Oral device to treat sleep apnea cleared by FDA

Australian-based Oventus has received clearance from the U.S. Food and Drug Administration for an oral device to treat obstructive sleep apnea, according to a Sept. 2, 2019, company statement. The O₂Vent Optima is a customized, 3D-printed, nylon oral device that stabilizes the patient’s upper airway. According to the company, the device allows airflow to the back of the mouth while maintaining an oral seal and stable jaw position, bypassing nasal and other obstructions.

Guideline for Oral Appliance Therapy

The AASM and American Academy of Dental Sleep Medicine published a joint clinical practice guideline for treatment of sleep apnea with oral appliance therapy. The guideline recommends oral appliances for adult patients who cannot tolerate CPAP therapy or prefer an alternative to CPAP. According to Oventus, the O₂Vent Optima is unique in that it includes a separate airway to improve breathing for patients with obstructed nasal passages.

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