Vibrant Soundbridge Implantable Hearing Prosthesis System
Taiwan·Risk Class 3·MD·MED-EL Elektromedizinische Gerate GmbH·Registered Feb 10, 2010 – Feb 10, 2025Expired- Analysis ID
- 12c6bbeac57aa59092cd3bdf3fc6b43a
- License Form
- Department of Health Medical Device Import No. 020825
- Customs Code
- DHA00602082507
- Manufacturer
- MED-EL Elektromedizinische Gerate GmbH
- Manufacturer Country
- Austria
- Authorized Representative
- MELODY MEDICAL INSTRUMENTS 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 device
- Import Information
- Imported from abroad
- Registration Date
- Feb 10, 2010
- Expiry Date
- Feb 10, 2025
Top companies providing products similar to "Vibrant Soundbridge Implantable Hearing Prosthesis System"
Recently registered similar products
Access comprehensive regulatory information for Vibrant Soundbridge Implantable Hearing Prosthesis System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 12c6bbeac57aa59092cd3bdf3fc6b43a and manufactured by MED-EL Elektromedizinische Gerate GmbH. The authorized representative in Taiwan is MELODY MEDICAL INSTRUMENTS CORPORATION.
This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including MED-EL Elektromedizinische Geräte 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.