On November 6, 2025, AIOMEGA announced it has received FDA 510(k) clearance for its oral appliance, AIO Breathe, in children and adolescents with mild to moderate obstructive sleep apnea (OSA).
About AIO Breathe
The AIO Breathe is a custom oral appliance designed to reduce snoring and treat mild to moderate OSA in children ages 6 to 17 who have been diagnosed with snoring and/or OSA. The device consists of separate upper and lower intraoral trays that fit over the teeth and are individually fabricated based on intraoral scans and a dentist’s prescription.
The appliance incorporates right and left protrusive flanges on the buccal sides of the upper tray, which engage with corresponding vertical flanges on the lower tray. This engagement repositions the jaw to reflect the dentist’s prescribed anterior mandibular advancement. Mandibular plateaus, located on the occlusal cranial surfaces of the lower tray, guide the mandible downward to open the anterior airway.
Together, the plateaus and flanges allow vertical opening of the jaw while maintaining advancement in both open and closed mouth positions. This design increases tongue traction and promotes forward tongue movement, increasing the pharyngeal airway to improve airflow, reduce snoring, and alleviate symptoms of sleep apnea.
The pediatric AIO Breathe is substantially equivalent to the adult version (K233754), sharing the same design, engineering, and therapeutic technology.
About oral appliance therapy
Oral appliance therapy is a non-invasive treatment for snoring and sleep apnea, 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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