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.

The implantation of Bonebridge in bilateral congenital malformation of external and middle ear / 中华耳鼻咽喉头颈外科杂志

Objective@#To evaluate the auditory efficacy of Bonebridge implantation in patients with bilateral congenital malformation of external and middle ear.@*Methods@#Eleven cases (6 males and 5 females) had unilateral Bonebridge implantation. The age ranged from 8 to 26 and the average age was 16.9. Seven to ten days after operation, the first fitting was undergone. In acoustic sound field, the average auditory thresholds were respectively measured for unaided ears and Bonebridge implanted ears by pure tone auditory (PTA, 0.25, 0.5, 1, 2 and 4 kHz). For the group over 12-year-old, MSTM was applied to evaluate speech discrimination score (SDS). For the other cases, MLNT was used as the test material. The auditory efficacy post Bonebridge implantation would be analyzed and evaluated by comparing the differences between unaided ears and Bonebridge implanted ears.@*Results@#The bone conduction audibility threshold after Bonebridge implantation was as well as the preoperative. The auditory threshold with Bonebridge aided was improved to 25-35 dB HL, when compared to that of the unaided ears in the sound field. The SDS in the group over 12-year-old was improved about 50%; the efficacy was slightly limited for the other two cases (both less than 12 years old). Statistical analysis showed that there were significant differences between unaided ears and Bonebridge implanted ears in the sound field and SDS(P<0.05).@*Conclusions@#The auditory efficacy of Bonebridge is significant and noticeable in patients with bilateral congenital malformation of external and middle ear. Bonebridge provides a new and effective way for patient with congenital malformation of external and middle ear to reconstruct hearing.

Active Bone Conduction Prosthesis: BonebridgeTM

Introduction Bone conduction implants are indicated for patients with conductive and mixed hearing loss, as well as for patients with single-sided deafness (SSD). The transcutaneous technology avoids several complications of the percutaneous bone conduction implants including skin reaction, skin growth over the abutment, and wound infection. The Bonebridge (MED-EL, Austria) prosthesis is a semi-implantable hearing system: the BCI (Bone Conduction Implant) is the implantable part that contains the Bone Conduction-Floating Mass Transducer (BC-FMT), which applies the vibrations directly to the bone; the external component is the audio processor Amadé BB (MED-EL, Austria), which digitally processes the sound and sends the information through the coil to the internal part. Bonebridge may be implanted through three different approaches: the transmastoid, the retrosigmoid, or the middle fossa approach. Objective This systematic review aims to describe the world́ s first active bone conduction implant system, Bonebridge, as well as describe the surgical techniques in the three possible approaches, showing results from implant centers in the world in terms of functional gain, speech reception thresholds and word recognition scores. Data Synthesis The authors searched the MEDLINE database using the key term Bonebridge. They selected only five publications to include in this systematic review. The review analyzes 20 patients that received Bonebridge implants with different approaches and pathologies. Conclusion Bonebridge is a solution for patients with conductive/mixed hearing loss and SSD with different surgical approaches, depending on their anatomy. The system imparts fewer complications than percutaneous bone conduction implants and shows proven benefits in speech discrimination and functional gain.(AU)

Revisión sobre el manejo de atresia de conducto auditivo externo mediante el uso de dispositivos auditivos implantables osteointegrados: a propósito de un caso exitoso con un implante Bonebridge® / Review of the management of external auditory canal atresia using osseo integrated implantable hearing devices: report of a successful case with Bonebridge® implant

La atresia de conducto auditivo externo tiene una incidencia de 1 por 1.000 ó 2.000 nacidos vivos, predominantemente unilateral. Su manejo actual es controversial, en especial la cirugía de reconstrucción. En el último tiempo se han desarrollado dispositivos osteointegrados, que han revolucionado el tratamiento y cuestionado la indicación de cirugía. El liderazgo por un tiempo importante lo ha tenido el dispositivo tipo BAHA, pero que ha tenido problemas en el largo plazo, principalmente en relación con el tornillo del implante. En respuesta a estos problemas, se ha diseñado un nuevo implante osteointegrado de nombre Bonebridge®, con beneficios frente a su antecesor. Como en nuestro medio se tiene poca experiencia en este dispositivo se presenta una revisión a propósito de un caso clínico exitoso. El caso corresponde a un paciente de 18 años con hipoacusia de conducción máxima bilateral congénita, con diagnóstico de atresia de conducto auditivo externo bilateral, con inadecuada ganancia auditiva del cintillo óseo tradicional. Tanto la revisión bibliográfica como el caso clínico nos permiten aseverar que Bonebridge® corresponde a tratamiento adecuado en el manejo de la atresia del conducto auditivo externo, con ciertos beneficios sobre otros dispositivos y la cirugía.

The external auditory canal atresia has an incidence of 1 per 1000 or 2000 live births predominantly unilateral. Its management is controversial, especially with the decision of reconstructive surgery. Lately, have developed osseo integrated bone conduction devices, which have come to revolutionize the treatment and questioning the indication for surgery. The leadership for a long time its has had it the BAHA device type, but has several problems in long-term, mainly in relation to the screw used in the implant. In response to this problems, was designed a new osseo integrated implant named Bonebridge®, showing benefits over its predecessor. As in our setting there is little experience with this device, we present a review about a successful clinical case. The case is a patient of 18 years with a maximal bilateral hearing loss caused by a congenital bilateral atresia of the external auditory canal, and inadequate audition gain with traditional bone headband. As much the bibliographical overhaul as the clinical case allows to assert that Bone-bridge® corresponds to an alternative of treatment in the atresia of the external auditory canal and with certain benefits by on the other devices, as the surgery.