Safety Signal Generation for Sudden Sensorineural Hearing Loss Following Messenger RNA COVID-19 Vaccination: Postmarketing Surveillance Using the French Pharmacovigilance Spontaneous Reporting Database.

BACKGROUND: The World Health Organization recently described sudden sensorineural hearing loss (SSNHL) as a possible adverse effect of COVID-19 vaccines. Recent discordant pharmacoepidemiologic studies invite robust clinical investigations of SSNHL after COVID-19 messenger RNA (mRNA) vaccines. This postmarketing surveillance study, overseen by French public health authorities, is the first to clinically document postvaccination SSNHL and examine the role of potential risk factors. OBJECTIVE: This nationwide study aimed to assess the relationship between SSNHL and exposure to mRNA COVID-19 vaccines and estimate the reporting rate (Rr) of SSNHL after mRNA vaccination per 1 million doses (primary outcome). METHODS: We performed a retrospective review of all suspected cases of SSNHL after mRNA COVID-19 vaccination spontaneously reported in France between January 2021 and February 2022 based on a comprehensive medical evaluation, including the evaluation of patient medical history, side and range of hearing loss, and hearing recovery outcomes after a minimum period of 3 months. The quantification of hearing loss and assessment of hearing recovery outcomes were performed according to a grading system modified from the Siegel criteria. A cutoff of 21 days was used for the delay onset of SSNHL. The primary outcome was estimated using the total number of doses of each vaccine administered during the study period in France as the denominator. RESULTS: From 400 extracted cases for tozinameran and elasomeran, 345 (86.3%) spontaneous reports were selected. After reviewing complementary data, 49.6% (171/345) of documented cases of SSNHL were identified. Of these, 83% (142/171) of SSNHL cases occurred after tozinameran vaccination: Rr=1.45/1,000,000 injections; no difference for the rank of injections; complete recovery in 22.5% (32/142) of cases; median delay onset before day 21=4 days (median age 51, IQR 13-83 years); and no effects of sex. A total of 16.9% (29/171) of SSNHL cases occurred after elasomeran vaccination: Rr=1.67/1,000,000 injections; rank effect in favor of the first injection (P=.03); complete recovery in 24% (7/29) of cases; median delay onset before day 21=8 days (median age 47, IQR 33-81 years); and no effects of sex. Autoimmune, cardiovascular, or audiovestibular risk factors were present in approximately 29.8% (51/171) of the cases. SSNHL was more often unilateral than bilateral for both mRNA vaccines (P<.001 for tozinameran; P<.003 for elasomeran). There were 13.5% (23/142) of cases of profound hearing loss, among which 74% (17/23) did not recover a serviceable ear. A positive rechallenge was documented for 8 cases. CONCLUSIONS: SSNHL after COVID-19 mRNA vaccines are very rare adverse events that do not call into question the benefits of mRNA vaccines but deserve to be known given the potentially disabling impact of sudden deafness. Therefore, it is essential to properly characterize postinjection SSNHL, especially in the case of a positive rechallenge, to provide appropriate individualized recommendations.

Experience of sudden sensorineural hearing loss following a mild COVID-19 infection.

A woman in her 30s was referred to an otolaryngologist with an acute onset of aural fullness, noise sensitivity, unilateral sudden onset hearing loss, vertigo and tinnitus. She had a confirmed COVID-19 infection 5 weeks prior. A pure tone audiogram confirmed sensorineural hearing loss. MRI identified an empty sella of the pituitary gland and without an obvious cause for hearing loss. Oral prednisolone and betahistine were prescribed, and her audiovestibular symptoms slowly improved over the subsequent months. The patient continues to experience intermittent tinnitus.

The association between COVID-19 vaccination and idiopathic sudden sensorineural hearing loss, clinical manifestation and outcomes.

PURPOSE: Previous data demonstrated an increased incidence of Idiopathic Sensorineural Hearing Loss (ISSNHL) in 2021 compared to 2019-2020, suggesting an association with the anti-COVID-19 vaccine. We aimed to assess our center's incidence and compare the clinical manifestations and outcomes of vaccinated vs. unvaccinated patients. METHODS: A retrospective chart review of all patients diagnosed with ISSNHL during 2021 was conducted and compared to patients who presented in 2018-2020. Patient demographics, audiometry features, vaccination status, and prognosis were evaluated. RESULTS: Throughout 2021, 51 patients were diagnosed with ISSNHL, compared with 31 during 2020, 38 in 2019, and 41 in 2018, demonstrating a 64%, 34%, and 24% increase, respectively. Among patients who presented in 2021, 13 (25.4%) received the anti-COVID-19 vaccine within 30 days before their presentation, and 4 received it within 96 h. Most presented after receiving the second or third dose. Patient characteristics, audiometry features, and prognosis did not significantly differ between vaccinated and unvaccinated patients. CONCLUSIONS: A marked incline was seen in the 2021 ISSNHL incidence at our medical center, of which 25% of cases were within a month post-anti-COVID-19 vaccination. No significant difference was found in clinical manifestations and outcomes between vaccinated and nonvaccinated patients. While other justifications could be sought, an association cannot be ruled out, and further research is needed.

Sudden Hearing Loss Following Vaccination Against COVID-19.

Importance: Spontaneous adverse reaction reports of sudden hearing loss have been observed, and a population-based cohort study conducted in Israel showed an increase in the incidence of sudden sensorineural hearing loss (SSNHL) following vaccination with messenger RNA COVID-19 vaccine BNT162b2 (Pfizer-BioNTech). However, in this setting, the possibility of confounding remained. Objective: To assess a potential association between COVID-19 vaccinations and SSNHL. Design, Setting, and Participants: This register-based country-wide retrospective cohort study of 5.5 million Finnish residents was conducted from January 1, 2019, to April 20, 2022, and included all individuals who were identified from the population information system who were alive or born during the study period except individuals who had SSNHL during 2015 to 2018 according to specialized care derived diagnosis codes for SSNHL (International Statistical Classification of Diseases and Related Health Problems, Tenth Revision [ICD-10] code H91.2) as a primary or secondary diagnosis. Exposures: The a priori primary risk period was 0 to 54 days following each COVID-19 vaccination. The risk periods for different vaccine doses did not overlap so that a later vaccine exposure ended the previous risk period. The secondary risk period was from 55 days following each COVID-19 vaccination until a subsequent COVID-19 vaccination. A secondary analysis included a risk time from 0 to 54 days following a positive polymerase chain reaction test result for SARS-CoV-2. Main Outcomes and Measures: The incidences of SSNHL following COVID-19 vaccination were compared with the incidences before the COVID-19 epidemic in Finland. The Poisson regression model included calendar time, age, sex, diabetes, cardiovascular disease, other chronic diseases, and the number of visits in primary health care. Results: For the 5.5 million Finnish residents included in the study, the comparison time comprised 6.5 million person-years, the primary risk time of 1.7 million person-years, and the secondary risk time of 2.1 million person-years. Before the COVID-19 epidemic in Finland, 18.7/100 000 people received a diagnosis of SSNHL annually. The study data suggested no increased risk for SSNHL following any COVID-19 vaccination. In particular, adjusted incidence rate ratios with 95% confidence intervals for the BNT162b2 vaccine's 3 doses were 0.8 (95% CI, 0.6-1.0), 0.9 (95% CI, 0.6-1.2), and 1.0 (95% CI, 0.7-1.4), respectively. There was no association between SARS-CoV-2 infection and an increased incidence of SSNHL. Conclusions and Relevance: The results of this cohort study show no evidence of an increased risk of SSNHL following COVID-19 vaccination. The study accounted for previous disease and other potential confounding factors. These results are based on diagnosis codes in specialized care but still need to be verified in settings that are capable of evaluating the degree of hearing loss.

Audiometry-Confirmed Sudden Sensorineural Hearing Loss Incidence among COVID-19 Patients and BNT162b2 Vaccine Recipients.

OBJECTIVE: To compare sudden sensorineural hearing loss (SSNHL) incidence rates over the coronavirus disease 2019 (COVID-19) outbreak and the COVID-19 vaccination campaign periods to pre-COVID-19 periods. STUDY DESIGN: Retrospective cohort. SETTING: Secondary hospital. PATIENTS: Patients >12 years with auditory-confirmed SSNHL were enrolled. COVID-19 status and BNT162 inoculation records ≤28 days before SSNHL diagnosis were retrieved. Patients were categorized according to their date of presentation over four equal periods: 1) July 2018-April 2019 (first prepandemic period), 2) May 2019-February 2020 (second prepandemic period), 3) March 2020-December 2020 (COVID-19 outbreak), and 4) January 2021-October 2021 (BNT162b2 vaccinations campaign). INTERVENTIONS: Pre- and post-COVID-19 emergence; BNT162b2 vaccine. MAIN OUTCOME MEASURES: Incidence rate ratios (IRRs) were calculated to compare SSNHL cases during the COVID-19 and vaccination periods with pre-COVID-19 periods. RESULTS: Of the 100 patients with SSNHL over the four periods, 1 had COVID-19 and 8 were vaccinated. The annual SSNHL incidence was 12.87, 12.28, 13.45, and 19.89 per 100,000 over periods 1 to 4, respectively. SSNHL incidence over the third period was not significantly different than the first/second periods (IRR = 1.045, 95% confidence interval [CI] = 0.629-1.85, ρ = 0.788, and IRR = 1.095, 95% CI = 0.651-1.936, ρ = 0.683, respectively), whereas SSNHL incidence rate over the fourth period was higher (IRR = 1.545, 95% CI = 0.967-2.607, ρ = 0.068, and IRR = 1.619, 95% CI = 1-2.73, ρ = 0.05, respectively). SSNHL incidence in vaccine recipients was lower than prepandemic unvaccinated patients (IRR = 0.584, 95% CI =0.464-1.67, ρ = 0.984, and IRR = 0.612, 95% CI =0.48-1.744, ρ = 0.92, respectively). CONCLUSION: There were fewer SSNHL cases during the first COVID-19 months. Although the SSNHL rate over the COVID-19 vaccination campaign increased, it was not higher for patients who received the BNT162b2 vaccine.

Sudden sensorineural hearing loss and coronavirus disease 2019.

OBJECTIVE: To determine if otolaryngologists and audiologists of the American Academy of Otolaryngology - Head and Neck Surgery have noticed an increase in the incidence of sudden sensorineural hearing loss during the coronavirus disease 2019 pandemic. METHODS: A questionnaire was developed for the purpose of providing a cross-sectional descriptive analysis of perceived association between the coronavirus disease 2019 pandemic and an increase in the incidence of sudden sensorineural hearing loss. RESULTS: Of respondents, 63.0 per cent did not notice an increase in sudden sensorineural hearing loss during the coronavirus disease 2019 pandemic. There was a weak positive correlation between patients identified with sudden sensorineural hearing loss and the percentage of coronavirus disease 2019 positive patients reported by each medical care provider (Spearman correlation = 0.20, 95 per cent confidence interval = 0.05-0.33). There was no association between geographical location and perceived increase in sudden sensorineural hearing loss (p = 0.38). CONCLUSION: The majority of respondents did not perceive an increase in the incidence of sudden sensorineural hearing loss during the coronavirus pandemic, regardless of geographical region.

Assessment of Sudden Sensorineural Hearing Loss After COVID-19 Vaccination.

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.

Blood Viscosity in COVID-19 Patients With Sudden Deafness.

BACKGROUND: Changes in blood viscoelastic properties have been proposed previosuly as etiopathogenesis for severe complications in COVID-19 and some cases of Sudden Deafness (SD). This is an attempt to verify if SD cases in patients admitted for SARS-Cov-2 infection can be correlated. PATIENTS AND METHODS: A prospective follow-up was carried out with COVID-19 patients, monitoring their blood viscosity (BV) at high shear rate (300 s-1) and inquiring them periodically for eventual hearing loss. This measurement was extended to cases bearing of SD in 2019 and 2020 without infection and a control group of healthy normoacoustic subjects. RESULTS: The normality range was 4,16 ± 0,62 cps. 330 cases admitted for COVID-19 were evaluated from February 24th, 2020 to March 24th, 2021, 85 of them attended in ICU. After anamnesis and Audiometric Tone Thresholds developed as soon as possible, 9 SD were detected, all belonging to ICU group. The mean BV was 4,38 ± 0,43 cps in the ward group, 4,53 ± 0,39 cps in the ICU patients without SD, and 4,85 ± 0,52 cps in the cases with SD, with statistically significant differences. Highest BV elevations in the SD cases were detected between days 6 and 10 of hospital admission. In 2019 four cases consulted with SD, and another two did it in 2020 without a diagnosis of COVID-19, with normal BV values. CONCLUSIONS: During SARS-Cov-2 infection, patients may show high BV and SS, although an inpatients control group and a larger sample volume are necessary to confirm the predisposition to hyperviscosity. The incidence of hearing damage is considerable if its possible appearance is taken into account, within the limitations of critical patients with COVID-19.

Incidence and duration of self-reported hearing loss and tinnitus in a cohort of COVID-19 patients with sudden chemosensory loss: A STROBE observational study.

AIMS: To investigate the self-reported audiological symptoms in a cohort of coronavirus disease 2019 (COVID-19) patients and monitor improvement or recovery. MATERIAL AND METHODS: Following the STROBE guidelines for observational studies, a retrospective questionnaire concerning audio-vestibular symptoms was conducted in a cohort of Danish COVID-19 patients with self reported chemosensory loss. Data regarding demographics, symptoms onset, duration and remission was registered in a REDCap database. RESULTS: Of the 225 respondents with chemosensory loss, 59 (26.2%) reported concomitant hearing loss (10.7%) or tinnitus (16.4%). In a follow-up questionnaire focused on ear-symptoms, severity, and duration (n=31), 17 reported hearing loss and 21 reported tinnitus. Debut of hearing loss and tinnitus were on average 10 and 30 days respectively, after onset of initial symptoms. Among the hearing loss patients, only two patients experienced full recovery, whereas 15 had partial or no recovery after on average 266 days from COVID-19 symptom onset. Among the tinnitus patients, 7/21 had full recovery, while 14 had partial or no recovery after on average 259 days from COVID-19 symptom onset. CONCLUSION: In a large Danish cohort of COVID-19 patients, a significant proportion experienced concomitant audiological symptoms which seem long lasting and with negative impact on quality of life. This study warrants further investigation of the association between COVID-19 and audio-vestibular symptoms, and the need for rehabilitation among convalescents.

Evolution of incidence of audiovestibular disorders during the pandemic COVID-19 period.

PURPOSE: Despite sporadic case reports describing hearing problems in patients with coronavirus disease 2019 (COVID-19), whether COVID-19 affects the audiovestibular system remains unclear. This study assessed the evolution of incidence of audiovestibular disorders during the pandemic COVID-19 period. METHOD: Three audiovestibular disorders namely, sudden sensorineural hearing loss (SSHL), autonomic dysfunction, and Meniere's disease (MD) were analyzed and compared from 2016 to 2020. RESULTS: The annual new cases at our clinic comprised overall 2107, 1997, 1984, 2068, and 1829 from 2016 to 2020, respectively, and the respectively annual cases of SSHL were 54, 46, 42, 45 and 38. Accordingly, annual incidences of SSHL in relation to overall cases of audiovestibular disorders were 2.6%, 2.3%, 2.1%, 2.2% and 2.1% from 2016 to 2020, respectively, exhibiting a non-significant difference (p > 0.05). In contrast, incidence of autonomic dysfunction in the year 2020 was 15.3%, which revealed significantly higher than 8.5-13.1% from 2016 to 2019 (p < 0.001). Restated, the incidence of autonomic dysfunction in 2020 displayed a significantly higher percentage than the other 4 years. Conversely, the incidence of MD in 2020 was 9.8%, showing a significant decline compared with the other 4 years (12.6-15.6% from 2016 to 2019, p < 0.001), CONCLUSION: Evolution of incidence of audiovestibular disorders during the pandemic COVID-19 period revealed increase in the incidence of autonomic dysfunction and decrease in that of MD, while incidence of SSHL remained unchanged from 2016 to 2020. Thus, the SARS-CoV-2 may less affect the audiovestibular system.

Catastrophic bilateral sudden sensorineural hearing loss following COVID-19.

Since December 2019, when it was first detected in Wuhan, the SARS-CoV-2 (COVID-19) has spread across the globe. The pandemic has had an unprecedented impact on the global population with >110 million confirmed cases and 2.5 million deaths. The most common initial symptoms of COVID-19 infection are cough, dyspnoea, fever, malaise and anosmia. Severe clinical manifestations include respiratory compromise, pneumonia, organ failure and death. There have been many other less common symptoms as a result of COVID-19 described in the literature, including significant rates of olfactory dysfunction. However, we believe there has been only one other previously documented cases of bilateral hearing loss.Sudden sensorineural hearing loss is a relatively common presentation seen by otolaryngologists. It is defined as rapid hearing loss, ≥30 dB occurring over 3 consecutive days in three contiguous sound frequencies. The exact pathological process is yet to be fully characterised, though it is most commonly unilateral and commonly develops shortly following viral infection. Treatment typically consists of glucocorticoid steroids administered orally, via intratympanic injection or a combination of both routes though there are currently no standardised management of these patients.Bilateral sudden sensorineural hearing loss (SSNHL) is rare, accounting for <2% of all cases. We describe a case of bilateral SSNHL in a 68-year-old patient who presented with profound hearing loss shortly after symptomatic infection with COVID-19, which at the time of publication is the first such case reported in the literature.

Deafness after COVID-19?

This article presents a case of sudden bilateral deafness in the context of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) infection and resultant coronavirus disease 2019 (COVID-19). After treatment in the intensive care unit for acute respiratory distress syndrome and acute kidney failure, hearing ability had drastically changed. While hearing had been subjectively normal before the infection, deafness was now measured on the left and profound hearing loss on the right ear. The patient was treated with cochlea implants on the left and a hearing aid in the right ear. The hearing loss is most likely a complication of COVID-19.

Sudden hearing loss and coronavirus disease 2019: the role of corticosteroid intra-tympanic injection in hearing improvement.

BACKGROUND: Coronavirus disease 2019 was first seen in December 2019. Due to the insidious and complex nature of the disease, the list of symptoms is rapidly expanding. So far, few studies have reported sudden sensorineural hearing loss as a possible symptom of coronavirus disease 2019. CASE REPORT: A 60-year-old woman with a complaint of sudden sensorineural hearing loss and subjective severe tinnitus presented to the ENT clinic. Coronavirus disease 2019 was subsequently confirmed with a polymerase chain reaction test. At the time of presentation, she was treated with intra-tympanic dexamethasone. Improvements in hearing threshold and speech perception, and a subjective reduction in tinnitus, were observed after treatment. CONCLUSION: This case report supports evidence from other case reports of a possible association between coronavirus disease 2019 and sudden sensorineural hearing loss. Sudden sensorineural hearing loss may be a symptom of this disease that behaves as an underlying aggravating factor. Intra-tympanic injection of corticosteroids is recommended for managing these patients during the pandemic.