LivaNova’s aura6000 system has obtained premarket approval (PMA) from the US Food and Drug Administration (FDA), charting a course for an anticipated launch of the moderate- to severe obstructive sleep apnoea (OSA) treatment in 2027.
Aura6000 treats OSA patients using proximal hypoglossal nerve stimulation (p-HGNS). The British company’s neuromodulation modality works via a pulse generator implanted under the skin near the clavicle on the trunk of the hypoglossal nerve that is responsible for controlling the muscles in the tongue.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
By detecting breathing patterns, aura6000 delivers synchronised electrical pulses to the hypoglossal nerve, causing the tongue to move forward and stiffen, thereby preventing airway collapse during sleep. The system is suitable for use in patients with an apnoea-hypopnea index (AHI) (a scale to measure sleep apnoea severity) between 15 and 65, who have either not succeeded or proven ineligible for first-line OSA treatment therapies such as controlled positive airway pressure (CPAP).
CPAP is viewed as the gold standard treatment for OSA, and commonly involves a mask worn over the mouth that is connected to a machine that acts as a ventilator to deliver a steady stream of pressurised air to keep the airways open during sleep. While highly effective, many patients find it initially difficult to wear the mask, citing discomfort.
LivaNova’s PMA for aura6000 was supported by data from the British company’s OSPREY trial (NCT04950894).The 150-patient, sham-controlled trial met its primary safety and efficacy points, per a data readout from November 2024, demonstrating median AHI reduction of 66.2% and median oxygen desaturation index reduction of 63.3% after six months of p-HGNS therapy as compared to baseline.
Additional data from the OSPREY trial, released in May 2025, revealed that the study’s treatment arm responder rate was 65%, with responders defined by improvements on AHI.
With the PMA in hand, LivaNova is continuing preparations for its next-generation OSA device. The company noted that this device is being designed for compatibility with magnetic resonance imaging (MRI) and will feature enhanced remote and secure configuration management capabilities. Pending a PMA supplement review, LivaNova anticipates launching the system in H1 2027.
Ahmet Tezel, LivaNova’s chief innovation officer, said: “FDA approval of the aura6000 marks a transformative moment for LivaNova and represents a major step forward for patients struggling with inadequately treated OSA.
“With FDA approval secured, we are advancing the device toward an even more sophisticated, next-generation system for patients and, ultimately, commercialisation.”
OSA causes the airways to narrow or close during sleep, resulting in short periods of not breathing (apnoeas). A common condition, approximately 30 million individuals in the US are living with OSA, as per the American Lung Association (ALA).
According to a report by GlobalData, the global neurological devices market will reach a valuation of $20.9bn in 2033, up from $12.5bn in 2023.
Other companies in the ‘sleep medicine’ field using alternative OSA treatments to neuromodulation include ProSomnus Sleep Technologies, which raised $38m in February 2026 to advance the global expansion of its oral appliance therapy (OAT) devices for OSA. OAT involves the use of a mouthguard-like device that is worn by users while they sleep to hold the lower jaw forward to alleviate OSA symptoms.
