Vivos CARE Devices Gain 510(k) Nod as Study Links Narrow Arches to Higher AHI
Vivos Therapeutics’ study of 100 adults found that narrower intermolar distance and higher palatal height correlate with higher Apnea-Hypopnea Index scores (p<0.001). Its FDA-cleared CARE devices, including the first 510(k) oral appliance for severe OSA, have treated tens of thousands and often eliminate the need for CPAP within 12 months.
1. Study Links Dental Morphology to OSA Severity
The recent adult study of 100 participants compared 50 OSA patients with 50 controls and found that narrower transverse intermolar distance and higher palatal height were significantly associated with elevated Apnea-Hypopnea Index scores (p<0.001). Linear regression confirmed these craniofacial parameters as strong predictors of OSA severity across all demographics.
2. Vivos CARE Device Treatment Advantages
Vivos CARE devices have FDA clearance for mild, moderate and severe adult OSA and moderate-to-severe OSA in children ages 6–17, including a unique 510(k) clearance for severe adult OSA granted in November 2024. Tens of thousands of patients treated by over 2,000 providers often complete therapy within 12 months, reducing or eliminating the need for nightly CPAP, oral appliances or neurostimulation.