A custom-made device designed to fit in an individual ear, made from an impression of that ear, and through which the acoustic output from a hearing aid is conveyed to the eardrum, or in which transducer components of a hearing aid are aligned. It is made of s
| Company | Devices | Share |
|---|---|---|
| Dreve Otoplastik Gmbh | 324 | 50% |
| Pro3Dure Medical Gmbh | 143 | 22% |
| Detax Gmbh | 104 | 16% |
| Gn Hearing A/S | 67 | 10% |
| Innovation Meditech Gmbh | 7 | 1% |
| Hearing Lab Technology, Llc | 2 | 0% |
| Uline, Inc. | 2 | 0% |
Company = labeler of record on GUDID. 7 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 |
|---|---|---|
| ESD | Hearing aid, air conduction | 386 |
| ESD | Hearing Aid, Air Conduction | 186 |
| ESD | Hearing Aid, Air-Conduction, Prescription | 174 |
| OSM | Hearing aid, air conduction with wireless technology | 76 |
| EWD | Protector, Hearing (Insert) | 4 |
| LDG | Kit, earmold, impression | 2 |
Use these as the dimensions to specify in a tender line.
649 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Earmould, custom-made", from 7 companies. The largest labeler is Dreve Otoplastik Gmbh with 50% of records.
ESD (Hearing aid, air conduction), ESD (Hearing Aid, Air Conduction), ESD (Hearing Aid, Air-Conduction, Prescription), OSM (Hearing aid, air conduction with wireless technology)
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.