The AIO Breathe is cleared for children as young as 6 years old with mild to moderate OSA.
The US Food & Drug Administration (FDA) has granted clearance for the pediatric use of AIOMEGA’s flagship device, the AIO Breathe, in children and adolescents with mild to moderate obstructive sleep apnea (OSA). The pediatric version features an identical design, engineering, and therapeutic technology as the adult device. It is not an expander.
“As a company committed to advancing airway and sleep health across the lifespan, we are thrilled to make AIO Breathe available to younger patients,” says sleep physician Raghavendra V. Ghuge, MD, MBA, DABSM, FAASM, the founder and CEO of AIOMEGA, in a release. “Obstructive sleep apnea in children is often under‑recognized yet carries profound implications—from impaired neurocognitive development and growth delays to cardiovascular and metabolic disturbances.”
Studies estimate the prevalence of OSA in the general pediatric population at approximately 1% to 4%. In practice, the risks are even higher among children with craniofacial abnormalities, neuromuscular disorders, or obesity.
“With clearance of the pediatric version of AIO Breathe, we are now positioned to offer a novel, noninvasive airway enhancement solution that may fill a critical gap in pediatric sleep‑disordered breathing management,” Ghuge says. “Our goal is to support improved sleep, growth, behavior, and cardiovascular wellness for children impacted by OSA.”
About AIO Breathe (Pediatric Version)
The pediatric version of AIO Breathe maintains the same patented AAVOAT (Adaptive Antero-Vertical Open Airway Therapy) design that gives the adult version clearance and is optimized in size for children. Key features include:
- Noninvasive oral‑airway-enhancement device engineered to reduce airway collapsibility during sleep
- FDA‑cleared indication for children (ages 6 to 11) and adolescents (ages 12 to 17) with mild to moderate OSA
- Compatibility with existing clinical workflows (already in use for adults)
AIOMEGA product portfolio includes AIO Breathe, AIO Breathe MB, AIO Swift, AIO Grit, AIO Brut, and AIO Revive.
