| 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. |
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| Device | MED-EL CI System |
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| Generic Name | Implant, cochlear |
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| Applicant | Med-El Corp.
Furstenweg 77a
Innsbruck 6020 |
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| PMA Number | P000025 |
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| Supplement Number | S134 |
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| Date Received | 02/12/2025 |
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| Decision Date | 11/26/2025 |
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| Product Code |
MCM |
| Docket Number | FDA-7023 |
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| Notice Date | 12/12/2025 |
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| Advisory Committee |
Ear Nose & Throat |
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| Supplement Type | Panel Track |
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| Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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| Recalls | CDRH Recalls |
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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 CI System for expanding the indication for use. The expanded device indications include children 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 (SNHL) who obtain limited benefit from acoustic amplification in the ear(s) to be implanted and is indicated for the following pediatric populations: Children aged 7 months to 17 years, 11 months must demonstrate a bilateral SNHL as follows. • Children implanted at 7-11 months of age should demonstrate a profound SNHL, defined by a 3-frequency pure-tone average (PTA3) of ?90 dB HL at 500, 1000, and 2000 Hz. • Children implanted at 12-71 months of age should demonstrate a moderately-severe to profound SNHL in the low frequencies, defined by a PTA3 ? 55dB HL at 500, 1000, and 2000 Hz and a severe to profound SNHL in the high frequencies with thresholds not better than 70 dB HL at 2000-8000 Hz. • Children implanted at 6 years to 17 years, 11 months of age should demonstrate a moderate to profound SNHL in the low frequencies, defined by a low-frequency PTA (LFPTA) >40 dB HL at 250, 500, and 1000 Hz with thresholds not better than 65 dB HL at 3000-8000 Hz. • Children implanted at 7 months to 5 years, 11 months of age must also demonstrate insufficient functional access to sound with appropriately fitted amplification and aural habilitation. Children who lack the requisite language to complete word recognition testing should demonstrate either a lack of progress or plateau on an accepted scale of auditory skill development (e.g., LittlEARS Auditory Questionnaire (LEAQ), Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS)). Children with the requisite language to complete word recognition testing should demonstrate a percent correct score ? 40% on a developmentally appropriate test of word recognition (e.g., based on age, cognitive ability, language skills, and clinical judgement). • Children implanted at 6 years to 17 years, 11 months of age should demonstrate limited benefit from hearing aids, 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 (e.g., Consonant-Nucleus- Consonant [CNC] Words). • Children implanted under 12 months of age should show repeatable behavioral test results that are consistent with objective/electrophysiological test results.¿ • MED-EL strongly recommends a hearing aid trial of at least 1-3 months for children without previous hearing aid experience. Risk of ossification or lack of aidable hearing may preclude a hearing aid trial. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling |
Labeling Part 2 |
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