AIOMEGA Announces National Breathe Academy to Train Clinicians in FDA Cleared Adult and Pediatric OSA Treatment Pathways

Clinician training program supports FDA‑cleared adult and pediatric AIO Breathe devices, including prescriptive PLL and growth‑responsive replacement program

TYLER, TX, UNITED STATES, October 1, 2026 /EINPresswire.com/ — AIOMEGA LLC announced the national release of the AIOMEGA Breathe Academy, a clinician training program designed to support the company’s FDA cleared adult and pediatric wearable oral devices for airway stabilization. The Academy provides structured education, certification pathways, and clinical implementation guidance for hospital systems, sleep centers, ENT practices, dental sleep medicine providers, orthodontists, and dentists specialized in TMD.

The Academy launch follows growing clinical adoption of AIOMEGA’s treatment pathways for both adult and pediatric obstructive sleep apnea (OSA), reflecting increased interest in structured, clinician directed airway stabilization.

FDA Cleared Indications for Use

AIO Breathe — Adult Device
FDA 510(k) K233754 — Indications for Use: “Intended to reduce or alleviate snoring, mild to moderate Obstructive Sleep Apnea (OSA) while sleeping in adults.”

AIO Breathe PDS — Pediatric Device
FDA 510(k) K252525 — Indications for Use: “The AIO Breathe is intended to reduce snoring and to treat mild and moderate obstructive sleep apnea in children 6–17 years of age who are diagnosed with snoring and/or mild or moderate obstructive sleep apnea.”

These indications are stated exactly as cleared by the U.S. Food and Drug Administration.

Linking the Academy to FDA Cleared Devices
The AIOMEGA Breathe Academy is built around the company’s two FDA cleared wearable oral devices and the clinician directed prescription tools that support their implementation.

AIO Breathe (Adult)
FDA cleared oral device for adult OSA, supported by a clinician-controlled prescription pathway and a non-titration treatment approach aimed at eliminating need for recurrent titration. There is no need for a morning-repositioner (as stated in FDA clearance).

AIO Breathe PDS (Pediatric)
FDA cleared pediatric wearable oral device for OSA, designed for growth responsive alignment and sequential airflow improvement during craniofacial development. There is no need for

Posterior Leaning Flange (PLL) Option
Clinicians may specify a posterior leaning flange angle greater than 90 degrees when prescribing AIO Breathe devices. The device itself does not change; PLL is a prescriptive option within the FDA cleared design. This option supports airway stability in both adult and pediatric pathways and is included in Academy training.

Clinician Directed Prescription and Guidance Systems
To support consistent, geometry aligned prescription planning, the Academy integrates AIOMEGA’s clinician controlled guidance tools:
• AIO Rx — the clinician’s prescription pathway for selecting mandibular advancement, vertical opening, plateau height, and device specifications based on airway behavior and craniofacial geometry.
• SMART Rx — the clinician-controlled guidance system that supports airway stabilization decision making using patient specific inputs, airway behavior patterns, and stability testing results.
• AIOMEGA Clinical Guidance System — the combined framework of AIO Rx and SMART Rx used to support reproducible, clinician directed prescription planning for both adult and pediatric pathways.

These tools guide clinicians in writing prescriptions for the FDA cleared AIO Breathe (adult) and AIO Breathe PDS (pediatric) wearable oral devices. They do not modify the devices or their FDA cleared indications.

Founder Statement
“Clinicians want a clear, reproducible pathway for treating OSA using wearable oral devices that support airway stabilization,” said Raghavendra Ghuge, Founder of AIOMEGA. “The AIOMEGA Breathe Academy connects our FDA cleared adult and pediatric devices with a structured training system that supports safe, consistent implementation across clinical settings.”

Clinical Need
Pediatric and adult OSA require structured, clinician directed pathways that support airway stabilization using wearable oral devices. AIOMEGA’s devices provide:
• Growth responsive airway stabilization
• Clinician guided prescription pathways
• Behavior responsive airway mechanics
• Non titration adult treatment options
• Clinician controlled implementation

The Academy ensures clinicians can adopt these pathways safely and consistently.

Inside the AIOMEGA Breathe Academy
The Academy provides structured training in:
• Adult and pediatric implementation pathways
• Multi segment collapsibility assessment
• Airway behavior interpretation
• Stability testing protocols
• Clinical documentation standards
• Guidance system training for AIO Rx and SMART Rx
• Integration of the AIOMEGA Clinical Guidance System
• Incorporation of AAVOAT and CAOM frameworks
• Approaches that support a one and done, non titrating regimen for adult patients when clinically appropriate
• Clinical governance and QA guidance
All training modules are educational in nature and support clinician decision making. They do not modify the FDA cleared devices or their intended use.

The Academy is designed for:
• Pediatric sleep medicine
• ENT and pulmonology
• Dental sleep medicine
• Orthodontics
• Dentists specialized in TMD
• Hospital systems
• Youth athlete airway programs

AIOMEGA App for Patients and Athletes
The AIOMEGA App is a subscription based digital platform designed for patients and athletes to track sleep, health, wellness, and performance. The app is therapy agnostic and can be used whether a patient is using a wearable oral device, another manufacturer’s device, or no device at all.

The AIOMEGA App does not sense or measure physiological signals on its own. Instead, it collates and displays data retrieved from user inputs or from external wearables selected by the patient or athlete. Features include:
• Nutrition tracking with USDA food label integration, food and meal prep and planning
• Sleep architecture
• Weight loss or weight gain goal setting
• Exercise tracking, including run/walk metrics
• Calorie burn calculations
• Performance reflection tools for athletes
Patients and athletes may download the app independently. Clinicians, dentists, or coaches may invite users to share their data; access is only granted if the user accepts the invitation.
The AIOMEGA App is not part of the FDA cleared devices and does not modify their intended use.

Call to Action
Clinicians and institutions interested in Academy enrollment or device adoption may contact AIOMEGA at:
info@aiomd.com www.aiomd.com Phone: (903) 787 7533

About AIOMEGA LLC
AIOMEGA is a medical technology company focused on growth responsive airway stabilization for pediatric and adult obstructive sleep apnea. The company’s FDA cleared wearable oral devices integrate clinician guided prescription pathways, craniofacial alignment, and performance only airway mechanics to deliver structured airway stabilization treatment options supported by PDAC CMS approval.
From life’s morning sunrise of childhood to its aging sunset, let AIOMEGA support your journey to airway health.

Raghavendra Vithalrao Ghuge
AIOMEGA LLC
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