Hearing research · 2026
Efficacy and safety of intracochlear corticosteroid delivery as salvage therapy for complete sudden sensorineural hearing loss.
СтатьяНазвание и аннотация: Перевод в очереди
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Li Wei, Zhang Andi, Fang Yanqing, Wang Yi, Tang Dongmei, Ma Ying, Fan Xintai, Huang Yibo, Xu Jianghong, Zhao Hui, Wang Jing, Dai Chunfu, Wang Wuqing, Shu Yilai, Li Huawei
Аннотация
IMPORTANCE: Complete idiopathic sudden sensorineural hearing loss (ISSNHL, defined as pure-tone average ≥ 95 dB HL according to the 2021 WHO hearing loss classification) is a refractory otoneurological emergency with extremely poor prognosis. Conventional intratympanic therapy depends on passive diffusion across the round window membrane, leading to inadequate intracochlear drug accumulation and limited hearing recovery.
OBJECTIVE: To evaluate the efficacy and safety of intracochlear corticosteroid delivery as salvage treatment for complete ISSNHL that is refractory to 2 weeks of conventional therapy.
DESIGN, SETTING, AND PARTICIPANTS: Prospective and controlled clinical study. A total of 83 patients with complete ISSNHL refractory to conventional treatment were enrolled and assigned to 3 intracochlear groups and 1 intratympanic control group. Of these, 80 patients completed the 1-month follow-up and were analyzed.
INTERVENTIONS: Intracochlear triamcinolone acetonide (IC-TA), intracochlear dexamethasone sodium phosphate (IC-Dex), intracochlear Dex plus Dex-soaked gelfoam (IC‑Dex‑TMgel), or intratympanic Dex (IT-Dex). Intracochlear delivery was performed via a microinjection system using 30 µL aliquots.
MAIN OUTCOMES AND MEASURES: Primary outcomes were 1-month change in PTA (ΔPTA) and adverse events (AEs). Secondary outcomes included speech recognition rate, vertigo, tinnitus, and prognostic factors.
RESULTS: Eight mild, transient adverse events (AEs) were reported in the intracochlear groups (exacerbated vertigo, n=5; tongue numbness, n=2; exacerbated tinnitus, n=1), all resolving within 2 weeks. The median 1-month ΔPTA was 13.75 dB HL (interquartile range, 9.69-24.69) for IC-TA, 23.13 dB HL (11.25-32.50) for IC-Dex, 21.25 dB HL (15.00-28.13) for IC-Dex-TMgel, and 6.88 dB HL (0.00-16.88) for IT-Dex (overall P = 0.005). All intracochlear groups demonstrated significantly greater hearing improvement than the control group. Slight recovery (SR, ΔPTA ≥ 15 dB HL) occurred in 80% (IC-Dex-TMgel), 70% (IC-Dex), 50% (IC-TA), and 30% (IT-Dex). Disease duration (P < 0.001) and preoperative Dizziness Handicap Inventory (DHI) score (P = 0.020) were independently associated with hearing outcomes. Intervention within 17.5 days of symptom onset was associated with superior recovery.
CONCLUSIONS AND RELEVANCE: To our knowledge, this is the first prospective controlled clinical trial providing preliminary evidence that intracochlear corticosteroid injection was associated with hearing improvement and a favorable safety profile for salvage treatment of complete ISSNHL. Disease duration and preoperative vertigo (DHI score) were independently associated with hearing outcomes. Early intervention within 17.5 days of onset was associated with superior recovery. This strategy may represent a promising salvage approach for managing this refractory otoneurological emergency.
OBJECTIVE: To evaluate the efficacy and safety of intracochlear corticosteroid delivery as salvage treatment for complete ISSNHL that is refractory to 2 weeks of conventional therapy.
DESIGN, SETTING, AND PARTICIPANTS: Prospective and controlled clinical study. A total of 83 patients with complete ISSNHL refractory to conventional treatment were enrolled and assigned to 3 intracochlear groups and 1 intratympanic control group. Of these, 80 patients completed the 1-month follow-up and were analyzed.
INTERVENTIONS: Intracochlear triamcinolone acetonide (IC-TA), intracochlear dexamethasone sodium phosphate (IC-Dex), intracochlear Dex plus Dex-soaked gelfoam (IC‑Dex‑TMgel), or intratympanic Dex (IT-Dex). Intracochlear delivery was performed via a microinjection system using 30 µL aliquots.
MAIN OUTCOMES AND MEASURES: Primary outcomes were 1-month change in PTA (ΔPTA) and adverse events (AEs). Secondary outcomes included speech recognition rate, vertigo, tinnitus, and prognostic factors.
RESULTS: Eight mild, transient adverse events (AEs) were reported in the intracochlear groups (exacerbated vertigo, n=5; tongue numbness, n=2; exacerbated tinnitus, n=1), all resolving within 2 weeks. The median 1-month ΔPTA was 13.75 dB HL (interquartile range, 9.69-24.69) for IC-TA, 23.13 dB HL (11.25-32.50) for IC-Dex, 21.25 dB HL (15.00-28.13) for IC-Dex-TMgel, and 6.88 dB HL (0.00-16.88) for IT-Dex (overall P = 0.005). All intracochlear groups demonstrated significantly greater hearing improvement than the control group. Slight recovery (SR, ΔPTA ≥ 15 dB HL) occurred in 80% (IC-Dex-TMgel), 70% (IC-Dex), 50% (IC-TA), and 30% (IT-Dex). Disease duration (P < 0.001) and preoperative Dizziness Handicap Inventory (DHI) score (P = 0.020) were independently associated with hearing outcomes. Intervention within 17.5 days of symptom onset was associated with superior recovery.
CONCLUSIONS AND RELEVANCE: To our knowledge, this is the first prospective controlled clinical trial providing preliminary evidence that intracochlear corticosteroid injection was associated with hearing improvement and a favorable safety profile for salvage treatment of complete ISSNHL. Disease duration and preoperative vertigo (DHI score) were independently associated with hearing outcomes. Early intervention within 17.5 days of onset was associated with superior recovery. This strategy may represent a promising salvage approach for managing this refractory otoneurological emergency.