FDA Clears Vivos Oral Appliance for Mild-to-Moderate Obstructive Sleep Apnea

The FDA has cleared Vivos Therapeutics’ daytime-nighttime oral appliance for mild-to-moderate obstructive sleep apnea as a Class II device.

The FDA previously rejected the device for 510(k) clearance in 2021 when it was registered as a Class I device for palatal expansion.

The appliance works by opening the airway through expansion of the palate, training the tongue to rest in the proper position and changing patient’s breathing from oral to nasal. The agency clearance was supported by data demonstrating that the appliance widened the palates of 97 percent of patients.

The device can replace current treatments such as continuous positive airway pressure (CPAP), the company said.