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Device Explorer · FDA GUDID · GMDN 47374

Cochlear implant/auditory brainstem implant sound processor

An external component of a cochlear implant (CI) or auditory brainstem implant system that typically consists of a battery-powered microphone/transmitter (transducer) designed to convert sound waves from the environment into electrical signals which are transm

US‑registered devices788in commercial distribution
Companies5labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription70%Rx‑only share
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Share of device records

Med-El Elektromedizinische Geräte Gesellschaft M.B.H.41653%
Advanced Bionics, Llc18523%
Cochlear Limited10613%
Advanced Bionics Corporation446%
Neurelec375%

Top labelers

CompanyDevicesShare
Med-El Elektromedizinische Geräte Gesellschaft M.B.H.41653%
Advanced Bionics, Llc18523%
Cochlear Limited10613%
Advanced Bionics Corporation446%
Neurelec375%

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

Brand names on the register (sample)

Neuro Cochlear Implant SystemNaida CI Q70BNaida CI M90Naida CI Q90Sky CI™ M90 Sound ProcessorNaida CI AquaCaseT-Mic 2T-CommNeptune™ ConnectAuria™ Direct ConnectAuria™ T-Mic™Auria™ iConnectPlatinum Series ™ HeadpieceChorus™ Sound ProcessorNaida CI Q70Naida CI Q30

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

FDA product codes

CodeNameDevices
MCMImplant, Cochlear501
MCMImplant, cochlear257
MCMIMPLANT, COCHLEAR250
PGQCochlear Implant With Combined Electrical Stimulation And Ac95
PFOActive implantable bone conduction hearing system6

GMDN & GCC registration

  • GMDN code 47374 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 70% · 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) · 3

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How many cochlear implant/auditory brainstem implant sound processor products are registered in the US?

788 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 sound processor", from 5 companies. The largest labeler is Med-El Elektromedizinische Geräte Gesellschaft M.B.H. with 53% of records.

Which FDA product codes apply?

MCM (Implant, Cochlear), MCM (Implant, cochlear), MCM (IMPLANT, COCHLEAR), PGQ (Cochlear Implant With Combined Electrical Stimulation And Ac)

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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