New University of Michigan Tinnitus Discovery — Signal Timing

[UHPTS]

I wrote to Dr. Susan Shore today.

She said they won't finish their trial now till the end of 2021 due to COVID-19.

Wonder what excuse she will use next year and then next and so on.

 

[Sironketchup]

The fact that Lenire misses many of the compliance requirements for FDA approval simply tells me that the work into getting their product out there must not have been very complete or extensive. Essentially the best thing about FDA approval is you know that the evidence required to pass approval is extensive, reviewed and complete. This means you know that your product will stand up over time and that it is suitable for its purpose as well.

Desyncra got FDA approval. Desyncra seems to be as effective as "shining a flashlight in your ears"?

 

[DaveFromChicago]

To Sironketchup:

As I have reported on previous occasions, the fact that there was FDA approval was one of the prime motivators for my decision to invest $5,267.00 in Desyncra. In retrospect not only was it as useless as shining a flashlight on my head would have been; I could have downloaded various tinnitus masking tracks on YouTube and created a very similar sound. How Desyncra persuaded the FDA to grant approval is a total mystery. Someone on this forum said that it is not even offered in the US any longer.

 

[DaveFromChicago]

tommyd87's report on how Lenire cannot yet fulfill FDA standards is much appreciated and in fact gratifying; perhaps they have elevated their requirements so that credulous candidates will not spend extensively for what would be the equivalent derived from seeing an Astrologer.

 

[tommyd87]

tommyd87's report on how Lenire cannot yet fulfill FDA standards is much appreciated and in fact gratifying; perhaps they have elevated their requirements so that credulous candidates will not spend extensively for what would be the equivalent derived from seeing an Astrologer.

I know that FDA has granted approval to useless stuff. I believe that they review their work after this to ensure the same stupid types of products don't get released again.

I also wonder whether the Desyncra device did happen to be the first product of its kind to be released? We have had that problem in Australia with other questionable medical products which get given approval as they are new but turn out to be really questionable in their performance.

I think the regulators here also have learnt from their failures and also have improved their criteria. I know that they don't like the embarrassment of making such errors in their decision making.

 

[DaveFromChicago]

To tommyd87:

Now that I think back on this, your comments are very insightfully germane in this context.

The first sound modulation device was Neuromonics, which allegedly blended sound tones with music. The young lady who posts "My Life With Tinnitus" on You Tube tried it (at a cost of $5,000.00), and had no improvement.

Then, my Audiologist's group offered SoundCure. Four of their patients tried it; they reported that it was irritating and also resulted in no improvements. I believe that SoundCure is no longer in business.

You know my story regarding Desyncra.

A physician mentioned to me that for awhile these sound "therapies" were all the rage and promoted widely.

At first I thought that such unqualified promotions were very unscrupulous, but later decided that given the pervasiveness of this condition, the allegedly convincing data from various submitted clinical trials, and the total absence of any other viable treatment, all these professionals were willing to try anything that had even a remote chance of success.

However, what turned out to be blanket, unqualified failures (with their absurdly high costs) may very probably have heightened the FDA's rigorous awareness regarding new treatments.

When I mentioned Lenire to my wife, she exploded with the retort: "After Desyncra, don't you dare withdraw any more from your 401k to pay for a second useless device." And, believe me, my wife's temper could intimidate Godzilla.

At least this definitely works to our advantage; whatever is now approved will be held to a much stricter standard.

 

[tommyd87]

To tommyd87:

Now that I think back on this, your comments are very insightfully germane in this context.

The first sound modulation device was Neuromonics, which allegedly blended sound tones with music. The young lady who posts "My Life With Tinnitus" on You Tube tried it (at a cost of $5,000.00), and had no improvement.

Then, my Audiologist's group offered SoundCure. Four of their patients tried it; they reported that it was irritating and also resulted in no improvements. I believe that SoundCure is no longer in business.

You know my story regarding Desyncra.

A physician mentioned to me that for awhile these sound "therapies" were all the rage and promoted widely.

At first I thought that such unqualified promotions were very unscrupulous, but later decided that given the pervasiveness of this condition, the allegedly convincing data from various submitted clinical trials, and the total absence of any other viable treatment, all these professionals were willing to try anything that had even a remote chance of success.

However, what turned out to be blanket, unqualified failures (with their absurdly high costs) may very probably have heightened the FDA's rigorous awareness regarding new treatments.

When I mentioned Lenire to my wife, she exploded with the retort: "After Desyncra, don't you dare withdraw any more from your 401k to pay for a second useless device." And, believe me, my wife's temper could intimidate Godzilla.

At least this definitely works to our advantage; whatever is now approved will be held to a much stricter standard.

I think it was the same in Australia although with therapeutic pillows and beds. Often these were priced at three times the cost of a standard premium pillow or bed and they tended to claim that they provided benefits to people with bad backs. Basically some savvy doctors came with some engineers and checked them out and actually managed to disprove all their claims about how they provided back relief.

The end result was how did the therapeutic goods regulator approve a bed which was no different to any of the regular ones you can buy.

The simple answer was that they found out that the checks used on products were never anywhere near as rigorous as they were when it came to actual medicines. This means that the system now virtually prevents any possibility that these 'treatments' can get through the approval processes.

Hence now we get no more dodgy beds on morning tv being sold by a dodgy spokesperson claiming that they have therapeutic benefits.

This is why I think that we will see much more robust outcomes in the hearing medicine space and if Dr. Shore's device is approved for use then I would think it must be of the highest standard with the highest performance benefit too.

 

[Greg Sacramento]

If regenerative hearing treatments targets the cochlear side and the Dr. Shore device targets jaw and similar instigated tinnitus then this will be a winner without a doubt.

Agree.

Wonder what excuse she will use next year and then next and so on.

The U of M device:
Being in a quiet period, non complete press and public released communication question answering exposure is not so uncommon even with a non drug clinical application, regardless of not being a public company. Patent filing applications may also be under review. They may be considering longer term safety, but have known the below for a long time which is a plus:

Research indicate that fusiform apical dendrites receive excitatory inputs from parallel fibers and inhibitory inputs from midbrain auditory nuclei and neighboring cartwheel and stellate cells (Rubio and Wenthold, 1999). On the other hand, the cell body receives inhibitory inputs from nearby cartwheel cells, vertical cells, ventral cochlear nucleus, and midbrain auditory nuclei (Zhang and Oertel, 1994).

Somatosensory input from one particular source or modality could reduce the ability of inputs from another source to influence the firing rate of a CWC. Activation of as few as three PF synapses is sufficient to significantly elevate spontaneous CWC firing rates (Roberts and Trussell, 2010), suggesting that activity of only a small fraction of the total population of PF inputs to a CWC would be required to elevate firing rates to levels that would evoke endocannabinoid release.

-------------------------------------------
Regulation of medical drugs and devices involves competing goals of assuring safety and efficacy while providing rapid movement of innovative therapies through the investigative and regulatory processes as quickly as possible. The United States and the European Union approach these challenges in different ways. This involves a lot when there's a need to be regulated. Should innovative therapies be regulated for devices - I say that they should when directed use is above the shoulders or heart. Simulation for the lower spine with back injury is quite effective along with exercises after.
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Other thoughts, but there are several more:

U of M will contract with a bio-medical engineering firm that will work closely with U of M in-house.

Susan Shore has stated that the problem with jaw and neck needs to be fixed for lasting results. Any infection component is important to solve. Example: Those that smoke with TMJ can cause spiking as bacteria can enter gum pockets that move position of teeth and jaw - and from this, salvia gland problems can develop.

This device is bio-medical and it's bio engineering would be of focus of PF synapses and CWC firing rates. Other devices such as TENS does not provide successful bio medical simulation to the jaw. Electric razor and electric tooth brush, don't usually upset cranial nerves with tinnitus unless also placed to the ear. The other device method - the tongue company caused vibrations that appear to upset nerves within the mouth - my take. This was a posted concern that I had some time ago. Also long steady periods of vibration noise within mouth is not good with tinnitus.

MIT has been involved with device design for many years and what they found was that their bio-med technology had concerns from working computer input modeling. This may have to do with cranial nerves wearing down, becoming tired to accept signals. Problems were also raised in computer models for both possible early and midterm therapy periods with over accepted signals and these would be the trigeminal, facial nerve and the vagus nerve. Blood flow runs in arteries and veins in the neck. For those with circulation, blood pressure/pulse, artery and vein disease or injury and atherosclerosis, there may be concern with simulation due to blood clotting. Also with nerves and salvia glands of mouth.

All in all, I think that the U of M device will be very helpful for many.

 

[Michael01]

The first sound modulation device was Neuromonics, which allegedly blended sound tones with music. The young lady who posts "My Life With Tinnitus" on You Tube tried it (at a cost of $5,000.00), and had no improvement.

I tried Neuromonics as well, and initially it was helpful, until my ears started developing noises that it could not block out. Also I had major issues with the guy that they use for repairing them if something goes wrong, as something did go very wrong, and their practice of providing refurbished devices if the faulty one was sent in led to one failure after another, until I finally got tired of it and just said no, which is where I'm at today. Up a creek without any sort of method of filtering out these annoying sounds.

 

[Greg Sacramento]

I agree, having worked for a couple ethical VC-backed adventures. It does move the goalposts substantially in a way that's not necessarily beneficial to patients, though. Research institutions want to produce groundbreaking research which withstands peer review and reproduction. VCs want an exit which allows them to make ~10-100x back on their initial investment. This could lead to a product that's so good it's super profitable, but it can also lead to all kinds of shenanigans to hit a certain valuation and hold it long enough for the backers to, essentially, pump and dump. That's not my forte, but at the risk of namedropping someone I namedrop too much, I bet @Greg Sacramento has some thoughts here.

Vermont Guided Tours?

I agree. I think that the University of Michigan will contract with Stryker Medical of Michigan.

 

[ajc]

JUST RECEIVED THIS FROM UNIVERSITY OF MICHIGAN!

To those who have reached out to us regarding our tinnitus trial:

As of now, our trial is continuing as planned. However, due to the
coronavirus pandemic, we have had to extend our trial to at least late
2021, as we were forced to partially shut down for nearly 5 months.

We know that this is disappointing to everyone, ourselves included, but be
assured that we continue to strive toward a tinnitus remedy in the most
ethical manner: by following basic science and conducting a rigorous,
randomized, double-blinded, crossed trial.

We will send another update at the end of next year.

Thank you for your understanding.

Best wishes,

The Michigan Tinnitus Team

 

[DaveFromChicago]

As I reported previously, our Chicago Tribune had their article about them on 01/05/18.

That gave them two years and two months before the COVID-19 shutdown began in mid March 2020 for how many clinical trials, I wonder, in addition to the previous ones that the Tribune reported on.

Let's face it - after the Tribune article they had 112 weeks to determine if this was going to yield any substantial results.

Let's hope that in the not-to-distant future a drug will be introduced that will render them irrelevant (since they have cast themselves so far into the indefinite future).

 

[tommyd87]

As I reported previously, our Chicago Tribune had their article about them on 01/05/18.

That gave them two years and two months before the COVID-19 shutdown began in mid March 2020 for how many clinical trials, I wonder, in addition to the previous ones that the Tribune reported on.

Let's face it - after the Tribune article they had 112 weeks to determine if this was going to yield any substantial results.

Let's hope that in the not-to-distant future a drug will be introduced that will render them irrelevant (since they have cast themselves so far into the indefinite future).

I think Dr. Shore's device could actually end up being surpassed by other treatments such as regenerative hearing medicine, except for when it is providing treatment for somatic issues which cannot yet be treated by such medicine.

My theory is that the reason that these trials are taking so long to complete is because there tends to be a high research component associated with this treatment that University of Michigan and Dr. Shore seem strongly focused on achieving. This is in contrast to, say, Otonomy who will work to get their treatment through the trials and approved in the most effective way that is possible.

I'm pretty sure that this is the same situation which we have actually seen with other research based companies such as Hough Ear Institute who have decided that there is a need to get their treatment through these research focused studies first before taking the treatment through the clinical trials. This is despite their partner pharma organisation (Oblato) having sufficient stuff available to them to proceed with the clinical trials now.

Noting what you said about the time taken by University of Michigan and Dr. Shore to complete trials, I wouldn't be surprised if there was further research work being undertaken as a part of this clinical trial. Thus this would explain the delay which we are noticing with this.

 

[DaveFromChicago]

To tommyd87:

So far, within let's say three years how many participants have completed their trials and with what results?

Three years being 156 weeks, at an individual trial period of 12 weeks this would total 13 different groups.

Imagine if 90% had their tinnitus eliminated. Wouldn't this be sufficient for presentation for marketing clearance to the FDA?

 

[tommyd87]

To tommyd87:

So far, within let's say three years how many participants have completed their trials and with what results?

Three years being 156 weeks, at an individual trial period of 12 weeks this would total 13 different groups.

Imagine if 90% had their tinnitus eliminated. Wouldn't this be sufficient for presentation for marketing clearance to the FDA?

This process and outcome would be sufficient. However, the question that I have had (and I am sure many others have had too) is why Dr. Shore and/or University of Michigan have not specifically stated stuff about their trial processes, when other pharma companies conducting clinical trials have done this? For example, many other companies such as those undertaking the COVID-19 vaccine development have explicitly stated their process to everyone interested in its development process.

If Dr. Shore or University of Michigan have limitations around the number of participants who can participate in a trial in one session then this is also fine, however it would be quite simple for someone to come out and explain that this is the way which the trial process needs to operate. This apparent desire for Dr. Shore to seemingly to remain guarded with what is going on with this is simply fuelling the skepticism that some have over its process and ability to function meaningfully.

If the outcomes from using the device are highly beneficial and the device's efficacy is proven through the trial process then wonderful, we will have a clear winner.

However, I guess that there will still be some who err on the side of caution with this device considering how little information has been disclosed to date.

 

[F-u-T]

My theory is that the reason that these trials are taking so long to complete is because there tends to be a high research component associated with this treatment that University of Michigan and Dr. Shore seem strongly focused on achieving.

My theory is that Dr Shore gets the same paycheck every two weeks whether or not her trial is done next month or in ten years.

 

[tommyd87]

My theory is that Dr Shore gets the same paycheck every two weeks whether or not her trial is done next month or in ten years.

I wouldn't be stunned by this at all. Although I think that there will be a resolution to this soon, something says this is why the private providers are so much keener and motivated to deliver a solution sooner.

 

[UKBloke]

JUST RECEIVED THIS FROM UNIVERSITY OF MICHIGAN!

To those who have reached out to us regarding our tinnitus trial:

As of now, our trial is continuing as planned. However, due to the
coronavirus pandemic, we have had to extend our trial to at least late
2021, as we were forced to partially shut down for nearly 5 months.

We know that this is disappointing to everyone, ourselves included, but be
assured that we continue to strive toward a tinnitus remedy in the most
ethical manner: by following basic science and conducting a rigorous,
randomized, double-blinded, crossed trial.

We will send another update at the end of next year.

Thank you for your understanding.

Best wishes,

The Michigan Tinnitus Team

Similar email just hit my inbox, which I suppose is encouraging in as much as Dr. Shore did at least add me to their mailing list as promised after she and I corresponded last year.

 

[Michael01]

Just had a similar e-mail hit my inbox much to my disappointment. I'll post the e-mail so everyone can see.

 

[wwtsai]

I wrote to Dina Kutinsky regarding this webinar...

Asked her if there would be an announcement regarding Shore's device...

She noted that Shore is making 'great progress', but no announcement yet.

They will forward me more information regarding the webinar as we get closer to the date.

Did they ever forward the webinar information to you?

We're two days out and they haven't updated their site with the webinar details.

I would like to attend and watch, if possible.

 

[DebInAustralia]

Did they ever forward the webinar information to you?

We're two days out and they haven't updated their site with the webinar details.

I would like to attend and watch, if possible.

https://mailchi.mp/med/join-us-october-5-hearing-research-webinar

I'll post the link to their recording for those who miss this.

 

[Michael01]

Thanks for that. Should be interesting.

 

[wwtsai]

Did anyone catch the webinar? Something came up at work so I couldn't.

 

[GlennS]

we have had to extend our trial to at least late
2021

Surprise, surprise. I take it COVID-19 hasn't interrupted her tenured salary regardless of how little work she's been doing?

 

[weab00]

Surprise, surprise. I take it COVID-19 hasn't interrupted her tenured salary regardless of how little work she's been doing?

View attachment 40951

This is why I have more faith in business ventures like Frequency Therapeutics or Otonomy. Their return is based on the efficacy of the drug, and of course they need to deliver good results to patients in order to make shareholders' pockets happy. This means getting the drug out ASAP.

Shore doesn't seem to mind taking her sweet time, what does she care?

 

[sssing]

Did anyone catch the webinar? Something came up at work so I couldn't.

Yes, I caught it. But there was nothing new in her presentation...

 

[tommyd87]

Yes, I caught it. But there was nothing new in her presentation...

I was going to say that I had a feeling that Dr. Shore would not speak about the device but rather about something else. This lack of discussion is what people are getting irritated with. If Dr. Shore simply said some stuff about how the trials are progressing, about the timeline or even that she simply can't comment about it because of some reason, then this would alleviate many people's concerns about it.

This is why I have more faith in business ventures like Frequency Therapeutics or Otonomy. Their return is based on the efficacy of the drug, and of course they need to deliver good results to patients in order to make shareholders' pockets happy. This means getting the drug out ASAP.

Shore doesn't seem to mind taking her sweet time, what does she care?

I agree and as a result this will be why we shall see results from one or both these companies before probably seeing results from Dr. Shore. Some people consistently refer to the fact that this has a lot to do with Dr. Shore spending time researching things and working through all available avenues to get her device right. Really I find this hard to believe since Dr. Shore has not given any major information out about her device ever.

Essentially something doesn't add up with it at the moment. My view is that companies like Otonomy are going to be transparent and accountable as they have to answer to shareholders.

 

[Michael01]

Yes, I caught it. But there was nothing new in her presentation...

Still I'd like to hear the entire webinar. I was intending to hear it but while I was waiting for it to start I accidentally dozed off and missed the entire webcast, much to my disappointment.

 

[Greg Sacramento]

Susan Shore with other researchers have published many studies going back years. This link appears to be an extension of that research. The one concern that I have beyond all of this is that somatic cervical tinnitus is from injury. There's many possible injury conditions that can occur within the neck and some can be very serious that involve blood vessels, damaged nerves and brain stem. So I'm clueless on how her device will address this.

https://stm.sciencemag.org/content/10/422/eaal3175.full

 

[ajc]

The one concern that I have beyond all of this is that somatic cervical tinnitus is from injury. There's many possible injury conditions that can occur within the neck and some can be very serious that involve blood vessels or damaged nerves. So I'm clueless on how her device will address this.

It probably won't address tinnitus caused by somatic condition, like physical injury to blood vessels or damage to nerves.

That's a whole different ballgame to somatic tinnitus, which some 80% of all tinnitus sufferers have.

In Dr. Shore's context, somatic tinnitus means the ability to modulate your tinnitus loudness or pitch by certain physical movements (such as moving your head, chin, neck, opening your mouth wide).

There are two definitions of "somatic tinnitus" and the confusion is from the fact that they get interchanged a lot.

1) tinnitus from a somatic cause (e.g., neck or TMJ).

2) tinnitus you can modulate somatically (e.g., by moving your jaw).

Most tinnitus is in category 2 but most is not in category 1. You can and often do have cochlear injury and still be able to affect loudness and pitch with your jaw, etc.

Dr. Shore's device treats 2), not 1).