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
AIO Breathe® Clinical Evidence Published in SLEEP
n = 50 | n = 200 | n = 250
AIO Breathe® has published clinical research in SLEEP available through Oxford Academic. Published adult AIO Breathe® research includes clinical cohorts of 50, 200, and 250 patients with obstructive sleep apnea (OSA). A fourth publication addresses the AIO Breathe® PDS pediatric clinical workflow for children ages 6–17
Published in SLEEP, Volume 48, Supplement 1, 2025: 0796 AIO BREATHE for OSA: Matching Airflow to Oxygen Demand with CONNECTED-ARC-OF-MOTION, AI-PREDICTIVE Oral Device Geometry and ON-DEMAND-AIRFLOW Delivery | SLEEP | Oxford Academic
Results
Group included mild, moderate and severe OSA. N = 50. Mean pre-RX AHI was 20.07, AHI range was 9-38, 1 Std. dev was 11.01. Mean pre-LSAT was 84.60%, LSAT range was 78% - 91% with mean of 84.60%. Mean Post-RX AHI was 2.13, AHI range was 0 – 4.5 with 1 Std. Dev of 1.46. Mean Post RX-LSAT was 92.4%, LSAT range was 90% - 96%.
Conclusion
AIO BREATHE effectively treated all severities of OSA (up to AHI 38 and LSAT 78%) in this group. HSAT proved effective therapy (AHI < 5, LSAT >90%).
Published in SLEEP, Volume 49, Supplement 1, 2026: 0603 Tavmlr (Total Antero-Vertical Mandibular-Lingual Repositioning) Device: A Breath-to-Breath Real-Time Demand-Based Optimization of Airflow in OSA | SLEEP | Oxford Academic
Results
(N=200)
1. Severe OSA: N = 60. Mean RX-AHI 2.4, RX-AHI range 0 – 4.8, 1 Std. Dev of 1.7. Mean RX-LSAT 91.2%, RX-LSAT range 90% - 95%. Hypoxic Burden: DXHB< 90% = 37%
Mean RXHB< 90% = 0.0%.
2. Moderate OSA: N = 100: Mean RX-AHI 2.0, RX-AHI range 0 – 4.5,
3. Mild OSA: N = 40: Mean RX-AHI 1.1, Mean RX-LSAT 93.1%,
Conclusion
AIO Breathe® delivered optimal airflow to meet patient’s oxygen demand with residual AHI< 5, LSAT>90%, HB< 90% 0%. Optimization of airflow may minimize need for oral appliance titration.
Published in SLEEP, Volume 49, Supplement 1, 2026: 0649 How Aavoat (Adaptive Antero-Vertical Open Airway Therapy) Will Become the New Gold Standard for Treatment of OSA | SLEEP | Oxford Academic
Results
250 cases with AIO Breathe. AAVOAT:
DX-AHI MEAN 24.2 (DX-AHIMAX 79.5),
RX-AHI MEAN 2.2 (RX-AHI MAX 8),
Overall RX-AHI < 5 was 99.6%,
compliance 96%.
Overall success 95.61%.
Conclusion
AAVOAT (Adaptive Antero-Vertical Open Airway Therapy) design of AIO Breathe Unique AI-predictive flange/plateau design geometry successfully delivered breath-to-breath real-time demand-based optimization of airflow, irrespective of OSA severity or phenotype.
AIO Breathe® PDS | Children Ages 6–17
A 2-in-1 Workflow: AIO Breathe PDS Immediately Controls OSA in Children (6–17 Years) and Sequentially Supports Maxillary-Mandibular-Dental Growth
Published in SLEEP, Volume 49, Supplement 1, 2026: 0876 A 2-in-1 Workflow: Aio Breathe PDS Immediately Controls OSA in Children (6-17 Years) and Sequentially Supports Maxillary-Mandibular-Dental Growth | SLEEP | Oxford Academic
Results
AAVOAT™ (AIO Breathe® PDS) device provides immediate and ongoing control of OSA, and sequential ongoing support of maxillary-mandibular growth throughout childhood. Growth Responsive Replacement Schedule (GCRS™) is unique design and process feature of AIO Breathe.
Conclusion
AAVOAT (Adaptive Antero-Vertical Open Airway Therapy) in treatment of OSA in 6–17-year-old children can be a reasonable non-invasive therapeutic modality in mild and moderate OSA and for snoring. Clinician (Dentist) guided GCRS™ should be employed while considering pediatric OSA treatment.
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.
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.
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.
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AIOMEGA® — Advanced Intraoral Medical Devices
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