AIO BREATHE (adults), AIO BREATHE PD (children) for Obstructive Sleep Apnea and Snoring.
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.”
Indications for Use
AIO Breathe is prescribed in adults (18 years and up) as treatment for moderate and mild Obstructive Sleep Apnea (OSA) and snoring.
AIO Breathe PD is prescribed in children (6-17 years of age) as treatment for moderate and mild OSA and snoring.
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:
How to order AIO BREATHE
Prescription of physician or dentist
If you have questions, please call Sleep Medicine Institute of Texas at (903) 787-7533 or email us at Request an Appointment at the Sleep Medicine Institute of Texas (sleeptyler.com). A consultation with our Sleep Physicians or Dentist may help determine if AIO BREATHE is right for you. You may also email AIOMEGA directly at info@aiomd.com.
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.
