The American Academy of Dental Sleep Medicine sent a letter to the FDA Oct. 20 highlighting its concerns with consumer protection for oral appliances used in treating snoring and obstructive sleep apnea.
The AADSM said in its letter that it is aware of companies marketing and delivering mail-order appliances without dental supervision, which it said has resulted in faulty devices and patient harm. It also highlighted new research that shows increased reporting of direct-to-consumer oral appliances to the FDA Manufacturer and User Facility Device Experience database in recent years.
The organization asked the FDA to create a consumer protection webpage dedicated to intraoral devices for snoring and/or obstructive sleep apnea appliances.
The request comes shortly after the FDA published a consumer webpage with updated guidance on clear aligners. The webpage explains the benefits, risks and appropriate use of clear aligners, including the importance of an in-person examination before treatment and ongoing supervision by a licensed practitioner during treatment.
The AADSM said a webpage on oral appliances should include similar information as the clear aligner webpage, including the need for a prescription and licensed supervision, as well as the lack of authorization for direct-to-consumer devices.
