and participants must have no more than the moderate hearing loss up to 12.5 kHz. It's not uncommon for people to have normal hearing through 8 kHz and then start to see signs of hearing loss at 10 kHz, 12.5 kHz, 16 kHz - as we get older, the high frequency region is typically where we first notice hearing loss. Also as you mentioned, all of our participants have somatic tinnitus meaning that they are able to change the loudness or pitch of their tinnitus by doing some kind of head, neck, or facial movement. Our treatment is targeting the DCN which is one of the first spots where multimodal sensory input is combined in the brainstem. So if a person clenches their jaw or tilts their head to the side and their tinnitus changes, that gives us an indication that those two pathways (auditory & somatosensory) are contributing to the perception of their tinnitus. And that pathway is also where we are targeting our treatment. We haven't tested our device on participants that can't modulate their tinnitus, however the vast majority of people are able to modulate their tinnitus at least to some degree.

Hope that answered your questions! Feel free to reach out if you have any more.

Best,
Travis L. Riffle, AuD, PhD, CCC-A
Postdoctoral Research Fellow
Kresge Hearing Research Institute
University of Michigan
2335A Medical Science Unit 1