New University of Michigan Tinnitus Discovery — Signal Timing

[Dizzyhead888]

This device is getting a lot of hype because there's plenty of "science" behind it, but that doesn't necessarily mean it's great.

A 13–20 point improvement in TFI scores for 65% of patients is good, and I'll take it, but it's not exactly compelling. I've seen many alternative treatments and research studies on different interventions show similar results on paper.

If someone's tinnitus severity is in the 70s or 80s, it's likely to remain severe. I do wonder, though, if there are any super-responders who experienced improvements of 30 points or more in TFI.

The hopeful part is that using the device for longer than six weeks might lead to greater suppression, but we don't know that yet.

 

[Kam75]

I have said several times in this thread that the device will not be on the market before 2030 in the US and not before 2035 outside the US.

Unfortunately, from what I can see, it seems that my prediction was quite accurate.

So many more years of suffering... But I hope it will be worth it and that we will finally see the light at the end of the tunnel.

 

[NeroRay]

Not surprised about the outcome, but still a bit disappointed. It seems they know it's not ready for human use yet. I don't want to sound pessimistic, but I'm afraid this might end up being shelved.

 

[DimLeb]

Those of you outside the US, would you consider traveling to the US for treatment?

I would consider it, but for some, it just isn't possible. Money, responsibilities, noise exposure, etc. I personally also have ETD and spasm issues so I hesitate to get on an airplane. But who knows in 10 years' time lol.

 

[be6z]

I heard they're short by 3 million, according to Pearson.

I don't think this suggests any real issue. From my understanding, seed funding is quite common for early-stage medical companies, especially when they're preparing for FDA approval. Larger companies usually wait until the 510(k) is at least submitted before getting involved.

They're trying to raise between 1.5 and 3 million, which means they only need around 30 to 60 investors. I may be wrong, but I think they'll get there.

 

[Applejuice]

When I look at the exclusions for the study from ClinicalTrials.gov, it lists:

Exclusion Criteria:

• Diagnosis of Meniere's disease
• Diagnosis of Semicircular Canal Dehiscence
• Unilateral or bilateral cochlear implant recipients
• Diagnosis of acoustic neuroma
• Evidence of retrocochlear disease
• Certain medications and conditions (will be reviewed at screening)

But nothing about excluding multi-tone tinnitus. Where did you find the multi-tone exclusion?

Yeah, you're right. It seems I read it somewhere but can't find the source now. Strange, but I apologize.

 

[dd314]

I just watched the Q&A session. I may have missed it, but did they mention any specific amount of hearing loss that could affect its effectiveness?

There was someone asking the opposite question, about hyperacusis patients turning the volume down very low, and she said you just have to be able to hear the audio. As long as you can hear it, it should work. I would think this also applies to people who turn the audio up in the opposite direction.

This device is getting a lot of hype because there's plenty of "science" behind it, but that doesn't necessarily mean it's great.

A 13–20 point improvement in TFI scores for 65% of patients is good, and I'll take it, but it's not exactly compelling. I've seen many alternative treatments and research studies on different interventions show similar results on paper.

If someone's tinnitus severity is in the 70s or 80s, it's likely to remain severe. I do wonder, though, if there are any super-responders who experienced improvements of 30 points or more in TFI.

The hopeful part is that using the device for longer than six weeks might lead to greater suppression, but we don't know that yet.

This is slightly off-topic, but as a point of comparison, there was a tDCS study that had an average -30 point TFI reduction, and no one here even talks about it.

 

[UKBloke]

I think it would have really helped if they had at least informed us prior that they haven't submitted to the FDA. When I discovered that fact, I asked a specific question about the last trial and whether or not the issues with the cross-over data would necessitate a third trial. Unfortunately, by the time I'd been able to gather my wits and send the post, it didn't reach the floor.

Anyhow, to some degree, they've already provided an answer. The short film that Jon showed at the end explicitly states that Auricle plans new clinical trials. The timeline slides imply that as well. What they're not clear about is whether or not these trials will be pre- or post-release. I can hazard a guess, however.

This is such an odd situation, but I firmly believe getting caught out in the way they did when they increased the treatment protocol to 6 weeks is what really poleaxed them. In hindsight, a small interim trial could have flagged those issues prior. Obviously hindsight is a wonderful thing.

With the data they have, I still believe they are bullish on the technology, but they clearly have a spanner in the works over something. They've kind of stated the need for further trials without specifically stating when, how, or even why. But I have to make an observation and say that something like the rationale of developing technology while informing us that said technology is really simple just comes across a bit bizarre. Anyhow, it appeared Jon was being very diplomatic about all of that, and I suppose we'll never really know what's going on behind the scenes, and the politics at play.

With all that said, I respect Jon's choice to limit further investment types because that goes a long way to shielding individuals, particularly patients, from financial loss. If his approach to that had been any different, I'd be getting Lucchino vibes, but I'm not.

I'm more than thirty years in with this condition, and seven years post-worsening with sound sensitivity to boot. I joined Tinnitus Talk six years ago with the specific objective of following the Lenire and UMich releases. It's been a long haul, but I've now reached the end of the road for both.

Tinnitus Quest appears to be moving along quite nicely, so I'll wait and see what news that brings, but I'll be watching any progress from much further afar from now on. Cheers all.

 

[withintention]

I just watched the Q&A session. I may have missed it, but did they mention any specific amount of hearing loss that could affect its effectiveness?

@vttbx, they didn't say that exactly, but the clinical trials had an exclusion criterion for people with hearing loss below 50 dB.

 

[NewEnglander]

Yesterday's Q&A was much appreciated. Still, it remains mystifying. We have a device that, according to the first part of Monday's session, has been proven safe and effective, and possibly even more effective with longer use. Its efficacy was first reported seven years ago, in January 2018, across major media outlets such as Newsweek and NPR. It has a global market and was described yesterday as a fairly simple device.

It could save the U.S. military billions in partial and full tinnitus disability payments. Yet Lenire, which many say barely works if at all, is already FDA-approved and available, while the Shore device, which apparently does work, has not even been submitted to the FDA and is still years away from market.

As someone who has relied on in-ear white noise just to sleep for more than 30 years, this is difficult to understand. Auricle was founded in 2019 and still has no funding for this breakthrough device? Wouldn't the U.S. military have an interest in helping get this approved by the FDA?

It's hard to fathom what is going on, but optimism is a weapon, and I'll continue to hope for the best. Much love to everyone, and thank you Hazel, Susan, and Jon for all you're doing for us.

 

[LGuapo]

By the time the device reaches the market, I won't be able to hear the frequencies of my most bothersome tinnitus sounds. That's it for me. Susan Shore's device just won't work in my case. It'll simply be too late.

I have the same concern, but a few facts keep me from losing all hope. One is that since Shore et al. are essentially treating the DCN fusiform cells and related auditory and somatic connections as a black box system, they don't really know how their treatment works physiologically at the cellular level. Because of that, they don't know how close in frequency the treatment tone needs to be. Maybe it's within one critical band, maybe two, maybe more.

Also, their animal trials were successful even though their method of determining tinnitus pitch in animals is, at best, indirect (for example, using startle response). It seems entirely possible that the difference in frequency between their assumed value and the actual value was more than minimal, yet the animals still showed improvement.

Lastly, they don't know what effect presbycusis has on their treatment. It could be that as presbycusis progresses, the difference in frequency between the tinnitus tone and the treatment tone matters less for effectiveness. It's uncertain and perhaps even unlikely, but it's not unreasonable.

 

[withintention]

There was someone asking the opposite question, about hyperacusis patients turning the volume down very low, and she said you just have to be able to hear the audio. As long as you can hear it, it should work. I would think this also applies to people who turn the audio up in the opposite direction.

This is slightly off-topic, but as a point of comparison, there was a tDCS study that had an average -30 point TFI reduction, and no one here even talks about it.

View attachment 62890

@dd314, not only is there a whole thread about that study, but I actually replicated the study with the help of the NYU Langone academic medical center, and provided a detailed report of my results.

 

[Eloy79]

The event was great, but the result wasn't so good. We'll have to increase our donations to Tinnitus Quest; for now, that's all I can see.

 

[dipp]

I have the same concern, but a few facts keep me from losing all hope. One is that since Shore et al. are essentially treating the DCN fusiform cells and related auditory and somatic connections as a black box system, they don't really know how their treatment works physiologically at the cellular level. Because of that, they don't know how close in frequency the treatment tone needs to be. Maybe it's within one critical band, maybe two, maybe more.

Also, their animal trials were successful even though their method of determining tinnitus pitch in animals is, at best, indirect (for example, using startle response). It seems entirely possible that the difference in frequency between their assumed value and the actual value was more than minimal, yet the animals still showed improvement.

Lastly, they don't know what effect presbycusis has on their treatment. It could be that as presbycusis progresses, the difference in frequency between the tinnitus tone and the treatment tone matters less for effectiveness. It's uncertain and perhaps even unlikely, but it's not unreasonable.

Thanks a lot. I really needed to read something like this. Let's hope that some of what you said turns out to be right.

 

[AfroSnowman]

By the time the device reaches the market, I won't be able to hear the frequencies of my most bothersome tinnitus sounds. That's it for me. Susan Shore's device just won't work in my case. It'll simply be too late.

I need to find a way to process the fact that I won't see my tinnitus reduced in my lifetime. I'm done. It's hard to accept.

Just a hopeful note: Lenire had similar hearing loss restrictions during its clinical trials (I think it might have been 50 dB as well), but when it went to market, they allowed up to 80 dB of loss at high frequencies.