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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMED-EL CI System
Generic NameImplant, cochlear
ApplicantMED-EL CORP.
FURSTENWEG 77a
INNSBRUCK 6020
PMA NumberP000025
Supplement NumberS129
Date Received10/25/2023
Decision Date10/03/2024
Product Code MCM 
Docket Number 24M-4668
Notice Date 11/08/2024
Advisory Committee Ear Nose & Throat
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement for the MED-EL Cochlear Implant (CI) System for expanding the indications for use. The expanded device indications include individuals with bilateral hearing loss who meet the following criteria:The MED-EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for individuals with debilitating sensorineural hearing loss who obtain limited benefit from acoustic amplification in the ear(s) to be implanted and is indicated for the following patient populations: • Individuals of eighteen (18) years of age or older with bilateral moderate to profound sensorineural hearing loss who obtain limited benefit from appropriately-fit hearing aids. These individuals typically demonstrate a low-frequency pure-tone average of greater than 40 dB HL (at 250 Hz, 500 Hz, and 1000 Hz) and thresholds not better than 65 dB HL at 3000-8000 Hz. Limited benefit from hearing aids is defined by test scores of 50% correct or less in the ear to be implanted and 60% or less in the non-implant ear on recorded tests of monosyllabic word recognition (Consonant-Nucleus-Consonant [CNC] Words).• MED-EL strongly recommends a hearing aid trial prior to implantation (if not already completed), but radiological evidence of cochlear ossification may preclude a hearing aid trial.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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