FDA.reportPublic FDA data

Cochlear implant system waterproof kit

Definition
A collection of non-sterile devices intended to be used with a cochlear implant system to protect the externally worn components in wet and/or rugged environments (e.g. for swimming, showering). The set typically consists of a sound processor case, waterproof microphone, and a connecting cable. This is a reusable device.
GUDID devices
21
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840094452725Naida CI AquaCaseAdvanced Bionics, LLCCI-74312023-01-13
00840094452992Chorus™ Protective CaseAdvanced Bionics, LLCCI-74322022-12-09
09321502026888NucleusCOCHLEAR LIMITEDZ4632732014-09-24
09321502045797Cochlear™ Aqua+COCHLEAR LIMITEDP14347552020-07-08
09321502063722Cochlear™ Aqua+COCHLEAR LIMITEDP18405932022-11-30
09321502063739Cochlear™ Aqua+COCHLEAR LIMITEDP18405962022-11-30
09321502069922Cochlear™ Aqua+COCHLEAR LIMITEDP18405962022-11-30
09321502069939Cochlear™ Aqua+COCHLEAR LIMITEDP18405932022-11-30
09321502054263Cochlear™ Nucleus® 8 Aqua+ CoilCOCHLEAR LIMITEDP17497072022-11-29
09321502054270Cochlear™ Nucleus® 8 Aqua+ Coil (5(I))COCHLEAR LIMITEDP17497082022-11-29
09321502054294Cochlear™ Nucleus® 8 Aqua+ CoilCOCHLEAR LIMITEDP17497102022-11-29
09321502054300Cochlear™ Nucleus® 8 Aqua+ Coil (5(I))COCHLEAR LIMITEDP17497112022-11-29
09321502039079Nucleus® 7 Aqua + CoilCOCHLEAR LIMITEDP7897472017-06-28
09321502039086Nucleus® 7 Aqua + CoilCOCHLEAR LIMITEDP7897462017-06-28
09321502034289Cochlear™ Aqua+ for Kanso®COCHLEAR LIMITEDZ5945432016-10-13
09321502036214Nucleus® 7 Aqua+COCHLEAR LIMITEDZ5445832017-06-28
09321502044967Osia® 2 Aqua+COCHLEAR LIMITEDP13026992020-09-05
09321502055284Cochlear™COCHLEAR LIMITEDP14347552020-07-08
07630016835247Naida CI AquaCase™Advanced Bionics, LLCCI-74312015-10-24
07630016835254Naida CI AquaCase™Advanced Bionics, LLCCI-74312015-10-24
07630016863875Chorus Protective Case Advanced Bionics AGCI-74322019-03-15