New University of Michigan Tinnitus Discovery — Signal Timing

My hunch is that Susan Shore must not be able to get compensated financially for a commercial device based on her University research. Why else would they move at a maddening slow pace. The U of Mich is a nonprofit tax exempt university. They have no incentive to release the device commercially. If she could line her pockets with the revenue this device will generate it would have been released 5 years ago.

 

Not casting aspersions on Dr. Shore... but sometimes it seems academia is more concerned with research grants and government money.

 

I just hope she sticks to her timeline of a release in 2020

 

How long does FDA take to approve a medical device? Wonder if they have submitted for approval yet.

 

Usually only about 6 months. So Dr. Shore might actually hit her target of this year!

 

There doesn’t seems to be a clear answer. Some medical devices don’t require trials, this one does.
Medical devices are divided in three classes: 1-2 and 3. This device would probably fall under class 2 is my guess, like most medical devices.
She’s been working on this for years. Drugs usually take longer than medical devices to go through all FDA steps (7-10 years if not fast tracked). So I’m a bit surprised this device has taken this long.


Class I – These devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Examples include enema kits and elastic bandages. 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process.

Class II – Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits. 43% of medical devices fall under this category.

Class III – These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this category.

Sorry I couldn’t be more help! All we can do is guess at this point.

 

After Dr. Shore's device is released, would it be mandatory to visit the US to purchase or it could be purchased online unlike the Lenire treatment? Anyone knows anything about this matter?

 

I‘m sure it will require some kind of visit to a medical clinic in the US to purchase the device. I still think we are going to be waiting a few years for availability though.

 

I highly doubt it. They are expecting to release results of their study by mid 2020. 6 months is not enough time to ramp up production and set up a distribution network, etc. I think early 2022 is a good conservative bet and anything before that would be gravy. This assumes that the trial goes well, so fingers crossed!

 

You don't become a researcher at a university if you want to line your pockets. Susan Shore must have known this from the outset. If making money fast is your main objective you make sure to get into the private sector once you graduate. All of the academic researchers I know are ideological people to some degree. Her research is at a different pace and money and investors can be the catalyst that gives private companies the edge on many occasions but in the end a private company is dependent on the outcome of the research. Sooner or later something must come from it or else they go bankrupt. Susan Shore can watch over the quality of research and if it all fails it's one lesson learned. Being a good researcher doesn't mean being a successful entrepreneur either but I'm sure commercialization won't be an issue when her device turns out to yield good results. It won't be for lack of a market

 

While I wouldn't be eligible for the trial, a hopeful update on the timeline for the Michigan Tinnitus Device I was very happy to hear back from Dr. Shore after emailing her this afternoon, and I'd encourage any others to contact her. I had also asked her about general eligibility to use the device given somatic vs non-somatic types of T. This was her response:

Hi Chris,

Unfortunately you would not qualify for the trial as participants have
to live within 100 miles, even if you fit the other criteria. But we
should be done with the trial in the summer and I am adding your name to
our mailing list for updates at that time.

best wishes,

Susan Shore

 

Did Dr. Susan Shore really commit to releasing the device after this trial?

I know she’s mentioned this is the idea, but doesn’t it depend on the results of this trial?

Do we really know if this is going to be the final trial?

In fact, how many trials have there been so far? Is this the second?

 

That's your opinion, and a pessimsitic one if you ask me. I'm sticking to mine.

I may be a severe sufferer now, but I was once very good at business. Commercialization and globalization are two completely different things.

 

Anyone knows if her device could help somatosensory pulsatile tinnitus ?

 

Unfortunately, pulsatile tinnitus is a disqualification for participating in the trial.

 

Just basing it on experience with other rollouts of treatments, studies, etc. I hope I am wrong for everyone's sake.

 

Donate to Dr. Shore... maybe old news for Tinnitus Talk.

https://leadersandbest.umich.edu/find/#!/give/basket/fund/333613

 

My bro, I will buy it for you and send it myself.

 

This is a disqualification criteria, but I sincerely believe that if the cause of somatosensory pulsatile tinnitus is somewhat resolved, the device could help!

As I think Lenire has the potential to help with stress-induced pulsatile tinnitus.

 

I agree, it certainly could! The trial won't render an opinion on this due to the disqualification - it won't have data on this particular subtype. However, that's not to say it won't work and provide some benefit! I hope it casts a wide net as a solution.

 

This what Susan Shore told me about noise induced tinnitus, if the device can help us with noise induced

”Our first trial included those with noise induced tinnitus so I would predict yes.”

 

Is there data on the first trial? How is it compared to Lenire's last trial before they launched?

 

Aren't the positive results from this (and Minnesota) more dramatic than Lenire? That's my understanding which is why some are shifting their hope to this.

 

Small sample, but 10% remission ain’t nothing. Also, appears to be better the longer you use it, and should include NIT folks.

 

Neuromod had way more patients/participants, but what she has over them is RCT and double blinding for placebo. Not to say one is better than the other but hers seems more promising efficacy wise, and if shown so, she may not have to do another trial after this one. She has said she aims for 2020 commercialization a few times, but as I always add, she hasn't promised it either.

 

If Susan Shore's device comes out, will the distribution of it will be done by a private company which will have bought the marketing rights to the device? Or is it the university itself that will set up the distribution with its partner clinics?

 

Yes, would very much like to see data on the first trial as well!

 

Thanks for sharing that post!

 

My only concern here is the precision of the programming and the appropriate site application of the electrodes (?) from secondary sources. I’d gladly go to Ann Arbor for a more precise application.

 

A summary some of you may find useful.

Dr. Susan Shore’s DeNovo device is developed under the umbrella of the University of Michigan. It’s a neuromodulation signal timing device treatment to reduce the tinnitus volume.

Susan Shore’s treatment is based off of the circuitry in the dorsal cochlear nucleus (DCN) in which somatosensory input is integrated with auditory input to produce long term plasticity in the DCN fusiform cells. Their treatment harnesses this plasticity by generating a somatosensory stimulus. This is an electrical stimulus that they either put on the cheek (trigeminal) or on the neck (dorsal column). This stimulus targets the hyperactivity of the fusiform cells in the DCN that generate the tinnitus, to induce long term depression.

Visualizing Tinnitus in the DCN:

Visualizing Tinnitus

Depending on how you can modulate your tinnitus the stimulus will be applied on the neck or on the cheek. To be clear, for this to work well you most likely need to have a tinnitus with a somatic component.

There should be clinical trial results published somewhere in 2020.

Tinnitus Hub recently interviewed her at the Tinnitus Research Initiative. She’s been working on it for 15 years already and has tinnitus herself.

Susan Shore on Bimodal Stimulation for...

There are some informational videos on youtube on her research. The Neural Bases and Neuroengineering of Tinnitus (old video) for example. It really shows that she is really dedicated to tinnitus research and has advanced a lot into understanding the pathology of tinnitus (see fusiform cells in Dorsal Cochlear Nucleus).

"The Neural Bases and Neuroengineering of...

This article refers to the results of her initial trial:

Auditory-somatosensory bimodal stimulation desynchronizes brain circuitry to reduce tinnitus in guinea pigs and humans:

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

The interesting bit is at the bottom of the article: “Tinnitus reduction reached an average of 12.2 dB in the fourth week of active treatment. Of the 20 participants tested, 2 reported complete elimination of their tinnitus toward the end of the active treatment period.”