Targeted Hypoglossal Neurostimulation Study #3

The objectives of this study are to evaluate the safety and effectiveness of the aura6000
System for the treatment of moderate to severe obstructive sleep apnea (OSA) in individuals
who have failed or do not tolerate positive airway pressure (PAP) therapy or have failed or
are intolerant of or refuse indicated alternative OSA treatments (such as oral appliances,
positional devices and conventional sleep surgeries). PAP failure is defined as an inability
to eliminate OSA (AHI > 20 despite PAP usage) and PAP intolerance is defined as: 1) inability
to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of
use per night); or 2) unwillingness to use PAP (for example, a patient returns the PAP system
after attempting to use it). The results of this study are anticipated to provide reasonable
assurance of the safety and effectiveness of the aura6000 System when used as intended and to
support the application for FDA Premarket Approval of the system.

Inclusion Criteria:

- Age >18 years

- Individual has failed or does not tolerate PAP therapy

- Has failed or refuses alternative OSA treatments (e.g.surgery, oral appliances, and
behavioral treatments)

- AHI ≥ 20 (Moderate to severe OSA)

Exclusion Critera:

- Implanted with another active implantable device

- Body mass index (BMI) ≥ 35 kg/m²