Sorry, forgot to follow up on this thread. Below is my continued conversation with Sam. It does seem like he is walking back his initial statement about being demoing the device, which is a little disappointing, (although maybe he would in person just not in writing?) But at least we have confirmation that it's the same device as the one from the linkedin article.
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The FDA has told us we are a Class II medical device. Legally this means we have serious and potentially criminal liabilities if we go around testing our device on patients without an ethics board approval or at the very least a clinician present. While we're considered a non-significant risk device we are in a very real way interacting with an internal organ and don't yet know what side-effects may occur (e.g. we had no idea we would reduce tinnitus, but imagine our liability if somehow we caused tinnitus).
We're about to start enrolling subjects in an IRB approved dosage trial for which tinnitus is not a disqualifying condition. Under IRB approval we're legally protected then to administer our technology to anyone enrolled. If someone has tinnitus and reports it helps or doesn't help their symptoms it'll be recorded. And if someone tries our device and for whatever reason decides they don't want to complete the whole protocol they're allowed to stop at any point and for any reason.
So until the FDA clears us for over-the-counter use, IN WRITING the only thing I can legally offer to patients asking to test our technology for certain conditions is the ability to be enrolled in a trial where their condition doesn't disqualify them.
Sam
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On Aug 26, 2019, at 7:32 PM, lcj wrote:
Hi Sam, if these testers want, are they able to come to your office to try the device? Or do they need to sign up for a clinical trial first?
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On Aug 24, 2019, at 11:22 AM, Samuel Owen <
sam.owen@otolithlabs.com> wrote:
It's been slightly updated but not ready for commercial sale. We'll be able to try multiple power levels in our office.
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On Aug 24, 2019, at 2:04 AM, lcj wrote:
No prob! I hope you get a lot of testers
Btw is this the same device as the one that Spencer Salter found accidentally works on tinnitus patients (through his testing on motion sickness)? Or has it been updated?
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