For documentation purposes, we cannot accept links to external websites for printing instructions, instructions for use, etc. Instructions need to be included as a PDF or as text on the NIH 3D Print Exchange website. - 04.30.20

The following refers to: 

3dpx-013615

The FDA has authorized production of ear saaver outside of the normal clearance pathway during the Covid-19 pandemic, based on Part 5, section D of the “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff.”

This ear saver has undergone review in a clinical setting and is recommended when fabricated as instructed.