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Vibrant Soundbridge Implantable Hearing Prosthesis System - Taiwan Registration 12c6bbeac57aa59092cd3bdf3fc6b43a

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 Gerรคte 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.

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12c6bbeac57aa59092cd3bdf3fc6b43a
Registration Details
Taiwan FDA Registration: 12c6bbeac57aa59092cd3bdf3fc6b43a
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Device Details

Vibrant Soundbridge Implantable Hearing Prosthesis System
TW: ็พŽๆจ‚่ฟชไธญ่€ณๆคๅ…ฅๅ™จ็ณป็ตฑ
Risk Class 3
MD

Registration Details

12c6bbeac57aa59092cd3bdf3fc6b43a

Department of Health Medical Device Import No. 020825

DHA00602082507

Company Information

Product Details

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: โ—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 โ— 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/-โ—The patient's anatomy allows the float converter to be fixed to the appropriate middle ear structure. โ—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. โ—Patients must be 18 years of age or older. โ—Patients should have reasonable expectations and be psychologically and emotionally stable regarding the benefits and limitations of middle ear implants.

G ENT device

Imported from abroad

Dates and Status

Feb 10, 2010

Feb 10, 2025

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