| 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 | NUCLEUS COCHLEAR IMPLANT SYSTEM |
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| Generic Name | Implant, cochlear |
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| Applicant | Cochlear Americas
10350 Park Meadows Drive
Lone Tree, CO 80124 |
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| PMA Number | P970051 |
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| Supplement Number | S140 |
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| Date Received | 12/23/2015 |
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| Decision Date | 06/20/2016 |
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| Product Code |
MCM |
| Advisory Committee |
Ear Nose & Throat |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval for the optional acoustic component amplifies low frequency sound, and sends it into the ear canal. The acoustic component is intended to provide access to these low frequency sounds for some Cochlear Nucleus implant recipients.The acoustic component is indicated for recipients of traditional Cochlear Nucleus implants with unaided air conduction thresholds less than or equal to 85 dB HL between 125 Hz and 2000 Hz following surgery. The acoustic component should only be used when behavioural audiometric thresholds can be obtained and the recipient can provide feedback regarding sound quality.Speech perception testing should be completed before and after fitting with the acoustic component to ensure that the recipient performs as well, if not better, with the acoustic component than without it. |
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