AIOMEGA® AIO BREATHE®: FDA CLEARED FOR PEDIATRIC & ADULT OBSTRUCTIVE SLEEP APNEA

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    • Clinicians
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  • HOME
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Ages: 41 years, 12 years and 7 years

From life’s dawn to life’s sunset, let AIOMEGA® support your journey to airway health.

Shown Above: AIO Breathe® devices made for a family with ages 41, 12, and 6 years. 



An AIOMEGA® AIO Breathe® Oral device is a prescription-only medical device provided through a licensed healthcare professional. 


It is designed and fabricated based on the records, measurements, and instructions your clinician provides.

Your clinician determines whether a prescription oral device is appropriate for you and guides every step of the process. 

what is AIOMEGA®?

AIOMEGA® is a medical technology company focused on helping people breathe better and sleep better. We design and manufacture custom oral devices that support healthy nighttime breathing without machines, masks, or hoses. Our team includes sleep physicians, dentists, engineers, and medical‑device specialists who share one goal: improving sleep, health, and quality of life through simple, effective, patient‑friendly solutions.

 

AIOMEGA® devices are made using advanced digital design and precision manufacturing, ensuring every patient receives a comfortable, personalized fit. We partner with trained providers across the country to deliver safe, reliable care backed by real‑world clinical data.  


 AIOMEGA® develops custom airway devices for patients of ages 6 years and up, using advanced digital workflows and precision manufacturing. 

what is AIO Breathe®?

AIO Breathe® is a small, custom‑made oral device you wear while you sleep. It gently supports your jaw in a comfortable position that helps keep your airway open, making it easier to breathe throughout the night. There are no machines, no masks, and nothing to plug in — just a smooth, lightweight device designed specifically for your mouth.

 

 Each device is individually crafted based on your digital scans, so it fits securely and feels natural to wear. Most patients adapt quickly and begin noticing improvements in snoring, nighttime breathing, and overall sleep quality within the first few nights. 


 AIO Breathe® is designed for children (6 years and older), teens, and adults, with each device custom‑made to fit your age, anatomy, and comfort needs. 

Why Patients Choose AIO Breathe®

 

 

AIO Breathe® is chosen by patients who want a comfortable, personalized, and effective solution for better sleep and easier nighttime breathing.

  • Comfortable & Easy to Wear — Most patients adjust quickly and appreciate how natural it feels.
  • Gentle, Natural Feel — AIO Breathe® is designed to support nighttime breathing without relying on strong jaw positioning. Patients appreciate waking up without jaw soreness, bite changes, or the need for morning adjustments.
  • Custom‑Made for You — Designed from a digital scan of your teeth for a precise, personalized fit.
  • No Masks or Hoses — A simple, quiet solution that fits seamlessly into your nightly routine.
  • Travel‑Friendly — Small, discreet, and easy to take anywhere.
  • Provider‑Guided Care — Your dentist or sleep provider supports you at every step.
  • Proven Real‑World Results — Published real‑world evidence shows substantial improvements in nighttime breathing and oxygen levels with AIO Breathe®, helping patients sleep more comfortably and wake feeling more refreshed.

HOW THE PROCESS WORKS

Step 1: Meet With Your Provider

Step 3: Your Custom Device Is Crafted

Step 1: Meet With Your Provider

  

 Your journey begins with a relaxed consultation where your provider learns about your sleep, breathing, and comfort needs. This visit sets the foundation for a personalized treatment plan. 

Step 2: A Quick Digital Scan

Step 3: Your Custom Device Is Crafted

Step 1: Meet With Your Provider

  

 Instead of messy impressions, your provider takes a fast, comfortable digital scan of your teeth. This scan becomes the blueprint for your custom device. 

Step 3: Your Custom Device Is Crafted

Step 3: Your Custom Device Is Crafted

Step 3: Your Custom Device Is Crafted

 Your scan is used to create a device made specifically for you—designed to fit your age, anatomy, and comfort preferences. Every AIO Breathe® device is individually fabricated for a precise, personalized fit. 

Step 4: Fitting & Comfort Check

Step 4: Fitting & Comfort Check

Step 3: Your Custom Device Is Crafted

 When your device arrives, your provider ensures it fits comfortably and shows you how to use it. Most patients adjust quickly and appreciate how natural it feels. 

Step 5: Ongoing Support

Step 4: Fitting & Comfort Check

Step 5: Ongoing Support

Your provider stays connected with you throughout your journey, making sure your device continues to feel comfortable and support your breathing as intended. 

What Patients Experience With AIO Breathe®

 

  AIO Breathe® is designed to make nighttime breathing feel natural, gentle, and comfortable — so you can sleep more deeply and wake feeling more refreshed.

  • Gentle, Natural Breathing Support — Most patients describe the device as light, comfortable, and easy to wear throughout the night.
  • Wake Up Without Jaw Soreness — AIO Breathe® does not rely on strong jaw positioning, so patients typically wake without jaw discomfort or bite changes.
  • Easy Morning Transitions — Because the device feels natural, most patients do not need a morning adjustment and can start their day normally.
  • More Restful Nights — Patients often report deeper sleep, easier breathing, and feeling more refreshed in the morning.
  • Real‑World Improvements — Published real‑world evidence shows substantial improvements in nighttime breathing and oxygen levels with AIO Breathe®, helping patients sleep more comfortably and wake feeling more restored.

Most patients find AIO Breathe® comfortable to wear. As with any oral device, individual experiences may vary.

Frequently Asked Questions

Please reach us at info@aiomd.com if you cannot find an answer to your question.

 AIO Breathe® is a custom‑made oral device that helps you breathe more comfortably at night so you can sleep more deeply and wake feeling more refreshed. It’s small, gentle, and easy to wear — a simple alternative for people who want better sleep without masks or machines. 


 Most patients describe AIO Breathe® as light, natural, and easy to wear throughout the night. As with any oral device, individual experiences may vary, but the design is intended to feel gentle and unobtrusive from the start. 


 Most patients wake without jaw soreness or bite changes because AIO Breathe® does not rely on strong jaw positioning. The device is designed to feel gentle and natural throughout the night. 


 Morning Repositioner: A device that is generally recommended with other oral appliances for readjusting your bite in the morning. This is not necessary when you use AIO BREATHE® for treatment of OSA. This language is quoted verbatim from AIO Breathe® FDA‑cleared Indications for Use. 


 Most patients adjust within a few nights. The device is designed to feel gentle and natural from the start, and the adaptation period is typically short and easy. 


 Yes. AIO Breathe® is small, discreet, and easy to pack — perfect for travel, overnight stays, and busy schedules. Many patients appreciate how simple it is to take with them wherever they go. 


 Daily cleaning with a soft brush and mild soap is usually all that’s needed. Rinse the device with cool water and let it air‑dry. Your provider will give you simple care instructions to help keep the device fresh and long‑lasting. 


 Coverage varies by plan. Many patients use HSA or FSA funds, and some insurance plans may offer benefits depending on your specific policy. Your provider can help you understand your coverage and guide you through the verification process. 


Yes. AIO Breathe® PDS is FDA‑cleared for children ages 6–17. It is custom‑made to feel gentle and natural, helping kids breathe more comfortably at night. Parents appreciate how easily their children adapt to the device and how simple it is to use as part of a bedtime routine. 


With proper care, most devices last several years. Your provider will check the fit and condition during routine follow‑ups to ensure long‑term comfort and performance. 


Yes. Your dentist or sleep provider will schedule periodic follow‑up visits to ensure the device remains comfortable, fits well, and continues to support your nighttime breathing effectively over time. 


PATIENT & PARENT TESTIMONIALS of AIO Breathe® and AIO Breath

Parent of 12‑year‑old patient Gabriel L -among the first pediatric users of AIO Breathe® PDS

Parent of 12‑year‑old patient Gabriel L -among the first pediatric users of AIO Breathe® PDS

Parent of 12‑year‑old patient Gabriel L -among the first pediatric users of AIO Breathe® PDS

 “AIO Breathe® made such a difference for my son. He started sleeping through the night again, and his mornings are so much easier. The device was simple for him to get used to, and our whole family feels the improvement.” 

Judy P

Parent of 12‑year‑old patient Gabriel L -among the first pediatric users of AIO Breathe® PDS

Parent of 12‑year‑old patient Gabriel L -among the first pediatric users of AIO Breathe® PDS

 “AIO Breathe® felt comfortable from the very first night. I was able to sleep more naturally and woke up feeling rested in a way I hadn’t experienced in years.” 

Nancy M

Parent of 12‑year‑old patient Gabriel L -among the first pediatric users of AIO Breathe® PDS

Nancy M

 “AIO Breathe® is small, comfortable, and easy to use. It fits naturally for me, and I’ve been sleeping more comfortably and waking up feeling more refreshed.” 

Holly M

Holly M

Nancy M

 “I’ve been sleeping more deeply with AIO Breathe®, and I wake up feeling refreshed and ready for the day.” 

Koen C

Holly M

Randy C

“My sleep feels deeper and more restorative with AIO Breathe®. I wake up feeling clearer and more energized.” 

Randy C

Holly M

Randy C

“I’ve been waking up feeling more refreshed and energized since using AIO Breathe®. It’s made a noticeable difference in my days.” 

cleaning & caring for you AIO Breathe®

AIO Breathe® is designed for simple, everyday use. Following these steps helps maintain comfort, hygiene, and device longevity for both adults and children.

 

1️⃣ Insert

Before inserting brush and floss your teeth. Make sure both trays are clean and dry.

Upper tray   Gently position the upper tray over your teeth and press upward until it seats evenly.

Lower tray   Hold the lower tray with both hands and press downward until it fits securely.

Comfort notes   You may position both trays simultaneously. Some patients find this easier while inserting. You do not need to clench your teeth for the device to work. Increased saliva during the first few nights is normal and usually decreases with use.


2️⃣ Remove

Always remove the device gently using two hands.

Lower tray first   Place both thumbs near the gum line and lift upward evenly.

Upper tray next   Place 1–2 fingers on each side near the gum line and pull downward gently, side‑to‑side.

Important   Do not pull on the flanges. Do not remove with one hand.


3️⃣ Clean

Clean the device every morning after removal.

Daily cleaning

  • Rinse trays with cold or room‑temperature water.
  • Use a soft toothbrush and mild hand soap to gently scrub inside and outside. Do not use dish-washing soap or abrasive soap.
  • Rinse thoroughly to remove all soap.
  • Dry with a clean towel.

Weekly deep clean   Wash the ventilated storage case with soap and water and allow it to fully air‑dry.

Do NOT use   Hot water, alcohol, bleach, denture tablets, toothpaste, or abrasive cleaners.


4️⃣ Store

Place both trays in the provided ventilated storage case.

Storage guidelines   Keep the device in a cool, dry place. Avoid direct heat (cars, windowsills, heaters). Keep away from pets and small children.

Travel tips   Always use the protective case. If exposed to heat or cold, allow the device to return to room temperature before use.

Copyright © 2026  AIOMEGA®  LLC - All Rights Reserved.


  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. 

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AIOMEGA® SLEEP 2026 - Booth #968

  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:

  • Adult OSA therapy
  • Pediatric PDS outcomes
  • Next‑generation digital workflows

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