Alexander Lein (Wien, AT), Wolf-Dieter Baumgartner (Wien, AT), Dominik Riss (Wien, AT), Wolfgang Gstöttner (Wien, AT), Lukas D. Landegger (Wien, AT), David T. Liu (Wien, AT), Thomas Thurner (Wien, AT), Erich Vyskocil (Wien, AT), Faris F. Brkic (Wien, AT)
Background: The BCI 602 is a new transcutaneous bone conduction implant with smaller dimensions. However, limited patient numbers restrict the statistical power and generalizability of current studies. The present systematic review and meta-analysis summarize early audiological and medical outcomes of individuals implanted with the BCI 602 due to mixed or conductive hearing loss.
Materials and Methods: Following the Preferred Reporting items for Systematic Reviews and Meta-Analyses guidelines, 107 studies were reviewed, and 6 (5.6%) were included in the meta-analysis. The data on study and patient characteristics, surgical outcomes, and audiological test results were extracted from each article. Meta-analysis employed the fixed-effect and random-effects models to analyze the mean differences between pre- and postoperative performances.
Results: In total, 116 patients were evaluated. No intra-operative adverse events were reported, while postoperative complications were reported in 3% of patients. Studies consistently showed significant improvements in audiological outcomes, quality of life, and sound localization in the aided condition. In the meta-analysis, we observed a significant difference in the unaided compared to the aided condition in sound field thresholds (n = 112; MD, -27.05 dB; p < 0.01), signal to noise ratio (n = 96; MD, -6.35 dB; p < 0.01), and word recognition scores (n = 96; MD, 68.89%; p < 0.01).
Conclusion: The implantation of the BCI 602 was associated with minimal surgical complications and excellent audiological outcomes. Therefore, our analysis indicates a high level of safety and reliability. Further research should focus on direct comparisons with other bone conduction implants and long-term functional outcomes.
D.R. is receiving grants from MED-EL outside the submitted work. L.D.L. receives research funding from Decibel Therapeutics and Amgen and has worked as an independent consultant for Gerson Lehrman Group and Conclave Capital. No other disclosures were reported.