Changes in Bone Conduction Implant Geometry Improve the Bone Fit in Mastoids of Children and Young Adults

Wenzel, Claudia; Schilde, Sebastian; Plontke, Stefan K.; Rahne, Torsten

doi:10.1097/mao.0000000000002798

Cited by 14 publications

(22 citation statements)

References 31 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The findings of Wenzel et al confirm that changes in the dimensions of the internal part of the BCI602 benefit patients in all age groups and with all indications. According to prior authors, placement of the BCI602 requires less bone removal than the BCI601, and "the newer BCI 602 transducer is more likely than its predecessor to be completely accommodated in the mastoid bone" [45]. In our experience, the flexible design and the transition between the receiver coil and the floating mass transducer makes it possible to properly position the implant even in difficult anatomical conditions.…”

Section: Discussionmentioning

confidence: 71%

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

Cywka

Skarżyńśki

Król

et al. 2021

JCM

View full text Add to dashboard Cite

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.

show abstract

Section: Discussionmentioning

confidence: 71%

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

Cywka

Skarżyńśki

Król

et al. 2021

JCM

View full text Add to dashboard Cite

show abstract

“…Based on a retrospectively analyzed large cohort of children and young adolescents, Rahne et al described an (hypothetical) optimal form of the FMT as a truncated cone to fit in almost all mastoids [33]. 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].…”

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

Self Cite

View full text Add to dashboard Cite

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.

show abstract

“…Moreover, studies, help to predict the ideal implant size in children and determine the position of BI300, are rare. Although, especially in childhood, most common indication of BCIs are external ear canal/middle ear malformation and chronic otitis media; patients from non-otological cases were also selected to create an average population, similarly to other researcher groups [ 15 , 16 ]. The idea behind our patient selection (i.e., otological and non-otological cases together) was, that previous study of pediatric uni- and bilateral ear canal atresia patients indicated that neither age nor diagnosis of atresia reliably predict a lower chance of identifying adequate bone thickness at typical implant sites, and no significant difference in bone thickness was found on the affected site compared to non-affected side [ 17 ].…”

Section: Discussionmentioning

confidence: 99%

Pediatric morphometric study to guide the optimized implantation of the Osia® 2 implant system

Pósta

Perényi

Szabó

et al. 2022

Eur Arch Otorhinolaryngol

View full text Add to dashboard Cite

Purpose Continuous technological advances result in the availability of new bone conduction hearing implants, of which their suitability for pediatric patients is of major concern. The CochlearTMOsia® 2 is a new active osseointegrated steady-state implant system that uses digital piezoelectric stimulation to treat hearing loss. The implant in the United States was approved for patients aged 12 years and above, whereas the CE mark is independent of age, the only requirement is body weight of at least 7 kg. Therefore, further clinical studies are required to assess device characteristics in younger patients. The aim of our study was to perform a morphometric study among 5–12-year-old children, and to develop a surgical protocol for Osia 2 system implantation based on these findings. Methods We examined retrospectively cranial CT scans of 5–12-year-old patients from our clinical database. We measured the bone and soft-tissue thickness in the region of interest, and the position of the sigmoid sinus. 3D printed temporal bones were also used for planning. Results Soft-tissue thickness varied between 3.2 ± 0.5 mm and 3.6 ± 0.6 mm and bone thickness varied between 3.5 ± 1.1 mm and 4.7 ± 0.3 mm. The sigmoid sinus was located 1.3 ± 0.2 cm posterior to the ear canal, and the anterior distance was 4.8 ± 0.9 to 7.1 ± 1.1 mm. Conclusions Our morphometric studies showed that patients aged 5–12 have different anatomical dimensions compared to adults, but that implantation of the Osia 2 system is feasible in these patients using an altered implant positioning recommended by our data. The Cochlear™ Osia® 2 is, therefore, an option for hearing rehabilitation in younger pediatrics.

show abstract

Changes in Bone Conduction Implant Geometry Improve the Bone Fit in Mastoids of Children and Young Adults

Cited by 14 publications

References 31 publications

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

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

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

Pediatric morphometric study to guide the optimized implantation of the Osia® 2 implant system

Contact Info

Product

Resources

About