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International Journal of Bioprinting                                Progress in bioprinted ear reconstruction




            which govern advanced therapeutic medicinal products,   one level IV study demonstrates that this is very much
            may provide some guidance [37,38] .                an evolving field. However, it is a field that holds much
               Despite the progress in regulatory approval for   promise, and the emergence of human trials internationally
            3D-printed medical  devices,  such  as the  FDA-approved   attests  to  this.  Notably,  phase  1 and  2  human  trials  are
            AXIOM 20 3D printer and iFuse-3D implant, clear    currently underway in the United States and are due to be
                                                                                      [45,46]
            regulatory pathways for 3D-bioprinted tissues and their   completed by February 2028  . This demonstrates that
            clinical applications are still needed .           this particular innovation has the potential to be adopted
                                        [39]
                                                               into clinical practice soon. However, a number of regulatory
            4.2. Adjuvant considerations                       and practical concerns still need to be overcome. There
            From a surgical standpoint, this emerging technology   is tremendous translational potential, and even if it may
            should be examined holistically, including adjuvant   not necessarily become a routine component of microtia
            techniques and factors that may impact outcomes.   reconstruction overnight, auricle bioprinting may pave
                                                               the way for 3D printing in other reconstructive efforts in
            4.2.1. Additional cover                            plastic surgery over the next decade.
            In some trauma or burns cases, when more skin cover is
            necessary and cannot be sourced locally, a radial forearm   Acknowledgments
            pre-laminated flap may be a good source of additional skin,
            with an auricular scaffold implanted in the forearm before   None.
            the main reconstruction . Alternatively, good outcomes
                                [2]
            are achievable with skin grafts on top of 3D-printed   Funding
            scaffolds . As with allografts, a temporoparietal fascial   None.
                   [3]
            flap may be used with scaffolds to help mitigate soft tissue
            complications . However, this carries additional local   Conflict of interest
                       [4]
            morbidity and prolongs operating time, so ultimately, a
            flap is not needed in the reconstruction at all.   None.

            4.2.2. Hearing restoration                         Author contributions
            Conductive  hearing loss  is  present  in  85%  of microtia   Conceptualization: Anna Onderková
            case ; thus, canalplasty is usually required to obtain a   Supervision: Deepak M. Kalaskar
               [35]
            patent external auditory canal (EAC). The timing of the   Visualization: Anna Onderková
            canaloplasty is linked to planned auricular reconstruction.   Writing – original draft: Anna Onderková
            It is typically done after it so an unoperated and   Writing – review & editing: Anna Onderková, Deepak M.
            unscarred field is preserved for auricle placement, and   Kalaskar
            the delay avoids the need to center the framework over a
            drilled-out canal .                                Ethics approval and consent to participate
                         [40]
               3D printing is also being developed for EAC     Not applicable.
            reconstruction , and so far, techniques like using drug-
                        [41]
            releasing implants have been incorporated to prevent   Consent for publication
            postoperative restenosis . Tympanic membranes are
                                [42]
            also being printed , as are ossicles . However, these   Not applicable.
                                          [44]
                           [43]
            efforts appear to be at a more fledgling stage than auricular
            reconstruction,  probably because  of  the more  complex   Availability of data
            functional requirements. Many techniques and materials   Not applicable.
            used for auricular reconstruction may eventually be
            transferrable  to  other  reconstructions,  such  as  the  EAC   References
            and vice versa.
                                                               1.   Humphries S, Joshi A, Webb WR,  et  al., 2021. Auricular
            5. Conclusion and future outlook                      reconstruction: Where are we now? A critical literature
            The  auricle  is  uniquely  histologically  suitable  for  3D   review. Eur Arch Oto-Rhino-Laryngol, 279(2): 541–56.
            printing, but a plethora of challenges remain. The fact that   https://10.1007/s00405-021-06903-5
            the majority of the existing evidence in this field is thus   2.   Rendón-Medina MA, Hanson-Viana E, Arias-Salazar L,
            far only foundational and that this review identified only   et  al., 2022, Auricular total reconstruction with radial


            Volume 9 Issue 6 (2023)                        304                        https://doi.org/10.36922/ijb.0898
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