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International Journal of Bioprinting                                      3D-printed middle ear prostheses

























            Figure 3. First-generation 3D-printed PORP. (A) Successfully 3D-printed prosthesis (macro photography by M.Sc. (Tech) Pekka Paavola). (B) Structural
            deviation in the cup. (C) Broken shaft.

            inspection and imaged with micro-CT. After that, the   Table 1. Accuracy of 3D printing in the first-generation PORP
            dimensions of the PORPs were measured individually. In
            the 3D model, the shaft diameter and the functional length   3D model  Sample no.  Shaft diameter   Functional length   a
                                                                                    (mm)
                                                                                                (mm)
            of the prostheses were designed to be 0.400 mm and 1.893
            mm, respectively. Table 1 shows the mean measures of the                0.400       1.893
            14 prostheses together with their standard deviations (SD).   Prostheses  1  0.439  1.931
            On  average,  the  printed  prostheses  had  shaft  diameter   2        0.432       1.935
            54 μm thicker and functional length 64 μm longer than in     4          0.444       1.927
            the model. The SD for shaft diameter was 21 μm and 57 μm     8          0.406       2.012
            for functional length. As for accuracy and reproducibility,   12        0.447       1.966
            the SDs of the printed PORPs as well as size differences
            when comparing the printed PORPs and the 3D models           13         0.480       2.075
            are close to the micro-CT’s imaging resolution (40.09 μm),   14         0.486       1.885
            suggesting that 3D printing of PORPs is precise.             15         0.460       1.928
               After visually analyzing the first-generation 3D-printed   16        0.442       1.942
            PORPs with a success rate of 54%, we decided to increase     17         0.474       2.062
            the shaft diameter from 0.400 to 0.600 mm. Also, cup         19         0.465       1.871
            flanges were made larger in order to prevent sharp edges     21         0.471       1.966
            in printing. In  addition, as some of the  PORPs’ plates     27         0.461       1.967
            were broken when detaching them from the supporting          30         0.444       1.929
            structures,  we reduced  the  hole sizes  in  the  prosthesis   Mean
            plate. In Figure 4A, a second-generation PORP is shown                  0.454       1.957
            in 3D model format, and, in  Figure 4B, a 3D-printed   SD               0.021       0.057
            second-generation PORP is photographed by the photo   Range             0.406–0.484  1.871–2.075
            stacking technique. When printing this second-generation   14 prostheses analyzed with micro-CT with their mean and standard
            PORPs, 129 out of 130 prostheses were classified as   deviation (SD).
            successfully printed. Only one prosthesis was classified   a Functional length means distance from the bottom of the cup part to
            as unsuccessfully printed due to a broken shaft. Thus, the   the outer surface of the plate.
            modifications mentioned before improved the printing   tympanotomy. The METF was measured with intact
            success rate significantly.
                                                               ossicular chain, without incus, and with a titanium Kurz
               The functionality of the second-generation 3D-printed   Clip Partial Flexibal prosthesis or a second-generation
            PORPs was tested in LDV (Figure 4A). Figure 4D and E    3D-printed PORP. In Figure 5, mean (solid line) METFs
            demonstrate  a 3D-printed  PORP placed between stapes   measured in different ME transduction modes are plotted
            head and tympanic membrane through posterior       with their SDs (colored area). Displacement (in nanometers;

            Volume 9 Issue 4 (2023)                        179                         https://doi.org/10.18063/ijb.727
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