Consulting Wallah › Device Explorer › Other devices › Cochlear implant system, external-microphone
Device Explorer · FDA GUDID · GMDN 35643

Cochlear implant system, external-microphone

A battery-powered assembly of devices [cochlear implant (CI)] intended for the partial restoration of auditory sensation to a severely/profoundly deaf person. It consists of an inner electrode array implanted in one cochlea and connected to a receiver-stimulat

US‑registered devices194in commercial distribution
Companies4labelers on GUDID
Single‑use11%of device records
Sterile9%labelled sterile
Prescription84%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Cochlear Limited15580%
Advanced Bionics, Llc2412%
Neurelec147%
Medline Industries, Inc.11%

Top labelers

CompanyDevicesShare
Cochlear Limited15580%
Advanced Bionics, Llc2412%
Neurelec147%
Medline Industries, Inc.11%

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

Brand names on the register (sample)

Neuro Cochlear Implant SystemHiRes 90K™ Magnet InsertHiRes 90K™ Replacement MagnetHiFocus Mid-Scala Electrode Instrument KitHiRes 90K™ Magnet Insert DummyInsertion Gauge PlasticAB RemoteHiRes™ Ultra Temporary Non Magnetic PlugHiRes 90K™ HiFocus™ 1J Electrode Instrument KitHiRes 90K™ Surgical Tool KitRecess Marking Template for HiRes 90K™HiRes 90K™ Mock UpBTE-ICS Template for HiRes 90K™Coil Gauge for HiRes 90K™Metal Insertion TubeSlotted ICS Electrode Insertion Tube

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

FDA product codes

CodeNameDevices
MCMIMPLANT, COCHLEAR159
MCMImplant, cochlear24
MCMImplant, Cochlear17
PGQHybrid cochlear implant16
LXHOrthopedic Manual Surgical Instrument3
MDMInstrument, Manual, Surgical, General Use2

GMDN & GCC registration

  • GMDN code 35643 · implantable
  • Single‑use 11% · sterile 9% · Rx‑only 84% · 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

Outer Diameter (Millimeter) · 3Length (Centimeter) · 3

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

How many cochlear implant system, external-microphone products are registered in the US?

194 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cochlear implant system, external-microphone", from 4 companies. The largest labeler is Cochlear Limited with 80% of records.

Which FDA product codes apply?

MCM (IMPLANT, COCHLEAR), MCM (Implant, cochlear), MCM (Implant, Cochlear), PGQ (Hybrid cochlear implant)

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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