The sham control procedure will be performed in the study clinic using the Vivaer ARC Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).

Characterizing the type and frequency of adverse events reported. Subjects will be asked about possible side effects or adverse experiences related to the study procedure at each follow up visit. All events will be documented and identified as to its relationship and level of relatedness to the study device and/or study procedure. Date of onset, seriousness, intensity, duration and outcome will be documented.

The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. 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 range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.

These data represents the NOSE Scale average score from baseline at 3 months

The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. 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 range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.

These data represents the NOSE Scale average score from baseline at 6 months

The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. 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 range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.

These data represents the NOSE Scale average score from baseline at 12 months

The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. 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 range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.

These data represents the NOSE Scale average score from baseline at 12 months

The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. 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 range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.

Measurement is # improvement in NOSE Scale score from baseline

These data represents percent improvement in NOSE Scale score from baseline at 6 months

The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. 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 range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.

These data represents percent improvement in NOSE Scale score from baseline at 12 months

The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. 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 range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.

These data represents percent improvement in NOSE Scale score from baseline at 12 months

The ESS evaluates the self-reported likelihood of dozing or falling asleep in 8 daytime situations with likelihood rated No Chance (0), Slight (1), Moderate (2), or High Chance (3).40 The total of the scores across the 8 questions can be categorized and interpreted as: 0-7 It is unlikely that you are abnormally sleepy. 8-9 You have an average amount of daytime sleepiness. 10-15 You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24 You are excessively sleepy and should consider seeking medical attention.

The mean change in Epworth Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure.

Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.

The ESS evaluates the self-reported likelihood of dozing or falling asleep in 8 daytime situations with likelihood rated No Chance (0), Slight (1), Moderate (2), or High Chance (3).40 The total of the scores across the 8 questions can be categorized and interpreted as: 0-7 It is unlikely that you are abnormally sleepy. 8-9 You have an average amount of daytime sleepiness. 10-15 You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24 You are excessively sleepy and should consider seeking medical attention.

The mean change in Epworth Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure.

Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.

The ESS evaluates the self-reported likelihood of dozing or falling asleep in 8 daytime situations with likelihood rated No Chance (0), Slight (1), Moderate (2), or High Chance (3).40 The total of the scores across the 8 questions can be categorized and interpreted as: 0-7 It is unlikely that you are abnormally sleepy. 8-9 You have an average amount of daytime sleepiness. 10-15 You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24 You are excessively sleepy and should consider seeking medical attention.

The mean change in Epworth Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure.

Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.

The ESS evaluates the self-reported likelihood of dozing or falling asleep in 8 daytime situations with likelihood rated No Chance (0), Slight (1), Moderate (2), or High Chance (3).40 The total of the scores across the 8 questions can be categorized and interpreted as: 0-7 It is unlikely that you are abnormally sleepy. 8-9 You have an average amount of daytime sleepiness. 10-15 You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24 You are excessively sleepy and should consider seeking medical attention.

The mean change in Epworth Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure.

Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.

Medications tracked during the trial were antihistamines, decongestants, leukotriene inhibitors, intranasal steroids, anticholinergics, and immunotherapy. Use of nasal strips/cones was also tracked.

The sham control procedure will be performed in the study clinic using the Vivaer ARC Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).

Sham: The sham control procedure will be performed in the study clinic using the Vivaer ARC Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).

Total of all reporting groups

Overall percentage for analyzed participants

Patients self-identified race and ethnicity. Race and ethnicity classifications were adapted from US Food and Drug Administration-recommended classifications. These data were assessed to aid in interpretation of trial generalizability and conclusions and frame any relevant implications for clinical care.

The primary and secondary end point measures of this trial analyzed at 3, 6, and 12 months post procedure were (1) responder rate, where a responder was defined as 20% or greater improvement (decrease) in NOSE Scale score or 1 or greater NOSE Scale severity category improvement16from baseline, and (2) the mean change in NOSE Scale score from baseline.

Ease-of-breathing VAS is a 100-mm scale, where 0=no difficulty breathing and 100=extreme difficulty breathing.

VAS=visual analog scale.

A 2:1 site-stratified randomization will be used to allocate participants with NAO to either the active treatment arm (Vivaer procedure) or the control arm (sham procedure)

The sham control procedure will be performed in the study clinic using the Vivaer ARC Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).

Participants receiving the sham procedure may elect to crossover to the active treatment arm (Vivaer procedure) within 30 days after the 3-month follow-up evaluation provided they still meet all eligibility criteria. Continued follow-up will be conducted at 1, 3, 6, 12, and 24 months after the Vivaer procedure to provide additional information on longer-term efficacy and duration of treatment effect.

Participants that received the sham procedure and do not elect to crossover or no longer meet all eligibility criteria will be exited from the study following the 3-month evaluation.

The NOSE Scale is a patient self-reported questionnaire consisting of 5 symptoms of nasal obstruction: nasal congestion, nasal blockage, trouble breathing, trouble sleeping, and getting enough air during exercise. Patients will report over the past 1 month how much the symptoms have been a problem. Total score ranges from 0 to 100, where higher scores indicate worse obstruction.

This study will measure the mean change in NOSE Scale from baseline to 3 months after procedure.

At baseline, all patients were classified as having extreme or severe obstruction, based on the NOSE-scale severity classification system. This outcome measure shows the difference in overall score between baseline and 3 months.

Characterizing the type and frequency of adverse events reported. Subjects will be asked about possible side effects or adverse experiences related to the study procedure at each follow up visit. All events will be documented and identified as to its relationship and level of relatedness to the study device and/or study procedure. Date of onset, seriousness, intensity, duration and outcome will be documented.

Adverse events considered at least possibly related to the device and/or procedure

The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. 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 range, 5-25), (range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.

Measurement is # improvement in NOSE Scale score from baseline, the lower the score the less obstruction or a change to lower score indicates improvement in nasal airway obstruction.

These data represents percent improvement in NOSE Scale score from baseline at 3 months

The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.

The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. 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 range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.

These data represents the NOSE Scale average score from baseline at 3 months

The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.

The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. 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 range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.

These data represents the NOSE Scale average score from baseline at 6 months

The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.

The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. 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 range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.

These data represents the NOSE Scale average score from baseline at 12 months

The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.

The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. 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 range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.

These data represents the NOSE Scale average score from baseline at 12 months

The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.

The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. 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 range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.

Measurement is # improvement in NOSE Scale score from baseline

These data represents percent improvement in NOSE Scale score from baseline at 6 months

The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. 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 range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.

These data represents percent improvement in NOSE Scale score from baseline at 12 months

The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.

The NOSE Scale is a validated disease-specific health status instrument used by clinicians to measure the outcome of patients treated for nasal obstruction. 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 range, 5-25), range, 30-50), severe (range, 55-75), or extreme (range, 80-100) nasal obstruction, based on responses to the NOSE survey.

These data represents percent improvement in NOSE Scale score from baseline at 12 months

The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.

The ESS evaluates the self-reported likelihood of dozing or falling asleep in 8 daytime situations with likelihood rated No Chance (0), Slight (1), Moderate (2), or High Chance (3).40 The total of the scores across the 8 questions can be categorized and interpreted as: 0-7 It is unlikely that you are abnormally sleepy. 8-9 You have an average amount of daytime sleepiness. 10-15 You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24 You are excessively sleepy and should consider seeking medical attention.

The mean change in Epworth Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure.

Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.

The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.

The ESS evaluates the self-reported likelihood of dozing or falling asleep in 8 daytime situations with likelihood rated No Chance (0), Slight (1), Moderate (2), or High Chance (3).40 The total of the scores across the 8 questions can be categorized and interpreted as: 0-7 It is unlikely that you are abnormally sleepy. 8-9 You have an average amount of daytime sleepiness. 10-15 You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24 You are excessively sleepy and should consider seeking medical attention.

The mean change in Epworth Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure.

Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.

The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.

The ESS evaluates the self-reported likelihood of dozing or falling asleep in 8 daytime situations with likelihood rated No Chance (0), Slight (1), Moderate (2), or High Chance (3).40 The total of the scores across the 8 questions can be categorized and interpreted as: 0-7 It is unlikely that you are abnormally sleepy. 8-9 You have an average amount of daytime sleepiness. 10-15 You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24 You are excessively sleepy and should consider seeking medical attention.

The mean change in Epworth Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure.

Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.

The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.

The ESS evaluates the self-reported likelihood of dozing or falling asleep in 8 daytime situations with likelihood rated No Chance (0), Slight (1), Moderate (2), or High Chance (3).40 The total of the scores across the 8 questions can be categorized and interpreted as: 0-7 It is unlikely that you are abnormally sleepy. 8-9 You have an average amount of daytime sleepiness. 10-15 You may be excessively sleepy depending on the situation. You may want to consider seeking medical attention. 16-24 You are excessively sleepy and should consider seeking medical attention.

The mean change in Epworth Sleepiness Scale score from baseline was also analyzed at 3-, 6-, and 12-months post procedure. NOSE Scale and Epworth Sleepiness Scale data were also collected at 1 month post procedure.

Data reported here is from 3M as 12M was not included because of the long-term follow-up focus of the report.

The combined active treatment group contains patients from the index active treatment arm and the crossover active treatment arm. The term baseline in the index active treatment arm refers to the out-come measure value prior to original active treatment procedure, and in the case of the crossover active treatment arm, baseline refers to the value reported at the time of requalification for crossover.

Medications tracked during the trial were antihistamines, decongestants, leukotriene inhibitors, intranasal steroids, anticholinergics, and immunotherapy. Use of nasal strips/cones was also tracked.

The sham control procedure will be performed in the study clinic using the Vivaer ARC Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).

Sham: The sham control procedure will be performed in the study clinic using the Vivaer ARC Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).