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# Vivos Gets Sleep Apnea Device Cleared
- URL: https://www.fdaweb.com/vivos-gets-sleep-apnea-device-cleared/
- Published: 2023-01-04T12:00:00.000Z
- Updated: 2026-09-14T18:10:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153470

FDA has cleared a Vivos Therapeutics 510(k) for its daytime-nighttime appliance for treating obstructive sleep apnea (OSA) and snoring in adults. The company says the device offers a new treatment regimen that “opens the airway by expanding the palate and training the tongue to rest in proper position and converts patients to nasal as opposed to oral breathing.” The device can also be used in conjunction with other treatment modalities, such as myofunctional therapy or continuous positive airway pressure.

The clearance was based on clinical data demonstrating that 28% of treated patients had their OSA resolved, 86% of patients improved their airway size, and 97% of patients increased the width of their palate which allows the tongue to rest in proper position, thus avoiding a potential airway obstruction, the [company says](https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwiuwYut%5FK78AhUqg4kEHcGCBCoQFnoECB8QAQ&url=https%3A%2F%2Fwww.globenewswire.com%2Fnews-release%2F2023%2F01%2F04%2F2582808%2F0%2Fen%2FVivos-Therapeutics-Receives-FDA-510-k-Clearance-of-its-Flagship-DNA-Oral-Appliance-for-Treatment-of-Obstructive-Sleep-Apnea.html&usg=AOvVaw0JLEBy3Jq2Xa1SCVL0ANh9). The device, it adds, has been marketed for several years for orthodontic treatment, such as expansion of the jaw and positioning of teeth in adults and children, and it is still available to be used for those applications.