An assembly of battery-powered devices designed to record and analyse the faint sounds hair cells in the inner ear emit [otoacoustic emission (OAE)] in response to a stimulus (e.g., click, tone burst, pure-tone signals) to test for a deficiency of function in
| Company | Devices | Share |
|---|---|---|
| Otodynamics Limited | 71 | 68% |
| Etymotic Research, Inc. | 10 | 10% |
| Vivosonic Inc | 10 | 10% |
| Interacoustics A/S | 5 | 5% |
| Welch Allyn, Inc. | 4 | 4% |
| Maico Diagnostics Gmbh | 2 | 2% |
| Neurosoft, Ooo | 1 | 1% |
| Hearx Group (Pty) Ltd | 1 | 1% |
| Diagnostic Group Llc | 1 | 1% |
Company = labeler of record on GUDID. 9 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 | 102 |
| GWJ | Stimulator, Auditory, Evoked Response | 66 |
| EWO | AUDIOMETER | 6 |
| ETY | Tester, Auditory Impedance | 2 |
| PTP | Tympanometer, Exempt | 1 |
Use these as the dimensions to specify in a tender line.
105 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Otoacoustic emission system, battery-powered", from 9 companies. The largest labeler is Otodynamics Limited with 68% of records.
EWO (Audiometer), GWJ (Stimulator, Auditory, Evoked Response), EWO (AUDIOMETER), 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.