The US Food and Drug Administration has cleared Aiomega’s AIO Breathe mandibular repositioning device for the treatment of snoring or mild to moderate obstructive sleep apnea (OSA) in adults. 

The oral appliance acts by increasing the patient’s airway during sleep, improving the ability to exchange air, thereby reducing the tendency to snore and alleviating signs of OSA.

AIO Breathe features right and left protrusive flanges that engage with corresponding right and left vertical flanges. This engagement repositions the jaw to reflect the dentist’s prescribed anterior mandibular advancement and is maintained while the mouth is open or closed.

Additionally, mandibular plateaus guide the mandible downward, thus opening the anterior airway. The plateaus and flanges allow vertical opening of the jaw and work together to maintain advancement in open and closed mouth positions.

AIO Breathe was designed by Tyler, Texas-based Raghavendra V. Ghuge, MD, MBA, DABSM, FAASM, the founder and CEO of Aiomega. “I designed AIO Breathe, supported by multiple patents, to overcome several shortcomings of conventional oral appliances used for treatment of OSA,” says Ghuge in a release. 

According to a release from the company, the features of the mandibular repositioning device, along with its light weight and small form factor, provide an attractive option for those who seek treatment for OSA.

Photo caption: AIO Breathe

Photo credit: Aiomega