Apnex Clinical Study of the Hypoglossal Nerve Stimulation (HGNS®) System to Treat Obstructive Sleep Apnea

Pivotal Study of the Apnex Medical™ Hypoglossal Nerve Stimulation (HGNS) System to Treat Obstructive Sleep Apnea

The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the Apnex Medical Hypoglossal Nerve Stimulation (HGNS) System as a potential therapeutic option for individuals with moderate to severe Obstructive Sleep Apnea (OSA) that have failed or do not tolerate positive airway pressure (PAP) therapy.

Inclusion Criteria:

• Age 21 to 80 years
• Body mass index (BMI) ≤ 35 kg/m²
• Previously diagnosed with Moderate to severe OSA
• Individual has failed or does not tolerate PAP therapy