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
| Company | Devices | Share |
|---|---|---|
| Gn Hearing A/S | 99 | 82% |
| Cochlear Limited | 14 | 12% |
| Soundwave Hearing, Llc | 7 | 6% |
Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| OSM | Hearing aid, air conduction with wireless technology | 75 |
| OSM | Hearing Aid, Air-Conduction with Wireless Technology, Prescr | 46 |
| MCM | IMPLANT, COCHLEAR | 14 |
| QUH | Self-Fitting Air-Conduction Hearing Aid, Over The Counter | 7 |
Use these as the dimensions to specify in a tender line.
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.
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)
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.