New University of Michigan Tinnitus Discovery — Signal Timing

[Nick47]

So when do we think the device will come out now? We went from this summer 2023 to now 2025?

Originally I thought early 2024. Now I'm pretty much resigned to late 2025 or some bollocks.

 

[ploughna]

So when do we think the device will come out now? We went from this summer 2023 to now 2025?

in the end, it all boils down to money - bringing the product from prototype stage to something that can be manufactured reliably in volume, FDA (and other) regulatory approvals, launch onto market, enlisting audiologists and providing them with support, training, etc.

It all adds up, that's why I posted the link to funding status of Auricle - even if FDA approval were achieved today, not until they have quite a few $M in the bank and more than 2 employees will this start to move.

Having said all that, I'm sure they're not standing still - a funding round could be closed anytime (I'm sure this is the primary focus of the Auricle CEO), and from there, investors will be looking for quick results. Sufficient funds could see something like this to market in 12-24 months.

Just my $0.02 - I could be way off, but have some experience in product development and bringing new products to market.

P.S.

It may not be a valid comparison at all but here's the funding trajectory of Neuromod.

They started with €200K of seed funding in 2011 (vs. Auricle $350K in 2021).

€6.8M in 2015, €8M 2019, €10M 2020, €30M 2023.

So it was 8 years (launched in 2019) from seed funding to product launch. And they're still in investment mode, not yet profitable.

 

[IndyMLVC]

So it was 8 years (launched in 2019) from seed funding to product launch. And they're still in investment mode, not yet profitable.

I'm going to die with this, aren't I.

 

[Jonno02]

Thank you for the explanation, which the remainder of this post will assume is correct.

Indeed, they are plotted exclusively in the direction that slants towards the Active treatment working (i.e. the outer edges of the error bars show greater efficacy for Active vs the given mean value, and the outer edges of the error bars show lesser efficacy for Control vs the given mean value).

This seems odd at face value. Although, I readily admit that I know neither the specific statistical methodology used in this case, nor how scientific papers generally plot error bars at large.

You're most welcome.

It's a strange choice, but if indeed it is a standard deviation error bar, it should be equal at both sides, so if you imagine the same length of error bar going the opposite direction, you get a good idea.

 

[haha ear go eeee]

I'm going to die with this, aren't I.

This shit is exactly why we need compassionate use for these treatments. It takes wayyyy too long for these things to become widely available. A lot of us are on the brink of suicide and don't have the willpower to wait for a wide release because they've already been waiting for years or even decades. It's ridiculous that companies like Xenon Pharmaceuticals aren't offering compassionate usage of their trial drugs.

 

[JimmyStrong]

in the end, it all boils down to money - bringing the product from prototype stage to something that can be manufactured reliably in volume, FDA (and other) regulatory approvals, launch onto market, enlisting audiologists and providing them with support, training, etc.

It all adds up, that's why I posted the link to funding status of Auricle - even if FDA approval were achieved today, not until they have quite a few $M in the bank and more than 2 employees will this start to move.

Having said all that, I'm sure they're not standing still - a funding round could be closed anytime (I'm sure this is the primary focus of the Auricle CEO), and from there, investors will be looking for quick results. Sufficient funds could see something like this to market in 12-24 months.

Just my $0.02 - I could be way off, but have some experience in product development and bringing new products to market.

P.S.

It may not be a valid comparison at all but here's the funding trajectory of Neuromod.

They started with €200K of seed funding in 2011 (vs. Auricle $350K in 2021).

€6.8M in 2015, €8M 2019, €10M 2020, €30M 2023.

So it was 8 years (launched in 2019) from seed funding to product launch. And they're still in investment mode, not yet profitable.

Damn, that's crazy to think about. Now just imagine how long it's going to take with a potential hearing loss cure. I get why the guy above feels like he's going to die with this.

 

[ErikaS]

This shit is exactly why we need compassionate use for these treatments. It takes wayyyy too long for these things to become widely available. A lot of us are on the brink of suicide and don't have the willpower to wait for a wide release because they've already been waiting for years or even decades. It's ridiculous that companies like Xenon Pharmaceuticals aren't offering compassionate usage of their trial drugs.

I completely agree with you from a debilitation factor and knowing our community deserves relief as soon as possible, but it's the FDA laws/regulations that puts such limitation. I learned this with Dr. Shore's following response:

The terms and conditions for 'compassionate care use' per the FDA are extremely specific, and it is only granted for immediately life-threatening diseases where there are no cleared therapies.

That was a big learning point for me. I was not aware compassionate care use was based on if there are no cleared therapies. Hence, why Xenon Pharmaceuticals can't just jump to compassionate use because there are other cleared drugs that target epilepsy and MDD. Not to mention their name, but this is why Hough Ear Institute initially discussed compassionate care use because it would be the first pharmaceutical to specifically target hair cell regeneration for hearing loss and tinnitus. But, we all saw how that went, unfortunately. Nothing goes the right or quick way for us.

However, this same FDA pushed and rushed vaccines into millions of people that actually led many to Tinnitus Talk with other debilitating conditions. Not trying to get into a vax argument, just pointing out flaws, inconsistencies, and more of humanity and society.

 

[IndyMLVC]

However, this same FDA pushed and rushed vaccines into millions of people that actually led many to Tinnitus Talk with other debilitating conditions. Not trying to get into a vax argument, just pointing out flaws, inconsistencies, and more of humanity and society.

Doesn't want to get into a vax argument but makes an incredibly stupid comment about something being rushed when it wasn't and has been studied for many, many years.

 

[slc]

I guess that's my question too. I totally understand why they did not report the week 13-18 based on study parameters/bias. However, inquiring minds would want to know why the treatment really didn't seem too effective for the second group after weeks 13-18. Makes me wonder if they needed a longer washout from the "sound only"?

Your comment prompted me to look for studies that focussed on sound therapy. I found the following cited in the abstract of "Sound Therapy to Reduce Auditory Gain for Hyperacusis and Tinnitus" by James A. Henry, which supports the notion of Dr. Shore's "sound only" group not having sufficient washout time. Here is the quote from James A. Henry:

There is evidence that sound therapy can reduce auditory gain and, thus, can reduce the loudness of tinnitus and that these effects are sustained beyond the period of stimulation with the sound (Munro & Merrett, 2013; Parazzini et al., 2011; Schaette et al., 2010). There is also evidence that sound therapy can reduce the effects of hyperacusis by increasing loudness tolerance (i.e., raising the threshold level at which sound becomes uncomfortable; Formby et al., 2003; Gold et al., 1999).

I next tried to read Schaette et al.'s "Acoustic stimulation treatments against tinnitus could be most effective when tinnitus pitch is within the stimulated frequency range", but only the first part was available online. In a pilot study (n=15), they found that if a person's tinnitus pitch was below 6 kHz, there was a reduction in tinnitus. Since the full article wasn't displayed, I didn't get to read about lasting effects, if any. But, I guess this might also raise the question of the tinnitus pitch/pitches of participants in Dr. Shore's studies and the response to audio only treatment (as well as the treatment pitches used for the audio only). So, it seems very reasonable to consider whether there were lingering effects that interfered when Dr. Shore's study participants crossed over to receive bi-modal treatment.

Acoustic stimulation with hearing aids or noise devices is frequently used in tinnitus therapy. However, such behind-the-ear devices are limited in their high-frequency output with an upper cut-off frequency of approximately 5–6 kHz. Theoretical modeling suggests that acoustic stimulation treatments with these devices might be most effective when the tinnitus pitch is within the stimulated frequency range. To test this hypothesis, we conducted a pilot study with 15 subjects with chronic tinnitus. Eleven subjects received hearing aids and four subjects noise devices. Perceived tinnitus loudness was measured using a visual analog scale, and tinnitus-related distress was assessed using the Tinnitus Questionnaire. After six months of device usage, reductions of perceived tinnitus loudness were seen only in subjects with a tinnitus pitch of less than 6 kHz. When subjects were grouped by tinnitus pitch, the group of patients with a tinnitus pitch of less than 6 kHz (n = 10 subjects) showed a significant reduction in perceived tinnitus loudness (from 73.4 ± 6.1 before to 56.4 ± 7.4 after treatment, p = 0.012), whereas in subjects with a tinnitus pitch of 6 kHz or more (n = 5 subjects) tinnitus loudness was slightly increased after six months of treatment (65.0 ± 4.7 before and 70.6 ± 5.9 after treatment), but the increase was not significant (p = 0.063). Likewise, tinnitus-related distress was significantly decreased in the low-pitch group (from 31.6 ± 4.3 to 20.9 ± 4.8, p = 0.0059), but not in the group with high-pitched tinnitus (30.2 ± 3.3 before and 30.0 ± 5.1 after treatment, p = 1). Overall, reductions in tinnitus-related distress in our study were less pronounced than those reported for more comprehensive treatments. However, the differences we observed between the low- and the high-pitch group show that tinnitus pitch might influence the outcome of acoustic stimulation treatments when devices with a limited frequency range are used.

 

[andrewdaniels]

Originally I thought early 2024. Now I'm pretty much resigned to late 2025 or some bollocks.

I'm wondering if it's even longer, unfortunately... I can't remember if it was here where someone posted how long it took Neuromod to commercialize Lenire. Wouldn't surprise me if Dr. Shore's device was out 2026-2027...

Your comment prompted me to look for studies that focussed on sound therapy.

Thank you for taking the time to look into this. Makes me think they needed a longer washout period before bimodal treatment, but I'm not an expert or a scientist. I will be thankful when this is released and we can all try it out.

 

[annV]

but only the first part was available online.

Full article attached.

 

[slc]

Full article attached.

Thanks! Roland Schaette et al. makes an interesting point (for those whose tinnitus pitch was less than 6 kHz) in the title of "Acoustic stimulation treatments against tinnitus could be most effective when tinnitus pitch is within the stimulated frequency range" and in the paper itself that the biggest changes occurred during the first two months of audio treatment. Given Roland Schaette et al. show rapid response to acoustic treatment (but limited to those whose tinnitus pitch was less than 6 kHz), what were the effects on the audio-only group in the Dr. Shore study that would have seemed to have interfered with the bimodal treatment. Also, for those of us presently using sound therapy (especially Bluetooth or maskers delivered right to ears), would that be a contraindication and best to stop using sound therapy before using the Auricle device?

If there is a future set of questions sent to Dr. Shore, it would be very useful to ask whether before doing the Auricle bimodal treatment, one needs to stop maskers, Bluetooth ocean sound, etc. -- and for how long.

As subjects were seen after 1, 2, 3, and 6 months of treatment, we could also analyze the time course of tinnitus loudness and distress (Fig. 4). The biggest changes took place in the first two months of device usage, suggesting a time constant of weeks for the effects of acoustic stimulation.

 

[Jim Vasilakis]

I completely agree with you from a debilitation factor and knowing our community deserves relief as soon as possible, but it's the FDA laws/regulations that puts such limitation. I learned this with Dr. Shore's following response:

That was a big learning point for me. I was not aware compassionate care use was based on if there are no cleared therapies. Hence, why Xenon Pharmaceuticals can't just jump to compassionate use because there are other cleared drugs that target epilepsy and MDD. Not to mention their name, but this is why Hough Ear Institute initially discussed compassionate care use because it would be the first pharmaceutical to specifically target hair cell regeneration for hearing loss and tinnitus. But, we all saw how that went, unfortunately. Nothing goes the right or quick way for us.

However, this same FDA pushed and rushed vaccines into millions of people that actually led many to Tinnitus Talk with other debilitating conditions. Not trying to get into a vax argument, just pointing out flaws, inconsistencies, and more of humanity and society.

They didn't rush anything regarding vaccines. The technology had already been available for years. And there aren't any actual studies that link hearing loss with the vaccines with actual association. It's best to not spread fear against the vaccines.

 

[AnthonyMcDonald]

not yet profitable.

Not surprised since Lenire doesn't f*cking work lol.

 

[Fightthearmy]

It wouldn't surprise me either if Dr. Shore's device was out 2026-2027... Should create a website called FDAexposed by then, on why it took several years to approve the Michigan Device, and the corruption within the FDA that must have been involved with the approval of Neuroscam.

 

[Brian Newman]

Nah, she's researching hyperacusis too. I just don't think she's focusing on that as much as she is tinnitus right now.

She is? It seemed like when she was asked about it, nope, and that's it.

 

[Jorge P. Simoes]

This seems odd at face value. Although, I readily admit that I know neither the specific statistical methodology used in this case, nor how scientific papers generally plot error bars at large.

I think they decided to do so to make the figures "cleaner", otherwise the error bars would overlap in some figures (for example in Figure 3 during the treatment phase), which is also important information IMO. Both ways of showing the results are common in health research (although having the error bars in both directions is more common), and I would say it depends on what information the researchers want to highlight in their figures

 

[dj_newark]

She is? It seemed like when she was asked about it, nope, and that's it.

I don't know what it seems like, but she is researching hyperacusis. She has confirmed that for me in an email.

 

[silenceismusic]

So now it's a "race" on whether XEN1101 and similar medications or the Auricle makes it to the market first. I'll check back in 3 years lol.

 

[aarond23]

We're already at 10 years on the news of this device and we still have years to wait to be able to use it. It's discouraging to say the least. I am fortunate to have a more milder case of tinnitus than some others, but still would love to have some control over the condition and would very much love to try this device, but it does seem like it's a long way away from being a reality.

 

[kingsfan]

We're already at 10 years on the news of this device and we still have years to wait to be able to use it. It's discouraging to say the least. I am fortunate to have a more milder case of tinnitus than some others, but still would love to have some control over the condition and would very much love to try this device, but it does seem like it's a long way away from being a reality.

That's what bums me out. Many of us will have even worse tinnitus by the time this comes to market, so possibly be right back at where we are right now in terms of our loudness and discomfort.

 

[dj_newark]

That's what bums me out. Many of us will have even worse tinnitus by the time this comes to market, so possibly be right back at where we are right now in terms of our loudness and discomfort.

Yeah, but I think with continued use of the device we'll see further improvement in symptoms. They had to cap the use of the device timewise for the trial. But once it's yours, it's yours to use as you want and you can use it till the cows come home if need be!

 

[Aussie Lea]

Yeah, but I think with continued use of the device we'll see further improvement in symptoms. They had to cap the use of the device timewise for the trial. But once it's yours, it's yours to use as you want and you can use it till the cows come home if need be!

Continued use could give better results, but it could be the other way around too, no? What if maladaptive plasticity takes once again place in the brain over time (over several months of device use for example) and you either start getting worse from the treatment or you hit a permanent threshold where you won't improve any longer.

This hasn't been tested very long-term like that. Yes, Phase 2 study gave better results with the longer treatment duration, but it doesn't necessarily mean e.g., 3 months of continued device use keeps giving better and better results. You can't translate it like that IMO!

We will know when the device becomes properly available and people start using it more and more. I just wouldn't ASSUME anything...

 

[dj_newark]

Continued use could give better results, but it could be the other way around too, no? What if maladaptive plasticity takes once again place in the brain over time (over several months of device use for example) and you either start getting worse from the treatment or you hit a permanent threshold where you won't improve any longer.

This hasn't been tested very long-term like that. Yes, Phase 2 study gave better results with the longer treatment duration, but it doesn't necessarily mean e.g., 3 months of continued device use keeps giving better and better results. You can't translate it like that IMO!

We will know when the device becomes properly available and people start using it more and more. I just wouldn't ASSUME anything...

Further studies will be needed, but I think it's highly unlikely that it would make you worse. I could be wrong of course, almost everything in this thread is merely speculation.

 

[Pixelito]

I will hope and pray we hear some kind of optimistic news by the end of the year.

 

[LGuapo]

That's what bums me out. Many of us will have even worse tinnitus by the time this comes to market, so possibly be right back at where we are right now in terms of our loudness and discomfort.

Not just worse tinnitus, but further hearing loss due to aging. My perceived tinnitus frequency is right on the upper edge of my audible spectrum. It's inevitable that eventually that frequency will be completely inaudible to me. It really is a race against time situation.

 

[SilverFox]

I think it's highly unlikely that it would make you worse

It's really not known. Lenire uses superficially the same approach and it has made some people worse.

 

[lolkas]

We are all speculating here about Auricle's progress with FDA and other things. It's definitely at snail's pace and not as fast as we all would like.

If they know what they are doing - the device could be out in ~2 years. Production takes time - you will be surprised how quickly this stuff can be built to the "Lego mode" in China and then shipped to the USA for it to be "screwed in together". So that is not that big of a problem, unless for some odd reason they will be doing everything in the USA (I don't see why the electronic parts could not all be done in China and shipped to the USA just to put it in the case lmao.)

Audiologist training - most likely to be done remote. Auricle will just show audiologists how to connect the device to the computer, launch Auricle software and make whatever adjustments are needed for it to be set up for the particular patient. It would probably have a tinnitus matching module in it so that the device is programmed correctly.

Technical support - can also be set up rather quickly. The device is pretty limited device in its functionality, therefore troubleshooting and such is relatively light.

That being said, if XEN1101/BHV-7000 will have come out by then (if not earlier) and prove to be working - Auricle sales might be in real danger. I can guarantee you that Xenon Pharmaceuticals, let alone Pfizer's Biohaven, have more resources to produce their drugs in massive quantities than Auricle. And the general population is also lazy, they will take a pill if it works instead of carrying some device and doing a 30 minute routine every day.

 

[dj_newark]

It's really not known. Lenire uses superficially the same approach and it has made some people worse.

The similarities are VERY superficial. I wouldn't compare the two just because they are both bimodal stimulation.

 

[andrewdaniels]

The similarities are VERY superficial. I wouldn't compare the two just because they are both bimodal stimulation.

Not doubting at all, because I'm eagerly awaiting Dr. Shore's device as opposed to trying Lenire.

However, what would you say the major differences are (besides the double blind study)? Is there a different mechanism of action in the stimulation (i.e. cheek and neck vs. tongue) that makes a difference?