Abstract
PurposeAim 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.MethodsIn 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).ResultsFour 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).ConclusionWe 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.
Highlights
In 2012, the Bonebridge (BCI 601) was introduced by MEDEL, Innsbruck, Austria. This semi-implantable, active, transcutaneous bone conduction (BC) hearing device came into widespread use in the treatment of conductive and mixed hearing loss or in single-sided deafness (SSD)
No skin penetration is necessary for sound transmission, representing a major advantage compared to percutaneous active BC devices in use for the same indication for more than 30 years [2]
Implantation was conducted based on insufficient hearing rehabilitation after tympanoplasty and secreting radical cavity (n = 8), medical indication because of recurrent chronic otitis externa when using hearing aids and not solvable by canaloplasty (n = 8), malformations (n = 12), or in SSD as contralateral routing of signal (CROS) (n = 4)
Summary
In 2012, the Bonebridge (BCI 601) was introduced by MEDEL, Innsbruck, Austria. This semi-implantable, active, transcutaneous bone conduction (BC) hearing device came into widespread use in the treatment of conductive and mixed hearing loss or in single-sided deafness (SSD). The implantable part of the Bonebridge consists of the floating mass transducer (FMT), the demodulator, and a coil for receiving data from the sound processor, which is held outside on the skin surface by a magnet in the receiver coil. No skin penetration is necessary for sound transmission, representing a major advantage compared to percutaneous active BC devices in use for the same indication for more than 30 years [2]. Speech recognition and sound field threshold outcomes of the Bonebridge and bone-anchored hearing solutions can be considered equivalent [4]
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