Melody middle ear implant system
Taiwan·Risk Class 3·MED-EL Elektromedizinische Geräte GmbH·Registered Feb 10, 2010 – Feb 10, 2025Expired- Analysis ID
- a354230d70a085fac4ecb118377f1e15
- Customs Code
- DHA00602082507
- Manufacturer
- MED-EL Elektromedizinische Geräte GmbH
- Manufacturer Country
- Austria
- Authorized Representative
- QUALTECH CONSULTING CORPORATION
- Intended Use
- 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.
- Product Type (Level 1)
- G ENT Science
- Import Information
- import
- Registration Date
- Feb 10, 2010
- Expiry Date
- Feb 10, 2025
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Access comprehensive regulatory information for Melody middle ear implant system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number a354230d70a085fac4ecb118377f1e15 and manufactured by MED-EL Elektromedizinische Geräte GmbH. The authorized representative in Taiwan is QUALTECH CONSULTING CORPORATION.
This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including VIBRANT MED-EL HEARING TECHNOLOGY GMBH, and 1 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.