Data for: Design and technical validation of a low-cost, titanium sheet metal TORP (SM-T) for manufacturing and use in LMICs

Total Ossicular Replacement Prosthesis (TORPs) are common practice to restore hearing in conductive hearing impaired. However, TORPs are expensive and scarcely available in Low and Middle Income Countries (LMICs). Therefore, the aim of this article was to develop and validate an open-source design of a TORP that can be produced locally in LMIC hospitals. This study showed that a 9 EURO titanium sheet metal TORP (SM-T) that is bend into shape can easily and reliably be formed by local surgeons. Tests showed accurate dimensions and short learning curves for SM-T production by surgeons. Tests also showed that complete re-bending cycles for corrections can be safely done multiple times. Moreover, sound transmission tests showed comparable properties with commercial TORPs. Cadaver ear fitting showed a good fit in the middle ear, without conflicts between SM-T and anatomical features. In conclusion, this SM-T design has proved to be feasible for implementation in LMICs.

This repository holds design files (SolidWorks file, STEP file, DXF file, PDF drawing, and bending instructions) required to reproduce the design, and the relevant test results. The sheet metal part needs to be cut with a high precision laser cutter. Our parts were produced by Laser Technology Janssen, Wijchen, the Netherlands. PETG 3D printed parts were FDM printed on a Prusa iMK3s printer.

The design is further described in a journal publication (currently under review) under a similar title.