0876 A 2-in-1 Workflow: Aio Breathe PDS Immediately Controls OSA in Children (6-17 Years) and Sequentially Supports Maxillary-Mandibular-Dental Growth

Abstract Introduction US FDA cleared AIOMEGA®’s AIO Breathe® PDS (K252525) on 11/06/2025 for treatment of snoring and mild-to-moderate OSA in 6–17-year-old children. Under the direct supervision of a Dentist the device combines a sequentially customizable dental covering and flange-plateau technology for Adaptive Antero-Vertical Open Airway Therapy (AAVOAT™ for treatment of pediatric OSA in 6–17-year-olds and support of maxillo-mandibular-dental growth and development. This pediatric version shares identical design, engineering, and therapeutic technology as the adult device—offering a seamless adaptation to the pediatric patient population and the same benefits that it has provided in adults (18 and older). These benefits include CBCT scan proven immediate airway enlargement, sleep study proven greater than 95% success in OSA control and control of symptoms. Methods Sleep Physician performs evaluation and polysomnographic diagnosis of mild-moderate OSA and UARS in 6–17-year-old patients and refers appropriate patient (post-T&A or non-surgical, non-CPAP and CPAP-failure) to the Dentist. The Dentist completes evaluation, patient selection, tailors' treatment and places the patient on AIO Breathe® PDS. The dentist performs follow-ups (growth and development) at regular intervals, performs new scans and provides sequential devices to maintain treatment of OSA and to support maxillary-mandibular growth and development. The sleep physician performs OSA follow-ups and periodic sleep testing to confirm presence/control of OSA and symptoms. Multi-disciplinary team approach is maintained between physician-dentist throughout growth and development. Results AAVOAT™ (AIO Breathe® PDS) device provides immediate and ongoing control of OSA, and sequential ongoing support of maxillary-mandibular growth throughout childhood. Multi-disciplinary approach ensures best results for following changes in pediatric OSA. Permanent improvement or resolution of OSA in children is expected to occur with this approach as was previously observed with maxillary expansion in the Vivos study. Conclusion AAVOAT (Adaptive Antero-Vertical Open Airway Therapy) in treatment of OSA in 6–17-year-old children could be as effective as oral appliances in adults and CPAP in children. Supporting age-dependent maxillary-mandibular-dental growth while effectively treating OSA with the same device seems to be a reasonable non-invasive substitute and could improve the physical and neuro-cognitive growth of the next generation of children and adolescents with OSA. Support (if any) AIOMEGA, LLC