Clinical UM Guideline

This document addresses the use of minimally invasive techniques to inactivate the posterior nasal nerve (PNN) and thereby decrease the symptoms of chronic rhinorrhea or nasal congestion. Currently there are three devices on the market proposed for this procedure, the ClariFix^® device (Stryker, Plymouth, MN) which is a cryotherapy tool, and two radiofrequency tools: the RhinAer^™ Stylus (Aerin Medical, Austin, TX) device and the Neuromark^® system (Neurent Medical, Braintree, MA).

Note: For additional information regarding the treatment of rhinitis, please see:

• CG-SURG-117 Balloon Dilation of the Eustachian Tubes
• SURG.00079 Nasal Valve Repair

Note: For a high-level overview of this document, please see “Summary for Members and Families” below.

Not Medically Necessary:

Minimally invasive treatment of the posterior nasal nerve, such as cryotherapy or radiofrequency therapy, to decrease the symptoms of allergic or nonallergic rhinitis is considered not medically necessary in all cases.

This document describes clinical studies and expert recommendations, and explains whether posterior nasal nerve (PNN) ablation is clinically appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

PNN ablation is a procedure meant to treat chronic rhinitis, which causes ongoing nasal symptoms like a runny or stuffy nose. The goal is to reduce nerve activity in the nose using a device that applies cold (cryotherapy), heat (radiofrequency), or laser energy. Two types of devices are currently available: cryotherapy (ClariFix) and radiofrequency (RhinAer and Neuromark). These procedures are usually done in a clinic with local numbing medicine. Some people may feel better after the treatment, but the current studies do not show that this treatment has been proven to improve health in a clear and reliable way. Side effects can include nosebleeds, pain, dryness, and changes inside the nose.

What the Studies Show

PNN ablation aims to reduce nerve activity in the nose to lessen symptoms like runny nose and congestion. Cryotherapy uses very cold temperatures to affect the nerve, while radiofrequency uses controlled heat. These treatments are less invasive than older surgeries, but repeat treatments may be needed because nerves can grow back over time. Standard care for chronic rhinitis still includes avoiding triggers, medicines like antihistamines (for example, loratadine [Claritin]) or nasal steroids (for example, fluticasone [Flonase]), and allergy therapy.

Laser treatment for the same purpose has been minimally studied. The only published studies have methodological concerns including lack of a control group and retrospective design.

Some studies show that people report fewer symptoms after PNN ablation. However, many of these studies have problems. They often include small numbers of people, do not compare treatment to a placebo (sham) group, or only follow people for a short time. Some studies that did include a comparison group showed better results with treatment, but follow-up was limited. Side effects such as nosebleeds, headache, and discomfort were reported. In some cases, the bleeding required medical treatment. Better studies are needed to know if this treatment improves health over time. Experts reviewing all available studies found the level of evidence to be low, meaning results are uncertain.

Is this clinically appropriate?

Minimally invasive PNN ablation, including cryotherapy and radiofrequency treatments, is not clinically appropriate because it has not been proven to improve health. Studies show mixed results and have important weaknesses, as discussed earlier. Some people report symptom relief, but it is unclear if the treatment works better than placebo or standard care.

There are also risks, including nosebleeds that may need treatment, pain, dryness, and possible changes to nasal structures. Because the benefits are uncertain and the risks are not fully known, the balance between benefit and harm is unclear. PNN ablation is not clinically appropriate in any situation at this time. Unnecessary treatments can lead to therapies that do not help.

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The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Not Medically Necessary:
When the code describes a procedure indicated in the Clinical Indications section as not medically necessary.

Summary

Chronic rhinitis is characterized by persistent inflammation or irritation of the nasal lining, which results in symptoms including runny nose, congestion, and post-nasal drip. Standard treatment approaches include allergen avoidance, antihistamines, nasal corticosteroids and decongestants, nasal irrigation, and allergy immunotherapy. Surgical approaches have also been explored, including the most recent ablation of the PNN, which is intended to denervate the nasal passage and decrease rhinitis symptoms.

Published PNN ablation studies have demonstrated statistically significant short-term improvement in symptoms of chronic rhinitis, often measured through subjective scores like the Total Nasal Symptom Score (TNSS) or Reflective TNSS (rTNSS). The validity of these findings is undermined by serious methodological limitations, including small sample sizes, high attrition rates, lack of blinding, limited follow-up, and reliance on non-validated or self-reported symptom scales. Most studies lack a comparator or sham control group, and adverse events (AEs) such as epistaxis, nasal dryness, or new anatomical changes have been reported. Given that rhinitis is a very common condition, the affected population is large and well-suited to support higher-quality research. Systematic reviews have echoed concerns about bias and inconsistent follow-up data. Safety data are also limited, with reports of adverse events such as epistaxis and procedure-related discomfort. Reflecting these uncertainties, the International Consensus Statement on Allergy and Rhinology (ICAR) assigns a low level of evidence (Grade C; Wise, 2023). Based on the current evidence, PNN ablation has not been shown to be clinically appropriate or considered effective for the routine treatment of chronic rhinitis.

Discussion

Chronic rhinitis is categorized as allergic, nonallergic or mixed subtypes. Chronic nonallergic rhinitis includes several subtypes of rhinitis which are not associated with an allergic or infectious etiology. Approximately 60 million people in the United States, about 1 in 5 individuals, are afflicted with chronic rhinitis (Kompelli, 2018; Krespi, 2020). Nonallergic chronic rhinitis affects 20 to 30 million individuals in the United States and represents approximately 25% of rhinitis cases (Sur, 2018). Similar symptoms are present in all subtypes: nasal congestion or obstruction, postnasal drip, itching, redness, clear rhinorrhea, sneezing and watery eyes. However, the underlying pathophysiology of allergic and nonallergic rhinitis differs. Allergic rhinitis is caused by exposure to specific sensitivity triggers, resulting in the secretion of multiple proinflammatory mediators. This mechanism manifests as nasal obstruction and rhinorrhea (Gerka Stuyt, 2021). Nonallergic rhinitis is thought to result from nociceptor and autonomic nerve dysregulation (Gerka Stuyt, 2021; Sur, 2018). Approximately 50% of those affected with chronic rhinitis have mixed rhinitis, which is characterized by allergic and nonallergic triggers (Rackerby, 2025). Initial treatment consists of avoidance of known triggers and pharmacologic management (Liu, 2010). Approximately 10% to 22% of individuals experience rhinitis which is refractory to medical management (Balai, 2023).

Surgical alternatives have been explored for individuals with intractable symptoms. The vidian nerve is responsible for the majority of the parasympathetic innervation to the secretory nasal mucosa via the preganglionic parasympathetic fibers of the greater petrosal nerve, which synapses at the pterygopalatine ganglion. This results in postganglionic innervation to the nasal mucosa via the PNN. Vidian neurectomy has been reported as effective in treating rhinitis, although persistent dry eye symptoms have also been reported as a possible complication. Due to the potential side effects, vidian neurectomy is not commonly performed anymore. PNN surgical resection or neurectomy selectively targets postganglionic parasympathetic fibers that are anatomically distal to the lacrimal innervation branch point, has also been effective to treat both allergic and nonallergic rhinitis while sparing lacrimal innervation (Hwang, 2017).

PNN ablation is a minimally invasive approach that targets the posterior nasal nerve at the middle and inferior meatus to reduce parasympathetic activity associated with chronic rhinitis symptoms. Techniques include cryotherapy, which applies cold under endoscopic visualization, and radiofrequency, which uses energy to disrupt nerve signaling while preserving surrounding tissue; these procedures are typically performed under local anesthesia. PNN ablation may also be performed using surgical dissection or other thermal modalities such as laser energy. While these approaches are intended to decrease secretory and vasomotor activity, repeat treatments may be required to maintain effect, as nerve regeneration takes place at a rate of 1-6 inches/month (Ehmer, 2022a).

In 2023, Balai assessed the effect of PNN treatment on the TNSS in a systematic review and meta-analysis. The review included 8 studies (n=463) that used minimally invasive techniques to treat chronic rhinitis: cryotherapy (n=6), radiofrequency therapy (n=1), or laser therapy (n=1). Six of these studies were non-randomized, unblinded, and uncontrolled studies for which the authors found a “serious” risk of bias for the reporting of the study’s subjective outcome measures. While limited evidence from two randomized controlled trials suggested greater TNSS improvement and higher response rates with active treatment compared to sham, the overall body of evidence is constrained by methodological limitations, including lack of comparator groups in most studies, short-term follow-up, and early crossover of sham participants to active treatment, which limits the ability to assess longer-term comparative efficacy. These limitations prevent determination that PNN ablation is clinically appropriate or considered effective for the treatment of chronic rhinitis.

Maddineni and associates (2025) retrospectively compared the effectiveness of two treatments for chronic rhinitis: surgical PNN neurectomy and in-office PNN ablation (using cryoablation or radiofrequency). The cohort included 55 individuals who had previously trialed ipratropium who were then treated with ablation (n=34), surgical neurectomy (n=26) or both procedures (n=9). Outcomes were measured using the 22-item Sinonasal Outcome Test (SNOT-22) questionnaire, particularly the rhinologic subdomain. Surgical neurectomy was associated with significant improvements in overall rhinologic symptoms and rhinorrhea, and it resulted in a greater reduction in sneezing compared to ablation. There was no statistically significant difference in total or subdomain SNOT-22 scores between the groups. Individuals who underwent neurectomy after a prior ablation showed no clear additional benefit. The authors concluded that while both interventions may be beneficial, neurectomy could offer greater symptom relief for select cases. Limitations included its retrospective design, a small sample size and use of the SNOT-22 scale compared to the TNSS scale. TNSS is generally used for measuring pure rhinitis severity, especially in clinical trials or interventions targeting nasal symptoms. TNSS is considered the better, more direct tool.

Cryotherapy

The ClariFix device was cleared by U.S. Food and Drug Administration (FDA) 510(k) on February 14, 2017, as a cryosurgical tool to treat adults with chronic rhinitis. The clearance was based on a study of 27 individuals and a review of related published literature regarding the use of cryosurgical ablation of tissue in the nasal passageways to treat rhinitis.

Hwang (2017) reported on a series of 27 adults with rhinorrhea with or without nasal congestion symptoms despite medical therapy of more than 3 months. Participants were treated with the ClariFix device in an office setting. The study included individuals with both allergic and nonallergic rhinitis. Individuals were evaluated using the TNSS and those with a minimum rhinorrhea and/or congestion subscore of 2 (moderate symptoms) were included. Treatment was completed in less than 20 minutes in all cases under topical or injected local anesthesia. TNSS mean scores decreased significantly at 7 days post-procedure compared to baseline (6.2 ± 0.5 vs. 4.3 ± 0.4; p<0.005). At 90 days, the 27 individuals continued to report a decline in the TNSS mean score at 2.7 ± 0.4; p<0.001. While the TNSS scores continued to decline at 180 days (2.3 ± 0.5) and 365 days (1.9 ± 0.3), 6 individuals (22%) were lost to follow-up at 180 days, and 12 individuals (44%) were lost to follow-up at 365 days. Individuals did report mild pain/discomfort, severe ear blockage and severe nasal dryness, all of which had improved or resolved at the 30-day follow-up. A moderate nosebleed, reported 27 days post-procedure, was managed by electrocautery of the bleeding site. The findings of this study were limited by its small size and the high rate of attrition during follow-up. In addition, as medication use was not tracked during the study, other factors for possible symptomatic improvement may have confounded the results.

In a prospective single-arm study by Chang (2020), 98 adults with chronic, medically intractable rhinitis were treated with PNN cryoablation. Participation was limited to individuals with moderate or severe rhinorrhea symptoms, mild to severe symptoms of congestion and at least 4 out of 12 total score on the rTNSS. The primary clinical endpoint, the total rTNSS, was evaluated at baseline and at 30-, 90-, 180- and 270-days post-procedure. Following treatment, the total rTNSS scores were significantly improved over baseline at all post-procedure evaluations: baseline (6.1 ± 1.9), at 1 month (2.9 ± 1.9, p<0.001), 3 months (3.0 ± 2.3, p<0.001), 6 months (3.0 ± 2.1, p<0.001), and 9 months (3.0 ± 2.4, p<0.001). The authors defined the minimal clinically important difference (MCID) as a 30% reduction in baseline score and the 9 months results show a 51% reduction in symptoms. Following the procedure, 29 AEs related to the procedure or device were reported. The AEs included 2 instances of epistaxis requiring office cautery or suction cautery in the operating room. The AEs also included 2 cases of new ostia (1 uncinate process perforation and 1 maxillary sinus accessory os) and 1 case of nasal synechia. Other reported AEs were headaches, dry eyes, and sinus infections. Four participants (4%) were lost to follow-up at or before the final 270-day follow-up and 3 participants were excluded due to ipratropium use during the post-procedure period (total dropout rate 7%).

Ow (2021) published additional post-procedure results (12-24 months) of the prospective single-arm study described above (Chang, 2020). Individuals were evaluated by office visit or phone regarding the change from baseline in the rTNSS. There were significantly improved total rTNSS scores at all timepoints between 12- and 24-month follow-ups. Participant satisfaction, as evaluated by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) showed significant improvement from baseline at 18 and 24 months. There were no additional serious AEs reported during the follow-up period. This follow-up study is limited by the significant drop-off, while 91 individuals participated in the 1-month follow-up, only 57 individuals completed the 24-month follow-up. The prospective, single arm and open-label study design presents a significant risk of uncontrolled bias.

The 3-month results of a prospective, multicenter, 1:1 randomized, sham-controlled, participant-blinded trial assessed whether cryotherapy of the PNN area is more effective than sham treatment to control the symptoms of chronic rhinitis (Del Signore, 2022). Adults with moderate or severe chronic rhinitis with a minimum baseline total rTNSS score of at least 4 (with a minimum score of 2 for rhinorrhea and 1 for nasal congestion) were eligible for the study. Participants were randomized to receive either active cryotherapy (n=64) or sham (n=63) treatment. At 90 days, 47/64 (73.4%) of the participants in the active treatment group and 23/63 (36.5%) of the participants in the sham treatment group reported a ≥ 30% reduction of rTNSS from baseline. The mean rTNSS 90 days after the procedure improved significantly more in the active treatment group compared to the sham treatment group (8.0 ± 1.6 at baseline to 4.3 ± 2.4 at 90 days compared to 8.1 ± 1.9 at baseline to 6.3 ± 2.5 at 90 days; respectively). Non-serious transient AEs were reported in 35 participants (32 active, 3 sham) and primarily consisted of headache and pain. Extended follow-up on participants is underway to evaluate the durability of treatment, but no follow-up studies have been published.

In 2023, Young published a systematic review and single arm meta-analysis assessing the efficacy of cryoablation of the PNN to manage the symptoms of chronic rhinitis. The meta-analysis included five studies (n=247) with outcomes reported at 1 and 3 months post-procedure. These five studies were those by Hwang, Chang, Yen, Gerka Stuyt, and Del Signore described above. Young, et al. noted that cryoablation appeared to be effective in reducing chronic rhinitis symptoms. The pooled rTNSS mean difference from baseline to 1 month was −3.48 points (95% confidence interval [CI]: −3.73 to −3.23) and from baseline to 3 months was −3.50 (95% CI: −3.71 to −3.29). The RQLQ demonstrated a -1.53-mean difference from baseline to 3 months across the three studies which reported this data. The meta-analysis shares the limitations described above for the constituent studies.

Desai and associates (2023) evaluated the efficacy and safety of intranasal cryotherapy to treat chronic rhinitis. The final analysis included eight studies with 472 participants. The studies demonstrated a significant improvement in the mean outcomes scores from baseline to the primary endpoint. All documented AEs were minor. There were several limitations noted by the authors. The analysis included one randomized controlled trial (RCT) and seven uncontrolled studies. Five of the uncontrolled studies were industry-sponsored. Published study results were limited to mean values and variances, individual participant data was not available. The initial data show clinically meaningful sustained reductions in nasal symptoms; however, citing the paucity of studies regarding this relatively new technology, the authors concluded that further studies, including RCTs, are needed to further analyze the efficacy of cryotherapy.

Kompelli and associates (2018) published a qualitative systematic review of cryotherapy for chronic rhinitis, noting that only one study (Hwang, 2017) specifically evaluated a cryosurgical device targeting the PNN, and that the available evidence is low quality, heterogeneous, and outdated. Contemporary studies primarily relied on symptom scoring measures such as TNSS or rTNSS, which have limited validation across broader populations (Calderón, 2019), restricting their generalizability. Yen (2020) evaluated cryoablation of the PNN at both the inferior and middle meatus in 30 individuals with moderate to severe rhinorrhea and mild to severe nasal congestion for at least 3 months, reporting significant symptom improvement at 3 months. However, the study was limited by small sample size, short follow-up, and lack of a control arm. Overall, the current evidence base is limited by methodological weaknesses, and although some individuals experience symptom improvement, a substantial proportion, up to 27% of cryotherapy recipients and 33% of radiofrequency therapy recipients, demonstrate limited therapeutic response, underscoring the need for larger, well-designed studies with long-term follow-up to better establish consistent clinical effectiveness and define the role of this therapy in the standard management of chronic rhinitis (Fan, 2022).

Radiofrequency Ablation

On December 20, 2019, the RhinAer stylus received FDA clearance as a tool for use in the destruction of soft tissue in the nasal airway, including in PNN regions to treat chronic rhinitis. The procedure requires only local anesthesia and can be performed in the office. It uses low-power RF energy to disrupt PNN activity with the intent to improve chronic rhinitis symptoms.

Stolovitzky and associates (2021) published an evaluation of the safety and efficacy of RF neurolysis of the PNN in the treatment of moderate to severe chronic rhinitis. Individuals were randomized to receive active treatment of the PNN area with a RF device (n=77) or with a sham device (n=39). The primary endpoint was the responder rate (at least a 30% improvement in rTNSS score from baseline) at 3 months. A significantly higher responder rate was reported in the active treatment arm compared to the sham arm 67.5% (95% confidence interval [CI], 55.9%-77.8%) compared to 41.0% (95% CI, 25.6%-57.9%) at 3 months. The rTNSS significantly improved over baseline (8.3; 95% CI, 7.9-8.7) at 3 months with an adjusted mean change of −3.6 (95% CI, −4.2 to −3.0). No serious AEs were reported. The study did not limit the use of prescribed medications but did track medication use. At 3-month follow-up 7 individuals (9.1%) in the active treatment arm and 5 individuals (12.8%) in the sham treatment group increased their use of medications during the follow-up. Individuals who increased their medication use were assigned to non-responder status, regardless of rTNSS scores.

At 3 months, participants were unblinded and individuals in the sham arm could cross-over to the treatment arm (n=27). Clinical outcomes at 12 months following active treatment and 6-month outcomes in the crossover arm were reported (Takashima, 2023). At 12 months post-procedure, the responder rate in the active group (n=67) was maintained (80.6%; 95% CI, 69.1%-89.2%). The rTNSS remained significantly improved over baseline (8.3; 95% CI, 7.9-8.7) at 12 months with an adjusted mean change of −4.8 (95% CI, −5.5 to −4.1). The clinical course following treatment in the crossover group was similar to the active treatment group. The responder rates at 3 and 6 months were 75.0% (95% CI, 53.3%- 90.2%) and 64.0% (95% CI, 42.5%-82.0%); respectively. There were no serious device or procedure related AEs reported within either of the treatment groups. As noted above, of the 39 participants assigned to the sham-control group at baseline, 27 crossed over to PNN at 3 months. These participants were included in the subsequent follow-up studies noted below. It should be noted that participants were excluded from crossover if they no longer met eligibility criteria (for example, insufficient symptom severity), declined further participation (n=1), or had intervening factors such as undergoing additional nasal procedures that required withdrawal from the study. The authors did not specify why 11 individuals were not eligible for active treatment (Takashima, 2023).

Extended follow-up results were reported at 2 years (Takashima, 2024) and 3 years (Stolovitzky, 2025). The studies included a combined cohort of 104 individuals from the original trial. Both analyses showed sustained, statistically and clinically significant reductions in the rTNSS. The mean rTNSS reduction at 2 years was reported as -5.3 points (64.6% improvement) and at 3 years was -4.7 points (57.3% improvement). The reduction in postnasal drip and cough was categorized as clinically meaningful. Additionally, quality of life significantly improved, with MiniRQLQ scores decreasing by −1.9 at 2 years and −1.8 at 3 years, and over 75% of individuals meeting MCID thresholds at both timepoints. At 2 and 3 years, 87.3% and 79.7% of participants (respectively) were classified as responders (≥30% rTNSS improvement). No new serious AEs were reported. The authors concluded that radiofrequency PNN ablation is a safe, effective, and minimally invasive alternative to surgical interventions, providing lasting symptom relief and reducing medication burden for individuals with CR. There were several limitations that may affect the interpretation of its long-term findings. There was significant attrition by the 3-year follow-up (59/104 [56.7%] individuals participated), raising concerns about potential bias despite sensitivity analyses. After the initial 3-month endpoint, the trial no longer maintained a blinded or controlled design, limiting the ability to isolate treatment effects from placebo or other influences. Medication use was not standardized, allowing individuals to start or stop treatments freely, which could confound symptom improvement results.

Ehmer and associates (2022b) reported on the results of a prospective, single-arm multicenter study which followed individuals with chronic rhinitis with a baseline of rTNSS of 6 or greater who underwent RF treatment to the PNN area (n=50). Participants were evaluated at 2-, 4-, 12-, 26- and 52-weeks post-procedure and 47 participants completed the study. The primary efficacy point was the change in rTNSS score from baseline through 12 weeks. The mean rTNSS score of 47 participants improved from 8.5 at baseline to 3.4 at 12 weeks. At 12 months, the mean rTNSS score was reported to be 3.6. An MCID, defined as an improvement of greater than 1 point, was achieved in 93.9% of participants at 12 weeks and in 100% of participants at 52 weeks. There were no serious AEs reported. This early study has some limitations, including a lack of blinding and a lack of control group.

A total of 34 individuals completed a 24-month post-procedure clinical outcomes evaluation (Ehmer, 2022a). Participants completed an rTNSS questionnaire and scored postnasal drip and chronic cough symptoms on a 6-point scale (with 0 being no problem). At 24 months, the mean rTNSS remained significantly improved over baseline (−5.5; 95% CI, −6.4 to−4.6; p<0.001; 65.5% improvement). A total of 97.1% (95% CI, 85.1%-99.5%) maintained a 1 point or greater improvement from baseline. While fewer individuals reported using oral medications and nasal breathing strips to manage symptoms at 24 months compared to baseline, the difference was not significant.

A prospective single-arm study reported on the 6-month outcomes of individuals who underwent radiofrequency neurolysis of the PNN to treat chronic rhinitis (Lee, 2022). Adults with moderate to severe chronic rhinitis, as evidenced by an rTNSS score of ≥ 6 were included (n=126). Treatment targeted tissue in the posterior middle meatus and superior portion of the posterior inferior turbinate. The adjusted mean rTNSS at baseline was 7.8. At 3 months post-procedure, there was a 53.8% improvement in rTNSS from baseline (mean change −4.2; 95% CI, −4.6 to −3.7). At 6 months post-procedure, there was a 62.8% improvement in rTNSS from baseline (mean change −4.9; 95% CI, −5.5 to −4.3). Participant symptom improvements were also reflected in the responder rate, Quality of Life (QOL) and RQLQ.

Lee (2024) reported further outcomes of the study. At 2 years post-procedure, the rTNSS scores documented at 3 months were maintained, with an adjusted mean change from baseline -4.5 (95% CI, -5.0 to -3.9). Percentage of individuals classified as responders with an MCID of 30% or greater improvement was reported as 85.5% at 1 year (in 117 participants) and 80.0% at 2 years (in 105 individuals). The study was limited by a lack of a comparator group and considerable attrition (16%).

In a 3-year follow-up of the original cohort, 101 of 129 treated individuals (78%) completed long-term assessment (Lee, 2025). The participants reported improvements in nasal symptoms, cough, postnasal drip, and disease-specific quality of life persisting through 36 months after RFA of the PNN. Mean rTNSS scores remained approximately 58% lower than baseline (adjusted mean rTNSS, 7.8 at baseline to 3.2 at 3 years; mean change of -4.5 points [95% CI, -5.1 to -4.0; p<0.001]). Approximately 81% of participants continued to meet responder criteria at 3 years. Interpretation of durability is limited by the single-arm, open-label design without a comparator or sham control, reliance on self-reported outcomes, and attrition over time, raising the possibility of reporting and selection bias if individuals with less favorable outcomes were less likely to participate in long-term follow-up.

A second device, the Neuromark system was cleared by the FDA in October of 2021. The approval was based on an unpublished, prospective, single-arm study of 11 individuals. The study showed no serious AEs with a 6-month follow-up. The Neuromark system has multiple proximal and distal microablation points to maximize the area that can be treated. The expanded treatment area was developed based on the hypothesis that the lack of improvement in some individuals treated with other devices is the result of inadequate treatment due to natural anatomic variations. The device is described as:

The device comprises a two-stage design, where proximal and distal flexible leaflets conform to patient anatomy, maximizing access to nerve-rich areas on the lateral wall of the nasal cavity, and allowing more posterior placement than the other available devices (Reh, 2023).

Reh and associates (2023) reported on the safety and efficacy of the Neuromark system in a prospective, single-arm, multicenter study. Eligible participants (n=36) with chronic rhinitis symptoms of 6 months or longer with a total minimum VAS NSS of 10.0 (rhinorrhea minimum score of 5.0, rTNSS of 2.0 or more for runny nose) underwent bilateral posterior nasal nerve disruption in an office setting. Post-procedure assessment scores were reported up to 3 months. At 3 months post-procedure, there was a mean 53% and 55% improvement for rhinorrhea and congestion from baseline scores, respectively. The responder rate (reduction of rTNSS of 30% or greater from baseline) was 78% (28/36). There were no serious AEs reported during the study. The authors anticipate following up with participants for up to 12 months, however only 3-month results were available.

In a prospective, multicenter, single-blinded, randomized sham-controlled superiority trial, Takashima (2026) evaluated impedance-controlled multipoint radiofrequency PNN ablation using the Neuromark system as an in-office, non-medication intervention for adults with chronic rhinitis. A total of 132 participants were randomized 2:1 to active treatment or sham control, with the primary endpoint defined as a ≥30% reduction in rTNSS at 90 days. The rTNSS responder rate was significantly higher in the active treatment arm compared with sham (73.3% vs. 35.0%, p<0.001), with improvements across nasal symptom burden, nasal obstruction, quality of life, and depression outcomes. Improvements were achieved without changes in background rhinitis medication use. There was one reported procedure-related serious AE of epistaxis requiring observation. Study limitations include the single-blind design and follow-up limited to 90 days.

Yen (2025) evaluated the Neuromark system in a prospective, multicenter, single-arm study. PNN ablation was evaluated in 80 adults with chronic rhinitis and 2-year outcomes were reported with 94% of participants completing follow-up. The mean rTNSS improved by -4.3 points at 24 months. The responder rates, defined as at least a 30% reduction from baseline, were 80% at 12 months, 79% at 18 months, and 76% at 24 months. There were no serious device or procedure related AEs during extended follow-up. Interpretation of these findings is limited by the absence of a randomized control or sham comparator and allowance for concomitant medication changes during follow-up which introduced potential bias and limits causal inference regarding treatment effect durability.

Studies evaluating RF devices have reported a low incidence of AEs. The FDA’s Manufacturer and User Facility Device Experience (MAUDE) database for the RhinAer and Neuromark systems has 10 AEs through February 2, 2023. The majority of AEs were epistaxis (9/10) with 3 events requiring blood transfusions and 8 events requiring an operative intervention (Torabi, 2024). The epistaxis events occurred between day 5 and day 33. The authors hypothesize that “the sphenopalatine artery (SPA) or a branch is directly provoked or exposed, which can lead to delayed epistaxis”.

Laser Ablation

Krespi (2020) conducted a small prospective study to evaluate the effectiveness of an endoscopic diode laser as a tool for PNN ablation. Individuals with chronic medically intractable rhinitis (n=32) underwent endoscopic laser ablation in an office or ambulatory surgical center. Individuals were followed for 90 days after treatment. Symptom severity and treatment outcomes were measured using the TNSS. The procedure was successfully performed in 31 of the participants. TNSS scores were significantly reduced after 90 days (mean ± Standard Deviation (SD); 6.0 ± 0.7 prior to ablation, 2.3 ± 0.4 at 90 days, p<0.001). The authors reported no laser safety events or other post-procedure complications. The value of this study is limited by multiple factors, including small size, no control arm, follow-up limited to 90 days, non-standardized concomitant use of medications, and the publication only of summarized data in the study.

Lin (2026) published a retrospective trial comparing radiofrequency ablation alone (RAPN) to a combined approach using radiofrequency plus CO₂ laser (RPN3). A total of 101 adults with chronic rhinitis which did not improve with medical treatment were included. RPN3 was applied to 76 participants and 25 participants received RAPN. Both treatments improved symptoms over 6 months, but the combined approach led to greater relief, especially for runny nose and nasal itching. Response rates were high in both groups, and side effects were generally mild and resolved with routine care. However, the study has important limitations. It was retrospective and done at a single center, which may introduce bias and limit how widely the results apply. The sample size was small, especially in the RAPN group, and treatments were not randomly assigned. Follow-up was limited to 6 months, and medication use was not controlled, which could affect results.

Additional Information

Concerns regarding the safety profile of PNN ablation remain, despite many studies describing the procedure as “safe,” because the available evidence base is limited in its ability to fully characterize risk. Most published studies are small, single-arm, or short-term investigations, often with high attrition and limited follow-up, which restricts detection of infrequent but clinically meaningful AEs (Chang, 2020; Del Signore, 2022; Stolovitzky, 2021). Although serious AEs are infrequently reported in trials, procedure-related complications such as epistaxis requiring intervention have been documented, including delayed bleeding events occurring days to weeks after treatment in both clinical studies and post-market surveillance analyses (Chang, 2020; Torabi, 2024). Non-serious but clinically relevant AEs, including headache and procedure-related pain, are commonly reported, particularly with cryotherapy, and may be underemphasized in study summaries despite their impact on the individual’s surgical experience (Del Signore, 2022). The predominance of short-term, controlled trial environments and the absence of large-scale, long-term registry or real-world data further limit confidence in the completeness of safety reporting. Collectively, these factors indicate that while PNN ablation is generally well tolerated in studied populations, the true risk profile remains incompletely characterized, particularly with respect to delayed or less common but potentially significant complications.

In 2023, Wise and colleagues published an updated International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis. The ICAR developed recommendations based on an evidence-based review. The ICAR noted that the procedure seems to be well tolerated, with the current evidence “largely based on industry-sponsored studies with limited long-term data.” The ICAR concluded the following:

Aggregate grade of evidence: C (Level 3: 2 studies, level 4: 4 studies, level 5: 5 studies)
Benefit: Improvement in rhinorrhea.
Harm: Risk of complications (e.g., epistaxis, temporary facial pain and swelling, headaches), limited long-term results.
Cost: Surgical/procedural costs, cost of device, potential time off from work.
Benefits-harm assessment: Potential benefit must be balanced with low risk of harm, especially considering limited long-term results.
Value judgments: Patients may experience an improvement in symptoms.
Policy level: Option.
Intervention: Cryoablation and radiofrequency ablation of the posterior nasal nerve may be considered in AR patients that have failed medical management, particularly for rhinorrhea.

Allergic rhinitis: A group of symptoms affecting the nose, which occur when someone breathes in something they are allergic to, such as dust, dander, or pollen. These symptoms include chronic sneezing, congestion or runny nose.

Cryoablation: A minimally invasive procedure using a closed-probe, gas-based system. This procedure uses extremely cold temperatures to selectively destroy nerve endings to create a block that stops the conduction of symptoms, such as rhinorrhea or congestion.

Nonallergic rhinitis: The symptoms are similar to those of allergic rhinitis; however, the immune system is not involved. Formerly known as vasomotor rhinitis, no vascular basis for this condition has been established.

Reflective Total Nasal Symptom Score (rTNSS): An evaluation of the TNSS after a predefined period of time (such as one month). rTNSS is used to assess the degree of overall effectiveness after the predefined time period. This is in contrast to instantaneous TNSS, in which TNSS is evaluated at a specific time in therapy (such as immediately preceding the next dose of a medication).

Total Nasal Symptom Score (TNSS): A symptom severity scoring system, consisting of four individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0 = none, 1 = mild, 2 = moderate, or 3 = severe. The four individual scores are then added together for a maximum 12-point score which is based on the individual’s perceived symptom severity over the preceding 12 hours.

Peer Reviewed Publications:

1. Balai E, Gupta KK, Jolly K, Darr A. Posterior nasal nerve neurectomy for the treatment of rhinitis: a systematic review and meta-analysis. Eur Ann Allergy Clin Immunol. 2023; 55(3):101-114.
2. Calderón MA, Casale TB, Demoly P. Validation of patient-reported outcomes for clinical trials in allergic rhinitis: a systematic review. J Allergy Clin Immunol Pract. 2019; 7(5):1450-1461.
3. Chang MT, Song S, Hwang PH. Cryosurgical ablation for treatment of rhinitis: a prospective multicenter study. Laryngoscope. 2020; 130(8):1877-1884.
4. Desai V, Sampieri G, Namavarian A, Lee JM. Cryoablation for the treatment of chronic rhinitis: a systematic review. J Otolaryngol Head Neck Surg. 2023; 52(1):37.
5. Del Signore AG, Greene JB, Russell JL, et al. Cryotherapy for treatment of chronic rhinitis: 3-month outcomes of a randomized, sham-controlled trial. Int Forum Allergy Rhinol. 2022; 12(1):51-61.
6. Ehmer D, McDuffie CM, McIntyre JB, et al. Long-term outcomes following temperature-controlled radiofrequency neurolysis for the treatment of chronic rhinitis. Allergy Rhinol (Providence). 2022a; 13:21526575221096045.
7. Ehmer D, McDuffie CM, Scurry WC Jr, et al. Temperature-controlled radiofrequency neurolysis for the treatment of rhinitis. Am J Rhinol Allergy. 2022b; 36(1):149-156.
8. Fan T, Chandna M, Gorelik D, et al. Correlation between middle turbinate insertion in relation to sphenopalatine foramen and failure rates of cryotherapy and radiofrequency treatment for chronic rhinitis. Int Forum Allergy Rhinol. 2023; 13(1):88-91.
9. Gerka Stuyt JA, Luk L, Keschner D, Garg R. Evaluation of in-office cryoablation of posterior nasal nerves for the treatment of rhinitis. Allergy Rhinol (Providence). 2021; 12:2152656720988565.
10. Hwang PH, Lin B, Weiss R, et al. Cryosurgical posterior nasal tissue ablation for the treatment of rhinitis. Int Forum Allergy Rhinol. 2017; 7(10):952‐956.
11. Kompelli AR, Janz TA, Rowan NR, et al. Cryotherapy for the treatment of chronic rhinitis: a qualitative systematic review. Am J Rhinol Allergy. 2018; 32(6):491‐501.
12. Krespi YP, Wilson KA, Kizhner V. Laser ablation of posterior nasal nerves for rhinitis. Am J Otolaryngol. 2020; 41(3):102396.
13. Lee JT, Abbas GM, Charous DD, et al. Clinical and quality of life outcomes following temperature-controlled radiofrequency neurolysis of the posterior nasal nerve (RhinAer) for treatment of chronic rhinitis. Am J Rhinol Allergy. 2022; 36(6):747-754.
14. Lee JT, Abbas GM, Charous DD, et al. Three-year outcomes after temperature-controlled radiofrequency ablation of the posterior nasal nerve for chronic rhinitis. Am J Rhinol Allergy. 2025; 39(6):398-409.
15. Lee JT, Abbas GM, Charous DD, et al. Two-year outcomes after radiofrequency neurolysis of posterior nasal nerve in chronic rhinitis. Laryngoscope. 2024; 134(5):2077-2084.
16. Lin CC, Hwang YL, Liao JY, et al. Radiofrequency ablation versus laser neurolysis of the posterior nasal nerve in patients with chronic rhinitis. Otolaryngol Head Neck Surg. 2026; 174(4):954-962.
17. Liu S, Wang H, Su W. Endoscopic vidian neurectomy: the value of preoperative computed tomographic guidance. Arch Otolaryngol Head Neck Surg. 2010; 136(6):595-602.
18. Maddineni S, Hwang PH, Patel ZM, et al. Posterior nasal nerve surgical neurectomy versus ablation for chronic rhinitis. Am J Otolaryngol. 2025; 46(1):104553.
19. Ow RA, O'Malley EM, Han JK, et al. Cryosurgical ablation for treatment of rhinitis: two-year results of a prospective multicenter study. Laryngoscope. 2021; 131(9):1952-1957.
20. Rackerby N, Ahn C, Ball BD, et al. Evolving paradigms of treatment of allergic and nonallergic rhinitis. Ann Allergy Asthma Immunol. 2025; 135(1):15-22.
21. Reh DD, Lay K, Davis G, et al. Clinical evaluation of a novel multipoint radiofrequency ablation device to treat chronic rhinitis. Laryngoscope Investig Otolaryngol. 2023; 8(2):367-372.
22. Singh AK, Kasle DA, Torabi SJ, Manes RP. Adverse events associated with ClariFix posterior nasal nerve cryoablation: a MAUDE database analysis. Otolaryngol Head Neck Surg. 2021; 165(4):597-601.
23. Stolovitzky JP, Ow RA, Silvers SL, et al. Effect of radiofrequency neurolysis on the symptoms of chronic rhinitis: a randomized controlled trial. OTO Open. 2021; 5(3):2473974X211041124.
24. Stolovitzky JP, Ow RA, Silvers SL, et al. 3-year outcomes of temperature-controlled radiofrequency ablation of the posterior nasal nerve in patients with chronic rhinitis. Int Forum Allergy Rhinol. 2025: e23577.
25. Sur DKC, Plesa ML. Chronic nonallergic rhinitis. Am Fam Physician. 2018; 98(3):171-176.
26. Takashima M, Ow RA, Thrasher RD, et al. Impedance-controlled multipoint radiofrequency ablation for chronic rhinitis: a randomized controlled trial. Int Forum Allergy Rhinol. 2026 Jan 8. Online ahead of print.
27. Takashima M, Stolovitzky JP, Ow RA, et al. Temperature-controlled radiofrequency neurolysis for treatment of chronic rhinitis: 12-month outcomes after treatment in a randomized controlled trial. Int Forum Allergy Rhinol. 2023; 13(2):107-115.
28. Takashima M, Stolovitzky JP, Ow RA, et al. Temperature-controlled radiofrequency ablation for the treatment of chronic rhinitis: two-year outcomes from a prospective multicenter trial. Int Forum Allergy Rhinol. 2024; 14(7):1182-1194.
29. Torabi SJ, Bitner BF, Abello EH, et al. Complications of novel radiofrequency device use in rhinology: a MAUDE analysis. Otolaryngol Head Neck Surg. 2024; 170(2):605-609.
30. Yan CH, Hwang PH. Surgical management of nonallergic rhinitis. Otolaryngol Clin North Am. 2018; 51(5):945‐955.
31. Yen D, B Conley D, O'Malley EM, Byerly TA, Johnson J. Multiple site cryoablation treatment of the posterior nasal nerve for treatment of chronic rhinitis: an observational feasibility study. Allergy Rhinol (Providence). 2020; 11:2152656720946996.
32. Yen DM, Davis GE, Ow RA, et al. Two-year clinical outcomes after multipoint impedance-controlled radiofrequency ablation of the posterior nasal nerve for treatment of chronic rhinitis. Ear Nose Throat J. 2025: 1455613251382759.
33. Young K, Bulosan H, Kejriwal S, et al. Efficacy of cryoablation on chronic rhinitis management: a systematic review and meta-analysis. Am J Rhinol Allergy. 2023; 37(4):502-511.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American Academy of Otolaryngology- Head and Neck Surgery (AAO-HNS). Position statement: PNN ablation for the treatment of chronic rhinitis. January 17, 2023. Available at: https://www.entnet.org/resource/position-statement-posterior-nasal-nerve/. Accessed on April 23, 2026.
2. American Rhinologic Society (ARS). Posterior nasal nerve ablation ARS position statement. January 2022. Available at: https://www.american-rhinologic.org/index.php?option=com_content&view=article&id=478:posterior-nasal-nerve-ablation&catid=26:position-statements&Itemid=197. Accessed on April 23, 2026.
3. U.S. Food and Drug Administration (FDA). 510(k) Premarket notification database. Summary of safety and effectiveness. Rockville, MD: FDA. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed on April 23, 2026.
   • ClariFix Device. K162608. February 14, 2017.
   • Neuromark System. K212666. October 22, 2021.
   • RHIN1 Stylus. K192471. December 20, 2019.
4. U.S. FDA. Allergic rhinitis: Developing drug products for treatment guidance for industry. September 2018. Available at: https://www.fda.gov/media/71158/download. Accessed on April 23, 2026.
5. Wise SK, Damask C, Roland LT, et al. International consensus statement on allergy and rhinology: allergic rhinitis - 2023. Int Forum Allergy Rhinol. 2023; 13(4):293-859.

1. American Academy of Allergy, Asthma & Immunology (AAAAI). Allergy, Asthma & Immunology Glossary. Available at: https://www.aaaai.org/Tools-for-the-Public/Allergy,-Asthma-Immunology-Glossary. Accessed on April 23, 2026.
2. American Academy of Otolaryngology- Head and Neck Surgery (AAO-HNS). Allergic Rhinitis (Nasal Allergies or Hay Fever). Available at: https://www.entnet.org/sites/default/files/uploads/PracticeManagement/Resources/_files/allergic-rhinitis-plain-language-summary.pdf. Accessed on April 23, 2026.

ClariFix
RhinAer
Temperature-controlled radiofrequency (TCRF) neurolysis

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