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. 2022 Apr 1;148(4):307-315.
doi: 10.1001/jamaoto.2021.4414.

Assessment of Sudden Sensorineural Hearing Loss After COVID-19 Vaccination

Eric J Formeister  1 , Matthew J Wu  2 , Divya A Chari  3 , Robert Meek 3rd  4 , Steven D Rauch  2 , Aaron K Remenschneider  3 , Alicia M Quesnel  2 , Ronald de Venecia  2 , Daniel J Lee  2 , Wade Chien  1 , C Matthew Stewart  1 , Deepa Galaiya  1 , Elliott D Kozin  2 , Daniel Q Sun  1
Affiliations

Assessment of Sudden Sensorineural Hearing Loss After COVID-19 Vaccination

Eric J Formeister et al. JAMA Otolaryngol Head Neck Surg. .

Erratum in

  • Error in Data.
    [No authors listed] [No authors listed] JAMA Otolaryngol Head Neck Surg. 2022 Nov 1;148(11):1082. doi: 10.1001/jamaoto.2022.3635. JAMA Otolaryngol Head Neck Surg. 2022. PMID: 36355364 Free PMC article. No abstract available.

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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Conflict of interest statement

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.

Figures

Figure 1.
Figure 1.. Reports of Sudden Sensorineural Hearing Loss (SSNHL) by Week of COVID-19 Vaccination
A, Distribution of reports of SSNHL by week of vaccination and time to onset after vaccination. The rate of SSNHL reports per 100 000 vaccine doses (blue line) is overlaid. B, Mean age of people reporting SSNHL to VAERS according to the time period reported who met the definition of probable SSNHL (n = 555). Note that the weekly time periods are identical in A and B. VAERS indicates Vaccine Adverse Events Reporting System.
Figure 2.
Figure 2.. Time to Onset of Sudden Sensorineural Hearing Loss (SSNHL) After COVID-19 Vaccination
A, Includes 555 cases reported to the VAERS database that met the definition of probable SSNHL during the period examined. B, Includes 21 patients in multi-institutional case series. The x-axis extends to only 15 days after vaccination because no new cases were observed after day 15. VAERS indicates Vaccine Adverse Events Reporting System.
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