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Assessment of Sudden Sensorineural Hearing Loss After COVID-19 Vaccination

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME
Key Points

Question  Is COVID-19 vaccination associated with sudden sensorineural hearing loss (SSNHL)?

Findings  In this cross-sectional study and case series involving 555 cases of SSNHL among adults reported to the Centers for Disease Control and Prevention Vaccine Adverse Events Reporting System, no increase in the rate of hearing loss after COVID-19 vaccination was found compared with the incidence in the general population. Assessment of 21 adult patients who presented to tertiary care centers with SSNHL after COVID-19 vaccination did not reveal any apparent associations with respect to clinical or demographic factors.

Meaning  These results suggest that there is no association between vaccination and the development of SSNHL among adults who received a COVID-19 vaccine.

Abstract

Importance  Emerging reports of sudden sensorineural hearing loss (SSNHL) after COVID-19 vaccination within the otolaryngological community and the public have raised concern about a possible association between COVID-19 vaccination and the development of SSNHL.

Objective  To examine the potential association between COVID-19 vaccination and SSNHL.

Design, Setting, and Participants  This cross-sectional study and case series involved an up-to-date population-based analysis of 555 incident reports of probable SSNHL in the Centers for Disease Control and Prevention Vaccine Adverse Events Reporting System (VAERS) over the first 7 months of the US vaccination campaign (December 14, 2020, through July 16, 2021). In addition, data from a multi-institutional retrospective case series of 21 patients who developed SSNHL after COVID-19 vaccination were analyzed. The study included all adults experiencing SSNHL within 3 weeks of COVID-19 vaccination who submitted reports to VAERS and consecutive adult patients presenting to 2 tertiary care centers and 1 community practice in the US who were diagnosed with SSNHL within 3 weeks of COVID-19 vaccination.

Exposures  Receipt of a COVID-19 vaccine produced by any of the 3 vaccine manufacturers (Pfizer-BioNTech, Moderna, or Janssen/Johnson & Johnson) used in the US.

Main Outcomes and Measures  Incidence of reports of SSNHL after COVID-19 vaccination recorded in VAERS and clinical characteristics of adult patients presenting with SSNHL after COVID-19 vaccination.

Results  A total of 555 incident reports in VAERS (mean patient age, 54 years [range, 15-93 years]; 305 women [55.0%]; data on race and ethnicity not available in VAERS) met the definition of probable SSNHL (mean time to onset, 6 days [range, 0-21 days]) over the period investigated, representing an annualized incidence estimate of 0.6 to 28.0 cases of SSNHL per 100 000 people per year. The rate of incident reports of SSNHL was similar across all 3 vaccine manufacturers (0.16 cases per 100 000 doses for both Pfizer-BioNTech and Moderna vaccines, and 0.22 cases per 100 000 doses for Janssen/Johnson & Johnson vaccine). The case series included 21 patients (mean age, 61 years [range, 23-92 years]; 13 women [61.9%]) with SSNHL, with a mean time to onset of 6 days (range, 0-15 days). Patients were heterogeneous with respect to clinical and demographic characteristics. Preexisting autoimmune disease was present in 6 patients (28.6%). Of the 14 patients with posttreatment audiometric data, 8 (57.1%) experienced improvement after receiving treatment. One patient experienced SSNHL 14 days after receiving each dose of the Pfizer-BioNTech vaccine.

Conclusions and Relevance  In this cross-sectional study, findings from an updated analysis of VAERS data and a case series of patients who experienced SSNHL after COVID-19 vaccination did not suggest an association between COVID-19 vaccination and an increased incidence of hearing loss compared with the expected incidence in the general population.

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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

Article Information

Accepted for Publication: January 3, 2022.

Published Online: February 24, 2022. doi:10.1001/jamaoto.2021.4414

Corresponding Author: Eric J. Formeister, MD, MS, Department of Otolaryngology–Head and Neck Surgery, Johns Hopkins University School of Medicine, 601 N Caroline St, 6th Floor, Baltimore, MD 21287 (eformei1@jh.edu).

Author Contributions: Drs Formeister and Sun had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Drs Galaiya, Kozin, and Sun contributed equally.

Concept and design: Formeister, Wu, Chari, Rauch, Remenschneider, Quesnel, Stewart, Galaiya, Kozin, Sun.

Acquisition, analysis, or interpretation of data: Formeister, Wu, Chari, Meek, Rauch, Remenschneider, Quesnel, de Venecia, Lee, Chien, Stewart, Kozin, Sun.

Drafting of the manuscript: Formeister, Wu, Chari, Stewart, Kozin, Sun.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Formeister, Wu, Sun.

Obtained funding: Sun.

Administrative, technical, or material support: Wu, Chari, Meek, Remenschneider, de Venecia, Galaiya, Sun.

Supervision: Chari, Remenschneider, Quesnel, Chien, Stewart, Galaiya, Kozin, Sun.

Conflict of Interest Disclosures: Dr Lee reported receiving personal fees from 3NT Medical and income and personal fees from Frequency Therapeutics outside the submitted work. Dr Quesnel reported receiving grants from Frequency Therapeutics and Grace Medical and personal fees from Frequency Therapeutics, and owning a patent for a protective drape to mitigate aerosol spread during otologic surgery (licensed to Grace Medical) outside the submitted work. No other disclosures were reported.

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