Recent content by Jonno02

This year, $650 million was cut from the medical research budget, and the reduction did not only affect cancer research (source). Meanwhile, since his inauguration on January 20, Trump’s golfing trips have cost U.S. taxpayers $26 million (source). Extrapolated out, that comes to $132 million a...

This is pretty catastrophic. FDA reviewers are not just clerks; they are scientific and engineering subject matter experts in their respective fields. These are not people who can simply be fired and replaced on a whim. If they leave, they will take their expertise to the private sector, making...

There is nothing in the data released from Dr. Shore’s publications to suggest that the treatment or device is unsafe. Efficacy and safety are entirely separate considerations. The FDA would question the safety of the device only if, for example, a certain percentage of the population...

The FDA does not care about commercial success. Their primary concern is determining whether the device poses an unacceptable risk of negative impacts to the end user.

From that whole post about reducing the FDA's protectorate remit and opening people like us up to conmen, your whole stance is, "I must protect Trump." Oh, apologies, he said, "inject disinfectant," which is worlds apart from injecting bleach. I'm relieved the medical doctors didn't listen to...

Ah, yes, having a notoriously anti-scientific figure who once suggested injecting bleach as a solution for COVID-19 will undoubtedly speed up approvals for safe treatments, right? YouTube and Google are already overrun with snake oil salesmen touting tinnitus “cures.” Do you really want to open...

I would suggest that there has been no further development because there is no objective measurement for testing treatment efficacy. For example, if there were a blood marker for tinnitus that could be objectively observed to decrease with the start of a treatment, we might see more active...

Because it's a brain condition, tinnitus is one of those things that just takes as long as it takes to resolve. In an alternate universe, we might have accidentally stumbled upon a cure years ago, like a drug designed for something else that, by pure chance, turns out to cure tinnitus. There are...

10 years is a drop in the ocean for researching, designing, and developing a brand-new medical device, especially when done in partnership with a university.

A lot of companies have social media policies, too. At the company I work for, anyone who shares information that hasn’t been officially released is instantly dismissed.

Please remember that a small clinical trial group emphasizes both super responders and super non-responders. Both can skew data in either direction.

In the same way that insulin doesn't work because diabetics need to keep injecting it? Get a grip; it's a treatment, not a cure.

Not quite. CE marking is proving the safety of your device via a notified body by showing you adhere to the Medical Device Regulations. It’s a huge task.

Saddening, but how many conditions have absolutely nothing on the horizon? Not saying the device will meet our hopes for volume reduction, but compared to thousands of other conditions, we're a rung up on the ladder as we have something coming.

You're probably right. We work with many start-ups, but they have permanent staff that need to be put on the next iteration even prior to launch. There is no visibility on Auricle's staffing level, but they probably aren't at that level. I don't particularly share the rampant pessimism here...