I wrote to Jon Pearson recently. Here is his response:
Thank you for reaching out, and for your interest in Professor Susan Shore's tinnitus research and the company that was established to gain regulatory clearance for and then commercialize Susan's novel device. I apologize for my tardy reply, but I make it a point to respond to all tinnitus sufferers that reach out to me directly, and you can imagine that I get a high-volume of inquiries.
We attempt to balance the provision of information with the need to handle confidential and non-public data with appropriate care. While we understand the desire of chronic tinnitus sufferers to want to know when a treatment will come to market, how much it will cost, how well it will work, and where it can be obtained, the reality is that most of these questions are not answerable today, and it is actually a disservice to sufferers to attempt to pre-empt the many complicated and challenging steps of regulatory clearance and then commercialization by providing off-the-cuff guesstimates. This can lead to frustration, which then causes distrust in both the research as well as the company attempting to bring the innovation to market.
Perhaps some perspective on the time domain is helpful. Professor Shore started her tinnitus research in the early 2000s. The initial years of research were on animals ('pre-clinical' research as the precursor to human trials), and the first human pilot study was not peer-reviewed and published until 2018. This means that nearly two decades elapsed until the first human pilot results were complete. I co-founded Auricle in 2019, funded the company on my own initially, and obtained outside funding in 2021. Please note that universities perform research and develop ideas, but that it is the work of companies to bring those ideas to life. Although the human pilot results were extremely promising, those results were on just 20 subjects with a prototype medical device. The second human trial will indeed conclude soon, but we must be careful in determining when those results are assessed and made public as there are stringent rules concerning the publication and dissemination of clinical trial data that may be used as part of a regulatory filing. As such, we will not be making public pronouncements that may compromise our ability to prosecute a regulatory clearance.
While the pace of developments may be disappointing, there is nothing about this process that can be forced or sped up—we are doing all that we can to focus resources on working with regulatory bodies to gain the necessary clearances so that we may one day bring a proven therapy to market. Given the lack of therapeutic tinnitus treatments—device or drug—regulatory agencies like the FDA are exceedingly (and appropriately) cautious in evaluating emergent therapies. I have spent my entire career commercializing medical devices, so I am familiar with the long and challenging pathway ahead, but I am CEO of this company—and have dedicated my career to it—because of my belief in the strength of Professor Shore's research and our common desire to bring relief to the millions of global tinnitus sufferers as quickly as we can.
I know that what I've written doesn't answer your questions, but I'm hopeful that you may understand that we are deeply involved in a complicated and challenging process that has no guaranteed outcomes for anyone. We are hopeful, however, and would like you to remain so as well.
Kind regards,
Jon Pearson
CEO & Co-founder
Auricle, Inc.