| TGA Action ID |
RC-2026-RN-00061-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Cochlear Osia Fitting Software 2 and Baha Fitting Software 6
Osia Fitting Software
Software Versions: 2.1.6, 2.1.5 and 2.1.4
Part Numbers: P1348426
Baha Fitting Software
Software Versions: 6.1.9 and 6.1.8
Part Number: P1682914 |
| ARTG Number |
161136, 375451 |
| Unique Device Identifier (UDI) |
Osia Fitting Software 2 : 09321502044905 , Baha Fitting Software 6 : 09321502053013 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class III |
| Reason for the Action |
A change made by a third-party licence validation service has prevented clinicians from opening certain versions of Osia Fitting Software (OFS) and Baha Fitting Software (BFS) since 19 January 2026. As a result, affected clinics may have been unable to complete fitting or programming sessions.
This problem does not impact the safety or clinical performance of the software, however may have caused disruption to scheduling appointments or programming devices for patients. |
| Instructions for Customers/Users |
Customers are advised to download and install the updated version of the software to restore programming functionality.
- For Cochlear Osia Fitting Software 2.1.7 - https://software.cochlear.com/hNs7PV
- For Cochlear Baha Fitting Software 6.1.10 - https://software.cochlear.com/xW1Dad
This action has been finalised on 28/9/2026. |
| Action Commencement Date |
28/01/2026 |
| Responsible Entity |
|
| Contact Information |
1800 800 989 - Cochlear Clinical Helpline |