FDA approves Genio hypoglossal nerve stimulator for obstructive sleep apnea

Nyxoah/Genio

FDA granted approval to Nyxoah's Genio implantable hypoglossal nerve stimulator for treating moderate-to-severe obstructive sleep apnea. Genio is a single implant placed under the chin that delivers stimulation to prevent airway collapse during sleep.

• First meaningful competitor to Inspire Medical's market-leading HNS position
• Single-device design placed subcutaneously under the chin; CE Mark in Europe 2021
• FDA approval opens large US market for alternative sleep apnea treatment
• Genio achieved 15% market share in early US accounts by mid-2026