The oral appliance is now approved to treat moderate to severe OSA and reduce snoring in children aged 6 to 17.

RT’s Three Key Takeaways:

1. FDA Clearance for Pediatric OSA: Vivos’ DNA oral appliance received FDA 510(k) clearance to treat moderate to severe OSA in children aged 6 to 17.
2. Clinical Results: In a clinical trial, the appliance showed a 62.7% improvement in moderate and severe OSA symptoms, with snoring reduced by 58% and airway volumes increased by 40%.
3. Orthodontic Treatment Compatibility: The device is intended for children who need both orthodontic treatment and management of OSA, offering a dual benefit in addressing sleep and dental issues simultaneously.

Vivos Therapeutics has received US Food and Drug Administration (FDA) 510(k) clearance to treat moderate to severe obstructive sleep apnea (OSA) and snoring in children with its DNA oral appliance. 

Vivos’ DNA appliance, which is part of its CARE line of OSA treatment appliances, is designed to reduce nighttime snoring and treat moderate to severe OSA in children aged 6 to 17. This Vivos device is intended for those diagnosed with snoring and/or OSA who also require orthodontic treatment.

“The FDA 510(k) clearance announced today is, to our knowledge, the first time any oral medical device has ever been approved to treat moderate to severe OSA in children. This clearance is the latest in a series of regulatory wins for Vivos, not just in the United States, but globally,” says Kirk Huntsman, chairman and CEO of Vivos, in a release. “It represents the culmination of a growing body of research and regulatory approvals confirming and validating the extraordinary potential and efficacy of our proprietary Vivos technology. In addition, this landmark clearance opens up an exciting and vast new market and enables us to directly address the needs of millions of children who currently suffer from sleep-related breathing disorders such as OSA.”

Results from a Clinical Trial in Children with OSA

A multi-site, multi-nation, controlled, prospective study in pediatric patients (6-17 years of age) served as the basis for this FDA approval. This study examined the effect of Vivos’ DNA oral medical device on increasing the pharyngeal airway, potentially reducing symptoms of OSA, and encouraging nasal breathing. 

Diagnosis of sleep-related breathing disorders, including snoring, upper airway resistance syndrome, and OSA, and need for orthodontic treatment was confirmed by clinical evaluation, orthodontic exam, a Pediatric Sleep Questionnaire, and a sleep study by the dentist and sleep physician. Each patient served as their own control, with measurements taken before and after treatment with the same devices, scorers, and questionnaires under the auspices of the WRG Institutional Review Board. 

All apnea-hypopnea index (AHI) measurements were taken with no device in the mouth.

Forty-eight patients (with a mean age 10.6 years) completed the study. Symptoms of sleep-related breathing disorders (such as fatigue, lack of attention, and snoring) decreased from 0.28 to 0.14 (a reduction of 50%), while snoring decreased by 58%. 

The improvement in moderate and severe AHI measurements was 62.7%. Ninety-six percent (96%) of patients improved or stayed the same while 92% improved by greater than 50% or one classification in the moderate and severe categories. One hundred percent of the severe patients achieved this milestone. Airway volumes increased by 40% on average. All values were highly statistically significant (p<0.0001). There were no safety concerns reported in the study.

Late last year, the DNA appliance received the first FDA clearance for an oral appliance to treat severe OSA.

Photo caption: DNA oral appliance

File photo