Sleep Apnea Device Receives FDA Approval

Randomized trial data support the approval, with sustained improvements in apnea severity observed.

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LivaNova PLC received FDA approval for the aura6000 System, a hypoglossal nerve stimulation therapy for obstructive sleep apnea.
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The device is indicated for adults with an apnea-hypopnea index between 15 and 65 who cannot tolerate first-line therapies.
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The aura6000 System is the first hypoglossal nerve stimulation device approved in the US without contraindications for complete concentric collapse.
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In the OSPREY trial, 65% of patients met responder criteria after 12 months, with significant reductions in apnea-hypopnea index.
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LivaNova plans to release a next-generation device in 2027, featuring MRI compatibility and a rechargeable battery lasting up to 15 years.

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