On Sept. 18, 2024, Vivos Therapeutics announced it received FDA 510(k) clearance for its oral appliance to treat moderate to severe obstructive sleep apnea (OSA) and snoring in children.
About Vivos’ DNA appliance
Vivos’ DNA appliance is an intraoral device designed to reduce snoring and treat moderate to severe OSA in children aged 6 to 17. It consists of either an upper tray, lower tray or both, and is designed to open the airway during sleep. It is intended for pediatric patients diagnosed with snoring and/or OSA who also require orthodontic treatment. The device is customized to the patient.
The FDA approval is based on results of a prospective study in pediatric patients that demonstrated reduced sleep-related breathing disorder symptoms, decreased snoring and improvement in apnea-hypopnea index (AHI) measurements.
According to the company’s press release, this is the first time an oral medical device has been approved to treat moderate to severe OSA in children.
The DNA appliance is part of Vivos’ complete airway repositioning and/or expansion (CARE) line of OSA treatment appliances. In Nov. 2023, Vivos Therapeutics received FDA 510(k) clearance for its line of CARE oral appliances for the treatment of severe OSA.
About OSA in children
Pediatric OSA occurs when a child’s airway becomes partially or completely blocked during sleep, causing breathing pauses. Symptoms include snoring, labored breathing during sleep, excessive daytime sleepiness and morning headaches. Children may also experience cognitive and behavioral problems, such as hyperactivity and poor school performance. Adenotonsillectomy is the most common treatment for OSA in children.
About oral appliance therapy
Oral appliance therapy is a non-invasive treatment for snoring and OSA, involving the use of a removable device worn in the mouth during sleep. These appliances, varying in appearance, are favored by some patients for their ease of use and portability, as they are smaller and more travel-friendly compared to traditional CPAP machines, taking a few weeks for most individuals to adapt to sleeping with them.
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