The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants will undergo bilateral treatment of the nasal airway in a single study procedure session. Each side of the nose will be treated as follows:

• Two (2) to six (6) nonoverlapping applications of RF energy are performed at the SSB per nostril.

The default treatment settings will be used for the study: temperature 60 C, power 4 watts, treatment time 18 seconds, and cooling time 12 seconds. No repeat ("touch up") procedures will be permitted after the initial procedure through the end of the study (36 months).

The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants in this study will undergo bilateral treatment of the nasal airway in a single study session.

The primary endpoint is improvement in self-reported Nasal Obstruction Symptom Evaluation (NOSE) Scale score from baseline recorded at the screening evaluation to 13 weeks after the procedure. The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of participants treated for nasal obstruction.43 The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as mild (range, 5-25), moderate (range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE Scale survey.

Responder percent: A responder is defined as at least 1 NOSE Scale class improvement or an improvement (decrease) in NOSE Scale score of 20% or more from baseline to 13 weeks after the procedure (eg, going from a score in the severe range (55-75) at preprocedure to a score in the moderate range (30-50) at the 3-month evaluation), or an improvement (decrease) in NOSE Scale score of 20% or more from screening at the 3-month evaluation.

target population for this study is adults suffering from symptoms attributed to NAO with evidence of SSB obstruction of the airway which may or may not include hypertrophied turbinates. This study requires severe or extreme symptoms demonstrated by a NOSE Scale score ≥ 55 and determination by the investigator that the SSBs are the primary or significant contributor to the nasal obstruction.

The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device with temperature control capable of delivering very low doses of energy.

The Vivaer ARC Stylus was cleared for use in the United States (U.S.) by the Food and Drug Administration (FDA) under 510(k) K172529 and the Aerin Console was cleared under 510(k) K162810.

The primary endpoint is improvement in self-reported Nasal Obstruction Symptom Evaluation (NOSE) Scale score from baseline recorded at the screening evaluation to 13 weeks after the procedure. The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of participants treated for nasal obstruction.43 The NOSE Scale consists of 5 items, each scored using a 5-point Likert scale to make a total score range of 0 through 100, where higher scores indicate worse obstruction. Severity of symptoms can be classified as mild (range, 5-25), moderate (range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE Scale survey.

The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants will undergo bilateral treatment of the nasal airway in a single study procedure session. Each side of the nose will be treated as follows:

• Two (2) to six (6) nonoverlapping applications of RF energy are performed at the SSB per nostril.

The default treatment settings will be used for the study: temperature 60 C, power 4 watts, treatment time 18 seconds, and cooling time 12 seconds. No repeat ("touch up") procedures will be permitted after the initial procedure through the end of the study (36 months).

Vivaer Arc Stylus: The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants in this study will undergo bilateral treatment of the nasal airway in a single study session.