Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)

A Pilot Study and Follow Up of the Use of a Hypoglossal Nerve Implant for Treatment of Obstructive Sleep Apnea

The objective of the study is to determine the safety and preliminary efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).

Inclusion Criteria:

• Moderate to severe obstructive sleep apnea (AHI 15 to 60).
• Cannot or will not tolerate CPAP treatment.
• Body mass index (BMI) between 25 and 40
• Able to read, understand, sign and date the written informed consent form