New University of Michigan Tinnitus Discovery — Signal Timing

[kingsfan]

Auricle just needs to get in touch with Purdue Pharma. They'll get it through the FDA without a hitch. **cough** OxyContin **cough**

 

[WilRic]

If I remember correctly, the active arm received electrical impulses so faintly that the participant soon habituated to them and did not feel them. In essence, they were blinded to whether or not they had active or placebo treatment. That's how Dr. Shore explained her blinding.

That's correct. It was double-blinded. The electrical impulses were close to the sensation threshold, so both the control and active groups found it difficult to tell if they were getting the somatosensory input. See here. If you stick an electrode on the back of your neck and are told that the stimulation will barely feel, I guarantee you will genuinely think you feel a faint buzz.

The pilot study with guinea pigs used three control groups: no bimodal, audio only, and electrical only.

Dr. Hubert Lim keeps making excuses for why Neuromod's trials didn't use any placebo control. He maintains that active dose comparator control was sufficient (giving each group a different stimulation pattern).

This is really important in terms of having a bit of hope in the Auricle device. Shore's previous research has been intensely focused on signal timing to mess around with Hebbian timing in neurons (e.g. this article). It is dense research. Neurmod's approach (developed without Lim onboard at the start) seems to have been to fool around with different timing patterns and see what happens (i.e., throwing spaghetti at the wall). Lim basically admitted that in his recent interview with a minor celebrity audiologist "Doctor" Cliff. The apologia was to suggest that Lenire will be improved over time as different timing patterns are observed in the user base.

 

[dj_newark]

Auricle just needs to get in touch with Purdue Pharma. They'll get it through the FDA without a hitch. **cough** OxyContin **cough**

I heard an explanation that made sense to me. Dr. Shore couldn't get her device picked up by 'big pharma,' who could get this through FDA approval quickly, because the patent isn't strong enough to stand up to a patent challenge. It seems that synchronized signal timing may not be proprietary enough to uphold the patent and may not withstand a legal challenge. So, instead, she had to form her own company with Pearson at the helm. However, he seems inexperienced at FDA matters and is probably fumbling through an FDA submission and learning as he goes.

If all this is true, it may be why submission is taking way too long!

 

[Bhaveen]

You are not getting this confused with the Bionics Institute technology, are you? They are looking at several more portable prototypes. I've heard nothing of new prototypes for Auricle.

Check the attached screenshot. This is the job description for the new Auricle employee on LinkedIn. To me, this suggests they are working on a take-home device. Something else seems to be mentioned in the second paragraph, which I think might be related to radiation, but I'm not entirely sure.

From what I've read about the FDA approval process, I believe the device needs to be in its final form before submission. This makes sense, as the FDA needs to review the exact version of the product they are approving.

What worries me is if a new device necessitates a new clinical trial. However, it could just be something related to aesthetics, so hopefully, it's not a major issue. Whatever the case, I can't imagine they have submitted anything to the FDA yet if they are still working on a take-home device.

I recall someone on Tinnitus Talk having experience with medical device submissions, and perhaps they can shed some light on this situation.

 

[RunningMan]

I think Dr. Shore's placebo was related to the timing.

In various places in the study, study charts, the Q&A, and even the recent webinar from Dr. Shore, the placebo/control/sham is stated as being auditory only. Only one place in some supplemental documentation does it mention a sham timing.

Of course, it's easy to have a placebo arm without the stimulation when it's set below the level of sensation in the active treatment. Dr. Shore responded about this in the Q&A.

 

[kingsfan]

Auricle just needs to get in touch with Purdue Pharma. They'll get it through the FDA without a hitch. **cough** Oxycontin **cough**

This was a little dark humor, not an actual suggestion. I guess for those who aren't familiar with Purdue Pharma and the US OxyContin epidemic - and just basically the FDA to the pharmaceutical executive pipeline.

 

[SarahMLFlemmer]

Are we there yet?

 

[Bhaveen]

Are we there yet?

If only. I think we have to wait till Pearson puts his big-boy pants on.

 

[dj_newark]

If only. I think we have to wait till Pearson puts his big-boy pants on.

Four years as CEO of Auricle Inc., and what has Pearson actually accomplished? Nothing, as far as anyone can tell. That's why more and more people are turning to their "personal projects" to treat their tinnitus!

 

[Bhaveen]

Four years as CEO of Auricle Inc., and what has Pearson actually accomplished? Nothing, as far as anyone can tell. That's why more and more people are turning to their "personal projects" to treat their tinnitus!

Those who seek out their own path are the real heroes—not Pearson. How did he even get the job? He has no prior experience in launching any health-related global medical devices and clearly lacks an understanding of the consumer. Yet, he has been handed this multimillion-dollar opportunity. I don't want my money going to this guy. Frankly, by the time they get anything up and running, other treatments will likely be available, so hopefully, I won't have to rely on him.

 

[kingsfan]

How did he even get the job? He has no prior experience in launching any health-related global medical devices and clearly lacks an understanding of the consumer. Yet, he has been handed this multimillion-dollar opportunity.

Nepotism.

 

[Kleiner]

Auricle is a dead horse now. Beyond science, Pearson's incompetence will make it explode. It's a succession of red flags without the slightest positive sign.

Even if he manages to bring it to market in several years, there will likely be better treatments available by then, or the patent will have expired.

 

[MiaVIL]

Auricle is a dead horse now. Beyond science, Pearson's incompetence will make it explode. It's a succession of red flags without the slightest positive sign.

Even if he manages to bring it to market in several years, there will likely be better treatments available by then, or the patent will have expired.

Is Susan Shore really going to let 20 years of research go to waste? Has it truly been abandoned? If so, why did she host that webinar back in June? It's hard to believe. She could leave behind a great legacy, but it seems like she doesn't care—or at least that's the impression I get.

 

[kingsfan]

Is Susan Shore really going to let 20 years of research go to waste? Has it truly been abandoned? If so, why did she host that webinar back in June? It's hard to believe. She could leave behind a great legacy, but it seems like she doesn't care—or at least that's the impression I get.

Not abandoned. Just moving through the halls of bureaucracy at a snail's pace.

 

[Nick47]

It's not abandoned, but it's moving at a snail's pace. Every day it's not available, another chunk of potential profit is lost. It is not in Auricle's favor to move slowly.

In addition, other treatments are progressing through clinical trials.

 

[Bob3382]

Auricle is a dead horse now. Beyond science, Pearson's incompetence will make it explode. It's a succession of red flags without the slightest positive sign.

Even if he manages to bring it to market in several years, there will likely be better treatments available by then, or the patent will have expired.

There are already numerous treatments that people on Tinnitus Talk can attest to. None of them work for everyone because, as we all know, every case of tinnitus is different. Yes, there are classifications and common symptoms associated with different types and causes of tinnitus, but if it were as simple as having one single cause, there would likely be a definitive cure.

My point is that many people have found relief through various treatments. Some have benefited from certain supplements, Cognitive Behavioral Therapy (CBT), alternative medications, electrical stimulation, cochlear implants, and a myriad of other options. The number of available treatments is steadily growing, though progress is slow.

However, the slow pace of advancements and the fact that, according to Dr. Shore, this treatment is only being tested on those with somatic tinnitus, makes me skeptical that it will be the universal "magic bullet" many hope for.

 

[dj_newark]

There are already numerous treatments that people on Tinnitus Talk can attest to. None of them work for everyone because, as we all know, every case of tinnitus is different. Yes, there are classifications and common symptoms associated with different types and causes of tinnitus, but if it were as simple as having one single cause, there would likely be a definitive cure.

My point is that many people have found relief through various treatments. Some have benefited from certain supplements, Cognitive Behavioral Therapy (CBT), alternative medications, electrical stimulation, cochlear implants, and a myriad of other options. The number of available treatments is steadily growing, though progress is slow.

However, the slow pace of advancements and the fact that, according to Dr. Shore, this treatment is only being tested on those with somatic tinnitus, makes me skeptical that it will be the universal "magic bullet" many hope for.

The Shore device is the only treatment that will reduce tinnitus volume. That's the treatment everyone needs. It's never been possible before until this device becomes available.

 

[antonio77]

There are already numerous treatments that people on Tinnitus Talk can attest to. None of them work for everyone because, as we all know, every case of tinnitus is different. Yes, there are classifications and common symptoms associated with different types and causes of tinnitus, but if it were as simple as having one single cause, there would likely be a definitive cure.

My point is that many people have found relief through various treatments. Some have benefited from certain supplements, Cognitive Behavioral Therapy (CBT), alternative medications, electrical stimulation, cochlear implants, and a myriad of other options. The number of available treatments is steadily growing, though progress is slow.

However, the slow pace of advancements and the fact that, according to Dr. Shore, this treatment is only being tested on those with somatic tinnitus, makes me skeptical that it will be the universal "magic bullet" many hope for.

I'm not sure if there are different types of tinnitus. I believe the condition is essentially the same for everyone, but what varies is the severity, duration, and how each person experiences it. For example, a person with hearing loss who doesn't use hearing aids to improve their hearing may perceive their tinnitus less, but that doesn't necessarily mean the tinnitus itself decreases. I think what works for one person may work for others, with the main difference being how long they've had tinnitus.

 

[dd314]

The Shore device is the only treatment that will reduce tinnitus volume. That's the treatment everyone needs. It's never been possible before until this device becomes available.

It might not be the only treatment.

There was a recent double-blinded randomized placebo-controlled trial that showed tDCS over the auditory cortex reduced TFI from an average of 75 to 45, and I'm sure that entails volume reduction. No one talks about it, but it had incredible results.

For those curious:

→ Repeated Bilateral Transcranial Direct Current Stimulation over Auditory Cortex for Tinnitus Treatment: A Double-Blinded Randomized Controlled Clinical Trial

 

[UKBloke]

This "different types of tinnitus" perspective is what has ultimately led to "muh heterogeneity" and the endless conveyor belt of clinical researchers all needing "another ten years" and a horde of gerbils.

The solution to tinnitus starts with one decent executive project manager. If these well-funded institutional players don't start getting on with it, I think citizen science will eventually take over.

 

[dd314]

This "different types of tinnitus" perspective is what has ultimately led to "muh heterogeneity" and the endless conveyor belt of clinical researchers all needing "another ten years" and a horde of gerbils.

The solution to tinnitus starts with one decent executive project manager. If these well-funded institutional players don't start getting on with it, I think citizen science will eventually take over.

There are two components to the etiology of tinnitus: the peripheral issue and the central generation. TMJ dysfunction and Meniere's disease are fundamentally different conditions, so it's reasonable to consider their resulting tinnitus as having different etiologies. However, the tinnitus is still being generated centrally, possibly by fusiform cells in the dorsal cochlear nucleus (DCN), as proposed in Dr. Shore's model.

 

[Nick47]

A load of off-topic rambling begins. Can you read?

 

[dj_newark]

I'm not sure if there are different types of tinnitus. I believe the condition is essentially the same for everyone, but what varies is the severity, duration, and how each person experiences it. For example, a person with hearing loss who doesn't use hearing aids to improve their hearing may perceive their tinnitus less, but that doesn't necessarily mean the tinnitus itself decreases. I think what works for one person may work for others, with the main difference being how long they've had tinnitus.

I believe you're wrong. Each person's case is as unique as a fingerprint. Sound, intensity, and every other factor vary from individual to individual. The only thing common to all is the source - the DCN, and the cause - hyperactive fusiform cells.

 

[Joeseph Stope]

I believe you're wrong. Each person's case is as unique as a fingerprint. Sound, intensity, and every other factor vary from individual to individual. The only thing common to all is the source - the DCN, and the cause - hyperactive fusiform cells.

Somehow, I'm cheered by the simplicity of your summary — but let me just play that through one more time.

The source... well, in my case, it was likely triggered by noise, which I suppose affected the DCN (dorsal cochlear nucleus) and fusiform cells. Unfortunately, my tinnitus is reactive, so loud noise causes a spike. My hearing had been quite sensitive to noise in the years leading up to the onset of tinnitus. Some tinnitus patients are spared this sensitivity but may experience dizziness or a feeling of fullness instead.

So while you might be spot on for most cases, it could be that the entire hearing system needs to be scrutinized for any damage.

 

[RunningMan]

For example, a person with hearing loss who doesn't use hearing aids to improve their hearing may perceive their tinnitus less, but that doesn't necessarily mean the tinnitus itself decreases.

I'm a person with hearing loss who doesn't use hearing aids to improve my hearing. But I perceive my tinnitus louder, not less. The tinnitus stands out even more when the environmental sounds are quieter due to hearing loss. Hearing aids amplify actual sounds, not tinnitus. So they can create more of a masking effect by amplifying external sounds while the tinnitus maintains its same internal level. I just met with an audiologist and might be trying some out soon.

In any case, I'm still hopeful the Susan Shore device will cause an objective reduction in tinnitus volume.

 

[Nick47]

Did anyone listen to Dr. Berthold Langguth on the Tinnitus Quest Q&A webinar, especially the part where he said we won't know how effective Dr. Shore's device will be until a larger trial is completed?

 

[Bhaveen]

Did anyone listen to Dr. Berthold Langguth on the Tinnitus Quest Q&A webinar, especially the part where he said we won't know how effective Dr. Shore's device will be until a larger trial is completed?

I couldn't catch it, but I will listen in due course. I would be very surprised if Dr. Langguth has inside information on Auricle, given their lack of communication. I recall Dr. Shore mentioning after the second trial that the focus would shift to commercialization and that the next studies would involve real-life feedback. She also indicated that she had worked with the FDA during the trial process, suggesting that they provided guidelines for conducting an appropriate trial. The FDA often gets a reputation for being a hindrance, but in Dr. Lim's interview, he described them as helpful and collaborative.

On the other hand, Auricle's decision to hire someone to design a "take-home" device worries me, as my understanding is that the device used in the study must be the one proposed for approval.

Overall, it's been two years since the second trial. If another trial were needed, we likely would have heard about it by now. I also wonder if some comments from other doctors or researchers stem from jealousy, as they haven't made progress in solving the problem. Lastly, someone on this board with experience in FDA submissions mentioned that they felt enough had been done to proceed.

 

[Nick47]

In Supplement 3, it states you can request depersonalized individual participant data from Dr. Shore but you need to have an academic or clinical interest and that it's to be used for future research. I'm not sure if we have anyone on here who would qualify.

Has anyone managed to get a hold of this?

 

[Nick47]

She and her colleagues are also working to develop pharmacological manipulations that could enhance stimulus timed plasticity by changing specific molecular targets.

But, she notes, any treatment will likely have to be customized to each patient, and delivered on a regular basis. And some patients may be more likely to derive benefit than others.

I thought the above was interesting. Right at the beginning of the thread.

 

[IYIiKe]

I thought the above was interesting. Right at the beginning of the thread.

I feel like that's a necessary disclaimer. Many people experience strong anxiety related to their tinnitus, and a reduction in volume might not seem significant to everyone. Additionally, since we cannot measure the extent of damage in individuals, it's reasonable to hypothesize that those with tinnitus and more extensive damage may not experience improvement or may have other factors that make them less likely to respond to treatment.