FDA.reportPublic FDA data

Cochlear implant/auditory brainstem implant external battery

Definition
An external component of a cochlear implant (CI) or auditory brainstem implant system designed to supply direct current (DC) to operate the electrically-powered and dependent components of the system. It is typically worn behind-the-ear (BTE), or is neck- or waist-worn, and may include an on/off switch. This is a reusable device.
GUDID devices
51
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00811204030539ZPower Rechargeable System for Hearing AidsZPOWER, LLCZ701-3122019-05-01
00811204030546ZPower Rechargeable System for Hearing AidsZPOWER, LLCZ701-3122019-05-01
00811204030553ZPower Rechargeable System for Hearing AidsZPOWER, LLCZ701-3122019-05-01
00811204030560ZPower Rechargeable System for Hearing AidsZPOWER, LLCZ701-3122019-05-01
00840094447578M Zn-Air Battery PakAdvanced Bionics, LLCCI-5501-2602023-01-13
00840094447615M Zn-Air Battery PakAdvanced Bionics, LLCCI-5501-1402023-01-13
00840094447653M Zn-Air Battery PakAdvanced Bionics, LLCCI-5501-1102023-01-13
00840094450240AA Battery Pack CaseAdvanced Bionics, LLCAB-75102022-12-09
00840094450899Auria™ HuggieAdvanced Bionics, LLCCI-7450-2002022-12-09
00840094450912Auria™ HuggieAdvanced Bionics, LLCCI-7450-3002022-12-09
00840094452312Zn-Air Battery PakAdvanced Bionics, LLCCI-5500-1802023-01-13
00840094452350Zn-Air Battery PakAdvanced Bionics, LLCCI-5500-2402023-01-13
00840094452626Zn-Air Battery PakAdvanced Bionics, LLCCI-5500-1202023-01-13
00840094452633Zn-Air Battery PakAdvanced Bionics, LLCCI-5500-1302023-01-13
00840094452657Zn-Air Battery PakAdvanced Bionics, LLCCI-5500-1502023-01-13
00840094452664Zn-Air Battery PakAdvanced Bionics, LLCCI-5500-1602023-01-13
00840094452688Zn-Air Battery PakAdvanced Bionics, LLCCI-5500-1902023-01-13
00850034007434ZPower Rechargeable System for Hearing AidsZPOWER, LLCZ602-3122017-12-22
00850034007496ZPower Rechargeable System for Hearing AidsZPOWER, LLCZ701-3122017-12-22
00850034007656ZPower Rechargeable System for Hearing AidsZPOWER, LLCZ602-3122017-12-22
00850034007663ZPower Rechargeable System for Hearing AidsZPOWER, LLCZ602-3122017-12-22
09321502063692Cochlear™ Personalisation CoverCOCHLEAR LIMITEDP18405312022-11-30
09321502063715Cochlear™ Personalisation CoverCOCHLEAR LIMITEDP18405912022-11-30
00840094447561M Zn-Air Battery PakAdvanced Bionics, LLCCI-5501-2802023-01-13
00840094447585M Zn-Air Battery PakAdvanced Bionics, LLCCI-5501-2702023-01-13
00840094447592M Zn-Air Battery PakAdvanced Bionics, LLCCI-5501-1202023-01-13
00840094447608M Zn-Air Battery PakAdvanced Bionics, LLCCI-5501-1302023-01-13
00840094447622M Zn-Air Battery PakAdvanced Bionics, LLCCI-5501-1502023-01-13
00840094447639M Zn-Air Battery PakAdvanced Bionics, LLCCI-5501-1902023-01-13
00840094447646M Zn-Air Battery PakAdvanced Bionics, LLCCI-5501-2502023-01-13
00840094447660M Zn-Air Battery PakAdvanced Bionics, LLCCI-5501-2402023-01-13
00840094448995AAA PowerPak AccessoryAdvanced Bionics, LLCCI-74032022-12-09
00840094450905Auria™ HuggieAdvanced Bionics, LLCCI-7450-1002022-12-09
00840094452640Zn-Air Battery PakAdvanced Bionics, LLCCI-5500-1402023-01-13
00840094452671Zn-Air Battery PakAdvanced Bionics, LLCCI-5500-1702023-01-13
00840094452695Zn-Air Battery PakAdvanced Bionics, LLCCI-5500-1102023-01-13
00840094452701Zn-Air Battery PakAdvanced Bionics, LLCCI-5500-2202023-01-13
09008737049997OPUS 2 FM Extension Kit anthraciteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.049992022-09-15
09008737050009OPUS 2 Children's Extension Kit anthraciteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.050002022-09-15
09008737050030OPUS 2 FM Extension Kit beigeMed-El Elektromedizinische Geräte Gesellschaft m.b.H.050032022-09-15
09008737050047OPUS 2 Children's Extension Kit beigeMed-El Elektromedizinische Geräte Gesellschaft m.b.H.050042022-09-15
09008737050078OPUS 2 FM Extension Kit redMed-El Elektromedizinische Geräte Gesellschaft m.b.H.050072022-09-15
09008737050085OPUS 2 Children's Extension Kit redMed-El Elektromedizinische Geräte Gesellschaft m.b.H.050082022-09-15
09008737050115OPUS 2 FM Extension Kit blueMed-El Elektromedizinische Geräte Gesellschaft m.b.H.050112022-09-15
09008737050122OPUS 2 Children's Extension Kit blueMed-El Elektromedizinische Geräte Gesellschaft m.b.H.050122022-09-15
09008737050153OPUS 2 FM Extension Kit greyMed-El Elektromedizinische Geräte Gesellschaft m.b.H.050152022-09-15
09008737050160OPUS 2 Children's Extension Kit greyMed-El Elektromedizinische Geräte Gesellschaft m.b.H.050162022-09-15
09008737050191OPUS 2 FM Extension Kit brownMed-El Elektromedizinische Geräte Gesellschaft m.b.H.050192022-09-15
09008737050207OPUS 2 Children's Extension Kit brownMed-El Elektromedizinische Geräte Gesellschaft m.b.H.050202022-09-15
09008737056414OPUS 2 Battery Pack Extension Kit anthraciteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.056412022-09-16
09008737056421OPUS 2 Battery Pack Extension Kit beigeMed-El Elektromedizinische Geräte Gesellschaft m.b.H.056422022-09-16