AIO Breathe®
Treatment
AIO Breathe®
A clinician-directed, custom-fabricated FDA-cleared oral airway platform for adult and pediatric obstructive sleep apnea — available at Sleep Medicine Institute of Texas.
What Is AIO Breathe®?
AIO Breathe® is an FDA-cleared, prescription-only oral airway device for the treatment of obstructive sleep apnea (OSA) and snoring in adults and, within its separate FDA-cleared pediatric indication, in children ages 6–17 diagnosed with snoring and/or mild or moderate OSA.
Unlike generic oral appliances, AIO Breathe® is a clinician-directed platform — prescribed, custom-fabricated from individualized dental records, professionally delivered, and supported by structured longitudinal follow-up. Sleep Medicine Institute of Texas is a flagship AIO Breathe clinical and referral center.
Why AIO Breathe® Is Different
AIO Breathe® is not a generic oral appliance. It is a clinician-directed platform with distinct adult and pediatric FDA-cleared pathways, a structured therapeutic framework, and integrated longitudinal care.
Adult + Pediatric FDA-Cleared Platforms
Separate FDA-cleared indications for adults and for children ages 6–17 (mild/moderate OSA)
Clinician-Directed Care
Prescribed, delivered, and monitored by a licensed sleep medicine physician — not self-fitted
Custom Digital Records
Individualized dental and intraoral records inform each device prescription
Precision Custom Fabrication
Each device is custom-fabricated to the individual patient's prescription
AAVOAT™ Framework
Integrates individualized anterior and vertical airway management
CAOM® Movement Concept
Coordinated movement design rather than a single fixed forward position
Growth-Conscious Pediatric Pathway
Structured reassessment and replacement program as children grow and develop
Structured Longitudinal Follow-Up
Ongoing clinical and dental reassessment built into the care pathway
Published Evidence
Supported by published clinical research
AAVOAT™ — The Therapeutic Framework
Adaptive Antero-Vertical Open Airway Therapy (AAVOAT™)
AAVOAT™ — Adaptive Antero-Vertical Open Airway Therapy — is the clinician-directed therapeutic framework underlying AIO Breathe®. It integrates individualized anterior and vertical airway management within a custom-fabricated oral airway platform, rather than applying a single fixed mandibular position to every patient.
AAVOAT™ describes the therapeutic framework. AIO Breathe® is the FDA-cleared device.
CAOM® — Connected-Arc-of-Motion®
Connected-Arc-of-Motion® (CAOM®)
CAOM® — Connected-Arc-of-Motion® — describes the connected, coordinated movement framework used within the clinician-directed AIO Breathe platform. Rather than treating mandibular positioning as a single fixed forward movement, CAOM® reflects the coordinated nature of the airway management approach built into the platform's design.
CAOM® is a design concept within the AIO Breathe platform. It does not independently diagnose or treat OSA.
Adult Platform
The adult AIO Breathe® platform is FDA-cleared for the treatment of obstructive sleep apnea and snoring in adults. It is prescription-only, clinician-directed, and custom-fabricated from individualized dental records and clinician-selected specifications.
Adult treatment begins with a sleep medicine evaluation and diagnostic sleep study. Following diagnosis, the treating physician determines whether oral appliance therapy is appropriate and, if so, obtains the clinical records needed to prescribe and fabricate the device. Follow-up sleep testing is typically recommended to assess treatment effectiveness.
FDA-Cleared Indication
FDA-cleared for the treatment of obstructive sleep apnea and snoring in adults. Prescription use only.
Pediatric Platform — Ages 6–17
AIO Breathe® holds a separate FDA clearance for use in children ages 6–17 diagnosed with snoring and/or mild or moderate obstructive sleep apnea. The pediatric platform supports a growth-conscious clinical pathway distinct from the adult pathway.
Pediatric OSA evaluation, diagnosis, and treatment selection are individualized and clinician-directed. AIO Breathe® is not indicated for severe pediatric OSA. Prescription use only.
FDA-Cleared Pediatric Indication
FDA-cleared for children ages 6–17 diagnosed with snoring and/or mild or moderate obstructive sleep apnea. Not indicated for severe pediatric OSA. Prescription use only.
Pediatric Obstructive Sleep Apnea → including Gabriel's real patient story — the first pediatric patient to receive AIO Breathe® following FDA clearance.
Growth-Conscious Replacement Program (GCRS)
Children continue to grow and develop. Dentition, device fit, jaw alignment, and craniofacial relationships may change over time. The Growth-Conscious Replacement Program (GCRS) supports clinician-directed reassessment and replacement of the pediatric AIO Breathe® device when growth or dental change makes a new device clinically appropriate.
Replacement timing is individualized and clinician-directed. GCRS does not guarantee facial growth, jaw expansion, or permanent OSA resolution. It is not an orthodontic expansion program.
The AIO Breathe® Clinical Pathway
AIO Breathe® is delivered through a structured, clinician-directed care pathway:
- 1
Sleep Medicine Evaluation
Comprehensive evaluation by a sleep medicine physician
- 2
Diagnosis and Sleep Testing
Diagnostic polysomnography or home sleep testing as clinically appropriate
- 3
Clinician-Directed Treatment Selection
Physician determines whether AIO Breathe® is appropriate for the individual patient
- 4
Dental and Intraoral Records
Individualized records obtained to inform the device prescription
- 5
Individualized Prescription
Clinician-directed prescription based on patient-specific evaluation
- 6
Precision Custom Fabrication
Device custom-fabricated to the individual prescription
- 7
Delivery and Fitting
Professional delivery, fitting, and patient instruction
- 8
Follow-Up and Outcome Reassessment
Structured follow-up including sleep testing to assess effectiveness
- 9
Pediatric Replacement When Appropriate
GCRS reassessment and replacement as growth and dental changes occur (pediatric patients)
Published Evidence and FDA-Cleared Indications
AIO Breathe® is supported by published clinical research and holds separate FDA clearances for adult and pediatric indications. Sleep Medicine Institute of Texas integrates published evidence into its clinical decision-making as part of individualized patient care.
Published evidence supports the platform. Individual patient outcomes vary. Consult a qualified sleep medicine physician to determine whether AIO Breathe® is appropriate for your condition.
AIOMEGA® Digital Health Platform
The AIOMEGA® App is a commercially available digital health platform available on the Apple App Store and Google Play. It supports longitudinal health and wellness tracking — including sleep, oxygenation, heart rate, blood pressure, body temperature, body composition, nutrition, hydration, fitness, and physical performance — providing patients with ongoing health context between clinical visits.
The AIOMEGA® App supports health and wellness tracking. It does not independently diagnose or treat obstructive sleep apnea, replace polysomnography, home sleep apnea testing, clinical diagnosis, professional interpretation, or clinician-directed follow-up. For patients whose schedules or occupations make sleep and alertness important, longitudinal awareness of sleep and wellness information may support more informed conversations with the treating clinician. The App does not provide fitness-for-duty, fitness-to-drive, fitness-to-fly, FAA, FMCSA, or occupational medical clearance.
AIO Breathe® is an FDA-cleared medical device. This page provides general public information about the AIO Breathe® platform available at Sleep Medicine Institute of Texas. It does not constitute medical advice. Consult a qualified sleep medicine physician to determine whether oral appliance therapy is appropriate for your condition. AAVOAT™, CAOM®, and GCRS describe platform concepts and programs; they do not represent independently FDA-cleared indications. The AIOMEGA® App is a commercially available digital health platform; it does not independently diagnose or treat OSA and does not replace clinical evaluation or sleep testing.
Learn Whether AIO Breathe® Is Right for You
Schedule a consultation at Sleep Medicine Institute of Texas to discuss evaluation, diagnosis, and whether AIO Breathe® is appropriate for your care.