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# Vivos Sleep Apnea Device Cleared
- URL: https://www.fdaweb.com/vivos-sleep-apnea-device-cleared/
- Published: 2023-11-29T12:00:00.000Z
- Updated: 2026-09-14T14:17:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155884

FDA has cleared a Vivos Therapeutics 510(k) for its Vivos CARE (Complete Airway Repositioning and/or Expansion) appliances for treating adults with severe obstructive sleep apnea (OSA).

The clearance was based on “statistically significant data” from 73 severe OSA patients that showed 80% of patients experienced an improvement of at least one classification or at least a 50% improvement in the Apnea Hypopnea Index, and 97% of patients improved or stayed the same, according to the company. “Treatment results with severe sleep apnea patients were actually better than with mild and moderate patients,” it says. “ Unlike all other oral appliances on the market, Vivos’ proprietary CARE appliances gradually reposition the hard and soft tissues that define the airway, thereby opening it up and optimizing its function and flow.”

Vivos says no “persistent” safety issues were found in any patient cohort.