FDA Grants First-Ever Clearance for Vivos Therapeutics' Oral Device to Treat Severe Sleep Apnea
Vivos Therapeutics has received FDA 510(k) clearance for its oral appliances, becoming the first company to offer an alternative treatment for severe obstructive sleep apnea (OSA) in adults. The clearance allows Vivos to market its removable CARE oral appliances as a clear alternative to CPAP or surgical neurostimulation implants for patients with severe OSA. The FDA clearance also marks the first time an oral appliance has been approved to treat moderate and severe OSA in adults. The statistically significant data submitted to the FDA showed that 80% of severe OSA patients experienced an improvement in their condition, with an average treatment time of just 9.7 months. Vivos' proprietary CARE appliances gradually reposition the hard and soft tissues of the airway, optimizing its function and flow.