Acupuncture plus steroids for sudden sensorineural hearing loss

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

This trial will test whether adding acupuncture to steroid treatment helps adults with sudden sensorineural hearing loss recover hearing and reduce symptoms like tinnitus and dizziness.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 256 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Eye & ENT Hospital of Fudan University (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Shanghai)
• Trial ID: NCT07575334 on ClinicalTrials.gov

What this trial studies

This is a multicenter, prospective, randomized controlled trial comparing real acupuncture versus sham acupuncture when both are given alongside a standard oral prednisone course for adults with sudden sensorineural hearing loss. Participants receive acupuncture or sham acupuncture three times per week for four weeks while taking prednisone (1 mg/kg/day, maximum 60 mg/day) with a 7-day taper. The primary outcome is hearing recovery measured by pure tone audiometry at 8 weeks, and secondary outcomes include word recognition, vestibular function, tinnitus, sleep quality, anxiety, and quality of life. Eligible adults are 18–70 years old with unilateral SSNHL of ≥30 dB across at least three consecutive frequencies and must start treatment within 14 days of symptom onset.

Who should consider this trial

Good fit: Adults aged 18–70 with unilateral sudden sensorineural hearing loss of at least 30 dB across three consecutive frequencies who can start treatment within 14 days and have no identifiable alternate cause are ideal candidates.

Not a fit: Patients with a known cause of hearing loss (for example acoustic neuroma, recent stroke, or head trauma), bilateral or chronic (>14 days) hearing loss, or those unable to attend frequent in-person acupuncture visits are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding acupuncture to standard steroid therapy could improve hearing recovery and reduce accompanying symptoms such as tinnitus and dizziness.

How similar studies have performed: Previous small randomized trials and meta-analyses have produced mixed, low-quality evidence suggesting a possible modest benefit from acupuncture for SSNHL, but results are not definitive.

Eligibility criteria

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.).

Where this trial is running

Shanghai

• Eye and ENT Hospital of Fudan University — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Weiming Hao, MD, Doctor

Conditions Sudden Sensorineural Hearing Loss; acupuncture; Sudden sensorineural hearing loss