Consulting Wallah › Device Explorer › Other devices › Earmould, preformed
Device Explorer · FDA GUDID · GMDN 62259

Earmould, preformed

A preformed device designed to fit in an ear canal and through which the acoustic output from a hearing aid is conveyed to the eardrum. It is made of soft synthetic polymer materials and may have various forms (e.g., plug-like, ear shape). This is a reusable d

US‑registered devices120in commercial distribution
Companies3labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription12%Rx‑only share
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Share of device records

Gn Hearing A/S9982%
Cochlear Limited1412%
Soundwave Hearing, Llc76%

Top labelers

CompanyDevicesShare
Gn Hearing A/S9982%
Cochlear Limited1412%
Soundwave Hearing, Llc76%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

GN HearingSoundwave HearingCochlear™ Hybrid™ Open Dome, 6 mmCochlear™ Hybrid™ Open Dome, 8 mmCochlear™ Hybrid™ Open Dome, 10 mmCochlear™ Hybrid™ Power Dome, 6 mmCochlear™ Hybrid™ Power Dome, 8 mmCochlear™ Hybrid™ Bass Single Dome, 6 mmCochlear™ Hybrid™ Bass Single Dome, 10 mmCochlear™ Hybrid™ Power Dome, 10 mmCochlear™ Hybrid™ Bass Double Dome, 6 mmCochlear™ Hybrid™ Bass Single Dome, 8 mmCochlear™ Hybrid™ Bass Double Dome, 10 mmCochlear™ Hybrid™ Bass Double Dome, 8 mmCochlear™ Hybrid™ Ear Lock, 60Cochlear™ Hybrid™ Ear Lock, 85

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

FDA product codes

CodeNameDevices
OSMHearing aid, air conduction with wireless technology75
OSMHearing Aid, Air-Conduction with Wireless Technology, Prescr46
MCMIMPLANT, COCHLEAR14
QUHSelf-Fitting Air-Conduction Hearing Aid, Over The Counter7

GMDN & GCC registration

  • GMDN code 62259 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 12% · OTC 6%
  • 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) · 12

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

How many earmould, preformed products are registered in the US?

120 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Earmould, preformed", from 3 companies. The largest labeler is Gn Hearing A/S with 82% of records.

Which FDA product codes apply?

OSM (Hearing aid, air conduction with wireless technology), OSM (Hearing Aid, Air-Conduction with Wireless Technology, Prescr), MCM (IMPLANT, COCHLEAR), QUH (Self-Fitting Air-Conduction Hearing Aid, Over The Counter)

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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