On Nov. 29, 2023, Vivos Therapeutics announced it received FDA 510(k) clearance for its line of Complete Airway Repositioning and/or Expansion (CARE) oral appliances for the treatment of severe obstructive sleep apnea (OSA).
About Vivos CARE oral appliances
Vivos’ removable CARE oral appliances represent a non-invasive alternative to CPAP for patients with severe OSA. The appliances gradually reposition the hard and soft tissues that define a patient’s airway, thereby opening it up and optimizing its function and flow. The FDA-cleared suite of appliances includes the DNA oral appliance, mRNA oral appliance and mmRNA oral appliance.
Data submitted to the FDA showed treatment results were better in patients with severe OSA compared to mild-to-moderate OSA. The average treatment time was 9.7 months.
According to the company’s press release, this is the first time the FDA has granted an oral appliance clearance to treat moderate and severe OSA in adults, along with PAP and/or myofunctional therapy, as needed.
About oral appliance therapy
Oral appliance therapy is a non-invasive treatment for snoring and sleep apnea, involving the use of a removable device worn in the mouth during sleep. These appliances, varying in appearance, are favored by some patients for their ease of use and portability, as they are smaller and more travel-friendly compared to traditional CPAP machines, taking a few weeks for most individuals to adapt to sleeping with them.
Read more industry news from the AASM.
