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

Abstract

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.

Systematic Review and Meta‐Analysis of a New Active Transcutaneous Bone Conduction Implant

“…The only other commercially available device in this class is the Bonebridge (MEDEL). 1,2,10 In a systematic review and meta-analysis of 14 1 Limitations were noted in pooling results for metaanalysis. Due to the relative rarity of SSD compared with CMHL, FG could not be meaningfully pooled for SSD meta-analysis.…”

“…Complications are an area of interest, as transcutaneous devices are traditionally accepted to have a lower overall risk of complications compared with percutaneous devices. 10 Souza et al performed a targeted systematic review of complications associated with the Bonebridge against other devices (Baha Attract and Sophono). This demonstrated a lower risk of device-specific complications with Bonebridge, and a minor and major complication rate of 6.1% and 5.7% respectively.…”

“…This demonstrated a lower risk of device-specific complications with Bonebridge, and a minor and major complication rate of 6.1% and 5.7% respectively. 10 Due to the novelty of the Osia, the follow-up duration of included studies was a median of 24 weeks (range 1.2-12 months), notably shorter than the Bonebridge studies, which report up to 12 years of follow-up. 1 Our results indicate a low explantation rate and infection rate, supported by our metaanalysis predicting low complication rates.…”

“…[5][6][7][8] Additionally, active transcutaneous devices have been reported to have improved gain at high frequencies compared with electromagnetic transduction used in older devices, [7][8][9] thus improving hearing at higher frequencies. 1,2,10 The first active transcutaneous bone conduction hearing device is the Bonebridge (MEDEL, Austria), which utilizes a cylindrical floating mass transducer as the active component. 1,6 In contrast to this, the Osia (Cochlear, Sydney, Australia) is a similar bone conduction device with a subcutaneous transducer which uses piezoelectric technology.…”

“…Active transcutaneous devices avoid skin‐related issues and attenuation, as an active subcutaneous vibrational component directly vibrates the bone and transmits this vibrational energy to the cochlea via bone conduction 5–8 . Additionally, active transcutaneous devices have been reported to have improved gain at high frequencies compared with electromagnetic transduction used in older devices, 7–9 thus improving hearing at higher frequencies 1,2,10 . The first active transcutaneous bone conduction hearing device is the Bonebridge (MEDEL, Austria), which utilizes a cylindrical floating mass transducer as the active component 1,6 .…”