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Objective: To assess long-term safety and effectiveness of a multipoint, impedancecontrolled, RF ablation device for treatment of chronic rhinitis through 12-month follow-up. Methods: A prospective, multicenter study. Bilateral posterior nasal nerve (PNN) ablation was performed on all participants. Assessments at 6-, 9-, and 12-month visits included Visual Analog Scale Nasal Symptom Score (VAS NSS), reflective Total Nasal Symptom Score (rTNSS), mini-Rhinoconjunctivitis Quality of Life Questionnaire (mini RQLQ), and adverse events. Results: Thirty-six participants were enrolled and 35 completed the 12-month followup. All 5 VAS NSS items demonstrated statistically significant improvement (p < .0001) over baseline at all 3 time points. The total rTNSS improved from 7.9 ± 1.8 at baseline to 4.3 ± 2.1 at 6-months, 3.8 ± 2.4 at 9-months, and 4.0 ± 2.1 at 12-months (all p < .0001). At 12-months, 91% (31/35) of participants had achieved the minimum clinically important difference (MCID) of a reduction from baseline of =1 point and 80% (28/35) of the participants met the responder criteria of =30% reduction from baseline. The total mean mini RQLQ was reduced from 3.0 ± 1.0 at baseline to 1.4 ± 0.8 at 6-months, 1.4 ± 1.0 at 9-months, and 1.3 ± 0.8 at 12-months (all p < .0001). At 12-months, 86% (30/35) of participants achieved the MCID of a reduction from baseline of =0.4 points for the mini RQLQ. No related serious adverse events occurred during the study. Conclusions: Impedance-controlled RF ablation of the PNN is safe and resulted in durable, significant improvement in rhinitis symptoms and quality of life through 12-month follow-up. [ABSTRACT FROM AUTHOR]

Objective: Evaluate 2‐year outcomes after lidocaine/epinephrine iontophoresis and tympanostomy using an automated tube delivery system for pediatric tube placement in‐office. Study Design: Prospective, single‐arm. Setting: Eighteen otolaryngology practices. Methods: Children age 6 months to 12 years indicated for tympanostomy were enrolled between October 2017 and February 2019. Local anesthesia of the tympanic membrane was achieved via lidocaine/epinephrine iontophoresis and tympanostomy was completed using an automated tube delivery system (the Tula® System). An additional Lead‐In cohort of patients underwent tube placement in the operating room (OR) under general anesthesia using only the tube delivery system. Patients were followed for 2 years or until tube extrusion, whichever occurred first. Otoscopy and tympanometry were performed at 3 weeks, and 6, 12, 18, and 24 months. Tube retention, patency, and safety were evaluated. Results: Tubes were placed in‐office for 269 patients (449 ears) and in the OR for 68 patients (131 ears) (mean age, 4.5 years). The median and mean times to tube extrusion for the combined OR and In‐Office cohorts were 15.82 (95% confidence interval [CI]: 15.41‐19.05) and 16.79 (95% CI: 16.16‐17.42) months, respectively. Sequelae included ongoing perforation for 1.9% of ears (11/580) and medial tube displacement for 0.2% (1/580) observed at 18 months. Over a mean follow‐up of 14.3 months, 30.3% (176/580) of ears had otorrhea and 14.3% (83/580) had occluded tubes. Conclusion: In‐office pediatric tympanostomy using lidocaine/epinephrine iontophoresis and automated tube delivery results in tube retention within the ranges described for similar grommet‐type tubes and complication rates consistent with traditional tube placement in the OR. [ABSTRACT FROM AUTHOR]

Objective: Safety and efficacy of the NEUROMARK® system for treating chronic rhinitis. Methods: A prospective, single‐arm, multicenter study was performed on adults with chronic rhinitis who underwent radiofrequency ablation to the posterior nasal nerves. Primary endpoints were device‐related serious adverse events (SAEs) at 1 month and change from baseline in visual analog scale nasal symptom scale (VAS NSS) for rhinorrhea and nasal congestion at 3 months. Total nasal symptom score (rTNSS) and mini Rhinoconjunctivitis Quality of Life Questionnaire (mini RQLQ) score were also evaluated. Results: Thirty‐six participants were enrolled and completed follow‐up at 1 and 3 months. Mean VAS NSS scores for rhinorrhea and nasal congestion demonstrated significant improvement at 3 months (both p <.0001). The mean percent changes from baseline in VAS rhinorrhea and nasal congestion were 53% and 55%, respectively. Total scores and all individual rTNSS items significantly improved (all p <.001) over the measured interval. Percent responder rate (≥30% reduction from baseline in total rTNSS) at 3 months was 78%. The total mean mini RQLQ scores, as well as all subdomains, improved significantly (all p <.0001). At 3 months, 89% of participants reported a minimal clinically important difference of ≥0.4 point improvement in the mini RQLQ score. No SAEs occurred during the study. Conclusions: The NEUROMARK System is a novel radiofrequency ablation device that provides safe and effective treatment to the posterior nasal nerves for patients with chronic rhinitis. Study participants experienced statistically significant and clinically meaningful improvement in symptoms and quality of life assessments at 3 months post‐procedure. Trial Registration: The study is registered at www.clinicaltrials.gov with the unique identifier of NCT05324397. Level of Evidence: 4. [ABSTRACT FROM AUTHOR]

Objectives/Hypothesis: To assess the long‐term (12–24 months) safety and effectiveness of cryoablation of the posterior nasal nerve as treatment for chronic rhinitis. Study Design: A multicenter, prospective, single‐arm clinical study. Methods: The study was conducted from February 2017 to April 2020. Study endpoints included change from baseline in the reflective Total Nasal Symptom Score (rTNSS), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), physician assessment of improvement using the Clinical Global Impression–Improvement (CGI–I), and the incidence of treatment‐related adverse events. Results: Ninety‐one participants completed the study through the initial 12‐month study period. Sixty‐two participants consented to the long‐term follow‐up with 57 completing the 24‐month follow‐up. Significant improvements in the total rTNSS were reflected in a median change from baseline of −3.0 or −4.0 at all timepoints (P <.001). Greater than 80.0% of participants achieved the minimum clinically important difference (MCID) of improvement by ≥1 point on the rTNSS at all follow‐ups. Total RQLQ scores indicated significant improvement (P <.0001) in quality of life. Over 77% of participants achieved the MCID (≥0.5 points) for the total RQLQ score. According to the CGI–I, ≥83.0% experienced improvement at all but the 12‐month visit (61.9%). One participant experienced two treatment‐related serious adverse events (epistaxis and retained pledget). A total of 29 nonserious treatment‐related AEs were reported in 23 participants; most events were transient and resolved with little to no intervention. Conclusions: Cryotherapy significantly and clinically improves rhinitis symptoms and quality of life with outcomes that are durable through 24 months after treatment. Level of Evidence: 4 Laryngoscope, 131:1952–1957, 2021 [ABSTRACT FROM AUTHOR]

Objectives/hypothesis: Evaluate technical success, tolerability, and safety of lidocaine iontophoresis and tympanostomy tube placement for children in an office setting.Study Design: Prospective individual cohort study.Methods: This prospective multicenter study evaluated in-office tube placement in children ages 6 months through 12 years of age. Anesthesia was achieved via lidocaine/epinephrine iontophoresis. Tube placement was conducted using an integrated and automated myringotomy and tube delivery system. Anxiolytics, sedation, and papoose board were not used. Technical success and safety were evaluated. Patients 5 to 12 years old self-reported tube placement pain using the Faces Pain Scale-Revised (FPS-R) instrument, which ranges from 0 (no pain) to 10 (very much pain).Results: Children were enrolled into three cohorts with 68, 47, and 222 children in the Operating Room (OR) Lead-In, Office Lead-In, and Pivotal cohorts, respectively. In the Pivotal cohort, there were 120 and 102 children in the <5 and 5- to 12-year-old age groups, respectively, with a mean age of 2.3 and 7.6 years, respectively. Bilateral tube placement was indicated for 94.2% of children <5 and 88.2% of children 5 to 12 years old. Tubes were successfully placed in all indicated ears in 85.8% (103/120) of children <5 and 89.2% (91/102) of children 5 to 12 years old. Mean FPS-R score was 3.30 (standard deviation [SD] = 3.39) for tube placement and 1.69 (SD = 2.43) at 5 minutes postprocedure. There were no serious adverse events. Nonserious adverse events occurred at rates similar to standard tympanostomy procedures.Conclusions: In-office tube placement in selected patients can be successfully achieved without requiring sedatives, anxiolytics, or papoose restraints via lidocaine iontophoresis local anesthesia and an automated myringotomy and tube delivery system.Level Of Evidence: 2b Laryngoscope, 130:S1-S9, 2020. [ABSTRACT FROM AUTHOR]

In Response to Letter to the Editor Regarding In-Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery Thank you for your comments regarding our article "In-Office Tympanostomy Tube Placement in Children Using Iontophoresis and Automated Tube Delivery."1 We appreciate the opportunity to provide additional information and clarification in response to your Letter to the Editor. Verbal and physical responses to the anesthesia assessment were evaluated to determine anesthesia effectiveness. [Extracted from the article]