A sterile device intended to be implanted for the functional reconstruction of segments of the ossicular chain (mallues, incus, and/or stapes bones) to facilitate the conduction of sound waves from the tympanic membrane to the inner ear. It is designed to trea
| Company | Devices | Share |
|---|---|---|
| Grace Medical, Inc. | 407 | 40% |
| Heinz Kurz Gmbh | 261 | 26% |
| Medtronic Xomed, Inc. | 202 | 20% |
| Gyrus Acmi, Llc | 94 | 9% |
| Spiggle & Theis Medizintechnik Gmbh | 27 | 3% |
| Audio Technologies Srl | 11 | 1% |
| Karl Storz Gmbh & Co. Kg | 8 | 1% |
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 |
|---|---|---|
| ETB | PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT | 549 |
| ETB | Prosthesis, Partial Ossicular Replacement | 522 |
| ETA | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL | 242 |
| JYJ | Gauge, Measuring | 28 |
| ETA | Replacement, Ossicular Prosthesis, Total | 19 |
| LBM | POROUS POLYETHYLENE OSSICULAR REPLACEMENT | 7 |
Use these as the dimensions to specify in a tender line.
1,010 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Ossicular prosthesis, partial", from 7 companies. The largest labeler is Grace Medical, Inc. with 40% of records.
ETB (PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT), ETB (Prosthesis, Partial Ossicular Replacement), ETA (REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL), JYJ (Gauge, Measuring)
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.