FDA Approves Aura6000, Bringing Hypoglossal Nerve
The FDA has approved the Aura6000 device, making it the third hypoglossal nerve stimulation system for treating obstructive sleep apnea in patients who
The Food and Drug Administration has approved the Aura6000 device, bringing the total number of approved hypoglossal nerve stimulation systems for obstructive sleep apnea to three. These devices are for patients with moderate-to-severe OSA who have failed positive airway pressure therapy.
Hypoglossal nerve stimulation, or HGNS, works by electrically stimulating specific branches of the nerve that controls the tongue. This stimulation causes the tongue to protrude forward, opening the airway during sleep. The implantation surgery is an outpatient procedure performed under general anesthesia. According to the authors in Montage magazine, this anatomy-sparing approach reduces the risks and recovery time associated with more traditional airway reconstruction surgeries.
The Three Approved Devices
The first device, Inspire from Inspire Medical Systems, received FDA approval in 2014. Over 120,000 patients have been implanted with it. The Genio 2.1 system from Nyxoah SA, a bilateral stimulator, was approved in 2025. The newest, the unilateral Aura6000 from LivaNova, gained approval in 2026.
A recent overview in Montage magazine compares the design and clinical features of these three devices. The data comes from device manuals and the key clinical trials that led to each device's approval.
| Feature | Inspire | Genio 2.1 | Aura6000 |
|---|---|---|---|
| Approval Year | 2014 | 2025 | 2026 |
| Stimulation Type | Unilateral | Bilateral | Unilateral |
| MRI Conditional | Full-body 1.5T & 3.0T | Full-body 1.5T & 3.0T | Head & extremity 1.5T & 3.0T |
| IPG Location | Infraclavicular | Submental | Submental |
| FDA Label for Down Syndrome* | Yes (age ≥13) | No | No |
*Inspire is also FDA approved for patients with Down Syndrome (Trisomy 21) who are 13 years or older.
Clinical Trial Outcomes
Each device demonstrated significant improvements in sleep apnea metrics and patient-reported outcomes in their respective trials. The trials were the STAR trial for Inspire, the DREAM trial for Genio, and the OSPREY trial for Aura6000.
The authors report that all trials showed clinically meaningful improvements in both polysomnographic results and patient symptoms, with acceptable safety profiles. The data includes metrics like the apnea-hypopnea index and the Epworth Sleepiness Scale.
| Trial (Device) | AHI Responder Rate* | ODI Responder Rate** | Serious Adverse Event Rate | Therapy Usage (hrs/night) |
|---|---|---|---|---|
| STAR (Inspire) | 2.1% | 5.6 | ||
| DREAM (Genio) | 1.8% | 6.1 | ||
| OSPREY (Aura6000) | 3.4% | 6.4 |
*AHI responders achieved a minimum 50% AHI reduction with a final AHI <20/hour. **ODI responders achieved a minimum 25% reduction in ODI.
The Evolution of HGNS Therapy
Over the past decade, hypoglossal nerve stimulation has moved from an emerging idea to an established therapy. The authors state that a balanced understanding of each device's features is now important for proper patient counseling and selection. They call this a valuable skillset for personalizing therapy.
Looking ahead, the authors identify several needs. Longitudinal data is required to track results over time and compare the long-term performance of different systems. Monitoring objective adherence will be key. They also suggest that multimodality approaches combining HGNS with weight loss, positional therapy, or other interventions warrant more study.
Finally, the authors note that more research is needed to directly compare safety, side effects, patient preference, and specific disease reduction metrics between the available devices. Dr. Ryan Soose, a co-author and director of the sleep division at the University of Pittsburgh, along with his colleagues, presented the final results of the large ADHERE Registry at the SLEEP 2026 meeting.
