Sleep Apnea Device Receives FDA Approval

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

By
Kathryn Wighton
March 19, 2026
2 min

MDSpire News

Objective:

To announce the FDA approval of the aura6000 System for treating obstructive sleep apnea in patients who have not responded to first-line therapies.

Approach:

Key Findings:

65% of patients met responder criteria at 12 months.
Median apnea-hypopnea index decreased from 34.3 to 11.0 events per hour over 13 months.
69% of treated patients achieved at least a 25% reduction in oxygen desaturation index.

Interpretation:

The aura6000 System represents a significant advancement in the treatment of obstructive sleep apnea, particularly for patients who are not candidates for traditional therapies.

Limitations:

The study population included patients with predicted risk of complete concentric collapse, which may not represent all obstructive sleep apnea patients.
Long-term efficacy and safety beyond the trial period remain to be fully established.

Conclusion:

The aura6000 System is the first hypoglossal nerve stimulation device approved in the US without contraindications related to complete concentric collapse, with promising results from clinical trials.