New University of Michigan Tinnitus Discovery — Signal Timing

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

 

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.

 

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!

 

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.

 

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.

 

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.

 

Are we there yet?

 

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!

 

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.

 

Nepotism.

 

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.

 

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

 

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.

 

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.

 

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.

 

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

 

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.

 

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