An implanted assembly of sterile devices intended to compensate for impaired hearing by transmitting vibrations to the middle ear. It is powered by a battery that is recharged inductively, via an external device. It consists of a capsule, containing the batter
| Company | Devices | Share |
|---|---|---|
| Envoy Medical Corporation | 54 | 100% |
Company = labeler of record on GUDID. 1 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 |
|---|---|---|
| OAF | Implant, Hearing, Active, Middle Ear, Totally Implanted | 54 |
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No closely related category with 50+ devices.
54 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Fully-implantable middle ear implant system", from 1 companies. The largest labeler is Envoy Medical Corporation with 100% of records.
OAF (Implant, Hearing, Active, Middle Ear, Totally Implanted)
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.