Multicentric study on surgical information and early safety and performance results with the Bonebridge BCI 602: an active transcutaneous bone conduction hearing implant

Georg Sprinzl, Joseph Toner, Assen Koitschev, Nadine Berger, Thomas Keintzel, Thomas Rasse, Wolf-Dieter Baumgartner, Clemens Honeder, Astrid Magele, Stefan Plontke, Gerrit Götze, Joachim Schmutzhard, Philipp Zelger, Stephanie Corkill, Thomas Lenarz, Rolf Salcher, Georg Sprinzl, Joseph Toner, Assen Koitschev, Nadine Berger, Thomas Keintzel, Thomas Rasse, Wolf-Dieter Baumgartner, Clemens Honeder, Astrid Magele, Stefan Plontke, Gerrit Götze, Joachim Schmutzhard, Philipp Zelger, Stephanie Corkill, Thomas Lenarz, Rolf Salcher

Abstract

Aim: This European multicentric study aimed to prove safety and performance of the Bonebridge BCI 602 in children and adults suffering from either conductive hearing loss (CHL), mixed hearing loss (MHL), or single-sided sensorineural deafness (SSD).

Methods: 33 patients (13 adults and 10 children with either CHL or MHL and 10 patients with SSD) in three study groups were included. Patients were their own controls (single-subject repeated measures), comparing the unaided or pre-operative to the 3-month post-operative outcomes. Performance was evaluated by sound field thresholds (SF), word recognition scores (WRS) and/or speech reception thresholds in quiet (SRT) and in noise (SNR). Safety was demonstrated with a device-specific surgical questionnaire, adverse event reporting and stable pure-tone measurements.

Results: The Bonebridge BCI 602 significantly improved SF thresholds (+ 25.5 dB CHL/MHL/SSD), speech intelligibility in WRS (+ 68.0% CHL/MHL) and SRT in quiet (- 16.5 dB C/MHL) and in noise (- 3.51 dB SNR SSD). Air conduction (AC) and bone conduction (BC) thresholds remained stable over time. All adverse events were resolved, with none unanticipated. Mean audio processor wearing times in hours [h] per day for the CHL/MHL group were ~ 13 h for adults, ~ 11 h for paediatrics and ~ 6 h for the SSD group. The average surgical length was 57 min for the CHL/MHL group and 42 min for the SSD group. The versatility of the BCI 602 (reduced drilling depth and ability to bend the transition for optimal placement) allows for treatment of normal, pre-operated and malformed anatomies. All audiological endpoints were reached.

Conclusions: The Bonebridge BCI 602 significantly improved hearing thresholds and speech understanding. Since implant placement follows the patient's anatomy instead of the shape of the device and the duration of surgery is shorter than with its predecessor, implantation is easier with the BCI 602. Performance and safety were proven for adults and children as well as for the CHL/MHL and SSD indications 3 months post-operatively.

Keywords: Bone conduction; Bone conduction implant; Bonebridge; Conductive hearing loss; Mixed hearing loss; Single-sided sensorineural deafness; Transcutaneous hearing implant.

Conflict of interest statement

This study was sponsored by MED-EL Medical Electronics, Innsbruck, Austria. The authors disclose no conflicts of interest.

© 2023. The Author(s).

Figures

Fig. 1
Fig. 1
Schematics for placement evaluation: a BCI 602 dimensions and horizontal bending angles; b BCI 602 dimensions and vertical bending angles. Index fingers and thumbs should be placed at the FMT and the positioning aid, respectively; c BC-FMT (Bone Conduction—Floating Mass Transducer) placement areas (1, 2, 3, 4) temporal bone; d coil section placement areas (A, B, C)
Fig. 2
Fig. 2
a AC and BC thresholds: CHL/MHL adults and paediatrics; b AC thresholds: SSD NH; c BC thresholds: SSD NH; square = mean AC; circle = mean BC; white = pre-operative; grey = 3-month post-operative; outer lines = standard deviations
Fig. 3
Fig. 3
a SF thresholds: all subjects; inverted triangle and white = mean unaided; triangle and grey = mean aided; outer lines = standard deviations. b SF PTA 4 thresholds: Box Plots, median = horizontal lines, +  = mean, circles = individual values; * = significance
Fig. 4
Fig. 4
WRS CHL/MHL: Box Plots, median = horizontal lines, +  = mean, circle = individual values; * = significance
Fig. 5
Fig. 5
SRT in quiet CHL/MHL: Box Plots, median = horizontal lines, +  = mean, circle = individual values; * = significance
Fig. 6
Fig. 6
SRT in noise a CHL/MHL in S0°N0°; b SSD in SSSDNNH and in S0°NNH; Box Plots: median = horizontal lines, +  = mean, circle = individual values; * = significance

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