Acupuncture Therapy for Sudden Sensorineural Hearing Loss (SSNHL-Acu)

Acupuncture Combined With Glucocorticoids Therapy for Sudden Sensorineural Hearing Loss：A Multicenter Randomized Controlled Clinical Trial

The goal of this multicenter, prospective, randomized controlled trial is to evaluate the efficacy and safety of acupuncture combined with corticosteroid therapy in treating sudden sensorineural hearing loss (SSNHL). The main questions it aims to answer are:

Does acupuncture combined with corticosteroids improve hearing recovery (pure tone audiometry, PTA) at 8 weeks compared with sham acupuncture combined with corticosteroids? Does this treatment improve secondary outcomes, including tinnitus, dizziness, sleep quality, anxiety, and quality of life? Researchers will compare acupuncture (experimental group) with sham acupuncture (control group) to determine the added therapeutic effect of acupuncture.

Participants will:

1. Receive either real acupuncture or sham acupuncture 3 times per week for 4 weeks.
2. Meanwhile, take oral prednisone (1 mg/kg/day, maximum 60 mg/day) for 7 days followed by a 7-day taper.
3. Undergo hearing tests (PTA, word recognition scores), vestibular function tests, and complete validated questionnaires (SF-36, HADS, ISI, DHI, THI, and TCM symptom scales) at baseline and weeks 1, 2, 4, 8, and 12.
4. Receive salvage intratympanic steroid injections if hearing does not improve sufficiently by day 14.

Study Overview

• Status: Recruiting
• Conditions: Sudden Sensorineural Hearing Loss (SSNHL)
• Intervention / Treatment: Procedure: Acupuncture; Procedure: Sham acupuncture

• Study Type: Interventional
• Enrollment (Estimated): 256
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weiming Hao, MD, Doctor; Phone Number: 86-18017321721; Email: haoweiming1993@163.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Eye and ENT Hospital of Fudan University
    • Contact: Weiming Hao, MD; Phone Number: 86-18017321721; Email: haoweiming1993@163.com
    • Principal Investigator: Yan Chen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 18 and 70 years;
• Meets the diagnostic criteria for sudden sensorineural hearing loss (SSNHL): sudden, unexplained sensorineural hearing loss occurring within 72 hours, with a hearing threshold decrease of ≥30 dB in at least three consecutive frequencies among 250, 500, 1000, 2000, 4000, and 8000 Hz (reference: previous audiologic examination or same frequencies of the contralateral ear);
• Unilateral SSNHL with self-perceived symmetrical hearing in both ears prior to the current episode (or supported by previous audiologic examination reports);
• Time from symptom onset to enrollment and treatment initiation within 14 days;
• Clear consciousness and logical responses, able to understand the scale items and complete the assessments;
• Agrees to participate in the trial and signs a written informed consent form.

Exclusion Criteria:

• Identifiable definite etiology after complete examination, including acoustic neuroma, cerebrovascular accident, trauma, Hunt syndrome, etc.;
• History of hearing abnormality (affected ear) or balance dysfunction prior to the current episode (including previous SSNHL, vestibular migraine, Meniere's disease, benign paroxysmal positional vertigo, congenital/hereditary/syphilitic hearing loss, otosclerosis, etc.);
• Presence of diseases for which systemic corticosteroid therapy is clinically not recommended (e.g., poorly controlled or insulin-dependent diabetes mellitus, history of peptic ulcer, active infection or tuberculosis, history of hepatitis B or C, pancreatitis, severe osteoporosis, osteonecrosis, etc.);
• Received systemic or local corticosteroid therapy for 10 days or more prior to enrollment;
• Presence of other diseases (e.g., severe skin disorders) that preclude completion of acupuncture treatment;
• Presence of severe organ dysfunction;
• Received acupuncture treatment within the past 12 months;
• Pregnant or breastfeeding women;
• Other reasons deemed by the investigator as unsuitable for participation in this clinical study (e.g., high anticipated difficulty in completing follow-up, obvious low compliance, etc.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture combined with corticosteroids group; Participants in this group will receive real acupuncture 3 times per week for 4 weeks, together with oral prednisone (1 mg/kg/day, maximum 60 mg/day) for 7 days followed by a 7-day taper, plus oral Ginkgo biloba extract for 4 weeks.	Procedure: Acupuncture; Main Acupoints (Fixed): Tinghui (GB2), Yifeng (SJ17), Tinggong (SI19), and Shuaigu (GB8) on the affected side; Baihui (GV20) at the vertex; Zhongzhu (SJ3) and Zulinqi (GB41) bilaterally. Adjunct Acupoints (Bilateral, selected based on TCM pattern differentiation): External Pathogen Invasion: Hegu (LI4) + Waiguan (SJ5) Liver Fire Harassing Upper: Yanglingquan (GB34) + Xingjian (LR2) Phlegm Fire Stagnation: Fenglong (ST40) + Neiting (ST44) Qi Stagnation and Blood Stasis: Xuehai (SP10) + Taichong (LR3) Kidney Essence Deficiency: Taixi (KI3) + Sanyinjiao (SP6) Spleen and Stomach Deficiency: Zusanli (ST36) + Qihai (CV6)
Sham Comparator: Sham acupuncture combined with corticosteroids group; Participants in this group will receive sham acupuncture (applied to the same acupoint locations as in the experimental group, while the needle tip does not penetrate the skin) 3 times per week for 4 weeks, together with oral prednisone (1 mg/kg/day, maximum 60 mg/day) for 7 days followed by a 7-day taper, plus oral Ginkgo biloba extract for 4 weeks.	Procedure: Sham acupuncture; The same acupoints are used, but with blunt-tip placebo needles that do not penetrate the skin. The needles are fixed with adhesive patches, and the procedure is identical to the real acupuncture group to maintain blinding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing improvement	Hearing improvement measured by the change in Pure Tone Audiometry (PTA) average (500, 1000, 2000, and 4000 Hz) from baseline to week 8, compared between the acupuncture + corticosteroid group and the sham acupuncture + corticosteroid group.	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing outcomes at multiple time points	Changes in PTA at weeks 1, 2, 4, 8, and 12	week 1, 2, 4, 8, and 12
Word Recognition Score (WRS)	Changes of WRS from baseline at weeks 1, 2, 4, 8, and 12	weeks 1, 2, 4, 8, and 12
Sudden hearing loss recovery grade	Complete, significant, partial, or no recovery according to the 2019 AAO-HNS guideline criteria	weeks 1, 2, 4, 8, and 12
TCM symptom score	Change from baseline to week 8 using the pattern-specific TCM symptom scale	week 8
Sensory Organization Test	Sensory Organization Test (SOT) scores at weeks 1, 2, 4, 8, and 12	weeks 1, 2, 4, 8, and 12
Insomnia Severity Index (ISI)	Changes from baseline at weeks 1, 2, 4, 8, and 12	weeks 1, 2, 4, 8, and 12
Dizziness Handicap Inventory (DHI)	Changes from baseline at weeks 1, 2, 4, 8, and 12	weeks 1, 2, 4, 8, and 12
Tinnitus Handicap Inventory (THI)	Changes from baseline at weeks 1, 2, 4, 8, and 12	weeks 1, 2, 4, 8, and 12
Hospital Anxiety and Depression Scale (HADS)	Changes from baseline at weeks 1, 2, 4, 8, and 12	weeks 1, 2, 4, 8, and 12
Quality of life (SF-36)	Changes from baseline at weeks 1, 2, 4, 8, and 12	weeks 1, 2, 4, 8, and 12
Aural fullness scale (AFS)	Visual analog scale (0-10) changes from baseline at weeks 1, 2, 4, 8, and 12	weeks 1, 2, 4, 8, and 12
Salvage treatment rate	Proportion of participants requiring intratympanic steroid injection due to insufficient hearing recovery at day 14	day 14
Safety outcome	Proportion of adverse events in both groups at week 8	week 8

Collaborators and Investigators

• Sponsor: Eye & ENT Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 3, 2026
• First Submitted That Met QC Criteria: May 3, 2026
• First Posted (Actual): May 8, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: acupuncture; Sudden sensorineural hearing loss (SSNHL)
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Loss; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss, Sudden; Therapeutics; Complementary Therapies; Acupuncture Therapy
• Other Study ID Numbers: SSHNL-Acupuncture-Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No