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Device Explorer · FDA GUDID · GMDN 58185

Cochlear implant/auditory brainstem implant external battery

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 w

US‑registered devices336in commercial distribution
Companies5labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription78%Rx‑only share
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Share of device records

Med-El Elektromedizinische Geräte Gesellschaft M.B.H.18756%
Cochlear Limited7723%
Advanced Bionics, Llc3912%
Zpower, Llc3210%
Advanced Bionics Ag10%

Top labelers

CompanyDevicesShare
Med-El Elektromedizinische Geräte Gesellschaft M.B.H.18756%
Cochlear Limited7723%
Advanced Bionics, Llc3912%
Zpower, Llc3210%
Advanced Bionics Ag10%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ZPower Rechargeable System for Hearing AidsM Zn-Air Battery PakZn-Air Battery PakAuria™ HuggieAA Battery Pack CaseAAA PowerPak AccessoryCochlear™ Battery CoverCochlear™ Personalisation CoverCochlear™ Battery HolderNucleusSONNET Rechargeable Battery MaxSONNET Rechargeable Battery Micro ProSONNET Rechargeable Battery Standard ProSONNET FM Kit whiteSONNET FM Kit greySONNET FM Kit ebony

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
MCMIMPLANT, COCHLEAR187
MCMImplant, Cochlear135
MCMImplant, cochlear36
ESDHearing Aid, Air Conduction32
OSMHearing Aid, Air Conduction With Wireless Technology32

GMDN & GCC registration

  • GMDN code 58185 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 78% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Centimeter) · 9

Use these as the dimensions to specify in a tender line.

How many cochlear implant/auditory brainstem implant external battery products are registered in the US?

336 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cochlear implant/auditory brainstem implant external battery", from 5 companies. The largest labeler is Med-El Elektromedizinische Geräte Gesellschaft M.B.H. with 56% of records.

Which FDA product codes apply?

MCM (IMPLANT, COCHLEAR), MCM (Implant, Cochlear), MCM (Implant, cochlear), ESD (Hearing Aid, Air Conduction)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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