AIOMEGA® AIO BREATHE®: FDA CLEARED FOR PEDIATRIC & ADULT OBSTRUCTIVE SLEEP APNEA
AIO Breathe® — FDA‑cleared for Adult & Pediatric OSA
AIO Breathe® — FDA‑cleared for Adult & Pediatric OSA
Therapy tailored to each patient's airway structure & function, not guesswork.
Clinicians-driven machine-Learning models for decisions before therapy begins.
Supported by 6 peer‑reviewed, prospective real‑world evidence publications led by Sleep Physicians and Dentists.
Sleep apnea therapy can fail when treatment is not aligned with the patient’s airway anatomy.
Modern sleep medicine still relies on trial‑and‑error approaches that do not account for the individual collapse pattern, airway geometry, or neuromuscular behavior of each patient. This leads to unpredictable outcomes, unnecessary titrations, and delayed relief.
CPAP, oral appliances, and surgery can work — but without anatomical insight, clinicians cannot reliably predict who will respond or why.
Most therapies are delivered without understanding the patient’s airway structure, collapse site, or functional behavior during sleep.
Patients cycle through devices, adjustments, and procedures because clinicians lack a predictive model to guide therapy selection.
AIOMEGA® fabricates a custom device based on the clinician’s digital scan and prescription specifications.
The clinician captures a digital intraoral scan (STL) and submits it with the order form through the AIO portal on this website.
The clinician determines all therapeutic parameters and device requirements based on their clinical evaluation.
AIOMEGA® manufactures the device to the exact specifications provided by the clinician.
AIOMEGA® devices are FDA-cleared for 6 -17-year-old children and 18+ years of age adult patients. They are used in medical settings where clinicians determine candidacy based on patient assessment.
Eligibility is based entirely on the clinician’s evaluation of airway anatomy and sleep physiology.
AIOMEGA® manufactures each device directly from the clinician’s digital scan and prescription specifications. Devices are fabricated using materials tested to ISO 10993 biocompatibility standards.
AIOMEGA® devices are used by clinicians in routine practice for patients who meet their clinical criteria.
Clinicians can submit a digital scan and prescription to begin fabrication of an AIOMEGA® device. AIOMEGA® builds devices based solely on the clinician’s anatomical and physiological assessment.
Please send us a message or call us for an appointment.
Feel free to fax any documents to (903) 787-8825
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AIOMEGA® — Advanced Intraoral Medical Devices
Information on this site does not replace professional medical advice.
Use of all devices must follow FDA-cleared labeling and clinician supervision.
Prescription-only medical devices. See FDA-cleared labeling for full safety information.
We’re excited to welcome you to SLEEP 2026 in Baltimore. Visit Booth #968 to meet the AIOMEGA® team and preview our latest clinical innovations.
Join us for three national poster presentations on June 15–16, featuring new research in: