A rubber-like material used to replicate the shape of an individual's ear canal for the manufacture of custom-made hearing aids and earmoulds. The device may be supplied as a two-component silicone (base and catalyst) which produces the usable product. This is
| Company | Devices | Share |
|---|---|---|
| Pro3Dure Medical Gmbh | 81 | 60% |
| Detax Gmbh | 40 | 29% |
| Jkr Laboratories, Inc. | 13 | 10% |
| Earlens Corporation | 2 | 1% |
Company = labeler of record on GUDID. 4 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 | 83 |
| ESD | Hearing Aid, Air-Conduction, Prescription | 41 |
| LDG | Kit, Earmold, Impression | 39 |
| EWD | Protector, Hearing (Insert) | 17 |
Use these as the dimensions to specify in a tender line.
136 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Earmould impression material", from 4 companies. The largest labeler is Pro3Dure Medical Gmbh with 60% of records.
ESD (Hearing Aid, Air Conduction), ESD (Hearing Aid, Air-Conduction, Prescription), LDG (Kit, Earmold, Impression), EWD (Protector, Hearing (Insert))
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.