Before the increase, the safety profile of oral appliances for OSA had been stable for over a decade. “Many other suppliers of oral appliances operate as dental laboratories and are not subject to the same reporting obligations,” Gallup says. Clinical ImplicationsWhile the spike in mechanical failure reports is notable, the researchers and manufacturers agree that oral appliances remain a safe and effective treatment for OSA. Evaluating the Telehealth ModelThe debate over the MAUDE data also touches on broader concerns regarding the safety and follow-up of telehealth-delivered oral appliances. “We remain committed to providing safe and effective oral appliances and to the continuous improvement of our products.”