Sleep Apnea Implant Cut AHI 74% in Patients With No Option

Jeff's Daily Pick. Some people with sleep apnea are turned away from the tongue nerve implant because of how their airway collapses. A new implant just cut their breathing pauses by 74%.

In the United States, Nyxoah presented the full 12 month results of its ACCCESS pivotal study at the International Surgical Sleep Society meeting in Los Angeles on October 15, 2026. The study tested the Genio implant, which stimulates the hypoglossal nerve on both sides, in people with obstructive sleep apnea and complete concentric collapse of the soft palate. That airway pattern currently has no commercially available neurostimulation option in the US. The company has submitted a premarket approval supplement to the FDA to expand Genio's indication to these patients.

The results

Both co primary endpoints were met on a full analysis set basis: an apnea hypopnea index (AHI) responder rate, per the Sher criteria, of 77.2%, and an oxygen desaturation index (ODI) responder rate of 87.7% (both p < 0.001). In the per protocol population, mean AHI fell from 33.6 to 10.4 events per hour, a median reduction of 74.3%, and mean ODI fell from 32.6 to 10.9, a median reduction of 71.9%. Daytime sleepiness on the Epworth scale improved by 5.3 points and the FOSQ 10 quality of life score by 2.3 points. Of patients, 94.7% reported improvement and 97.4% said they were satisfied and would choose the implant again.

No device or procedure related serious adverse events occurred through 12 months; four serious adverse events were reported, all judged unrelated. Patients will be followed for three years after implantation. The data were presented by Colin Huntley, co principal investigator, and confirm topline results announced on September 2.

Complete concentric collapse matters because it is a common reason patients who cannot tolerate CPAP are rejected for the existing hypoglossal nerve implant. A median residual AHI around 10 is mild apnea territory, not a cure, but for that group it is a large change. The next milestone is the FDA's review of the supplement, which Nyxoah filed with Breakthrough Device Designation.