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

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

doi:10.1186/s12916-025-04506-z

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

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 ZhangZhen Hu, Lintong Dai, Xiaohai Liu, Bingcai He, Xiaobing Pu, Wei Xu^*, Jianjun Ren^*, Yu Zhao^*

^*Corresponding author for this work

Research output: Contribution to journal › Article (Academic Journal) › peer-review

Abstract

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).

Original language	English
Article number	4
Number of pages	16
Journal	BMC Medicine
Volume	24
DOIs	https://doi.org/10.1186/s12916-025-04506-z
Publication status	Published - 28 Nov 2025

Bibliographical note

Publisher Copyright:
© The Author(s) 2025.

Keywords

Tinnitus
Acoustic therapy
Randomized controlled trial
Idiopathic sudden sensorineural hearing loss

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Wang, X., Qiu, K., Zhang, Y., Yang, S., Xu, Y., Mu, X., Luo, Y., Pang, W., Han, J., Hu, C., Chen, J., Ma, N., He, W., Dai, W., Zou, Y., Xiong, L., Chen, H., Chen, W., Zhang, D., ... Zhao, Y. (2025). Efficacy of standard care versus acoustic therapy on acute tinnitus in idiopathic sudden sensorineural hearing loss: a randomized controlled trial. BMC Medicine, 24, Article 4. https://doi.org/10.1186/s12916-025-04506-z

@article{0bc71e5ee6494d0ebc510abd581e4167,

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

abstract = "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).",

keywords = "Tinnitus, Acoustic therapy, Randomized controlled trial, Idiopathic sudden sensorineural hearing loss",

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

note = "Publisher Copyright: {\textcopyright} The Author(s) 2025. ",

year = "2025",

month = nov,

day = "28",

doi = "10.1186/s12916-025-04506-z",

language = "English",

volume = "24",

journal = "BMC Medicine",

issn = "1741-7015",

publisher = "BioMed Central Ltd",

}

Wang, X, Qiu, K, Zhang, Y, Yang, S, Xu, Y, Mu, X, Luo, Y, Pang, W, Han, J, Hu, C, Chen, J, Ma, N, He, W, Dai, W, Zou, Y, Xiong, L, Chen, H, Chen, W, Zhang, D, Zhang, G, Hu, Z, Dai, L, Liu, X, He, B, Pu, X, Xu, W, Ren, J & Zhao, Y 2025, 'Efficacy of standard care versus acoustic therapy on acute tinnitus in idiopathic sudden sensorineural hearing loss: a randomized controlled trial', BMC Medicine, vol. 24, 4. https://doi.org/10.1186/s12916-025-04506-z

TY - JOUR

T1 - Efficacy of standard care versus acoustic therapy on acute tinnitus in idiopathic sudden sensorineural hearing loss

T2 - a randomized controlled trial

AU - Wang, Xinyi

AU - Qiu, Ke

AU - Zhang, Yuyang

AU - Yang, Sen

AU - Xu, Yanhong

AU - Mu, Xiaosong

AU - Luo, Yaxin

AU - Pang, Wendu

AU - Han, Jiangnan

AU - Hu, Chunhong

AU - Chen, Jia

AU - Ma, Ning

AU - He, Wen

AU - Dai, Wei

AU - Zou, Yang

AU - Xiong, Lingfeng

AU - Chen, Hongchang

AU - Chen, Weifeng

AU - Zhang, Dengyun

AU - Zhang, Guanghui

AU - Hu, Zhen

AU - Dai, Lintong

AU - Liu, Xiaohai

AU - He, Bingcai

AU - Pu, Xiaobing

AU - Xu, Wei

AU - Ren, Jianjun

AU - Zhao, Yu

PY - 2025/11/28

Y1 - 2025/11/28

N2 - 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).

AB - 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).

KW - Tinnitus

KW - Acoustic therapy

KW - Randomized controlled trial

KW - Idiopathic sudden sensorineural hearing loss

U2 - 10.1186/s12916-025-04506-z

DO - 10.1186/s12916-025-04506-z

M3 - Article (Academic Journal)

C2 - 41310595

SN - 1741-7015

VL - 24

JO - BMC Medicine

JF - BMC Medicine

M1 - 4

ER -

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

Abstract

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Keywords

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