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PMA P000025S129

Device
MED-EL CI System
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S129
Product code
MCM
Decision date
2024-10-03
Classification
Ear, Nose, Throat
Generic name
Implant, cochlear
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.

Current openFDA PMA Record#

Device
MED-EL CI System
Applicant
Med-El Corp.
PMA number
P000025
Supplement
S129
Product code
MCM
Generic name
Implant, cochlear
Decision date
2024-10-03
Decision code
APPR
Date received
2023-10-25
Supplement type
Panel Track
Supplement reason
Change Design/Components/Specifications/Material
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.