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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameVIBRANT P/ VIBRANT D SOUNDBRIDGE SYSTEM
Classification Nameimplant, hearing, active, middle ear, partially implanted
Generic Nameimplantable middle ear hearing device
ApplicantVIBRANT MED-EL HEARING TECHNOLOGY GMBH
PMA NumberP990052
Date Received09/07/1999
Decision Date08/31/2000
Product Code
MPV[ Registered Establishments with MPV ]
Docket Number 00M-1583
Notice Date 10/27/2000
Advisory Committee Ear Nose & Throat
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the vibrant soundbridge system. This device is indicated for providing a useful level of sound perception to individuals via mechanical stimulatino of the ossicles. The vibrant soundbridge is intended for use in adults, 18 years of age or older, who have a moderate to severe sensorineural hearing loss and desire an alternative to an acoustic hearing aid. Prior to receiving the device, it is recommended that an individual have experience with appropriately fit hearing aids.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S006 S007 S008 S011 S012 
S013 S014 S015 S016 S018 S019 S020 S021 S022 
S023 S024 
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