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Objective: To explore the effectiveness and safety of round window niche drilling combined with intratympanic methylprednisolone injection for the salvage treatment of sudden sensorineural hearing loss (SSNHL) and its associated tinnitus after failed primary treatment.Method: SSNHL patients who showed a less than 10-dB improvement of pure-tone average after receiving standard systemic treatment and intratympanic steroid injection were enrolled. All included patients were randomly divided into two groups (control and study). Patients in the study group received round window niche drilling combined with daily intratympanic methylprednisolone for 7 times; the control group received only daily intratympanic methylprednisolone for 7 times. One month after treatment, the improvements of PTA, speech discrimination score (SDS), tinnitus and the incidence of adverse events were analyzed.Results: 20 patients (10 for each group) were included in this study. The baseline between two groups showed no statistical significance. Patients in the study group experienced an average hearing improvement of 20.38 dB, SDS 19.3 compared with 2.1 dB and SDS 2.0 in the control group. None (0%) in the control group and 4 patients (40%) showed marked recovery, 5 patients (50%) showed slight improvement of hearing in the study group after 1 month. All patients in the study group showed significant recovery of tinnitus. Both tinnitus handicap inventory and a symptom visual analogue scale between two groups revealed statistical differences (p < 0.001, p = 0.002, respectively). None in the control and study groups experienced vertigo, infection and facial paralysis.Conclusion: Round window niche drilling increases the contact area and time of methylprednisolone. It is an effective and safe salvage therapy of idiopathic SSNHL and its induced tinnitus. [ABSTRACT FROM AUTHOR]