Melody middle ear implant system - Taiwan Registration a354230d70a085fac4ecb118377f1e15

Middle ear implants are suitable for patients with hearing loss who have mild to severe hearing loss and cannot achieve results or sufficient benefits from traditional treatment methods, just like general surgery, the physician must evaluate the potential risks and benefits of the patient before deciding to implant the middle ear implant, and consider the patient's complete medical history to make a medical judgment. In addition: ●For patients with sensorineural hearing loss, the pure-tone air conduction threshold is within the following ranges: frequency (kHz): 0.5/1/1.5/2/3/4 Lower limit (dB HL): 10/10/10/15/25/40 Upper limit (dB HL): 65/75/80/80/85/85 ● For conductive or mixed hearing loss, the pure-tone bone conduction threshold should be in the following range: Frequency (kHz) : 0.5/1/1.5/2/3/4 BC upper limit (dB HL): 45/50/55/65/65/-●The patient's anatomy allows the float converter to be fixed to the appropriate middle ear structure. ●Patients with sensorineural hearing loss must still be a hearing aid user, should be used for an average of at least four hours a day for more than three months prior to surgical evaluation, or the patient is unable to wear it due to medical reasons or cannot be assisted by conventional hearing aids. ●Patients must be 18 years of age or older. ●Patients should have reasonable expectations and be psychologically and emotionally stable regarding the benefits and limitations of middle ear implants.

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