Medical Policy

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, 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). There are studies underway evaluating laser ablation of the PNN, but there is no FDA approved device at this time.

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

• CG-SURG-117 Balloon Dilation of the Eustachian Tubes
• MED.00091 Rhinophototherapy

Investigational and 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 investigational and not medically necessary in all cases.

Ablation of the PNN is proposed to improve symptoms of chronic rhinitis by reducing parasympathetic tone, secretions, and vasomotor activity. PNN ablation can be completed using surgical dissection or with thermal ablation using cryotherapy, radiofrequency, or laser energy.  

In 2023, Balai and colleagues assessed the effect of PNN treatment on the Total Nasal Symptom Score (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 (6), radiofrequency therapy (1), or laser therapy (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. The analysis found limited evidence showing that cryotherapy or radiofrequency therapy of the PNN results in a higher response rate and greater TNSS improvement in the active treatment group compared to the sham treatment group. This conclusion was based on two randomized, controlled trials (RCTs). The authors note that the quality of current evidence is limited based primarily on a lack of a comparator group in most studies and the short-term follow-up periods.

Cryotherapy

The ClariFix device was cleared by 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. While it is noted “there is paucity of studies concerning the vidian neurectomy by means of cryosurgery”, the FDA indicated that the safety profile and effectiveness results are comparable to the results published regarding cryosurgical ablation.

Hwang and colleagues (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 versus 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 improvement in symptoms may have confounded the results.

In an industry sponsored prospective single arm study by Chang and colleagues (2019), 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 Reflective TNSS (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 adverse events (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 headache, eye dryness, 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 and colleagues (2021) published additional post-procedure results (12-24 months) of the prospective single-arm study described above (Chang, 2019). 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. Randomized trials with a control or sham treatment arm evaluating outcomes are needed to evaluate the relative net health benefit of this treatment compared to standard treatment.

Cryotherapy has been used by others to ablate posterior nasal tissue. Kompelli and associates (2018) published a qualitative systemic review regarding cryotherapy for the treatment of chronic rhinitis. Only one study (Hwang, 2017 – described above) used a cryosurgical device to treat the PNN area. While the authors note that cryotherapy appears to be safe and efficacious, the past evidence includes only low quality, heterogeneous and outdated studies. The current studies use symptom scoring measures (TNSS or rTNSS) as a measure of efficacy within the treated population. These survey instruments have not been validated across a wide range of populations, limiting their general usefulness (Calderón, 2019).

Yen and colleagues (2020) evaluated cryoablation of the PNN at the inferior and middle meatus in 30 individuals with moderate to severe rhinorrhea and mild to severe nasal congestion for at least 3 months. The majority of previous studies were limited to applying cryoablation to the PNN at the middle meatus. While the participants reported significant symptom improvement at 3 months, the study was limited by the limited number of participants and follow-up and no control arm. This is representative of the body of evidence for this technology; larger studies with long-term follow-up are needed to better assess the safety and efficacy of this therapy.

The 3-month results of a prospective, multicenter, 1:1 randomized, sham-controlled, patient-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.

In 2023, Young and colleagues 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 DelSignore described above. Young, et al. note 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 of 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. The documented AEs were minor, no major AEs were reported. There were several limitations noted by the authors. The analysis included one 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 shows 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.

Radiofrequency (RF) Energy

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 posterior nasal nerve 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% CI, 55.9%-77.8%) versus 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. The authors anticipate follow-up through 2 years to assess durability of response.

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 contained 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 and colleagues (2024) reported on 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%).

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 studies showed no serious AEs with a 6-month follow-up. The Neuromark system device has multiple proximal and distal microablation points to maximize the area which 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.

Studies evaluating RF devices have reported 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”.

The majority of published studies are industry-sponsored with 12 months or less follow-up. Further studies with a comparator group and long-term follow-up are needed.

Laser Ablation

Krespi and colleagues (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 following 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.

Currently, there are no laser devices which are FDA approved for ablation in the nasal area in the treatment of rhinitis. Adequately powered randomized controlled studies are needed to evaluate net health benefits from the use of laser ablation for the treatment of chronic rhinitis.

Chronic rhinitis can be categorized as allergic, nonallergic and 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 obstruction, postnasal drip, itching, redness, clear rhinorrhea, and watery eyes. However, the underlying pathophysiology of allergic and nonallergic rhinitis differs. Allergic rhinitis is caused by exposure to specific sensitivity triggers which results in the secretion of multiple proinflammatory mediators, manifesting 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). Initial treatment consists of avoidance of known triggers and pharmacologic management (Liu, 2010). Approximately 10% to 22% of individuals with rhinitis are refractory to medical management (Balai, 2023).

There are surgical alternatives 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. PNN resection, which 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).

The PNN can be accessed at the middle and inferior meatus. Minimally invasive treatment using cryotherapy involves consecutive bilateral application of cold to the mucosa in the region of the PNN under endoscopic visualization. It can be performed under local anesthesia. Cryotherapy reduces parasympathetic tone and both secretory and vasoactive activity in the PNN area. The procedure may require periodic repeat sessions to maintain clinical benefit. Minimally invasive treatment may also use radiofrequency energy to disrupt the PNN activation process by destroying tissue in the PNN area while preserving surrounding tissue. There is no literature regarding whether repeat sessions might be required. Repeat sessions at some point may be required as peripheral regeneration takes place at a rate of 1-6 inches/month (Ehmer, 2022a).

Allergic rhinitis: A group of symptoms affecting the nose, which occur when someone breathes in something they are allergic to, such as dust, dander, insect venom, 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 maximum 12-point score which is based on the individuals perceived symptom severity over the preceding 12 hours.

The following codes for treatments and procedures applicable to this document 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 Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

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. 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.
9. 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.
10. 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.
11. Krespi YP, Wilson KA, Kizhner V. Laser ablation of posterior nasal nerves for rhinitis. Am J Otolaryngol. 2020;41(3):102396.
12. 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.
13. 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.
14. 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.
15. 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.
16. 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.
17. 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.
18. 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.
19. Sur DKC, Plesa ML. Chronic nonallergic rhinitis. Am Fam Physician. 2018; 98(3):171-176.
20. 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.
21. 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.
22. Yan CH, Hwang PH. Surgical management of nonallergic rhinitis. Otolaryngol Clin North Am. 2018; 51(5):945‐955.
23. 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.
24. 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. Aerin Medical. Clinical evaluation of low power radiofrequency energy applied to the posterior nasal nerve area for symptomatic relief of chronic rhinitis. NLM Identifier: NCT03727347. Last updated June 16, 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03727347?term=NCT03727347&draw=2&rank=1. Accessed on July 2, 2024.
2. 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 July 2, 2024.
3. 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 July 2, 2024.
4. 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 July 2, 2024.
   • ClariFix Device. K162608. February 14, 2017.
   • Neuromark System. K212666. October 22, 2021.
   • RHIN1 Stylus. K192471. December 20, 2019.
5. 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 July 2, 2024.

1. American Academy of Allergy, Asthma & Immunology (AAAAI). Allergic and Nonallergic Rhinitis. Available at: https://www.aaaai.org/Tools-for-the-Public/Allergy,-Asthma-Immunology-Glossary. Accessed on July 2, 2024.
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 July 2, 2024.

ClariFix
RhinAer
Temperature-controlled radiofrequency (TCRF) neurolysis

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member’s contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

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