'Inner Ear Support' Oral Capsule in Patients With Sudden Sensorineural Hearing Loss

Launched by FAR EAST BIO-TEC CO., LTD · May 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new oral supplement called 'Inner Ear Support' to see if it can help people with sudden sensorineural hearing loss (SSNHL), a condition where individuals experience rapid hearing loss, usually in one ear, often accompanied by ringing in the ears (tinnitus) or dizziness. The trial will include 80 participants aged 18 to 75 who have been diagnosed with SSNHL and started treatment within two weeks of their hearing loss. Participants will be randomly placed into two groups: one will receive standard treatment (like steroids) along with the 'Inner Ear Support' capsule taken twice daily for 28 days, while the other group will only receive standard treatment.

Throughout the study, which will last about 196 days, participants will undergo hearing tests and complete questionnaires to track their symptoms. This trial aims to determine whether 'Inner Ear Support' can improve hearing recovery and lessen tinnitus and dizziness, all while monitoring for any side effects. Ultimately, the goal is to see if this supplement can be a helpful addition to current treatments for SSNHL, enhancing the quality of life for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients aged between 18 and 75 years
• • Patients diagnosed with sudden sensorineural hearing loss as determined by the principal or sub-investigator
• • Average hearing threshold in the affected ear ≥ 60 dB
• • Initiation of treatment within two weeks of hearing loss onset
• Exclusion Criteria:
• • Patients with congenital or hereditary hearing loss
• • Patients with fluctuating hearing loss
• • Patients currently participating in other interventional treatments for sudden hearing loss
• • Patients who have undergone surgery on the affected ear
• • Patients with neurological or psychiatric disorders
• • Patients with heart failure or ischemic heart disease
• • Patients with immunodeficiency
• • Patients with vestibular schwannoma (acoustic neuroma)
• • Patients with other internal medical conditions deemed by the investigator to potentially interfere with the study conduct or outcomes
• • Pregnant patients
• • Patients with a known allergy to the investigational product
• • Patients currently using acetylcysteine or products containing ginkgo biloba extract
• • Patients with autoimmune diseases or currently receiving immunosuppressive therapy