An electroacoustic device intended to be worn in the ear to transmit sound to the ear from an external device for improved hearing or private listening. It is designed to fit either in the outer ear or is attached directly to a connecting element such as an ea
| Company | Devices | Share |
|---|---|---|
| Cochlear Limited | 34 | 52% |
| 3M Company | 10 | 15% |
| Interacoustics A/S | 7 | 11% |
| Etymotic Research, Inc. | 5 | 8% |
| Intelligent Hearing Systems Corp. | 5 | 8% |
| Natus Neurology Incorporated | 4 | 6% |
| Auditdata A/S | 1 | 2% |
Company = labeler of record on GUDID. 7 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 |
|---|---|---|
| MCM | IMPLANT, COCHLEAR | 24 |
| EWO | Audiometer | 18 |
| EWO | AUDIOMETER | 10 |
| PGQ | Hybrid cochlear implant | 10 |
| GWJ | Stimulator, Auditory, Evoked Response | 4 |
| GWF | Stimulator, Electrical, Evoked Response | 1 |
Use these as the dimensions to specify in a tender line.
66 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Earphone, insert", from 7 companies. The largest labeler is Cochlear Limited with 52% of records.
MCM (IMPLANT, COCHLEAR), EWO (Audiometer), EWO (AUDIOMETER), PGQ (Hybrid cochlear implant)
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.