A Case Report of Sudden Sensorineural Hearing Loss (SSNHL) After Administration of the COVID-19 Vaccine.

Since the issuance of the emergency use authorization (EUA) of 3 coronavirus disease 2019 (COVID-19) vaccines, there have been over 180 million individuals fully vaccinated in the United States (US). With the increasing administration of COVID-19 vaccinations, there have been over 550,000 adverse events reported in the Vaccine Adverse Event Reporting System (VAERS) with approximately 230,000 experienced after receipt of the Pfizer-BioNTech COVID-19 Vaccine as of September 23rd 2021. Audio-vestibular symptoms (including Sudden Sensorineural Hearing Loss (SSNHL)) secondary to immunizations has previously been evaluated. However, this report describes the first case of bilateral sudden sensorineural hearing loss potentially due to the Pfizer-BioNTech COVID-19 vaccine. We further review the available literature regarding the treatment of Sudden Sensorineural Hearing Loss, and the association of SSNHL with previous immunizations and COVID-19 infection. Lastly, we hypothesize the underlying potential mechanisms between SSNHL and the Pfizer-BioNTech COVID-19 vaccine.

Quality-of-life impact after in-office treatment of nasal valve obstruction with a radiofrequency device: 2-year results from a multicenter, prospective clinical trial.

BACKGROUND: Insufficiency of the nasal valve is increasingly being recognized as a cause of nasal airway obstruction. The condition is associated with many symptoms, including nasal congestion, sleep disturbance, snoring, and an overall decline in quality of life (QoL). An in-office, minimally invasive radiofrequency treatment of the nasal valve has been associated with improved symptoms of nasal obstruction and patients' QoL for a 6-month period in a noncontrolled, prospective, single-arm study. The purpose of this study was to determine whether the results achieved with radiofrequency treatment at 6 months would be sustained through 24 months. METHODS: Thirty-nine adult patients from an original cohort of 49 patients with severe to extreme Nasal Obstruction Symptom Evaluation (NOSE) Scale scores and dynamic or static internal nasal valve obstruction as the primary or significant contributor to obstruction were studied. Patients received intranasal bilateral radiofrequency treatment in a clinical study with a follow-up to 6 months, and were prospectively evaluated at 12, 18, and 24 months at 8 community-based otolaryngology practices. The patient-reported NOSE Scale score and 21 QoL questions were assessed. RESULTS: Clinically significant improvement from baseline in NOSE Scale score change demonstrated at 6 months (mean, 55.9; standard deviation [SD], 23.6; p < 0.0001) was maintained through 24 months (mean, 53.5; SD, 24.6; p < 0.0001). Responders (≥15-point improvement) consisted of 92.3% of participants at 6 months and 97.2% at 24 months. Responses to the QoL questions also showed improvement in patients' QoL. CONCLUSION: Treatment of the nasal valve with an in-office, transnasal temperature-controlled radiofrequency procedure was associated with stable and lasting improvement in symptoms of nasal obstruction and QoL through 24 months in this noncontrolled, single-arm study.

In-office treatment of nasal valve obstruction using a novel, bipolar radiofrequency device.

OBJECTIVES: To assess the safety and effectiveness of in-office bipolar radiofrequency treatment of nasal valve obstruction. STUDY DESIGN: Prospective, nonrandomized, multicenter case series. METHODS: Adult patients with a Nasal Obstruction Symptom Evaluation scale (NOSE) score ≥60 were selected. Patients were clinically diagnosed with dynamic or static internal nasal valve obstruction as primary or significant contributor to obstruction and were required to have a positive response to nasal mechanical dilators or lateralization maneuvers. Bilateral radio-frequency treatment was applied intranasally using a novel device, under local anesthesia in a single session. Safety and tolerance were assessed by event reporting, inspection, and Visual Analogue Scale (VAS) for pain. Efficacy was determined using the NOSE score and patient-reported satisfaction survey at 26 weeks. RESULTS: Fifty patients were treated. No device or procedure-related serious adverse events occurred. Soreness, edema, and crusting resolved by 1 month. The mean baseline NOSE score was 79.9 (SD 10.8, range 60-100), and all had severe or extreme obstruction. At 26 weeks, mean NOSE score was 69% lower at 24.7 (P < .0001) with 95% two-sided confidence intervals 48.5 to 61.1 for decrease. The decrease in NOSE score did not differ significantly between patients who did or did not have prior nasal surgery. Patient satisfaction mean by survey was 8.2 of 10. CONCLUSION: In office treatment of internal nasal valve obstruction using a bipolar radiofrequency device is safe and well-tolerated. Nasal obstruction, as assessed using the NOSE questionnaire at 26 weeks, was markedly improved with high patient satisfaction. LEVEL OF EVIDENCE: 2b, prospective cohort.