Michael Barbella, Managing Editor04.23.24
AIOMEGA has received U.S. Food and Drug Administration (FDA) clearance for its obstructive sleep apnea treatment device, AIO BREATHE.
AIO BREATHE is a new mandibular repositioning device designed by Tyler, Texas-based board-certified sleep physician and AIOMEGA Founder/CEO Raghavendra V. Ghuge, M.D. The individually customized intra-oral device functions as an antero-vertical mandibular repositioner when used during sleep. “I designed AIO BREATHE, supported by multiple patents, to overcome several shortcomings of conventional oral appliances used for treatment of OSA,” Ghuge said.
AIO Breathe acts by increasing the patient’s airway during sleep, improving ability to exchange air, thereby reducing the tendency to snore and alleviating signs of obstructive sleep apnea. 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 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 is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea while sleeping in adults.
OSA, a chronic medical sleep disorder affecting about 30% of the world’s population, is associated with lifelong oxygen deprivation and snoring during sleep. This may result in many cardiovascular and neurological complications such as hypertension, atrial fibrillation, stroke, congestive heart failure, and metabolic complications such as obesity and diabetes.
AIO BREATHE is a new mandibular repositioning device designed by Tyler, Texas-based board-certified sleep physician and AIOMEGA Founder/CEO Raghavendra V. Ghuge, M.D. The individually customized intra-oral device functions as an antero-vertical mandibular repositioner when used during sleep. “I designed AIO BREATHE, supported by multiple patents, to overcome several shortcomings of conventional oral appliances used for treatment of OSA,” Ghuge said.
AIO Breathe acts by increasing the patient’s airway during sleep, improving ability to exchange air, thereby reducing the tendency to snore and alleviating signs of obstructive sleep apnea. 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 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 is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea while sleeping in adults.
OSA, a chronic medical sleep disorder affecting about 30% of the world’s population, is associated with lifelong oxygen deprivation and snoring during sleep. This may result in many cardiovascular and neurological complications such as hypertension, atrial fibrillation, stroke, congestive heart failure, and metabolic complications such as obesity and diabetes.