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Objective: The 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 Source: Following 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 Method: The 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. Results: In 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). Conclusion: The 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. [ABSTRACT FROM AUTHOR]

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 TheMEDLINE, 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 1was 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. [ABSTRACT FROM AUTHOR]

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.

Objectives: This study investigated the effect of an active transcutaneous bone conduction implant (BoneBridgeⓇ) in the management of tinnitus in patients with unilateral sensorineural hearing loss.Methods: From October 2016 to July 2018, 15 patients with unilateral tinnitus accompanied by ipsilateral sensorineural hearing loss received BoneBridgeⓇ implants. Pure-tone average, tinnitus handicap inventory (THI), and a visual analogue scale (VAS) for awareness, loudness, and annoyance were measured before and 6 months after surgery. We defined improvement as a reduction of more than 20% between preoperative and postoperative VAS and THI scores, and changes in the THI of over 7 points were also assessed.Results: Mean THI scores before surgery (72.8 ± 16.1) had significantly improved by 6 months postoperatively (50.9 ± 18.9) (p = 0.003). VAS scores for loudness and annoyance also statistically significantly improved (p = 0.011 and 0.002). The amount of functional hearing gain correlated with changes in VAS scores for annoyance. This correlation was stronger with the improvement of high frequency hearing.Conclusion: BoneBridgeⓇ is beneficial in patients with tinnitus accompanied by sensorineural hearing loss. This finding can help select patients who will benefit most from bone conduction implants. [ABSTRACT FROM AUTHOR]

Purpose: To review types and frequencies of adverse events (AE) associated with bone-conduction hearing implants (BCHIs) and active middle-ear implants (aMEIs) as reported in the literature. Methods: Cochrane, PubMed, and EMBASE libraries were searched for primary articles in English or German language that reported on adverse events following BCHI or aMEI implantation, included at least five patients and were published between 1996 and 2016. Study characteristics, demographics, and counts of adverse events were tabulated and analyzed within the R statistical programming environment. Results: Following assessment of the reporting quality of adverse events, we present a brief guideline that potentially improves AE reporting in this field of research. For the full dataset, we summarize study-level adverse event frequencies in terms of ratio of events to ears (REE) by AE groups and by device. For a subset of studies, we also report cumulative incidence (risk) for minor- and major adverse-events by device and by device groups. Conclusions: Data analyzed in this review show that: (1) the reporting quality of adverse events associated with BCHI and aMEIs is often very low; (2) adverse events associated with BCHI and aMEIs are qualitatively different and not equally frequent among devices; (3) state-of-the-art implantable BCHIs and aMEIs are a safe treatment option for hearing loss. [ABSTRACT FROM AUTHOR]

Objectives/Hypothesis The aim of this study was to evaluate functional hearing gain, speech understanding, and preoperative bone-conduction thresholds with the bone-conduction implant Bonebridge. Study Design Retrospective study at a tertiary referral center. Methods Twenty-four consecutive Bonebridge patients were identified. Nine patients suffered from combined hearing loss (HL), 12 from atresia of the external auditory canal and three from single-sided deafness. One patient was lost to follow-up. Twenty-three patients were therefore analyzed. Results The overall average functional hearing gain of all patients (n = 23) was 28.8 dB (±16.1 standard deviation [SD]). Monosyllabic word scores at 65 dB sound pressure level in quiet increased statistically significantly from 4.6 (±7.4 SD) percentage points to 53.7 (±23.0 SD) percentage points. Evaluation of preoperative bone-conduction thresholds revealed three patients with thresholds higher than 45 dB HL in the high frequencies starting at 2 kHz. These three patients had a very limited benefit of their bone-conduction implants. Conclusions The Bonebridge bone-conduction implant provides satisfactory results concerning functional gain and speech perception if preoperative bone conduction lies within 45 dB HL. Level of Evidence 4. Laryngoscope, 124:2802-2806, 2014 [ABSTRACT FROM AUTHOR]

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., Competing Interests: Conflict of Interests The authors have no conflict of interests to declare., (Fundação Otorrinolaringologia. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commecial purposes, or adapted, remixed, transformed or built upon. ( https://creativecommons.org/licenses/by-nc-nd/4.0/ ).)