Development and In Vivo Evaluation of a Novel Bioabsorbable Polylactic Acid Middle Ear Ventilation Tube
BackgroundOtitis media with effusion (OME) is a widespread condition causing hearing impairment, particularly in pediatric populations. Existing non-absorbable middle ear ventilation tubes frequently necessitate secondary surgical removal. Bioabsorbable polylactic acid (PLA) offers a promising alternative due to its inherent biocompatibility and tunable degradation characteristics. This study aimed to design, fabricate, and comprehensively evaluate a novel PLA middle ear ventilation tube. MethodsBioabsorbable PLA tubes were designed and fabricated based on commercial models. In vitro biocompatibility was assessed according to ISO 10993 guidelines. In vivo evaluations were performed in a guinea pig model, including otoscopic examinations, auditory brainstem response (ABR) measurements, micro-computed tomography (micro-CT) imaging, and histological analyses. ResultsThe PLA tubes were successfully designed and fabricated, exhibiting dimensions comparable to commercially available products. In vitro testing confirmed their biocompatibility. In vivo observations demonstrated that the PLA segments remained stable, with no significant inflammation detected. ABR measurements revealed no adverse impact on hearing function. Micro-CT imaging confirmed tube integrity and displayed initial signs of degradation over a 9-month period. Histological analyses indicated a favorable tissue response with minimal foreign body reaction. ConclusionThe developed PLA middle ear ventilation tube represents a highly promising alternative to conventional non-absorbable tubes. It demonstrates excellent biocompatibility, preserves auditory function, and exhibits a controlled degradation profile. This preclinical study provides strong support for further investigation and subsequent clinical trials to validate its safety and efficacy in human patients.