Project description:ImportanceEmerging 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.ObjectiveTo examine the potential association between COVID-19 vaccination and SSNHL.Design, setting, and participantsThis 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.ExposuresReceipt 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 measuresIncidence of reports of SSNHL after COVID-19 vaccination recorded in VAERS and clinical characteristics of adult patients presenting with SSNHL after COVID-19 vaccination.ResultsA 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 relevanceIn 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.
Project description:OBJECTIVE:This study aimed to investigate the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patients presenting with only sudden sensorineural hearing loss (SSHNL) during the COVID-19 pandemic. METHODS:The study included five male patients who presented with the sole complaint of unilateral SSNHL to the otolaryngology outpatient clinic between 03-12 April 2020. The patients were referred to the infectious diseases clinic to be evaluated for SARS-CoV-2 by real time polymerase chain reaction (RT-PCR) testing. RESULTS:RT-PCR testing for SARS-CoV-2 was positive in one of the patients and negative in the other four patients. A positive response to COVID-19-specific treatment in the SARS-CoV-2 positive SSNHL patient was noted. CONCLUSION:It should be remembered that non-specific symptoms such as SSNHL could be the only sign with which to recognize a COVID-19 case. Awareness of such a non-specific presentation of COVID-19 patients is crucial during this pandemic period for preventing infectious spread through isolation and early initiation of COVID-19 targeted treatment.
Project description:ObjectiveCase reports of sudden sensorineural hearing loss (SSHL) following vaccines have led to concerns that vaccines may rarely cause hearing loss. Because of this concern, we analyzed for an association between SSHL and vaccinations.Study designWe used a case-centered method, equivalent to a case control design using immunization dates from all matched members of the population to calculate exposure to vaccines, rather than sampling.SettingKaiser Permanente Northern California (KPNC), 2007 to 2013.Subjects and methodsWe searched KPNC databases from 2007 to 2013 for all first-time diagnoses of SSHL. We used the date of any hearing- or ear-related visit in the 60 days prior to the first SSHL diagnosis as the onset date. Using only SSHL cases immunized in the prior 9 months, we compared the vaccine exposure in several risk intervals prior to onset with the exposure to the same vaccine during the same time period in all KPNC membership, matched to sex and age.ResultsDuring the study period, >20 million vaccines were administered at KPNC. In all risk intervals prior to onset of SSHL, we found no evidence of increased risk of immunization compared with matched controls. The odds ratios for vaccination 1 week prior to SSHL were 0.965 (95% confidence interval, 0.61-1.50) for trivalent inactivated influenza vaccine (TIV); 0.842 (0.39-1.62) for tetanus, reduced diphtheria, and reduced acellular pertussis; and 0.454 (0.08-1.53) for zoster vaccine.ConclusionA large-scale analysis applying a case-centered method did not detect any association between SSHL and previous receipt of TIV or other vaccines.
Project description:IntroductionTo compare inpatient treated patients with idiopathic (ISSNHL) and non-idiopathic sudden sensorineural hearing loss (NISSNHL) regarding frequency, hearing loss, treatment and outcome.MethodsAll 574 inpatient patients (51% male, median age: 60 years) with ISSNHL and NISSNHL, who were treated in federal state Thuringia in 2011 and 2012, were included retrospectively. Univariate and multivariate statistical analyses were performed.ResultsISSNHL was diagnosed in 490 patients (85%), NISSNHL in 84 patients (15%). 49% of these cases had hearing loss due to acute otitis media, 37% through varicella-zoster infection or Lyme disease, 10% through Menière disease and 7% due to other reasons. Patients with ISSNHL and NISSNHL showed no difference between age, gender, side of hearing loss, presence of tinnitus or vertigo and their comorbidities. 45% of patients with ISSNHL and 62% with NISSNHL had an outpatient treatment prior to inpatient treatment (p < 0.001). The mean interval between onset of hearing loss to inpatient treatment was shorter in ISSNHL (7.7 days) than in NISSNHL (8.9 days; p = 0.02). The initial hearing loss of the three most affected frequencies in pure-tone average (3PTAmax) scaled 72.9 dBHL ± 31.3 dBHL in ISSNHL and 67.4 dBHL ± 30.5 dBHL in NISSNHL. In the case of acute otitis media, 3PTAmax (59.7 dBHL ± 24.6 dBHL) was lower than in the case of varicella-zoster infection or Lyme disease (80.11 dBHL ± 34.19 dBHL; p = 0.015). Mean absolute hearing gain (Δ3PTAmaxabs) was 8.1 dB ± 18.8 dB in patients with ISSNHL, and not different in NISSNHL patients with 10.2 dB ± 17.6 dB. A Δ3PTAmaxabs ≥ 10 dB was reached in 34.3% of the patients with ISSNHL and to a significantly higher rate of 48.8% in NISSNHL patients (p = 0.011).ConclusionsISSNHL and NISSNHL show no relevant baseline differences. ISSNHL tends to have a higher initial hearing loss. NISSHNL shows a better outcome than ISSNHL.
Project description:BACKGROUND:Hypothyroidism, one of the prevalent endocrine disorders worldwide, has a broad spectrum of clinical manifestations, from an asymptomatic condition to myxedema coma. Although the majority of patients with hypothyroidism have minor clinical symptoms, which are recovered with levothyroxine treatment, some patients occasionally do experience fatal complications. Here we report, for the first time, the case of a patient who had hypothyroidism with simultaneous occurrence of rhabdomyolysis with acute kidney injury, moderate pericardial effusion, and sudden sensorineural hearing loss. CASE PRESENTATION:A 57-year-old man with a previous history of dyslipidemia and untreated hypothyroidism was admitted to the hospital due to shortness of breath, lethargy, lower extremity discomfort, and unilateral hearing loss. Laboratory results revealed rhabdomyolysis with acute kidney injury and severe hypothyroidism. We detected cardiomegaly without lung parenchymal infiltration on chest radiography and moderate pericardial effusion on transthoracic echocardiography. We performed pure tone audiometry and identified profound unilateral sensorineural hearing loss. Aggressive fluid resuscitation, levothyroxine treatment, and systemic and intratympanic steroid therapy alleviated the patient's severe hypothyroidism, rhabdomyolysis, and pericardial effusion; however, sensorineural hearing loss was not fully recovered. CONCLUSIONS:Early recognition of life-threatening complications is important in patients with severe hypothyroidism to prevent adverse outcomes. This case suggests that hypothyroidism should be considered in patients who have rhabdomyolysis with acute kidney disease and pericardial effusion. Moreover, sudden sensorineural hearing loss should be kept in mind as a rare complication of hypothyroidism.
Project description:Sudden hearing loss is an easily encountered disease in clinics, but its prognosis has not been completely elucidated. In the present study, we investigated the long-term prognosis of sudden hearing loss with 130 patients who were diagnosed based on strict criteria and provided uniform treatment. The patients with incomplete recovery were reevaluated after 2 months without receiving additional treatment. Hearing levels at different time points were compared. Moreover, the associated factors affecting the degree of hearing improvement over time were evaluated using stepwise multiple linear regression. After treatment, 73 out of the 130 (56.1%) patients attained incomplete recovery and were reevaluated after 2 months. Seventeen out of the seventy-three (23.3%) patients showed a grade promotion, fifty-four (74%) were constant, and two (2.7%) were aggravated. The mean interaural hearing differences (IHDs) showed significant improvement. Old age, poor initial IHD, and poor recovery grade were significantly associated with a profitable delayed hearing gain. Poorer hearing level at the time of onset might be a sign for slower recovery rather than a poorer prognostic factor. The treatment outcome of idiopathic sudden sensorineural hearing loss (ISSNHL) should be evaluated at least 2 months after treatment completion, and counseling is required due to the need for long-term follow-up in patients with ISSNHL.
Project description:ImportanceIdentification of adverse events after vaccination increases awareness of vaccine-associated complications, leading to early diagnosis and treatment. Evidence remains scarce on the association between the BNT162b2 messenger RNA (mRNA) COVID-19 vaccine (Pfizer-BioNTech) and sudden sensorineural hearing loss (SSNHL).ObjectiveTo assess the association between the BNT162b2 mRNA COVID-19 vaccine and SSNHL.Design, setting, and participantsThis retrospective, population-based cohort study was performed from December 20, 2020, to May 31, 2021, using data from the largest health care organization in Israel. Patients 16 years or older who received the first vaccine dose between December 20, 2020, and April 30, 2021, and the second vaccine dose between January 10, 2021, and April 30, 2021, were included.ExposuresReceipt of first and second BNT162b2 mRNA COVID-19 vaccine doses.Main outcomes and measuresThe main outcome was SSNHL based on International Classification of Diseases, Ninth Revision (ICD-9) codes in conjunction with concurrent prednisone dispensing. Observed cases of SSNHL, occurring within 21 days after each of the first and second vaccine doses, were compared with the expected cases based on the experience of the population in 2018 and 2019. Standardized incidence ratios (SIRs) and attributable risks were computed.ResultsOverall, 2 602 557 patients (mean [SD] age, 46.8 [19.6] years; 51.5% female) received the first dose of BNT162b2 mRNA COVID-19 vaccine, with 91 cases of SSNHL reported. Of these patients, 2 441 719 (93.8%) received the second vaccine dose, with 79 cases of SSNHL reported. The age- and sex-weighted SIRs were 1.35 (95% CI, 1.09-1.65) after the first vaccine dose and 1.23 (95% CI, 0.98-1.53) after the second vaccine dose. After the first vaccine dose, the estimated SIRs were more pronounced in female patients aged 16 to 44 years (SIR, 1.92; 95% CI, 0.98-3.43) and female patients 65 years or older (SIR, 1.68; 95% CI, 1.15-2.37). After the second vaccine dose, the highest estimated SIR was observed in male patients 16 to 44 years (SIR, 2.45; 95% CI, 1.36-4.07). The attributable risks were generally small, and the results were similar when 2019 was used as a reference to estimate the expected number of SSNHL cases.Conclusions and relevanceThis study suggests that the BNT162b2 mRNA COVID-19 vaccine might be associated with increased risk of SSNHL; however, the effect size is very small. Further studies are warranted to establish this possible association.
Project description:RationaleAccording to the World Health Organization reports, adult-onset hearing loss is the 15th leading cause of burden of disease, and is projected to move up to 7th by the year 2030, especially in high-income countries. Sudden sensorineural hearing loss is considered by otologists as a true otologic emergency. The current standard treatment for sudden hearing loss is a tapered course of oral high-dose corticosteroids. The described clinical case points to the validity of undertaking early hyperbaric oxygenation (HBO) therapy together with corticosteroids for full recovery of adult onset idiopathic sudden sensorineural hearing loss.Patient concernsA 44-year-old woman complained of an abrupt hearing deterioration in the left ear with the sensation of aural fullness and loud tinnitus presented for 48 hours. The patient was admitted to the Department of Otolaryngology of Public Hospital for diagnosis and treatment.DiagnosesThe patient was diagnosed with unilateral sudden idiopathic sensorineural hearing loss, assessed by measuring the tonal audiograms.InterventionsThe patient received treatment including oral high-dose corticosteroids combined with HBO protocol including 15 daily 1-hour exposures to 100% oxygen at 2.5 atmosphere absolute.OutcomesA pharmacotherapy combined with early HBO resulted in full recovery of hearing.LessonsEarly implementation of HBO to the pharmacotherapy in sudden sensorineural hearing loss may lead to full recovery of hearing. There is a need for systematic research to establish guidelines for optimal number of HBO sessions in relation to the timeframe from hearing loss symptoms onset to implementation of HBO therapy.