'Inner Ear Support' Oral Capsule in Patients With Sudden Sensorineural Hearing Loss
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Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06997406, who can take part
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- How often do I need to come in, and for how long each time?
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- Who runs it
- Far East Bio-Tec Co., Ltd
- Trial code
- NCT06997406
- Record updated
- 30 May 2025
- Original description
Sudden sensorineural hearing loss (SSNHL) is a medical condition where people experience rapid hearing loss, usually in one ear, over a short period of time (typically within 72 hours). It can affect people of any age, though it is more common among adults aged 40 to 60. In many cases, the exact cause remains unknown, but possible reasons include viral infections, immune-related problems, and reduced blood circulation to the inner ear. Along with hearing loss, many patients may also experience tinnitus (ringing in the ears) or dizziness.Read full original descriptionShow less
Explore the Benefit of 'Inner Ear Support' Oral Capsule in Patients With Sudden Sensorineural Hearing Loss - A Randomized, Open-label, Single-center Study
Sudden sensorineural hearing loss (SSNHL) is a medical condition where people experience rapid hearing loss, usually in one ear, over a short period of time (typically within 72 hours). It can affect people of any age, though it is more common among adults aged 40 to 60. In many cases, the exact cause remains unknown, but possible reasons include viral infections, immune-related problems, and reduced blood circulation to the inner ear. Along with hearing loss, many patients may also experience tinnitus (ringing in the ears) or dizziness.
The standard treatment for SSNHL often involves steroids, sometimes combined with hyperbaric oxygen therapy. However, the effectiveness of these treatments varies, and many patients do not fully recover their hearing. This study aims to explore whether an additional supplement-'Inner ear support' oral capsule-can improve hearing outcomes and relieve associated symptoms in patients with SSNHL.
The study will involve 80 participants who are randomly assigned to two groups. Both groups will receive standard treatment (including steroids and possibly hyperbaric oxygen therapy), but only the test group will take the 'Inner ear support' capsule twice daily for 28 days. Participants will be followed and evaluated over a period of 196 days through hearing tests and symptom questionnaires.
'Inner ear support' is a commercially available nutritional supplement that includes FB-1603 (an extract from Arthrospira maxima), GABA, gamma-oryzanol, and sesamin. Previous research has shown that FB-1603 and its active component, C-phycocyanin, have anti-inflammatory, antioxidant, and nerve-protective effects. Animal studies suggest it may help reduce tinnitus and prevent hearing deterioration.
This clinical trial is designed to evaluate whether 'Inner ear support' can enhance hearing recovery, improve tinnitus and dizziness symptoms, and be safely used as an additional treatment in patients with sudden hearing loss. All participants will be monitored for any potential side effects during the study period.
The ultimate goal of this study is to determine whether' Inner ear support' could become a helpful addition to current treatment methods for SSNHL, improving patient outcomes and quality of life.
Inclusion: 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: Patients who have undergone surgery on the affected ear; 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; Patients with neurological or psychiatric disorders; Patients with heart failure or ischemic heart disease; Patients with other internal medical conditions deemed by the investigator to potentially interfere with the study conduct or outcomes; Patients with congenital or hereditary hearing loss; Patients with fluctuating hearing loss; Patients currently participating in other interventional treatments for sudden hearing loss; Patients with immunodeficiency; Patients with vestibular schwannoma (acoustic neuroma); Pregnant patients.