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Listen to the melody of wonder ‐ Cochlear implant 【Date:2018-04-25】 unit:醫療器材及化粧品組

    What would happen if the world is silent? Feel anxiously when walking across the street, establish poor interpersonal relationships due to miscommunication, and have children’s learning ability in speech and language being affected, etc. The effects on hearing will be different dependent upon the damage site of the ear. The hearing of some patients can be recovered from adequate treatments or wearing hearing aids. In more severe circumstances, The patients may need to implant cochlear implants or other devices to compensate for hearing impairment.

    How can we hear sounds? When sound waves enter the path of middle ear and vibrate the eardrum, hair cells in cochlea create electrical signals, and then the auditory nerve will carry the signals to brain which turns them into sounds. Generally speaking, there are two types of hearing loss: conductive and sensorineural hearing loss. “Conductive hearing loss” is due to the structure problems with the ear canal, eardrum, or middle ear. This kind of hearing loss may possibly be improved or repaired by surgical operation, medicinal treatment,s or wearing a hearing aid. “Sensorineural hearing loss” is due to damage of the inner ear, also known as nerve-related hearing loss. Most of this kind of hearing loss patients may be improved by wearing hearing aids; few of them need to be surgically treated with cochlear implants since benefits cannot be achieved from conventional hearing aids. Cochlear implant is composed of receptors, electrodes, coils and speech processers. The receptors and electrodes are to be implanted by a surgeon. The speech processer is turned on by audio therapists. Cochlear implants collect sounds by the microphone of speech processer and transfer the sounds to signals, which in turn are transmitted to hearing nerves to induce auditory sensation.

    Cochlear implants are classified as Class III medical devices that are required to be assessed and approved by TFDA. They are indicated for use in patients who have severe hearing impairment and cannot achieve success or adequate benefit from hearing aid over three months. However, before implanting a cochlear implant, there must be an evaluation process by the medical team. Some hearing-impaired patients with non-functionality of the auditory nerves and the upper auditory pathway, external or middle ear infections, absence of cochlear development, tympanic membrane perforations, and patients who are not suitable in performing middle or inner ear surgery are not recommended to implant a cochlear implant. Patients and families should fully understand what surgery process is planned, along with the risks, benefits, and other options. Also, the patient's willingness to experience new acoustic sounds and cooperation in an auditory training program is critical to the success of the surgery.

    TFDA recommends that you discuss thoroughly with your surgeon about your overall health, your occupation, and your daily activities to choose the cochlear implant that suits you the best. Besides, be sure to strictly follow the preoperative and postoperative instructions. If you would like to learn more about your device, please consult your surgeon and visit the database at http://www.fda.gov.tw/MLMS/H0001.aspx. If you notice device-related problems, please file reports electronically at http://qms.fda.gov.tw, or call the adverse reaction reporting line at 02-2396-0100.