FDA Grants 510(k) Clearance for CARE Oral Appliances to Treat Adults with Severe OSA

The FDA announced it has granted 510(k) clearance for treating adults with severe obstructive sleep apnea (OSA) using removable complete airway repositioning and/or expansion (CARE) oral appliances. Appliances include the flagship DNA oral appliance, the mRNA oral appliance, and the mmRNA oral appliance. Unlike other oral appliances, these particular appliances gradually reposition both the hard and soft tissues that define the airway, opening it up to optimize airflow and function.

“…this is a huge development on the landscape of treatments for OSA,” said David McCarty, MD, in a press release. “As the medical profession has gained a better understanding of the complex factors contributing to OSA, we now recognize that a critical component to this condition is the form and functionality of the oral vault…This decision by the FDA could be life changing for patients who suffer from severe OSA and for whom other treatments have failed.”

Image credit: Paolese | stock.adobe.com

This FDA clearance comes approximately 11 months after the FDA granted 510(k) clearance for the DNA oral appliance to treat mild-to-moderate OSA, representing the first FDA clearance to an oral appliance to treat moderate and severe OSA alongside positive airway pressure (PAP) and myofunctional therapy, as needed, in adults aged 18 years and older.

“[This achievement] is even more important for the millions of severe OSA patients who are desperate for an effective alternative treatment. Before this, severe OSA patients’ only realistic treatment options were CPAP, neurostimulation implants, or other invasive surgeries,” noted Kirk Huntsman, CEO and chairman of Vivos Therapeutics, in the press release. “Today, they have what we believe is a far more desirable option that is very affordable and doesn’t require surgery or a lifetime of nightly use and intervention.”

The statistically significant data submitted to the FDA from 73 patients with severe OSA demonstrated that approximately 80% of patients had either experienced an improvement of at least 1 classification or at least an improvement 50% in the Apnea Hypopnea Index. In addition, treatment results for patients with severe sleep apnea patients were better than with mild and moderate patients. Further, 97% of the study participants had either experienced improved conditions or stayed the same and average treatment time was 9.7 months.

“…We believe this unprecedented decision by the FDA will generate broader acceptance throughout the medical community for [CARE] treatment options, leading to the potential for higher patient referrals and case starts as well as collaboration with medical professionals,” said Huntsman in the press release. “…This approval could also clear the way for greater reimbursement levels from medical insurance payors and Medicare.”

Reference

Biosphere. Vivos Therapeutics Receives First Ever FDA 510(k) Clearance for Oral Device Treatment of Severe Obstructive Sleep Apnea. News release. November 29, 2023. Accessed November 29, 2023. https://www.biospace.com/article/vivos-therapeutics-receives-first-ever-fda-510-k-clearance-for-oral-device-treatment-of-severe-obstructive-sleep-apnea-/