Updates – Frequently Asked Questions
We followed the ISO 10993 series of standards and FDA guidance for evaluating the biocompatibility of our mouthpiece. This was to ensure that we are effectively managing biological risk to our patients. The standard test duration for a non-implantable device with continuous surface contact with the mucosal membrane is 28 days. We passed all tests in the ISO protocol with safe levels of extractables, leachables, toxicity, and carcinogenicity.
When the FDA considered our biocompatibility test results, they concluded that our mouthpiece could have a maximum safe-use lifetime of 90 days. As a MedTech company producing a class IIa medical device, we need to have some use-by date on our device. We’ve accepted the FDA 90-day period as that standard for our safe-use period.
In real-world tests greater than 90 days, we observe mouthpiece surface discoloration and degraded functional performance in some scenarios. This is not surprising as the oral cavity is a hostile place for a device with delicate electronics. Further, the oral cavity chemistry will vary from patient to patient. To ensure that every patient has a consistent therapy experience, we believe that 90 days is also a reasonable functional-use period.
We want to be sensitive to the financial burden that a 90-day consumable places on our patients. To minimize this burden, we established a pricing approach to make the mouthpieces as affordable as possible. A replacement mouthpiece is only one-tenth the price of the initial device. We acknowledge this will be a financial burden for some patients, but we need to place the health of our patients and optimal therapy delivery ahead of any financial consideration.
For our very first customers and early adopters, we have some other thing in place, and you should contact [email protected] for more information.
We are confident that our mouthpiece will function safely and as intended for 90 days. Even though patients may perceive that their mouthpiece is performing as expected after this period, the safety and functional performance of the mouthpiece is not guaranteed. Anything beyond this time period places the patient at undue risk.