Sudden sensorineural hearing loss was reported after people received COVID-19 vaccines but appeared to occur less frequently than expected, a preliminary analysis suggested.
Incidence estimates of sudden sensorineural hearing loss after COVID-19 vaccination ranged from 0.3 to 4.1 per 100,000 per year based on Vaccine Adverse Events Reporting System () data, reported Eric Formeister, MD, MS, of Johns Hopkins University School of Medicine in Baltimore, and co-authors in .
The American Academy of Otolaryngology-Head and Neck Surgery estimates that sudden sensorineural hearing loss affects people annually, with about 66,000 new cases a year in the U.S.
"Among the otolaryngology community and larger medical community, there is a lot of interest surrounding a perception of an increased rate of sudden hearing loss that has been observed in some patients after COVID vaccination," Formeister told 鶹ý.
"However, sudden hearing loss can also occur naturally, so it is not known whether sudden hearing loss occurring after COVID vaccination is coincidental or may be related to the vaccine," he added. "Further, some patients who have suffered sudden hearing loss after the first dose have been hesitant to receive the second dose due to safety concerns."
Sudden sensorineural hearing loss often is a debilitating condition, noted Elliott Kozin, MD, of Massachusetts Eye and Ear in Boston, who wasn't involved with the study. "In addition to hearing loss, it may result in ear fullness, tinnitus, and occasionally dizziness," he told 鶹ý.
This report is "appropriately called a preliminary analysis, as we still do not have definitive data on the subject," but it's a critical first step to understanding SARS-CoV-2 vaccine safety and hearing health, Kozin said.
"Unanswered questions include whether providers should still recommend a second vaccination if a patient experiences hearing symptoms after an initial vaccine dose," he pointed out.
"In addition, treatment of sudden sensorineural hearing loss is typically a short course of oral or injected steroids," Kozin added. "We do not know if the treatment of sudden sensorineural hearing loss with steroids may decrease the efficacy of concurrent vaccination."
In VAERS, Formeister and colleagues found 147 reports of sudden hearing loss, deafness, deafness unilateral, deafness neurosensory, and hypoacusis associated with COVID vaccinations from December 14, 2020 to March 2, 2021.
Of these reports, 40 had a temporal association (hearing loss onset occurred within 3 weeks of vaccination) and high credibility (they had been reported by a healthcare clinician with documented audiologic findings or steroid treatment). These 40 reports were classified as "most likely."
The mean age in the most likely group was 56, and most cases (63%) involved women. Twelve people received Moderna vaccines and 28 received Pfizer. Sudden sensorineural hearing loss occurred an average of 4 days after vaccination. Thirty of the 40 cases were treated with steroids.
Based on about 86 million SARS-CoV-2 vaccine doses that had been administered in the U.S. during the study period and using only the 40 most likely reports, the researchers estimated a minimum incidence of 0.3 per 100,000 per year, assuming a single vaccine dose per person.
Maximum incidence, based on two vaccine doses per person and using all 147 VAERS reports in the time period, was estimated to be 4.1 per 100,000 per year. This took into account the fact that the exact number of unique individuals receiving a vaccine was unknown.
"These results so far provide evidence that COVID vaccination is not associated with sudden hearing loss," Formeister said.
"One of the pushes behind this publication is to urge clinicians and patients alike to report adverse events to the Vaccine Adverse Events Reporting System, so we may accrue more data to allow a more accurate prediction of the rate of sudden hearing loss after COVID-19 vaccination," he noted.
Patients who experience after vaccination should contact their healthcare provider immediately, Formeister added. Sudden sensorineural hearing loss is potentially treatable, but treatment efficacy is time-sensitive.
The reporting period did not include vaccines other than Pfizer and Moderna, the researchers acknowledged. VAERS reports are unverified and subject to underreporting bias. People may experience multiple adverse effects after vaccination and these may not be fully captured in VAERS.
Disclosures
The researchers reported no conflicts of interest.
Primary Source
JAMA Otolaryngology-Head & Neck Surgery
Formeister EJ, et al "Preliminary analysis of association between COVID-19 vaccination and sudden hearing loss using US Centers for Disease Control and Prevention Vaccine Adverse Events Reporting System data" JAMA Otolaryngol Head Neck Surg 2021; DOI: 10.1001/jamaoto.2021.0869.