Aura6000 Sleep Apnea Treatment: FDA Approval Expands Options Beyond CPAP

A new hypoglossal nerve stimulator (HGNS) implant called the Aura6000 from LivaNova has received pre-market approval from the FDA to treat moderate to severe obstructive sleep apnea (OSA) in people who cannot use CPAP. Obstructive sleep apnea is a widespread and often underdiagnosed sleep disorder estimated to affect more than 80 million Americans. The Aura6000’s FDA pre-market approval is supported by data from OSPREY, LivaNova’s large clinical study, which showed clinically meaningful improvements in sleep apnea severity and overall sleep quality for people using the device.

When are HGNS Implants Recommended for Sleep Apnea Treatment?

The most commonly prescribed treatment option for OSA is CPAP therapy, which uses a mask worn at night to deliver pressurized air to hold the airway open. The HGNS implant is a sleep apnea treatment option for people diagnosed with OSA who have tried CPAP and have been unsuccessful in using it. 

Hypoglossal nerve stimulator (HGNS) implants are not available to every person living with OSA, but can be an option for people with moderate to severe obstructive sleep apnea who meet certain criteria. To date, one of those criteria has been ensuring potential HGNS implant candidates do not have complete concentric collapse (CCC).

What is Complete Concentric Collapse (CCC)?

Complete concentric collapse (CCC) occurs when the walls of the upper airway get pulled together from all directions. The first HGNS implant available in the United States was the Inspire implant, which works by periodically stimulating the nerve that moves the tongue forward and out of the airway. Potential candidates for Inspire treatment showing signs of CCC during a procedure called a drug-induced sleep endoscopy are excluded from receiving the Inspire implant.

Why Aura6000 Sleep Apnea Treatment Approval Matters

LivaNova’s Aura6000 system is the first HGNS device to receive FDA pre-market approval without a specific contraindication for people with CCC and without a requirement for pre-implantation drug-induced sleep endoscopy. 

As a patient advocate living with OSA, I know that our community welcomes access to new treatment options. Making HGNS implants available to people with complete concentric collapse of their airway opens up new possibilities for a group previously excluded from consideration for HGNS treatment.”

– Emma Cooksey, Sleep Apnea Program Manager, Project Sleep

When Will the Aura6000 Implant Be Available?

With the FDA pre-market approval secured, the new Aura6000 implant will now go through final review steps with the FDA before becoming available to patients and surgeons to use in the United States. LivaNova estimates the launch on the US market in the first half of 2027.

What Treatment Options Are Available For Sleep Apnea?

There are a variety of FDA-approved treatments that can help people living with sleep apnea, including newer options like implantable therapies. However, finding the right treatment (or combination of treatments) can be a long and sometimes overwhelming process, often involving multiple specialists and decisions along the way. At Project Sleep, we aim to empower individuals with clear, accessible information about all available options—learn more in our Sleep Apnea Treatment Options Toolkit.

More on Sleep Apnea