Vivos Therapeutics said on Wednesday the U.S. health regulator has cleared its oral device treatment for severe obstructive sleep apnea (OSA).

The clearance is the first ever for an oral appliance, along with a mode of respiratory ventilation or exercise training program for the muscles around face, mouth and tongue, to treat moderate and severe OSA in adults.

According to Vivos, its treatment is an alternative to therapy devices that deliver air to a mask worn by patients to assist in breathing as well as surgically placed implants that send electrical signals to the brain.