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Background <p>Idiopathic sudden sensorineural hearing loss (ISSHL) frequently occurs with acute tinnitus, causing significant quality-of-life disturbances. Acoustic therapy (AT) is commonly used, but its efficacy remains uncertain. This study aimed to compare the short-term and long-term efficacy of standard care versus AT in reducing tinnitus-related disturbances in ISSHL patients.</p> Methods <p>This study was designed as a two-stage approach. In stage I, a multi-center, multi-arm randomized controlled trial was conducted from May 1, 2019, to April 12, 2024, across 19 hospitals in Sichuan, China, involving 213 ISSHL patients with tinnitus. In stage II, participants were given the option to either continue personalized AT treatment at home or explore alternative therapeutic options, with their decisions and subsequent outcomes objectively monitored and recorded over a period of 6 months. Participants were randomly assigned to four groups for a short-term (10 days) inpatient intervention: Group A (international standard care: systemic steroid), Group B (Chinese standard care: systemic steroid plus intravenous batroxobin), Group C (international standard care with daily AT), and Group D (Chinese standard care with daily AT). After discharge, participants underwent a 170-day follow-up with optional long-term domestic AT. The primary outcome was short-term tinnitus remission (TR). Secondary outcomes included short-term changes in Tinnitus Handicap Inventory (THI), Tinnitus Questionnaire (TQ), customized visual analog scale (VAS) for hearing loss (HL-VAS) and tinnitus (T-VAS), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), 36-Item Health Survey Short Forms (SF-36), and the Pittsburgh Sleep Quality Index (PSQI) scores, and long-term changes including TR and HL-VAS and T-VAS.</p> Results <p>Among 213 enrolled participants, short-term analyses showed no statistically significant differences in TR or other outcomes (THI, TQ, BAI, BDI, SF-36, PSQI) among groups. Long-term analyses revealed higher TR in severe ISSHL patients who received long-term domestic AT (45.5% vs. 20.0%, <i>P</i> = 0.034), with no significant differences in other outcomes. Severe adverse events and deaths were not reported.</p> Conclusions <p>AT may not provide immediate relief but shows potential for sustained TR in severe ISSHL. Future studies should optimize its timing, duration, and integration into treatment strategies.</p> Trial registration <p>This trial was registered at the Chinese Clinical Trial Registry (ChiCTR1900021725).</p>

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Efficacy of standard care versus acoustic therapy on acute tinnitus in idiopathic sudden sensorineural hearing loss: a randomized controlled trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月28日

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  • Xinyi Wang,
  • Ke Qiu,
  • Yuyang Zhang,
  • Sen Yang,
  • Yanhong Xu,
  • Xiaosong Mu,
  • Yaxin Luo,
  • Wendu Pang,
  • Jiangnan Han,
  • Chunhong Hu,
  • Jia Chen,
  • Ning Ma,
  • Wen He,
  • Wei Dai,
  • Yang Zou,
  • Lingfeng Xiong,
  • Hongchang Chen,
  • Weifeng Chen,
  • Dengyun Zhang,
  • Guanghui Zhang,
  • Zhen Hu,
  • Lintong Dai,
  • Xiaohai Liu,
  • Bingcai He,
  • Xiaobing Pu,
  • Wei Xu,
  • Jianjun Ren,
  • Yu Zhao

摘要

Background

Idiopathic sudden sensorineural hearing loss (ISSHL) frequently occurs with acute tinnitus, causing significant quality-of-life disturbances. Acoustic therapy (AT) is commonly used, but its efficacy remains uncertain. This study aimed to compare the short-term and long-term efficacy of standard care versus AT in reducing tinnitus-related disturbances in ISSHL patients.

Methods

This study was designed as a two-stage approach. In stage I, a multi-center, multi-arm randomized controlled trial was conducted from May 1, 2019, to April 12, 2024, across 19 hospitals in Sichuan, China, involving 213 ISSHL patients with tinnitus. In stage II, participants were given the option to either continue personalized AT treatment at home or explore alternative therapeutic options, with their decisions and subsequent outcomes objectively monitored and recorded over a period of 6 months. Participants were randomly assigned to four groups for a short-term (10 days) inpatient intervention: Group A (international standard care: systemic steroid), Group B (Chinese standard care: systemic steroid plus intravenous batroxobin), Group C (international standard care with daily AT), and Group D (Chinese standard care with daily AT). After discharge, participants underwent a 170-day follow-up with optional long-term domestic AT. The primary outcome was short-term tinnitus remission (TR). Secondary outcomes included short-term changes in Tinnitus Handicap Inventory (THI), Tinnitus Questionnaire (TQ), customized visual analog scale (VAS) for hearing loss (HL-VAS) and tinnitus (T-VAS), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), 36-Item Health Survey Short Forms (SF-36), and the Pittsburgh Sleep Quality Index (PSQI) scores, and long-term changes including TR and HL-VAS and T-VAS.

Results

Among 213 enrolled participants, short-term analyses showed no statistically significant differences in TR or other outcomes (THI, TQ, BAI, BDI, SF-36, PSQI) among groups. Long-term analyses revealed higher TR in severe ISSHL patients who received long-term domestic AT (45.5% vs. 20.0%, P = 0.034), with no significant differences in other outcomes. Severe adverse events and deaths were not reported.

Conclusions

AT may not provide immediate relief but shows potential for sustained TR in severe ISSHL. Future studies should optimize its timing, duration, and integration into treatment strategies.

Trial registration

This trial was registered at the Chinese Clinical Trial Registry (ChiCTR1900021725).