Important Safety Information

Safety Information - aura6000™

Short-form Safety Information for Physicians - aura6000™ System for Obstructive Sleep Apnea (US) (April 2026)

DEVICE DESCRIPTION: The aura6000 System for proximal hypoglossal nerve stimulation (pHGNS) consists of an implantable generator, an implantable stimulation lead, and an external programming system to change stimulation settings, which includes the aura6000 Clinical Manager (aCM), Remote Control & Charger (RCC), and Charging Antenna (CA).

INTENDED USE / INDICATION: The aura6000 System is indicated for the reduction of apneas, hypopneas, or both in adult patients with moderate to severe obstructive sleep apnea (OSA), defined as an apnea-hypopnea index (AHI) of ≥ 15 and ≤ 65. The aura6000 System is intended for patients who failed, do not tolerate, or are ineligible to be treated with current standard of care treatments such as positive airway pressure (PAP), oral appliances, or pharmacotherapy.

PAP failure is defined as an inability to eliminate OSA (AHI > 15 despite PAP usage). PAP intolerance is defined as an inability to use PAP > 5 nights per week for > 4 hours per night or an unwillingness to use PAP.

CONTRAINDICATIONS: Not for use in patients with: combined central and mixed AHI ≥ 25% of the total AHI; any functional or structural problem, medical illness, or condition that would prevent or interfere with implantation, activation, or continued use of the aura6000 System; an implantable device which may be susceptible to unintended interaction with the aura6000 System; any condition or procedure that has compromised neurological control of the upper airway; or in patients who are pregnant, planning to become pregnant, or breastfeeding.

Not for use in patients who require diathermy. Do not use shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy on patients implanted with an aura6000 System. Not for use in patients who require magnetic resonance imaging (MRI). The generator, lead, RCC, and CA are MR Unsafe devices.

WARNINGS & PRECAUTIONS: Product warnings and potential risks and adverse events are discussed in the aura6000 System manufacturer’s product labeling. The aura6000 System should only be prescribed and monitored by physicians who are experienced in the diagnosis and treatment of OSA and have specific training and expertise in the management of OSA and the programming and use of this device.

Use of the aura6000 System should be carefully considered in patients who fall outside the studied population, including: patients < 22 or > 75 years of age; patients with body mass index (BMI) > 35 kg/m2; or patients with AHI < 15 or > 65 events/hour. Drug-induced sleep endoscopy (DISE) is not required for patient selection and clinical studies did not exclude patients with complete concentric collapse (CCC) at the velum. However, CCC status was not systematically assessed as a separate subgroup nor characterized during enrollment, therefore clinicians should exercise judgment when evaluating patients with suspected or confirmed CCC. The safety and efficacy of the aura6000 System have not been established for pediatric use.

Do not modify the RCC or CA and do not use the RCC if it has been tampered with. Do not bypass system controls on the aCM computer or connect the aCM computer to insecure networks. Do not connect any non-LivaNova provided devices or accessories to the RCC or aCM computer. The use of non-approved or non-LivaNova components with the aura6000 System may damage the system or its components and increase the risk to the patient, resulting in loss of therapy or patient injury, and may void the product warranty. Device malfunction could cause painful stimulaStion or direct current stimulation which could cause nerve damage.

ADVERSE EVENTS: The most commonly reported side effects in randomized control trials (≥ 5% of patients) were headache, implant site pain, oropharyngeal pain, and difficulty swallowing. Other adverse events reported (≥ 2% of patients): implant procedure-related events, including pain (tongue, neck, ear), reduced sensation, implant site swelling, and tongue movement disturbance; and stimulation-related events, including discomfort, pain, and speech disorder. Most adverse events were mild or moderate in severity and no serious procedure-related adverse events were reported.

*The information contained in this summary represents partial excerpts of important prescribing information taken from the product labeling. The information is not intended to serve as a substitute for a complete and thorough understanding of the aura6000 System or the material presented in the manufacturer’s product labeling, nor does this information represent full disclosure of all pertinent information concerning the use of the product, potential safety complications, or efficacy outcomes.