Consulting Wallah › Device Explorer › Other devices › Cochlear implant/auditory brainstem implant extern
Device Explorer · FDA GUDID · GMDN 58184

Cochlear implant/auditory brainstem implant external coil

An external component of a cochlear implant (CI) or auditory brainstem implant system designed to transmit the electrical signals generated by the sound processor to the implantable receiver-stimulator and electrode array assembly (none included) of the hearin

US‑registered devices288in commercial distribution
Companies4labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription85%Rx‑only share
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Share of device records

Cochlear Limited20471%
Med-El Elektromedizinische Geräte Gesellschaft M.B.H.4215%
Advanced Bionics, Llc4114%
Advanced Bionics Ag10%

Top labelers

CompanyDevicesShare
Cochlear Limited20471%
Med-El Elektromedizinische Geräte Gesellschaft M.B.H.4215%
Advanced Bionics, Llc4114%
Advanced Bionics Ag10%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Zn-Air Battery PakAquaMic™3DUHP 3DUHP 3D PlusAquaMic™ 3DUniversal Headpiece UHP 2.0AquaMic™Concave UHPUniversal Headpiece UHPSlim HP StandardSlim HP MicSlim HP AquaMic™Slim HPCochlear™ Nucleus® 8 Nexa™ Aqua+ CoilCochlear™ Nucleus® 8 Aqua+ Coil (5(I))Cochlear™ Nucleus® 8 Aqua+ Coil

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

FDA product codes

CodeNameDevices
MCMIMPLANT, COCHLEAR155
MCMImplant, cochlear154
MCMImplant, Cochlear77

GMDN & GCC registration

  • GMDN code 58184 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 85% · 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) · 135Length (Inch) · 29Outer Diameter (Centimeter) · 4

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

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

288 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 coil", from 4 companies. The largest labeler is Cochlear Limited with 71% of records.

Which FDA product codes apply?

MCM (IMPLANT, COCHLEAR), MCM (Implant, cochlear), MCM (Implant, Cochlear)

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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