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

Summary

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.

Conditions

• Sudden Sensorineural Hearing Loss (SSNHL)
• Tinnitus

Interventions

DIETARY_SUPPLEMENT

Inner ear support

FB-1603 (150 mg): A cold water extract of Arthrospira maxima (a species of blue-green algae), rich in the antioxidant pigment C-phycocyanin (C-PC). GABA (126 mg): A natural calming neurotransmitter that can help reduce nerve-related overactivity. γ-Oryzanol (12 mg): A component from rice bran oil, known for its antioxidant properties. Sesamin (12 mg): A compound from sesame seeds, with potential neuroprotective and anti-inflammatory benefits.

Sponsors & Collaborators

• Far East Bio-Tec Co., Ltd

  lead INDUSTRY

Principal Investigators

• Pei-Hsuan Lin, P.h.D. · National Taiwan University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-01

Primary Completion

2025-12-31

Completion

2026-06-30

Countries

• Taiwan

Study Locations