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.
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!
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
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:
That's your opinion, and a pessimsitic one if you ask me. I'm sticking to mine.
Just basing it on experience with other rollouts of treatments, studies, etc. I hope I am wrong for everyone's sake.
This is a disqualification criteria, but I sincerely believe that if the cause of somatosensory pulsatile tinnitus is somewhat resolved, the device could help!
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.
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.
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.
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