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Device Explorer · FDA GUDID · GMDN 61243

Cochlear implant/auditory brainstem implant sound processor earhook

A small hook-shaped or formable device designed to be attached to the sound processor of a cochlear implant or auditory brainstem implant system to facilitate wearing behind the ear. It is typically made of synthetic polymer materials. This is a reusable devic

US‑registered devices101in commercial distribution
Companies2labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription84%Rx‑only share
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Share of device records

Cochlear Limited8584%
Advanced Bionics, Llc1616%

Top labelers

CompanyDevicesShare
Cochlear Limited8584%
Advanced Bionics, Llc1616%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Naida CI EarhookEarhookAuria™ Standard EarhookM EarhookCochlear™ Earmould AdaptorCochlear™ Tamper Resistant EarhookCochlear™ Hybrid™ Earhook with Removal ToolCochlear™ SnugfitCochlear™ Hugfit™Cochlear™ EarhookCochlear™ HeadbandNucleus

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

FDA product codes

CodeNameDevices
MCMIMPLANT, COCHLEAR70
MCMImplant, cochlear30
MCMImplant, Cochlear4
PGQHybrid cochlear implant1

GMDN & GCC registration

  • GMDN code 61243 · non‑implantable
  • Single‑use 0% · sterile 0% · 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

No structured size data on the register.

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

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

101 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 earhook", from 2 companies. The largest labeler is Cochlear Limited with 84% 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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