4.5 Article

Clinical and functional results after implantation of the bonebridge, a semi-implantable, active transcutaneous bone conduction device, in children and adults

Journal

EUROPEAN ARCHIVES OF OTO-RHINO-LARYNGOLOGY
Volume 279, Issue 1, Pages 101-113

Publisher

SPRINGER
DOI: 10.1007/s00405-021-06626-7

Keywords

Transcutaneous hearing implant; Bone-anchored hearing aid; Bone conduction implant; Conductive hearing loss; Mixed hearing loss

Funding

  1. Federal Ministry of Education and Science in Germany [BMBF 01KG1427]
  2. Projekt DEAL

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The study evaluated the surgical, clinical, and audiological outcomes of Bonebridge implantations. Results showed a significant improvement in hearing levels and clinically relevant benefit for patients with hearing loss.
Purpose Aim of the study was to evaluate the surgical, clinical and audiological outcome of 32 implantations of the Bonebridge, a semi-implantable transcutaneous active bone conduction implant. Methods In a retrospective cohort study, we analyzed data for 32 implantations in 31 patients (one bilateral case; seven age < 16 years) with conductive or mixed hearing loss, malformations, after multiple ear surgery, or with single-sided deafness as contralateral routing of signal (CROS). Results Four implantations were done as CROS. Five cases were simultaneously planned with ear prosthesis anchors, and 23 implantations (72%) were planned through three-dimensional (3D) virtual surgery. In all 3D-planned cases, the implant could be placed as expected. For implant-related complications, rates were 12.5% for minor and 3.1% for major complications. Implantation significantly improved mean sound field thresholds from a preoperative 60 dB HL (SD 12) to 33 dB HL (SD 6) at 3 postoperative months and 34 dB HL (SD 6) at > 11 postoperative months (p < 0.0001). Word recognition score in quiet at 65 dB SPL improved from 11% (SD 20) preoperatively to 74% (SD 19) at 3 months and 83% (SD 15) at > 11 months (p < 0.0001). The speech reception threshold in noise improved from - 1.01 dB unaided to - 2.69 dB best-aided (p = 0.0018). Conclusion We found a clinically relevant audiological benefit with Bonebridge. To overcome anatomical challenges, we recommend preoperative 3D planning in small and hypoplastic mastoids, children, ear malformation, and simultaneous implantation of ear prosthesis anchors and after multiple ear surgery.

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