Establishment of a Trans-round Window Inner Ear Continuous Drug Delivery System for the Treatment of Severe-to-profound Sudden Sensorineural Hearing Loss

  • End date
    Mar 1, 2024
  • participants needed
  • sponsor
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Updated on 4 October 2022


The investigators enrolled patients with total sudden deafness who had failed treatment with systemic combined intra-dural hormone injections. The patients were randomly divided into a pilot group and a control group for a randomized controlled clinical study, with the pilot group receiving a round window niche enlargement via round window inner ear administration and the control group receiving regular intra-drum injection hormone therapy

Condition Hearing Loss, Sudden
Treatment Surgical treatment of round window niche enlargement via round window for inner ear drug delivery, Drum chamber drug injection
Clinical Study IdentifierNCT05455398
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Age ≥ 18 years old, ≤ 65 years old
The diagnostic criteria for total deafness type of sudden deafness published in 2015 were met, and the patient had sudden, unilateral full-frequency severe or very severe sensorineural deafness with or without deafness, tinnitus, peri-aural numbness, vertigo, and dizziness, and the diagnosis of sudden deafness was supported by physical examination, pure tone audiometry(PTA), acoustic impedance, and auditory brainstem response(ABR). Magnetic resonance(MR) of the internal auditory tract ruled out the occupancy of the internal auditory tract and pontocerebellar region
Those with an onset of ≤ 6 weeks who have received a systemic application of glucocorticoid shock therapy, glucocorticoid intra-drum injections, and medication to improve inner ear circulation, but have not responded to treatment (PTA improvement < 15 dB)
No history of middle or inner ear surgery, no history of radiotherapy or chemotherapy; no general anesthesia - contraindication
Patients voluntarily participate in this study and sign an informed consent form

Exclusion Criteria

Bilateral sudden deafness, drug-based deafness, autoimmune diseases, specific infections, syndromic deafness malignant tumors
Pregnant and lactating women
Cannot tolerate general anesthesia surgery, and severe liver and kidney dysfunction
Any other conditions that the investigator believes should be excluded from this study
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