Implantation of a new active bone conduction hearing device with optimized geometry

Plontke, Stefan K.; Götze, G.; Wenzel, Claudia; Rahne, Torsten; Mlynski, Robert

doi:10.1007/s00106-020-00877-2

Cited by 18 publications

(26 citation statements)

References 35 publications

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“…In September 2019, the manufacturer introduced a follow-up model (BCI 602) in Europe, with reduced FMT dimensions, that improved the bone fit in mastoids of children and young adults [34]. However, in certain cases, like very young children, 3D virtual preoperative planning is still recommended [35]. For another, new bone conduction implant it was shown that the average minimum bone thickness was thicker than both the maximum transducer depth of 3 mm and the 2.7 mm bone involvement of the osseointegrating fixation screws.…”

Section: Discussionmentioning

confidence: 99%

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

Seiwerth

Fröhlich

Schilde

et al. 2021

Eur Arch Otorhinolaryngol

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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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Section: Discussionmentioning

confidence: 99%

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

Seiwerth

Fröhlich

Schilde

et al. 2021

Eur Arch Otorhinolaryngol

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“…The upgrade gives the same power output for effective amplification, but with nearly 50% less drilling depth. The Bonebridge BCI 602 has the same audiological and medical criteria as the first-generation device [22,23].…”

Section: The New Bonebridgebci 602mentioning

confidence: 99%

“…The transition can also bend medially up to 30° to accommodate curvature of the skull. A smaller drilling depth reduces drilling time and reduces the likelihood of dura exposure, decreasing surgical time significantly; in addition, self-drilling screws simplify handling [22,24,25] . The most significant difference between the two models is the shape and size of the internal part, where the thickness of the BC-FMT has narrowed from 8.7 to 4.5 mm (Figure 3).…”

Section: The New Bonebridgebci 602mentioning

confidence: 99%

“…The transition can also bend medially up to 30° to accommodate curvature of the skull. A smaller drilling depth reduces drilling time and reduces the likelihood of dura exposure, decreasing surgical time significantly; in addition, self-drilling screws simplify handling [22,24,25] . This is a considerable advantage and gives opportunities for using it on patients where it was impossible to use the first-generation implant due to limited anatomical conditions (the internal part was too large).…”

Section: The New Bonebridgebci 602mentioning

confidence: 99%

“…The transition can also bend medially up to 30 • to accommodate curvature of the skull. A smaller drilling depth reduces drilling time and reduces the likelihood of dura exposure, decreasing surgical time significantly; in addition, self-drilling screws simplify handling [22,24,25].…”

Section: The New Bonebridgebci 602mentioning

confidence: 99%

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The Bonebridge BCI 602 Active Transcutaneous Bone Conduction Implant in Children: Objective and Subjective Benefits

Cywka

Skarżyńśki

Król

et al. 2021

JCM

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Background: the Bonebridge hearing implant is an active transcutaneous bone conduction implant suitable for various types of hearing loss. It was first launched in 2012 as the BCI 601, with a newer internal part (BCI 602) released in 2019. With the new size and shape, the BCI 602 can be used in patients previously excluded due to insufficient anatomical conditions, especially in patients with congenital defects of the outer and middle ear. Objectives: the purpose of this study is to evaluate the objective and subjective benefits of the new Bonebridge BCI 602 in children who have hearing impairment due to conductive or mixed hearing loss. Safety and effectiveness of the device was assessed. Methods: the study group included 22 children aged 8–18 years (mean age 14.7 years) who had either conductive or mixed hearing loss. All patients were implanted unilaterally with the new Bonebridge BCI 602 implant. Pure tone audiometry, speech recognition tests (in quiet and noise), and free-field audiometry were performed before and after implantation. Word recognition scores were evaluated using the Demenko and Pruszewicz Polish Monosyllabic Word Test, and speech reception thresholds in noise were assessed using the Polish Sentence Matrix Test. The subjective assessment of benefits was carried outusing the APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire. Results: after implantation of the Bonebridge BCI 602 all patients showed a statistically significant improvement in hearing and speech understanding. The mean word recognition score (WRS) changed from 12.1% before implantation to 87.3% after 6 months. Mean speech reception threshold (SRT) before implantation was +4.79 dB SNR and improved to −1.29 dB SNR after 6 months. All patients showed stable postoperative results. The APHAB questionnaire showed that difficulties in hearing decreased after implantation, with a statistically significant improvement in global score. Pre-operative scores (M = 35.7) were significantly worse than post-operative scores at 6 months (M = 25.7). Conclusions: the present study confirms that the Bonebridge BCI 602 is an innovative and effective solution, especially for patients with conductive and mixed hearing loss due to anatomical ear defects. The Bonebridge BCI 602 system provides valuable and stable audiological and surgical benefits. Subjective assessment also confirms the effectiveness of the BCI 602. The BCI 602 offers the same amplification as the BCI601, but with a smaller size. The smaller dimensions make it an effective treatment option for a wider group of patients, especially children with congenital defects of the outer and middle ear.

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Efficacy of the Bonebridge BCI602 for Adult Patients with Single‐sided Deafness: A Prospective Multicenter Study

Kim,

Park,

Park

et al. 2023

Otolaryngol.--head neck surg.

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ObjectiveTo investigate the safety and efficacy of a novel active transcutaneous bone conduction implant (BCI) device for patients with single‐sided deafness (SSD).Study DesignProspective cohort study.SettingTertiary referral hospitals.MethodsThis prospective multicenter study was conducted at 15 institutions nationwide. Thirty adult (aged ≥19 years) SSD patients were recruited. They underwent implantation of an active transcutaneous BCI device (Bonebridge BCI602). Objective outcomes included aided pure‐tone thresholds, aided speech discrimination scores (SDSs), and the Hearing in Noise Test (HINT) and sound localization test results. The Bern Benefit in Single‐Sided Deafness (BBSS) questionnaire, the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire, and the Tinnitus Handicap Inventory (THI) were used to measure subjective benefits.ResultsThe mean aided pure‐tone threshold was 34.2 (11.3), mean (SD), dB HL at 500 to 4000 Hz. The mean total BBSS score was 27.5 (13.8). All APHAB questionnaire domain scores showed significant improvements: ease of communication, 33.6 (23.2) versus 22.6 (21.3), P = .025; reverberation, 44.8 (16.6) versus 32.8 (15.9), P = .002; background noise, 55.5 (23.6) versus 35.2 (18.1), P < .001; and aversiveness, 36.7 (22.8) versus 25.8 (21.4), P = .028. Moreover, the THI scores were significantly reduced [47.4 (30.1) versus 31.1 (27.0), P = .003]. Congenital SSD was a significant factor of subjective benefit (−11.643; 95% confidence interval: −21.946 to −1.340).ConclusionThe BCI602 active transcutaneous BCI device can provide functional hearing gain without any adverse effects and is a feasible option for acquired SSD patients with long‐term deafness.

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Implantation of a new active bone conduction hearing device with optimized geometry

Abstract: Implantation of a new active bone conduction hearing device with optimized geometry Bone conduction hearing implants S106 HNO • Suppl 2 • 2020 Discussion The dimensions of the BC-FMT are based on physical and technical requirements.

Cited by 18 publications

References 35 publications

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

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

The Bonebridge BCI 602 Active Transcutaneous Bone Conduction Implant in Children: Objective and Subjective Benefits

Efficacy of the Bonebridge BCI602 for Adult Patients with Single‐sided Deafness: A Prospective Multicenter Study

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