Vivaer® Procedure for Treatment of Nasal Airway Obstruction Study

Inclusion Criteria:

1. Age 18 to 85 years (inclusively).

2. Willing and able to provide informed consent.

3. Willing and able to comply with the subject-specific requirements outlined in theStudy Protocol.

4. Seeking treatment for nasal obstruction and willing to undergo an office-basedprocedure.

5. Baseline Nasal Obstruction Symptom Evaluation (NOSE) Scale score ≥ 55.

6. Nasal valve is a primary or significant contributor to the patient's nasalobstruction as determined by the study investigator (based on clinical presentation,physical examination, nasal endoscopy, etc.) and the patient has a positive responseto any of the following temporary measures (based on patient history or officeexam):

• Use of external nasal dilator strips (eg, Breathe Right Strips)

• Use of internal nasal dilator cones

• Modified Cottle Maneuver (manual elevation of the lateral nasal wall using asmall instrument or cotton-tipped applicator to open the nasal valve)

• Cottle Maneuver (manual lateral retraction of the cheek to open the nasalvalve)

7. Dissatisfaction with medical management as judged by the patient. Defined as failedmedical therapy (eg, decongestants, antihistamines, and/or nasal sprays for anappropriate period of time), but a positive response to internal or external nasaldilators.

Exclusion Criteria:

1. Prior surgery of the lateral nasal wall, including cephalic resection of the lowerlateral cartilage, dome division or suture plication, alar graft or spreader graftplacement.

2. Rhinoplasty, septoplasty, inferior turbinate reduction or functional endoscopicsinus surgery (FESS) within the preceding 3 months.

3. Severe case of any of the following: septal deviation, turbinate hypertrophy,polyps, or ptotic nose tip believed to be the primary contributor to the patient'snasal obstruction symptoms and warranting surgical intervention.

4. Any adjunctive surgical nasal procedure planned on the same day or within 6 monthsafter the Vivaer procedure.

5. Known or suspected to be pregnant or is lactating.

6. Participating in another clinical research study.

7. Other medical conditions which in the opinion of the investigator would predisposethe patient to poor wound healing or increased surgical risk, or poor compliancewith the requirements of the study.