Clinical Experience of Using Active Transcutaneous Bone Conduction Implants (Bonebridge) in Children Under 5 Years Old

Bae, Seong Hoon; Jung, Youngrak; Jung, Jinsei; Choi, Jae Young

doi:10.21053/ceo.2021.02208

Cited by 4 publications

(6 citation statements)

References 12 publications

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“…Moreover, Bae et al observed 1 (16.7%) major complication rate in 6 children under 5, presenting as postoperative lethargy and subsequent left abducens nerve paralysis with increased intracranial pressure. Removal of the BCI 601 resulted in patient recovery 9 . Of note, in the present study, 3 of the included patients were below the age of 5 14 .…”

Section: Discussionmentioning

confidence: 56%

“…Removal of the BCI 601 resulted in patient recovery. 9 Of note, in the present study, 3 of the included patients were below the age of 5. 14 Considering the surgical data for the BCI 602, implantation in children under 5 years of age as well as preoperated ears seems technically feasible and justifiable.…”

Section: Surgical Outcomesmentioning

confidence: 57%

“…8 Nevertheless, the BCI 601 had certain surgical limitations, particularly limited to the cortical bone thickness in the retrosigmoid area, preventing its implementation in patients with less bone availability. 9 This constraint is particularly relevant in very young children or patients with anomalies or multiple prior surgeries. 10,11 The second generation of active BC hearing implants from the abovementioned manufacturer, the BCI 602, received approval in 2019.…”

mentioning

confidence: 99%

“…Through subcutaneous placement, the BCI 601 surpasses the limitations of percutaneous devices and reduces infection risk and implant failure 8 . Nevertheless, the BCI 601 had certain surgical limitations, particularly limited to the cortical bone thickness in the retrosigmoid area, preventing its implementation in patients with less bone availability 9 . This constraint is particularly relevant in very young children or patients with anomalies or multiple prior surgeries 10,11 …”

mentioning

confidence: 99%

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Early Results With the New Active Bone‐Conduction Hearing Implant: A Systematic Review and Meta‐Analysis

Lein,

Baumgartner,

Riss

et al. 2024

Otolaryngol.--head neck surg.

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ObjectiveThe bone conduction implant (BCI) 602 is a new transcutaneous BCI with smaller dimensions. However, limited patient numbers restrict the statistical power and generalizability of the current studies. The present systematic review and meta‐analysis summarize early audiological and medical outcomes of adult and pediatric patients implanted with the BCI 602 due to mixed or conductive hearing loss.Data SourceFollowing the Preferred Reporting items for Systematic Reviews and Meta‐analyses guidelines, 108 studies were reviewed, and 6 (5.6%) were included in the meta‐analysis.Review MethodThe 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 (MDs) between pre‐ and postoperative performances.ResultsIn total, 116 patients were evaluated, including 64 (55%) adult and 52 (45%) pediatric patients. No intraoperative adverse events were reported, while postoperative complications were reported in 2 (3.1%) adult and 2 (3.8%) pediatric 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).ConclusionThe implantation of the BCI 602 was associated with minimal surgical complications and excellent audiological outcomes for both the pediatric and the adult cohort. Therefore, our analysis indicates a high level of safety and reliability. Further research should focus on direct comparisons with other BCIs and long‐term functional outcomes.

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Section: Discussionmentioning

confidence: 56%

Section: Surgical Outcomesmentioning

confidence: 57%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Early Results With the New Active Bone‐Conduction Hearing Implant: A Systematic Review and Meta‐Analysis

Lein,

Baumgartner,

Riss

et al. 2024

Otolaryngol.--head neck surg.

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“…Bone-conduction implants (BCIs) are useful in the rehabilitation of hearing loss in both children (1)(2)(3)(4)(5) and adults (6)(7)(8)(9). BCIs transmit sound by vibration of the skull, transmitting sound energy directly into to the cochlea.…”

Section: Introductionmentioning

confidence: 99%

Subtemporalis Muscle Middle Cranial Fossa Bone-Island Craniotomy Technique for Placement of an Active Transcutaneous Bone-Conduction Implant

et al. 2022

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Objective Placement of an active transcutaneous bone-conduction implant (BCI) requires drilling of a precise bone bed to accommodate the device and allow for fixation points to make appropriate contact with bone, which can be difficult even when lifts are used. We describe a subtemporalis muscle middle cranial fossa bone-island craniotomy technique that simplifies the procedure and obviates the need for lifts in securing the device. Study Design Prospective case series. Setting Tertiary academic medical center. Patients Seventeen patients underwent surgery for placement of 18 transcutaneous BCIs, 14 for conductive or mixed hearing loss, and 4 for single-sided deafness. Interventions Surgical placement of a transcutaneous BCI with a bone-island craniotomy technique. Main Outcome Measures Functional gain in air-conduction thresholds, aided air-bone gap, frequency of need for lifts, and minor and major complications. Results For the conductive or mixed hearing loss cohort, with the transcutaneous BCI in place, there was a highly statistically significant mean functional gain of 35.4 dB hearing level (HL) (range, 16.7–50.25 dB HL; standard deviation, 12.4 dB HL) compared with the unaided condition ( p < 0.0001; 95% confidence interval, 36.6–51.6 dB HL). Lifts were not needed in any case. There was one minor complication requiring a second procedure in a patient who had previously received radiation and no major complications. There was no device loss or failure. Conclusions A subtemporalis muscle middle cranial fossa bone-island craniotomy technique eliminates the need for lifts and is a safe and effective method for placement of a transcutaneous BCI.

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Surgical and audiological outcomes with a new transcutaneous bone conduction device with reduced transducer thickness in children

Willenborg

Lenarz

Busch

2023

Eur Arch Otorhinolaryngol

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Purpose Due to smaller bone thickness, young children with conductive or mixed hearing loss or single-sided deafness were previously most commonly treated with a percutaneous osseointegrated bone-anchored hearing aid (BAHA) or an active middle-ear implant. While the BAHA increases the risk of implant infections, skin infection, overgrowth of the screw or involvement of the implant in head trauma, middle-ear implant surgery involves manipulation of the ossicles with possible risk of surgical trauma. These complications can be omitted with transcutaneous bone conduction implant systems like the MED-EL Bonebridge system. The purpose of this study was to analyze whether the second generation of the Bonebridge (BCI 602) that features a decreased implant thickness with a reduced surgical drilling depth can be implanted safely in young children with good postoperative hearing performance. Methods In this study, 14 patients under 12 years were implanted with the second generation of the Bonebridge. Preoperative workup comprised a CT scan, an MRI scan, pure tone audiometry, or alternatively a BERA (bone conduction, air conduction). Since children under 12 years often have a lower bone thickness, the CT was performed to determine the suitability of the temporal bone for optimal implant placement using the Otoplan software. Results All patients (including three under the age of five) were successfully implanted and showed a good postoperative hearing performance. Conclusion With adequate preoperative workup, this device can be safely implanted in children and even children under 5 years of age and allows for an extension of indication criteria toward younger children.

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Clinical Experience of Using Active Transcutaneous Bone Conduction Implants (Bonebridge) in Children Under 5 Years Old

Cited by 4 publications

References 12 publications

Early Results With the New Active Bone‐Conduction Hearing Implant: A Systematic Review and Meta‐Analysis

Early Results With the New Active Bone‐Conduction Hearing Implant: A Systematic Review and Meta‐Analysis

Subtemporalis Muscle Middle Cranial Fossa Bone-Island Craniotomy Technique for Placement of an Active Transcutaneous Bone-Conduction Implant

Surgical and audiological outcomes with a new transcutaneous bone conduction device with reduced transducer thickness in children

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