Middle ear infections (otitis media) are common, especially among children, and if not treated in time, may lead to hearing loss. Professor Chin-Kuo Chen and his team at Keelung Chang Gung Memorial Hospital have developed a new handheld device that uses ultrasound imaging to detect middle ear effusion. This method overcomes the limitations of traditional otoscopy or tympanometry, offering a non-invasive, radiation-free solution suitable for both adults and children, enabling doctors to quickly and accurately diagnose otitis media.
Limitations of Traditional Detection Methods
Statistics show that more than 60% of infants under one year old have experienced middle ear infections, and this number rises to over 80% for children under three. The incidence of middle ear effusion caused by these infections ranges from 1.3% to 31.3%, which can result in hearing impairment.
Clinically, otoscopy and tympanometry are commonly used to diagnose middle ear effusion. However, these methods require the patient to remain still and are dependent on having an appropriate space for tympanometry. Moreover, the accuracy of the diagnosis heavily relies on the experience of the practitioner. While CT scans and MRIs can effectively detect middle ear effusion, their high cost and radiation exposure make them unsuitable for routine monitoring.
Advantages of the New Device
The new handheld device developed by Professor Chen’s team offers several key advantages:
Non-invasive: The device only requires placing the probe on the skin behind the ear on the mastoid bone, ensuring no discomfort for the patient.
Radiation-free: Unlike CT or MRI, this method is safer with no concerns about radiation exposure.
Suitable for adults and children: The device is not affected by patient age, ear canal size, or patient cooperation.
Fast and accurate: The device can complete the examination quickly, providing highly accurate diagnostic results.
Promising Clinical Trial Results and Market Potential
Professor Chen pointed out that the device has undergone cadaver testing and large-scale clinical trials, demonstrating an accuracy rate of 98%. It can effectively distinguish the characteristics of middle ear effusion. The device holds four major market advantages:
Improved diagnostic convenience: Currently, diagnosing middle ear effusion in ENT clinics requires a computer. Integrating this ultrasound imaging system into the diagnostic process will significantly improve convenience.
Better healthcare economics: According to the National Health Insurance Administration, there are around 500,000 outpatient visits for otitis media/middle ear effusion each year, with around 50,000 patients needing ultrasound checks. With an estimated reimbursement of 300 NHI points per check, this could generate an additional NT$750,000 in revenue annually.
Convenience for parents and patients: For dual-income families or patients with limited mobility, the ability to quickly diagnose middle ear effusion can prevent delayed treatment and unnecessary travel.
Broader application scope: Ultrasound is not affected by narrow ear canals or thickened eardrums, and can be used to track the treatment effects of middle ear effusion, making it ideal for patients who cannot undergo tympanometry.
Professor Chen emphasized that they are actively seeking licensing partners for this device, with the hope that it will soon be adopted for clinical use to benefit a broader population.
Resource (mandarin): 非侵入無輻射 超音波快速偵測中耳積水
