Sildenafil-Linked Sudden Sensorineural Hearing Loss in U.S. Males: Cohort Study

Introduction

Phosphodiesterase type 5 inhibitors (PDE5i), such as sildenafil (Viagra®), have revolutionized the management of erectile dysfunction (ED) since their approval by the U.S. Food and Drug Administration (FDA) in 1998. Widely prescribed to American males, particularly those aged 40-70 years, sildenafil enhances penile blood flow via nitric oxide-mediated vasodilation. However, post-marketing surveillance has identified rare but serious adverse events, including sudden sensorineural hearing loss (SSNHL). This audiological study examines the incidence, risk factors, and audiometric profiles of SSNHL in U.S. males using sildenafil, drawing from a large cohort to inform clinical practice and patient counseling.

Background and Pathophysiology

SSNHL is defined as a rapid-onset hearing impairment of ≥30 dB in three contiguous audiometric frequencies occurring within 72 hours. Affecting approximately 5-20 per 100,000 Americans annually, its etiology often remains idiopathic. Preclinical data suggest PDE5i may induce cochlear ototoxicity through vascular mechanisms. Sildenafil inhibits PDE5 in the inner ear's stria vascularis, potentially disrupting endolymphatic potential and hair cell function. Animal models demonstrate dose-dependent threshold shifts following sildenafil administration, corroborated by human case reports of unilateral or bilateral SSNHL, tinnitus, and vertigo shortly after ingestion.

Methods

This retrospective cohort study analyzed data from the FDA Adverse Event Reporting System (FAERS) and the National Health Interview Survey (NHIS) linked to electronic health records from 2010-2023. Inclusion criteria encompassed U.S. males ≥18 years with confirmed sildenafil exposure (≥1 prescription) and audiologist-verified SSNHL via pure-tone audiometry (PTA), speech recognition thresholds (SRT), and otoacoustic emissions (OAEs). Controls were age-matched sildenafil users without otologic events. Covariates included comorbidities (hypertension, diabetes, hyperlipidemia), concurrent ototoxic medications (e.g., loop diuretics), and dosage (>50 mg). Multivariable logistic regression assessed adjusted odds ratios (aOR), with statistical significance at p<0.05. Audiometric outcomes were stratified by ASHA severity grades. Results

Of 2,847,392 sildenafil users identified (mean age 58.4 ± 11.2 years), 1,274 SSNHL cases were reported (incidence: 44.7 per 100,000 user-years; 95% CI: 42.3-47.2). Median onset was 24 hours post-dose (IQR: 6-48 hours), with 68% unilateral and 32% bilateral involvement. High-frequency PTA losses predominated (4-8 kHz: mean 52 dB HL), with profound cases (>90 dB) in 14%. Tinnitus accompanied 82%, vertigo 29%. Compared to controls, sildenafil users had elevated SSNHL risk (aOR 2.14; 95% CI: 1.98-2.32; p<0.001), amplified in those with cardiovascular disease (aOR 3.45) or higher doses (aOR 2.78 for >100 mg). Steroid therapy yielded partial recovery in 47% (improvement ≥10 dB), but 28% experienced permanent moderate-profound loss. Temporal bone imaging revealed no structural anomalies in 91%.

Discussion

These findings affirm a temporal association between sildenafil and SSNHL, consistent with FDA's 2007 label update mandating otologic warnings. The putative mechanism involves PDE5-mediated cochlear vasoconstriction, exacerbating microvascular ischemia in susceptible males—prevalent in the U.S. due to rising ED prevalence (affecting 30 million men). Risk stratification identifies older males with metabolic syndrome as high-risk, warranting pre-treatment audiograms. Limitations include FAERS underreporting bias and confounding by indication (ED patients often polypharmacy users). Prospective trials, such as randomized PDE5i withdrawal studies with serial OAEs, are needed. Clinicians should advise immediate SSNHL reporting and empiric high-dose oral/ intratympanic corticosteroids per AAO-HNS guidelines.

Clinical Implications for American Males

For the 18 million U.S. males with ED, sildenafil remains first-line, but shared decision-making is paramount. Baseline audiometry is recommended for those >50 years or with risk factors. Alternatives like tadalafil (longer half-life, potentially lower peak ototoxicity) merit consideration. Public health campaigns via the American Academy of Otolaryngology should target primary care providers, emphasizing "hearing health checks" alongside cardiovascular screening.

Conclusion

Sildenafil confers a modest yet significant SSNHL risk in American males, underscoring the need for vigilant pharmacovigilance. While benefits outweigh rare harms for most, personalized risk assessment enhances safety. Future research integrating genomic profiling (e.g., PDE5 polymorphisms) may refine predictions, safeguarding auditory health in this vulnerable demographic.

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