A New Way to Breathe 

Sleep apnea impacts approximately 1 billion people worldwide [1]. It is a sleep disorder characterized by repeated 
disruptions in breathing during sleep. These interruptions can occur due to an obstruction of the upper airway, known as obstructive sleep apnea, or because the brain does not properly regulate breathing, known as central sleep apnea [1]. These breathing interruptions can cause brief wake-up periods throughout the night, negatively affecting both the quality and quantity of sleep. Sleep is essential for both physical and mental health, and chronic sleep disruption can contribute to a variety of health concerns. Symptoms of sleep apnea can include headaches, mood changes, and excessive daytime sleepiness. If left untreated, sleep apnea may also increase the risk of serious complications, including high blood pressure andcardiovascular disease [1].

Current treatments for sleep apnea include continuous positive airway pressure (CPAP) therapy, lifestyle 
modifications, positional therapy, medications in some cases, and surgical interventions [1]. Although CPAP is 
considered an effective treatment for many patients, some individuals experience difficulties with comfort and long
term adherence.The aura6000 system offers a potential alternative to CPAP therapy. The implant recently received FDA premarket approval for the treatment of moderate-to-severe obstructive sleep apnea in adults who are unable to use or tolerate CPAP therapy [2]. The device is the first hypoglossal nerve stimulation system approved for patients with complete concentric collapse, a pattern of airway obstruction in which the walls of the upper airway collapse inward [2].

The aura6000 system takes a different approach to treating obstructive sleep apnea. Rather than using continuous air pressure to keep the airway open, the device uses proximal hypoglossal nerve stimulation [3]. The hypoglossal nerve innervates the muscles involved in tongue movement, and electrical stimulation can activate these muscles to prevent airway collapse during sleep [3]. The system consists of five components: two implantable components, the 
Implantable Pulse Generator (IPG) and the lead. The external components consist of the Remote Control/Charger 
(RCC), Charging Antenna (CA), and the Clinical Manager (aCM), which is an external programming system used 
to adjust stimulation settings [3].  

The aura6000 system represents a shift from mechanically supporting breathing with external devices to directly 
targeting the neuromuscular mechanisms responsible for airway collapse. While surgical implantation means it may 
not be appropriate for every patient, the technology provides a promising alternative for individuals who cannot 
tolerate CPAP therapy. As implantable neurostimulation technologies continue to advance, devices such as aura6000 
could help expand personalized treatment options for patients with obstructive sleep apnea. 

Article written by Jennifer Joanna-Joan Villeneuve,
M.ESc Biomedical Engineering Candidate, B.ESc Mechatronic Systems & B.ESc Biomedical Engineering

References 
[1] “Sleep apnea: What is it?,” Cleveland Clinic, https://my.clevelandclinic.org/health/diseases/8718-sleep-apnea 
(accessed Aug. 12, 2026).  
[2] R. Aubrey, “Aura6000 sleep apnea treatment: FDA approval expands options beyond CPAP,” Project Sleep, 
https://project-sleep.com/aura6000-sleep-apnea-treatment/ (accessed Aug. 12, 2026).  
[3] “PMA P250013 summary of safety and effectiveness data,” FDA Safety and Effectiveness Document, 
https://www.accessdata.fda.gov/cdrh_docs/pdf25/P250013B.pdf (accessed Aug. 12, 2026). 

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