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

Riart

Int Arch Otorhinolaryngol

et al. 2022

Introduction Bone conduction implants, responsible for transmitting sound from an external processor to the inner ear, can be divided into active and passive, depending on the vibratory stimulus location. The use of transcutaneous device has increased, given its aesthetic appeal, the complications and limitations of percutaneous devices, and patient's treatment adherence, focusing mainly on efficacy. However, various complications are associated with the use of transcutaneous prosthesis, which can often be serious. Objective To approach the literature on complications involving transcutaneous bone-anchored prostheses through a systematic review of articles published in the past 10 years (2011–2021). Data Synthesis The MEDLINE, EMBASE, Scopus, and Cochrane Library databases were searched. All articles written in English reporting on currently available transcutaneous prosthesis implantation and its complications were selected. Studies on both children and adults were included. The data on complications were extracted, and complications were classified as minor or major and associated to each device used. Thirty-seven articles were included in the study, of which 14 were prospective cohort studies, 22 were retrospective case series, and 1 was a case report. Most studies (18) included both adults and children. Moreover, 901 implantations were performed, of which 552 implanted Baha Attract (Cochlear Ltd., Sydney, Australia), 244 implanted BoneBridge (MED-EL, Innsbruck, Austria), and 105 implanted Sophono (Sophono Inc., Boulder, CO, USA]). Furthermore, 192 adverse events were reported (total complication rate, 21.3%), with 161 minor complications (84.3%) and 31 major complications (16.1%). Conclusion Transcutaneous prosthesis is an audiological alternative with fewer complications than percutaneous prosthesis. However, its indication should be judicious because complications are common, and although most complications are minor, serious infections requiring explantation may develop.

Section: Discussionsupporting

confidence: 84%

“…Transcutaneous devices generally show a significant reduction in patient injuries when compared with percutaneous models. 4 19 20 27 28 29 30 31 32 …”

Section: Discussionmentioning

confidence: 99%

Complications of Transcutaneous Protheses – A Systematic Review of Publications Over the Past 10 Years

Riart

Int Arch Otorhinolaryngol

et al. 2022

Eur Arch Otorhinolaryngol

“…Zernotti et al investigated 14 congenital atresia patients implanted with the, at the time only available, active BCI601 and reported significant improvements in hearing thresholds and word recognition scores accompanied with low complication rates. Magele et al reported from six studies in their meta-analysis on children with CHL or MHL an average FG of 34 dB [8,[24][25][26]. Especially, the sound localization ability, which was investigated with white noise presented at a level of 40 dB SPL from randomized angles of − 90°, − 45°, 0°, 45°, or 90° showed very pleasing results for both the testet cohort of CHL cases.…”

Section: Discussionmentioning

confidence: 99%

Two Bonebridge bone conduction hearing implant generations: audiological benefit and quality of hearing in children

Šikolová

Urík

Hošnová

et al. 2021

Purpose The study aimed to evaluate audiological benefits, quality of hearing and safety of two Bonebridge generation: BCI601 and BCI602 (MED-EL, Innsbruck, Austria) in children. Methods Twelve children were implanted: five BCI601 and seven BCI602 comprising of ten conductive hearing loss, and two single sided deaf SSD subjects. Audiological outcomes tested were sound field audiometry, functional gain, speech recognition threshold (SRT50), speech recognition in noise (SPRINT) and localisation abilities. Subjective measures were Speech, Spatial and Qualities of Hearing Scale (SSQ12). Results The mean FG with the BCI601 was 25.0 dB and with the BCI602 28.0 dB. The benefit in SRT50 was 23.2 dB and 33.8 dB, respectively. The mean benefit in SPRINT was 15% and 6.7% and the localisation ability improved from 33.3° to 16° and from 26.2° to 17.6°, respectively. The two SSD subjects reported a FG of 17 dB, a benefit in SRT50 of 22.5 and a benefit in SPRINT of 20%. Subjective outcomes improved significantly and even exceeded the values of their age-and sex matched normal hearing peers. One revision was reported: a retroauricular emphysema above the implant occurred 12 months post-OP, it was resolved operatively with the implant still being functional. Conclusion The pediatric cohort reports significant audiological benefit, even exceeding that of the age- and sex matched control. The combination of the high safety and audiological benefit makes the Bonebridge a comfortable and effective option in hearing rehabilitation in children.

Eur Arch Otorhinolaryngol

“…The processor has 16-band digital equalizer, 16 independent compression channels, sound smoothing, speech and noise management, adaptive directional microphones, intelligent sound adapter, classifier 5 different programs, wind noise reduction, ambient sound, speech cracking, omnidirectional microphones, audio frequency range 250-8 kHz, wireless connectivity options via Bluetooth or telecoil to external devices such as mobile phones, and FM-systems. The processor is powered, There are many studies in the literature showing the effectiveness of the BCI 601 implant, and the device can provide improved hearing in both children and adults [8,[11][12][13][14][15][16][17][18]. The primary aim of this study is to evaluate the effectiveness of the Bonebridge BCI 602 implant in a group of adult patients with conductive or mixed hearing losses.…”

Section: Introductionmentioning

confidence: 99%

“…There are many studies in the literature showing the effectiveness of the BCI 601 implant, and the device can provide improved hearing in both children and adults [ 8 , 11 – 18 ]. The primary aim of this study is to evaluate the effectiveness of the Bonebridge BCI 602 implant in a group of adult patients with conductive or mixed hearing losses.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of the Bonebridge BCI 602 active bone conductive implant in adults: efficacy and stability of audiological, surgical, and functional outcomes

Cywka

Skarżyński

Król

et al. 2022

Purpose (1) To assess the effectiveness and safety of a bone-conduction implant, the Bonebridge BCI 602, in adults with conductive or mixed hearing loss. (2) To investigate whether the Bonebridge BCI 602 is at least as effective as the Bonebridge BCI 601 in such patients. Methods The study group included 42 adults who had either conductive or mixed hearing loss. All patients underwent Bonebridge BCI 602 implant surgery. Before and after implantation, pure-tone audiometry, speech recognition tests (in quiet and noise), and free-field audiometry were performed. Word recognition scores were evaluated using the Polish Monosyllabic Word Test. Speech reception thresholds in noise were assessed using the Polish Sentence Matrix Test. Subjective assessment of benefits was done using the APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire. Results The APHAB questionnaire showed that difficulties in hearing decreased after BCI 602 implantation. Both word recognition in quiet and speech reception threshold in noise were significantly better after BCI 602 implantation and remained stable for at least 12 months. A significant advantage of the device is a reduced time for surgery while maintaining safety. In this study, the mean time for BCI 602 implantation was 28.3 min ± 9.4. Conclusions The second-generation Bonebridge BCI 602 implant is an effective hearing rehabilitation device for patients with conductive or mixed hearing loss. Patient satisfaction and audiological results confirm its efficacy and safety. Its new shape and dimensions allow it to be used in patients previously excluded due to insufficient or difficult anatomical conditions. The new BCI 602 implant is as effective as its predecessor, the BCI 601.