An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of pati
| Company | Devices | Share |
|---|---|---|
| Path Medical Gmbh | 235 | 58% |
| Otodynamics Limited | 103 | 25% |
| Natus Medical Denmark Aps | 40 | 10% |
| Vivosonic Inc | 18 | 4% |
| Interacoustics A/S | 8 | 2% |
| Maico Diagnostics Gmbh | 2 | 0% |
Company = labeler of record on GUDID. 6 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 |
|---|---|---|
| GWJ | Stimulator, Auditory, Evoked Response | 513 |
| EWO | Audiometer | 251 |
| ETT | Cushion, Earphone (For Audiometric Testing) | 111 |
| ETY | Tester, Auditory Impedance | 35 |
| GXY | Electrode, Cutaneous | 8 |
| IKD | Cable, Electrode | 8 |
Use these as the dimensions to specify in a tender line.
406 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Evoked-potential audiometer", from 6 companies. The largest labeler is Path Medical Gmbh with 58% of records.
GWJ (Stimulator, Auditory, Evoked Response), EWO (Audiometer), ETT (Cushion, Earphone (For Audiometric Testing)), ETY (Tester, Auditory Impedance)
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.