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

Cywka, Katarzyna B.; Skarżyńśki, Henryk; Król, Bartłomiej; Skarżyński, Piotr H.

doi:10.3390/jcm10245916

Cited by 13 publications

(46 citation statements)

References 46 publications

(81 reference statements)

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“…The rate of lifts usage is much lower than in the last generation implant. 2,6,7,13 Importantly, no adverse side effects were observed in the group implanted with lifts, and, in particular, no wound infections or dehiscence occurred. Furthermore, similar postoperative BB602-aided thresholds were achieved in devices implanted with and without lifts.…”

Section: Discussionmentioning

confidence: 86%

“…This goes in hand with no reported adverse events after BB602 implantation by other authors. 2,6,7 As aforementioned, up to now, the literature remained scarce in terms of the safety and efficacy of lifts usage in BB602 implantation, whilst the use of lifts is wellestablished in BB601. 13,18,19 In our cohort, 4 implantations were conducted with the help of implant lifts.…”

Section: Discussionmentioning

confidence: 99%

“…6 Short thereafter, the same group published a study on 22 pediatric patients. 7 Similarly, very good results and, in particular, high safety and efficacy of the implant were reported. Importantly, none of the studies reported on any intra-or postoperative medical or technical complications.…”

mentioning

confidence: 88%

“…The indication area was not modified from the earlier version and extends from sensorineural (SNHL), mixed or conductive hearing loss (MCHL), and single‐sided deafness (SSD) 2,6 . From its introduction back in 2019, to the best of our knowledge, 3 single‐center series were published on BB602 2,6,7 . The first study by Sprinzl et al reported on 12 patients and 13 ears and showed exceptional surgical, audiological, and quality of life outcomes 2 .…”

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confidence: 99%

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Experience With the New Active Transcutaneous Bone‐Conduction Implant With Smaller Dimensions

Brkic

Baumgartner

Schlott

et al. 2023

Otolaryngol.--head neck surg.

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ObjectiveRecently, the Bonebridge 602 implant was introduced. Its smaller dimensions facilitate implantation even in surgically demanding cases. However, in extreme anatomical conditions, implant lifts are still required. We intended to report on the medical and audiological outcomes of all patients implanted with the implant with a secondary focus on the safety, efficacy, and feasibility of the use of 1‐mm lifts.Study DesignRetrospective cohort study.SettingTertiary academic center.MethodsWe retrospectively analyzed all patients implanted with the Bonebridge 602. Patient demographics and surgically‐specific data were collected from the medical charts. Furthermore, audiological results were assessed. Outcomes were compared between implantations with versus without lifts.ResultsTwenty‐one devices were implanted during the study period. Satisfactory audiological results were observed, while no intra‐ or postoperative adverse events occurred. The majority of patients were daily users at the end of the observation period (n = 20/21, 95.2%), and one patient (n = 1/21, 4.8%) was a nonuser after 6 months of use because of subjective dissatisfaction. Due to anatomical considerations, 1‐mm lifts were used in 4 implantations (19.0%). The application of lifts did not result in prolonged surgical times, complications, or shorter time of use, nor did it negatively affect audiometric results.ConclusionImplantations with the new and smaller Bonebridge were associated with gratifying medical and audiological outcomes. Still, in extreme anatomical conditions, 1‐mm lifts are necessary. Nonetheless, surgical placement with the help of lifts seems safe, effective, and feasible, and is a viable option in cases with challenging anatomies due to previous surgeries or anomalies.

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Section: Discussionmentioning

confidence: 86%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 88%

mentioning

confidence: 99%

See 2 more Smart Citations

Experience With the New Active Transcutaneous Bone‐Conduction Implant With Smaller Dimensions

Brkic

Baumgartner

Schlott

et al. 2023

Otolaryngol.--head neck surg.

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“…One option available is the BONEBRIDGE system (MED-EL, Innsbruck, Austria), an active transcutaneous bone conduction implant [7]. It is indicated for the treatment of patients with SSD as well as conductive or mixed hearing loss [8][9][10][11][12]. Its latest audio processor, the SAMBA 2 BB (AP2), offers more frequency and compression bands than its predecessor, the SAMBA BB (AP1).…”

Section: Introductionmentioning

confidence: 99%

Performance with a new bone conduction implant audio processor in patients with single-sided deafness

Wimmer

Zbinden

Gawliczek

et al. 2023

Eur Arch Otorhinolaryngol

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Purpose The SAMBA 2 BB audio processor for the BONEBRIDGE bone conduction implant features a new automatic listening environment detection to focus on target speech and to reduce interfering speech and background noises. The aim of this study was to evaluate the audiological benefit of the SAMBA 2 BB (AP2) and to compare it with its predecessor SAMBA BB (AP1). Methods Prospective within-subject comparison study. We compared the aided sound field hearing thresholds, speech understanding in quiet (Freiburg monosyllables), and speech understanding in noise (Oldenburg sentence test) with the AP1 and AP2. Each audio processor was worn for 2 weeks before assessment and seven users with single-sided sensorineural deafness (SSD) participated in the study. For speech understanding in noise, two complex noise scenarios with multiple noise sources including single talker interfering speech were used. The first scenario included speech presented from the front (S0NMIX), while in the second scenario speech was presented from the side of the implanted ear (SIPSINMIX). In addition, subjective evaluation using the SSQ12, APSQ, and the BBSS questionnaires was performed. Results We found improved speech understanding in quiet with the AP2 compared to the AP1 aided condition (on average + 17%, p = 0.007). In both noise scenarios, the AP2 lead to improved speech reception thresholds by 1.2 dB (S0NMIX, p = 0.032) and 2.1 dB (SIPSINMIX, p = 0.048) compared to the AP1. The questionnaires revealed no statistically significant differences, except an improved APSQ usability score with the AP2. Conclusion Clinicians can expect that patients with SSD will benefit from the SAMBA 2 BB by improved speech understanding in both quiet and in complex noise scenarios, when compared to the older SAMBA BB.

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A MAUDE database analysis on the new generation of active bone conduction hearing implants

Lein,

Baumgartner,

Landegger

et al. 2024

Laryngoscope Investig Oto

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ObjectiveTo analyze medical device reports (MDR) submitted to the Food and Drug Administration's (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events (AEs) in patients implanted with novel active bone conduction hearing implants (BCIs).MethodsWe conducted a search of the FDA MAUDE database on the newest generation of BCIs. Data were collected concerning device malfunctions, patient injuries, factors triggering these incidents, and the subsequent actions taken.ResultsIn total, 93 (16.7%) device malfunctions and 465 (83.3%) patient injuries with 358 subsequent interventions were identified, resulting in 558 AEs. Although the absolute AE number per device cannot be identified, the following trends were detected: Among the 494 AEs associated with OSI200, 55 (11.1%) reported device malfunctions and 454 (88.9%) cited patient injuries. Out of the 64 AEs linked to BCI602, 28 (59.4%) were associated with malfunctions, whereas 26 (40.6%) involved patient injuries. The most frequently reported particular AEs for the OSI200 were infection (n = 171, 34.6%), extrusion of the device (n = 107, 21.7%), and pain (n = 51, 10.3%). Conversely, no device output (n = 20, 31.3%) and loss of osseointegration (n = 7, 10.9%) were the most reported AEs for the BCI602. Various AEs led to 214 explanations and 77 revision surgeries. Sixty‐seven AEs reported conservative treatment.ConclusionThe current study provides an overview of the most commonly reported complications with new active BCIs. Although providing an overview, given the limitations of the FDA MAUDE database, our results have to be interpreted with caution.Level of Evidence4.

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

Cited by 13 publications

References 46 publications

Experience With the New Active Transcutaneous Bone‐Conduction Implant With Smaller Dimensions

Experience With the New Active Transcutaneous Bone‐Conduction Implant With Smaller Dimensions

Performance with a new bone conduction implant audio processor in patients with single-sided deafness

A MAUDE database analysis on the new generation of active bone conduction hearing implants

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