A sterile device intended to be implanted for the total functional reconstruction of the ossicular chain (mallues, incus, and stapes bones) to facilitate the conduction of sound waves from the tympanic membrane to the inner ear. It is designed to treat conduct
| Company | Devices | Share |
|---|---|---|
| Grace Medical, Inc. | 157 | 42% |
| Medtronic Xomed, Inc. | 106 | 28% |
| Gyrus Acmi, Llc | 63 | 17% |
| Heinz Kurz Gmbh | 50 | 13% |
| Spiggle & Theis Medizintechnik Gmbh | 1 | 0% |
| Tdm Co., Ltd. | 1 | 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 |
|---|---|---|
| ETA | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL | 315 |
| ETA | Replacement, Ossicular Prosthesis, Total | 180 |
| JYJ | Gauge, Measuring | 36 |
| ETB | PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT | 33 |
| LBN | REPLACEMENT, TOTAL OSSICULAR, PROSTHESIS, POROUS, POLYETHYLE | 8 |
| LBM | POROUS POLYETHYLENE OSSICULAR REPLACEMENT | 8 |
Use these as the dimensions to specify in a tender line.
378 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ossicular prosthesis, total", from 6 companies. The largest labeler is Grace Medical, Inc. with 42% of records.
ETA (REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL), ETA (Replacement, Ossicular Prosthesis, Total), JYJ (Gauge, Measuring), ETB (PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT)
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.