An electroacoustic device intended to be used for both the evaluation of hearing loss (audiometer function) and the evaluation of hearing aids while worn for optimal amplification [real-ear measurement (REM)]; some types may in addition be used to test hearing
| Company | Devices | Share |
|---|---|---|
| Auditdata A/S | 36 | 39% |
| Ws Audiology Usa, Inc. | 29 | 31% |
| Precision Cast Plastic Parts, Inc. | 7 | 8% |
| Interacoustics A/S | 6 | 6% |
| Etymotic Research, Inc. | 5 | 5% |
| Etymonic Design Incorporated | 4 | 4% |
| Medrx, Inc. | 3 | 3% |
| Sonova Ag | 1 | 1% |
| Neurosoft, Ooo | 1 | 1% |
| Db Diagnostic Systems, Inc. | 1 | 1% |
Company = labeler of record on GUDID. 10 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 |
|---|---|---|
| EWO | Audiometer | 126 |
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 19 |
| EWO | AUDIOMETER | 7 |
| OSM | Hearing aid, air conduction with wireless technology | 1 |
| GWJ | Stimulator, Auditory, Evoked Response | 1 |
| ETY | Tester, Auditory Impedance | 1 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
93 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Audiometric/hearing aid tester", from 10 companies. The largest labeler is Auditdata A/S with 39% of records.
EWO (Audiometer), ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems), EWO (AUDIOMETER), 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.