AIO BREATHE®: Airway-Focused Oral Appliance Therapy
AIO BREATHE® offers a modern, airway-first approach to oral appliance therapy for obstructive sleep apnea (OSA) and snoring. Designed around the natural movement of the jaw, AIO BREATHE® helps support airway opening during sleep while remaining small, lightweight, quiet, non-surgical, and travel-friendly.
For adults with snoring and mild to moderate OSA, AIO BREATHE® provides an FDA-cleared treatment option that may be especially helpful for patients who prefer an alternative to CPAP/BIPAP or have difficulty tolerating PAP therapy. AIO BREATHE® is FDA-cleared for adults and children ages 6–17 and supports growth-conscious, clinician-directed airway management in pediatric patients.
Severe OSA consideration: CPAP/BIPAP remains the usual first-line therapy for severe OSA. However, in carefully selected adults where PAP therapy, other treatments, or surgery have failed, are not tolerated, are declined, or are not viable, oral appliance therapy may be considered as part of a physician-directed, dentist-managed treatment plan with objective follow-up sleep testing.
For children and adolescents ages 6–17, sleep-disordered breathing requires early screening, medical referral when appropriate, and coordinated care tailored to growth, development, airway anatomy, and clinical needs. AIO BREATHE® supports this pediatric pathway through growth-conscious, clinician-directed airway management in pediatric patients.
Take the next step: If snoring, fatigue, poor sleep, or CPAP intolerance is affecting your health or your child’s well-being, ask about an airway-focused evaluation and whether AIO BREATHE® may be appropriate.
Clinical note: Treatment decisions should be made by qualified medical and dental professionals. AIO BREATHE® is FDA-cleared for adults and children ages 6–17; adult use includes snoring and mild to moderate OSA, while pediatric use supports growth-conscious, clinician-directed airway management under professional supervision and appropriate follow-up. Severe OSA cases require appropriate medical oversight, documentation, and objective follow-up.
To find out if an oral appliance is right for your snoring, schedule an appointment HERE.
February 23, 2024, Tyler, Texas, USA. Today, The United States Food and Drug Administration (US FDA) cleared AIOMEGA’s new medical device, AIO BREATHE, for treatment of Obstructive Sleep Apnea. AIOMEGA, LLC is a Tyler, Texas, based Biotechnology Startup.
AIO BREATHE is a “new mandibular repositioning device” that uniquely combines flanges and plateau to treat Obstructive Sleep Apnea.
Dr. Raghavendra Ghuge, MD, DABSM, FAASM, MBA who is the founder of AIOMEGA, is a Board-Certified physician and is President and CEO of Sleep Medicine Institute of Texas, a Tyler Texas based Adult and Pediatric Sleep Disorders Center founded in 2011. He is a Diplomate of the American Academy of Sleep Medicine since 2005 and a Fellow of the AASM.
With two decades of experience as an adult and pediatric sleep physician, Dr. Ghuge designed the unique characteristics of AIO BREATHE using six patents granted to him by the US Patent Office. The design overcomes several shortcomings seen with the use of legacy devices.
AIO Breathe – 510(k) Summary
Device Description:
AIO Breathe consists of two separate intraoral trays (upper, lower) that are customized to fit over all the teeth during sleep to reduce snoring and alleviate signs of Obstructive Sleep Apnea.
The device is manufactured at AIOMEGA facilities from intraoral scans using additive manufacturing with FDA cleared SLA 3D printing technology from FDA approved biocompatible resins.
AIO Breathe features right and left protrusive flanges that engage with corresponding right and left vertical flanges. This engagement repositions the jaw to reflect the dentist’s prescribed anterior mandibular advancement and is maintained while mouth is open or closed.
Additionally, mandibular plateaus guide the mandible downward, thus opening the anterior airway. The plateaus and flanges allow vertical opening of the jaw and work together to maintain advancement in open and closed mouth positions.
These design features create room and traction for the tongue to migrate forward and increase the patient’s pharyngeal space, improving ability to exchange air, thereby reducing the tendency to snore and alleviating signs of obstructive sleep apnea.
Operating Principle
AIO Breathe is a traction-based mandibular repositioning device that permits anterior, vertical, and lateral jaw movements and is designed to maintain an open airway intended to increase air exchange:
Indications for Use
AIO Breathe is intended to reduce or alleviate snoring, mild to moderate Obstructive Sleep Apnea (OSA) while sleeping in adults.
The unique features of this Mandibular Repositioning Device along with light weight and small formfactor combined with the use of biomedical materials provides an attractive option for those who seek treatment of OSA.
OSA is a chronic medical sleep disorder which is associated with lifelong oxygen deprivation and snoring during sleep resulting in many cardiovascular and neurological complications such as Hypertension, Atrial Fibrillation, stroke, congestive heart failure and metabolic complications such as obesity and Diabetes. It is considered a silent killer by many experts in the field. The conventional treatment of OSA is a CPAP device although a significant number refuse such therapy, and many are reluctant to seek help on account of hearing negative reports about CPAP. AIOMEGA’s AIO Breathe could provide a comfortable, convenient method of treatment to people around the world.
AIOMEGA® Receives Pediatric Clearance for AIO Breathe®—Expanding Innovative Sleep Apnea Treatment to Children Tyler, Texas – November 06, 2025 – AIOMEGA, a Texas biomedical company, today announced that the U.S. Food & Drug Administration (FDA) has granted clearance for the pediatric use of its flagship device, the AIO Breathe®, in children and adolescents with mild to moderate obstructive sleep apnea (OSA). The pediatric version features identical design, engineering, and therapeutic technology as the adult device—offering a seamless adaptation to the pediatric patient population. “As a company committed to advancing airway and sleep health across the lifespan, we are thrilled to make AIO Breathe available to younger patients,” said Dr. Raghavendra V. Ghuge, MD, MBA, DABSM, FAASM, the Founder and Chief Executive Officer of AIOMEGA. “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 prevalence in the general pediatric population at approximately 1 %–4 %. (Frontiers) In practice, the risks are even higher among children with craniofacial abnormalities, neuromuscular disorders, or obesity. (Dove Medical Press). Dr. Ghuge continued, “With clearance of the pediatric version of AIO Breathe, we are now positioned to offer a novel, non‑invasive airway enhancement solution that may fill a critical gap in pediatric sleep‑disordered breathing management. 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 AnteroVertical Open Airway Therapy) design that gives the adult version clearance and is optimized in size for children. Key features include: ● Non‑invasive oral‑airway-enhancement device engineered to reduce airway collapsibility and increase airway size during sleep and wake ● FDA‑cleared indication for children (ages 6 to 11) and adolescents (ages 12 to 17) with mild to moderate obstructive sleep apnea ● Sequential devices adjust for growth-related changes ● Seamless compatibility with existing clinical workflows (already in use for adults) ● Backed by AIOMEGA’s mission to integrate sleep‑medicine innovation into everyday health and performance. Clinical and Market Implications Pediatric OSA is associated with a spectrum of adverse conditions, including impaired cognitive performance, behavioral dysfunction, growth faltering, and elevated cardiovascular risk. (MDPI) Historically, treatment options have centered on surgery (e.g., adenotonsillectomy) and positive airway pressure modalities such as CPAP; yet a significant portion of children either fail first‑line therapy, are non‑adherent, or remain untreated. With FDA clearance for pediatric use, AIO Breathe provides sleep medicine specialists, otolaryngologists, pediatric pulmonologists, and dentists a new therapeutic option for children with obstructive sleep apnea. About AIOMEGA Founded by Dr. Raghavendra V. Ghuge, a board‑certified physician in sleep medicine, AIOMEGA is a biotech company dedicated to the health and well-being of every person on the planet by engineering and patenting solutions for true MEGA airway performance in sleep and sport. The company’s product portfolio includes AIO Breathe, AIO Breathe MB, AIO Swift, AIO Grit, AIO Brut, and AIO Revive. Media Contact: Advait Ghuge AIOMEGA LLC Tel: +1 (903) 787‑7533 Email: [contact@aiomd.com] Website: https://aiomd.com/
