An assembly of mains electricity (AC-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
| Company | Devices | Share |
|---|---|---|
| Otodynamics Limited | 39 | 76% |
| Intelligent Hearing Systems Corp. | 9 | 18% |
| Maico Diagnostics Gmbh | 2 | 4% |
| Interacoustics A/S | 1 | 2% |
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 |
|---|---|---|
| EWO | Audiometer | 51 |
| GWJ | Stimulator, Auditory, Evoked Response | 22 |
| GWL | Amplifier, Physiological Signal | 1 |
Use these as the dimensions to specify in a tender line.
51 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Otoacoustic emission system, line-powered", from 4 companies. The largest labeler is Otodynamics Limited with 76% of records.
EWO (Audiometer), GWJ (Stimulator, Auditory, Evoked Response), GWL (Amplifier, Physiological Signal)
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.