Objective: Following a report of sudden hearing loss in a patient taking phosphodiesterase type 5 inhibitor, and a Food and Drug Administration announcement concerning this class of drugs, a study was planned to investigate if ototoxicity occurs in patients using phosphodiesterase 5 inhibitor for erectile dysfunction.
Methods: Eighteen patients with erectile dysfunction who had been using phosphodiesterase 5 inhibitor were included in the study. Audiometric tests were performed on all patients, between the frequencies 250 and 16,000 Hz, before and 1, 5 and 72 hours after drug ingestion.
Results: Four patients showed a unilateral threshold decrease compatible with ototoxicity criteria; this change was reversible. A statistically significant difference in pre- versus post-drug hearing thresholds was observed in the right ear at 10,000 Hz (p = 0.008). There were no statistically significant hearing threshold differences at any other frequencies (p > 0.05).
Conclusion: Although temporary ototoxicity was noted in four patients, we could not find any permanent, deleterious effect of phosphodiesterase type 5 inhibitor on hearing thresholds.