Skin and soft tissue complications of bone-anchored hearing aids: Introducing a new classification system.

OBJECTIVES: There have been significant surgical and technological advances in bone-anchored hearing aid (BAHA) design, function, and implantation technique, but peri-implant skin complications remain the most frequent complication. The most important aspect in dealing with cutaneous complications is to identify the type of cutaneous lesion. Although Holger's Classification has been an extremely useful clinical tool, this grading system has been shown to be unsuitable for some cases. We therefore propose a new consistent and easy assessment classification of cutaneous complications associated with BAHA. METHODS: A retrospective clinical study was carried out at a tertiary centre, between January 2008 and December 2014. All patients under 18 years old with a unilateral BAHA were included in the study. RESULTS: A total of 53 children, with a BAHA, were included in the study. Post-operative skin complications were observed in 49.1% of the patients. Of the children, 28.3% presented with soft tissue hypertrophy, the most frequently reported skin complication, and grading according to the Holger's classification was not considered feasible. To overcome the difficulties we face in clinical practice, a new classification was developed and presented. CONCLUSION: The new proposed classification - Coutinho Classification - aims to fill the gaps in the one used currently by introducing new clinical features, most importantly the presence/absence of tissue overgrowth, and by providing a better description of what each category encompasses. This is an inclusive and objective new classification system, maintaining applicability, and useful in guiding the treatment.

Skin and soft tissue complications of bone-anchored hearing aids: Introducing a new classification system / Complicaciones de la piel y los tejidos blandos de los audífonos osteointegrados: introducción de un nuevo sistema de clasificación

Objectives: There have been significant surgical and technological advances in bone-anchored hearing aid (BAHA) design, function, and implantation technique, but peri-implant skin complications remain the most frequent complication. The most important aspect in dealing with cutaneous complications is to identify the type of cutaneous lesion.Although Holger's Classification has been an extremely useful clinical tool, this grading system has been shown to be unsuitable for some cases. We therefore propose a new consistent and easy assessment classification of cutaneous complications associated with BAHA.MethodsA retrospective clinical study was carried out at a tertiary centre, between January 2008 and December 2014. All patients under 18 years old with a unilateral BAHA were included in the study.ResultsA total of 53 children, with a BAHA, were included in the study. Post-operative skin complications were observed in 49.1% of the patients. Of the children, 28.3% presented with soft tissue hypertrophy, the most frequently reported skin complication, and grading according to the Holger's classification was not considered feasible.To overcome the difficulties we face in clinical practice, a new classification was developed and presented.ConclusionThe new proposed classification – Coutinho Classification – aims to fill the gaps in the one used currently by introducing new clinical features, most importantly the presence/absence of tissue overgrowth, and by providing a better description of what each category encompasses. This is an inclusive and objective new classification system, maintaining applicability, and useful in guiding the treatment. (AU)

Objetivos: La técnica de implantación de los audífonos osteointegrados (bone-anchored hearing aid [BAHA]) ha experimentado avances tecnológicos y quirúrgicos significativos en el diseño y en la función, aunque las complicaciones cutáneas periimplantarias son frecuentes. El aspecto más importante del tratamiento de las complicaciones cutáneas es identificar el tipo de lesión cutánea.Aunque la clasificación de Holger ha sido una instrumento clínico extremadamente útil, este sistema de clasificación ha demostrado ser inadecuado en algunos casos. Por lo tanto, proponemos una nueva clasificación, consistente y fácil, de las complicaciones cutáneas asociadas con BAHA.MétodosSe realizó un estudio clínico retrospectivo en un centro de tercer nivel, entre enero de 2008 y diciembre de 2014. Se incluyeron en el estudio todos los pacientes menores de 18 años a los que se colocó BAHA unilateral.ResultadosUn total de 53 niños a los que se colocaron BAHA fueron incluidos en el estudio. Se observaron complicaciones cutáneas postoperatorias en el 49,1% de los pacientes. El 28,3% de los niños presentaron hipertrofia de tejidos blandos, la complicación cutánea más frecuentemente reportada, y la clasificación de Holger no se consideró adecuada.Para superar las dificultades con que nos enfrentamos en la práctica clínica, se desarrolló y se presentó una nueva clasificación. (AU)

Análisis de la potencia de salida y del rendimiento auditivo de los dispositivos auditivos osteointegrados / Power output and hearing performance in osseointegrated auditory devices

Antecedentes y objetivos: Los dispositivos auditivos osteointegrados utilizan la transmisión del sonido por vía ósea para producir una mejoría auditiva. Los mecanismos y factores que intervienen en esta transmisión han sido ampliamente estudiados, sin embargo, existen otros aspectos que no conocemos, por ejemplo, la influencia que tiene la potencia de salida del procesador. El objetivo principal de este estudio fue conocer si existe alguna relación entre la potencia que emiten estos dispositivos y la mejoría auditiva que producen. Materiales y métodos: Hemos realizado un estudio en 44 pacientes portadores de un Baha® 5 percutáneo. De cada paciente se obtuvieron los umbrales de vía aérea y ósea en audiometría tonal liminar, en audiometría en campo libre, y en audiometría verbal en silencio y con ruido de fondo, tanto previa como posteriormente a la implantación. También se recogieron los umbrales de conducción ósea directa a través del procesador y los valores de ganancia en la potencia de salida del procesador. (AU)

Background and objective: Osseointegrated auditory devices are hearing gadgets that use the bone conduction of sound to produce hearing improvement. The mechanisms and factors that contribute to this sound transmission have been widely studied, however, there are other aspects that remain unknown, for instance, the influence of the processor power output. The aim of this study was to know if there is any relationship between the power output created by the devices and the hearing improvement that they achieve. Materials and methods: Forty-four patients were implanted with a percutaneous Baha® 5 model. Hearing thresholds in pure tone audiometry, free-field audiometry, and speech recognition (in quiet and in noise) were measured pre and postoperatively in each patient. The direct bone conduction thresholds and the power output values from the processors were also obtained. (AU)

Hearing rehabilitation with osseointegrated hearing implant in bilateral congenital external auditory canal atresia.

INTRODUCTION AND OBJECTIVES: Congenital atresia of the external auditory canal (EAC) is a congenital defect present in one in every 10,000-20,000 births. It causes conductive hearing loss, with an air-bone gap of 50-60dB. Early amplification is essential in bilateral cases to ensure normal language development. The aim of this study is to present the osseointegrated hearing implant as a treatment for bilateral EAC atresia, reviewing the audiometric results and the rate of complications. MATERIAL AND METHODS: Retrospective analysis of patients diagnosed with bilateral congenital EAC atresia under follow-up in the pediatric ENT clinic of the ENT and Head and Neck Surgery department of a Portuguese Tertiary Hospital, between 2003 and 2019. We reviewed the medical records and collected information on the assessment of the initial audiometric status. In the cases submitted for implantation with an osseointegrated hearing implant, we analyzed the details of follow-up, including immediate and long-term post-operative complications, as well as the audiometric results. RESULTS: We present 8 pediatric patients, 6 girls and 2 boys, with a diagnosis of bilateral congenital EAC atresia. The audiometric assessment revealed moderate to severe bilateral conductive hearing loss with a mean speech recognition threshold (SRT) of 51dB. Six patients underwent osseointegrated hearing implantation. All 6 patients showed good audiometric results, with an average SRT of 20dB and closure of the air-bone gap. CONCLUSIONS: The osseointegrated hearing implant was an effective treatment option in these patients, without significant morbidity or complications. Osseointegrated hearing implantation should be considered first line treatment for children with bilateral congenital EAC atresia, as it presents good functional results and a high level of patient satisfaction.

Hearing rehabilitation with osseointegrated hearing implant in bilateral congenital external auditory canal atresia

Introduction and objectives: Congenital atresia of the external auditory canal (EAC) is a congenital defect present in one in every 10,000–20,000 births. It causes conductive hearing loss, with an air-bone gap of 50–60dB. Early amplification is essential in bilateral cases to ensure normal language development. The aim of this study is to present the osseointegrated hearing implant as a treatment for bilateral EAC atresia, reviewing the audiometric results and the rate of complications.Material and methodsRetrospective analysis of patients diagnosed with bilateral congenital EAC atresia under follow-up in the pediatric ENT clinic of the ENT and Head and Neck Surgery department of a Portuguese Tertiary Hospital, between 2003 and 2019. We reviewed the medical records and collected information on the assessment of the initial audiometric status. In the cases submitted for implantation with an osseointegrated hearing implant, we analyzed the details of follow-up, including immediate and long-term post-operative complications, as well as the audiometric results.ResultsWe present 8 pediatric patients, 6 girls and 2 boys, with a diagnosis of bilateral congenital EAC atresia. The audiometric assessment revealed moderate to severe bilateral conductive hearing loss with a mean speech recognition threshold (SRT) of 51dB. Six patients underwent osseointegrated hearing implantation. All 6 patients showed good audiometric results, with an average SRT of 20dB and closure of the air-bone gap.ConclusionsThe osseointegrated hearing implant was an effective treatment option in these patients, without significant morbidity or complications. Osseointegrated hearing implantation should be considered first line treatment for children with bilateral congenital EAC atresia, as it presents good functional results and a high level of patient satisfaction. (AU)

Introducción y objetivos: La atresia congénita del canal auditivo externo (CAE) es un defecto congénito presente en uno de cada 10.000-20.000 nacimientos. Origina una pérdida auditiva conductiva, con un gap aire-hueso de 50-60dB. La amplificación temprana es fundamental en casos bilaterales para garantizar el normal desarrollo del lenguaje. El objetivo de este estudio es presentar el implante auditivo osteointegrado como tratamiento para la atresia bilateral del CAE, revisando los resultados audiométricos y la tasa de complicaciones.Material y métodosAnálisis retrospectivo de pacientes diagnosticados con atresia congénita bilateral del CAE en seguimiento en la consulta de otorrinolaringología pediátrica del departamento de otorrinolaringología y cirugía de cabeza y cuello, en un centro hospitalario terciario portugués, entre 2003 y 2019. Revisamos los registros médicos y recopilamos información sobre la evaluación del estado audiométrico inicial. En los casos sometidos a la implantación con implante auditivo osteointegrado, se analizaron los detalles del seguimiento, incluyendo las complicaciones postoperatorias inmediatas y a largo plazo, así como los resultados audiométricos.ResultadosPresentamos los casos de 8 pacientes pediátricos, 6 niñas y 2 niños, con diagnóstico de atresia congénita bilateral del CAE. La evaluación audiométrica reveló una pérdida auditiva de conducción bilateral de grado moderado a grave, con un Speech Recognition Threshold (SRT) medio de 51dB. Seis pacientes han sido sometidos a implantación con implante auditivo osteointegrado. Los 6 pacientes presentaron buenos resultados audiométricos, con un SRT medio de 20dB y cierre del gap aire-hueso. (AU)

Power output and hearing performance in osseointegrated auditory devices. / Análisis de la potencia de salida y del rendimiento auditivo de los dispositivos auditivos osteointegrados.

BACKGROUND AND OBJECTIVE: Osseointegrated auditory devices are hearing gadgets that use the bone conduction of sound to produce hearing improvement. The mechanisms and factors that contribute to this sound transmission have been widely studied, however, there are other aspects that remain unknown, for instance, the influence of the processor power output. The aim of this study was to know if there is any relationship between the power output created by the devices and the hearing improvement that they achieve. MATERIALS AND METHODS: Forty-four patients were implanted with a percutaneous Baha® 5 model. Hearing thresholds in pure tone audiometry, free-field audiometry, and speech recognition (in quiet and in noise) were measured pre and postoperatively in each patient .The direct bone conduction thresholds and the power output values from the processors were also obtained. RESULTS: The pure tone average threshold in free field was 39.29dB (SD 9.15), so that the mean gain was 29.18dB (SD 10.13) with the device. This involved an air-bone gap closure in 63.64% of patients. The pure tone average threshold in direct bone conduction was 27.6dB (SD 10.91), which was 8.4dB better than the pure tone average threshold via bone conduction. The mean gain in speech recognition was 39.15% (SD 23.98) at 40dB and 36.66% (SD 26.76) at 60dB. The mean gain in the signal-to-noise ratio was -5.9dB (SD 4.32). On the other hand, the mean power output values were 27.95dB µN (SD 6.51) in G40 and 26.22dB µN (SD 6.49) in G60. When analysing the relationship between bone conduction thresholds and G40 and G60 values, a correlation from the frequency of 1,000Hz was observed. However, no statistically significant association between power output, functional gain or speech recognition gain was found. CONCLUSIONS: The osseointegrated auditory devices generate hearing improvement in tonal thresholds and speech recognition, even in noise. Most patients closed the air-bone gap with the device. There is a direct relationship between the bone conduction threshold and the power output values from the processor, but only in mid and high frequencies. However, the relationship between power output and gain in speech recognition is weaker. Further investigation of contributing factors is necessary.

Evaluación de la calidad de vida y adherencia terapéutica en pacientes con hipoacusia neurosensorial unilateral manejados con dispositivos auditivos de conducción ósea en el Hospital Universitario Clínica San Rafael durante el período 2012-2017 / Assessment of the quality of life and therapeutic adherence in patients with unilateral sensorineural hearing loss managed with bone conduction hearing devices in the University Hospital Clínica San Rafael between 2012-2017

Introducción: los dispositivos audiológicos de conducción ósea ampliaron las opciones de tratamiento de las hipoacusias neurosensoriales unilaterales (HNU) y demostraron su eficacia clínica. No obstante, la valoración de la calidad de vida permite determinar la mejoría en las actividades cotidianas y la satisfacción del paciente con su tratamiento. Objetivo: determinar la calidad de vida y la adherencia terapéutica en pacientes con HNU manejados con dispositivos audiológicos de conducción ósea en el Hospital Universitario Clínica San Rafael en Bogotá D.C., Colombia, durante el período 2012-2017. Diseño: estudio observacional de corte transversal. Metodología: luego de la revisión de la historia clínica de los pacientes elegibles que asistieron a la consulta de otología del hospital, se aplicó la escala de evaluación de calidad de vida Glasgow Benefit Inventory (GBI) y el cuestionario de adherencia terapéutica. El puntaje de calidad de vida y el porcentaje de adherencia fueron analizados por medio de pruebas no paramétricas en relación con variables sociodemográficas y clínicas. Resultados: un total de 38 pacientes se incluyeron en el estudio. La mediana de la puntuación total del GBI fue de +36,1 (rango 0 a +61) y la adherencia reportada fue del 68%. No se identificó una diferencia estadísticamente significativa entre estas variables y el tipo de dispositivo de conducción ósea. Conclusiones: el uso de dispositivos de conducción ósea se asocia con una mejoría en la calidad de vida, alta tasa de adherencia y baja prevalencia de complicaciones. No se encontraron diferencias estadísticamente significativas entre los tipos de dispositivos disponibles en el mercado.

Introduction: bone conduction hearing devices have expanded the treatment options for unilateral sensorineural hearing loss and demonstrated their clinical efficacy. Nevertheless, the assessment of quality of life (QoL) allows to establish the patient's improvement in daily activities and their satisfaction with the treatment. Objective: to determine the QoL and treatment adherence of patients with sensorineural hearing loss treated with bone conduction hearing devices at Hospital Universitario Clinica San Rafael in Bogotá D.C., Colombia, between 2012-2017. Study design: crosssectional study. Methods: after the review of the medical history from the eligible patients who attended the hospital's otology clinic, a validated QoL questionnaire Glasgow Benefit Inventory (GBI) and an adherence questionnaire were filled out. The score of QoL questionnaire and percentage of adherence were analyzed by nonparametric tests in relation to sociodemographic and clinical variables. Results: a total of 38 patients were included in the study. The median of the total GBI score was +36.1 (range 0 to +61) and the reported adherence was 68%. We did not identify a statistically significant difference between these variables and the type of bone conduction hearing device. Conclusions: the use of bone conduction hearing devices is associated with an improvement in QoL, high adherence rate and low prevalence of complications, without identifying statistically significant differences between those devices currently available in the market.

Findings from the experience with the punch technique for auditory osseointegrated implants: A retrospective single center comparative study.

OBJECTIVE: To compare the punch technique and linear incision with soft tissue reduction for the placement of auditory osseointegrated implants (AOI) and analyze results of osseointegration obtained with the punch technique as measured with the Implant Stability Quotient (ISQ). METHODS: Case review of 34 patients who received auditory osseointegrated implants between January 2010 and July 2015 and were divided into two groups according to the surgical technique: 18 with the punch technique (PT) and 16 with the linear incision technique (LI). Minimum follow-up was four months (mean: 24 months; range 4-64 months). Included in the analysis were patient profiles and records of the demographic data, surgical indications, surgical technique, implant placement, surgical time, intraoperative complications, as well as postsurgical complications (Holgers classification) and implant stability quotients (ISQ). RESULTS: Use of larger abutments was significantly greater in the PT group (PT, 10mm; LI, 6mm, p<0.001). The PT technique resulted in a shorter procedure than the LI (PT, 20min; LI, 45min, p<0.001). Holgers classification scores identified significantly fewer skin complications one week after surgery for the PT group; however, only small differences were seen between the two groups at the one- and three-month control visits. CONCLUSIONS: As shown for our cohort, the punch technique for surgical placement of AOI is faster and presents fewer immediate postoperative complications when compared to the linear incision technique. The clinical application of the ISQ is a useful, easy method to demonstrate the status of osseointegration and, thus, the stability of the device.

Bone Anchored Hearing Aid (BAHA) in children: Experience of a tertiary referral centre in Portugal.

OBJECTIVES: The aim of this study is to describe the experience of a tertiary referral centre in Portugal, of the placement of BAHA in children. METHODS: The authors performed a retrospective analysis of all children for whom hearing rehabilitation with BAHA was indicated at a central hospital, between January 2003 and December 2014. RESULTS: 53 children were included. The most common indications for placement of BAHA were external and middle ear malformations (n=34, 64%) and chronic otitis media with difficult to control otorrhea (n=9, 17%). The average age for BAHA placement was 10.66±3.44 years. The average audiometric gain was 31.5±7.20dB compared to baseline values, with average hearing threshold with BAHA of 19.6±5.79dB. The most frequent postoperative complications were related to the skin (n=15, 28%). There were no major complications. CONCLUSIONS: This study concludes that BAHA is an effective and safe method of hearing rehabilitation in children.

Implante de audífono de conducción ósea osteointegrado: experiencia del Hospital Universitario de la Samaritana, Bogotá, D. C. / Bone anchored hearing aid: the Hospital Universitario de la Samaritana's experience, Bogotá, D. C.

Objetivo: Describir y comparar los resultados audiológicos pre y postquirúrgicos de los pacientes que fueron sometidos a implante de conducción ósea osteointegrado en el Hospital Universitario de la Samaritana, Bogotá D.C. Diseño: Estudio tipo Cohorte descriptiva. Métodos: Se evaluaron los resultados audiológicos pre y postquirúrgicos de 36 pacientes sometidos a Implante de audífono de conducción ósea osteointegrado. Resultados: Se observó una disminución estadísticamente significativa entre el valor de PTA pre y postquirúrgico (Diferencia = 36.94 dB; IC95% 35.2 a 38.7; p<0.001) Mejoría en la brecha Ósea ­ Aérea con una diferencia entre el valor previo y posterior a la intervención de 35.93 dB (IC95% 33.23 a 38.63; p<0.001). La diferencia entre el porcentaje de discriminación verbal antes y después del procedimiento quirúrgico fue de 6.67% (IC95% 1.41 a 11.92; p=0.008), con una reducción en los niveles de intensidad de sonido en la discriminación que fue de 32.26 dB (IC95% 29.21 a 35.32; p<0.001). Conclusión: Los resultados audiológicos esperados en pacientes con hipoacusia conductiva, mixta o neurosensorial unilateral que fueron sometidos a implante de audífono de conducción ósea osteointegrado muestran que el sistema ofrece un alto porcentaje de éxito y bajas tasas de complicaciones.

Objective: To describe and compare pre and postoperative audiological results in patients who received a bone conduction hearing aid implant and the Hospital Universitario de la Samaritana, Bogotá D.C. Design: A descriptive cohort study. Methods: A descriptive cohort study was conducted. We evaluated audiological results before and after the bone conduction hearing aid implant procedure in 36 patients. Results: A statistically significant decrease in the PTA value was observed after the implant procedure (difference= 36.94 dB; 95CI% 35.2 - 38.7; p<0.001) The bone-air gap also presented improvement after the intervention with a decrease of 35.93 dB (95%CI 33.23 - 38.63; p<0.001). The difference in verbal discrimination percentage after the surgical procedure was 6.67% (95%CI 1.41 - 11.92; p=0.008), with a decrease in sound intensity discrimination levels of 32.26 db (95%CI 29.21 - 35.32; p<0.001). Conclusion: The audiological results in patients with conductive, mixed or unilateral sensorineural hearing loss that received a bone conduction hearing aid implant show that this intervention offers a high success rate and low postoperative complications.

Resultados auditivos y de beneficios comunicativos en pacientes tratados con el implante activo de transmisión ósea Bonebridge® / Hearing results and communication benefits in patients treated with the active bone conduction implant Bonebridge®

El avance en dispositivos de rehabilitación auditiva ha logrado llegar a los dispositivos de transmisión ósea por medio de anclaje al hueso. El BAHA® (Bone Anchored Hearing Aid, Cochlear Co., Australia) es el más usado, dada su ganancia en el rango de frecuencias altas con menor distorsión de la señal; sin embargo, con complicaciones importantes, como infección, pérdida del implante y necesidad de cirugía revisional, que impactan en calidad de vida y costos. Debido a esto se han desarrollado implantes transcutáneos con menos complicaciones y resultados audiológicos similares, como el nuevo sistema activo de conducción ósea Bonebridge®. Objetivo: Describir los resultados auditivos y beneficios comunicativos del sistema implantable transcutáneo activo de conducción ósea Bonebridge® en hipoacusia conductiva y mixta. Diseño: Estudio pseudoexperimental tipo antes y después. Métodos: Se analizó a los pacientes implantados con el Bonebridge® entre octubre del 2012 y agosto del 2013, por el Servicio de Otología del Hospital Universitario Fundación Santa Fe de Bogotá, y se evaluaron ganancia funcional en audiometría, logoaudiometría, beneficio comunicativo y APHAB pre y posquirúrgico. Resultados: No se encontraron diferencias significativas en la vía ósea pre y postoperatoria. En las pruebas en campo libre solo hubo diferencia en la frecuencia de 500 Hz (P < 0,05). Se evidenció ganancia funcional en la discriminación del lenguaje en bisílabos a 60 dB SPL (nivel de presión sonora) (P: 0,042); se encontraron diferencias en el cuestionario de beneficio comunicativo APHAB (P: 0,043) en todas sus subcategorías, exceptuando aversión (P: 0,068). No hubo complicaciones. Conclusiones: El Bonebridge® es seguro y eficaz para la rehabilitación auditiva...

Advances in hearing rehabilitation devices have developed bone conduction devices through bone anchorage, BAHA® (Cochlear Bone Anchored Hearing Aid Co., Australia) is the most used because of its profit in the range of higher frequencies with less signal distortion, however, ought to its complications such as infection, implant loss and need for revisional surgery, which impact in costs and quality of life; transcutaneous implants have been developed with fewer complications and similar audiological results as the new active system Bonebridge® bone conduction. Objective: To describe the auditory results and communicative benefits of the active transcutaneous bone conduction implantable system Bonebridge® for treatment of conductive and mixed hearing loss. Desing: Pseudoexperimental before and after study. Methods: Patients who were implanted with Bonebridge® between October 2012 and August 2013 were analized by the Otology Department from the Fundación Santa Fe University Hospital in Bogotá, assessing functional gain in audiometry, speech audiometry and communicative benefit, APHAB, before and after surgery. Results: No significant differences in bone conduction were found before or after surgery. In free field test there was only a significant difference for 500 Hz frequency (P < 0.05), functional gain was observed in speech discrimination at 60 dB SPL disyllabic (P 0.042). There were differences for communicative benefit questionnaire (P 0.043) with the use of the device in every subcategories except aversion (P 0.068). There were no complications. Conclusion: Bonebridge® is safe and effective for hearing rehabilitations...

Implantes auditivos de conducción ósea percutáneo, transcutáneo: comparación / Percutaneous, Transcutaneous Bone Conduction Hearing Implants: comparison

Introducción: Los implantes de conducción ósea son alternativas en rehabilitación para pacientes con sordera conductiva/mixta o unilateral. Objetivo: Analizar desenlaces audiológicos, calidad de vida y percepción subjetiva de beneficios en pacientes con sordera conductiva y/o mixta o unilateral, usuarios del sistema transcutáneo Bonebridge®, o del sistema percutáneo BAHA®. Método: Estudio prospectivo en diez pacientes usuarios del sistema transcutáneo, y comparación con diez usuarios del sistema percutáneo. Evaluación audiológica, percepción de calidad de vida y satisfacción. Resultados: Con el sistema transcutáneo en sordera conductiva/mixta se registró ganancia promedio de 39 dB SPL (desviación estándar [DE] ±4; intervalo de confianza [IC] 95% 35-43), y con el sistema percutáneo, 33 dB SPL (DE ±7; IC 95% 26-40); diferencia de 6 dB SPL (EE ±3; IC 95% -1-13, p = 0,09). Discriminación de lenguaje con sistema transcutáneo 100% a 63 dB (DE ±2 dB; IC 95% 61-65) y con sistema percutáneo 100% a 58 dB (DE ±7 dB; IC 95% 51-65), diferencia de 5 dB (EE ±3 dB; IC 95% -2-12, p = 0,12). En sordera unilateral, la comparación de umbrales promedio con los dispositivos: 37 dB SPL (DE ±4; IC 95% 31-43) para el sistema transcutáneo y 32 dB SPL (DE ±3, IC 95% 27-37) para el sistema percutáneo, diferencia de 5 dB SPL (EE ±3; IC 95% -1-11, p = 0,09). Discriminación de lenguaje para sistema transcutáneo 100% a 66 dB SPL (DE ±7; IC 95% 55-77) y con sistema percutáneo 100% a 64 dB SPL (DE ±5; IC 95% 56-72), diferencia de 2 dB SPL (EE ±4; IC 95% –9-13, p = 0,7). Promedio total para percepción de beneficios con el uso de los dispositivos: 33 (DE ±18; IC 95% 20-46) para el sistema transcutáneo y 22 (DE ±12; IC 95% 13-31) en sistema percutáneo, diferencia de 11 puntos (EE ±7; IC 95% –3-25, p = 0,12). El nivel de satisfacción fue cuantificado de manera semejante, excepto en: Aspectos generales, sub-ítem Comodidad a favor del sistema transcutáneo. Conclusiones: Los beneficios audiológicos, satisfacción y calidad de vida identificados en los pacientes con el sistema Bonebridge son evidentes y comparables a los que han logrado los pacientes con el sistema BAHA...

Introduction: Hearing bone conduction implants are alternatives available for hearing rehabilitation in patients with conductive mixed hearing loss or unilateral deafness. Objective: To analyze audiological outcomes, quality of life and subjective hearing benefits perception in patients with conductive mixed hearing loss or unilateral deafness, users of percutaneous BAHA® system, or transcutaneous active bone conduction system Bonebridge®. Materials and Methods: Prospective study on 10 patients with transcutaneous system compared with 10 users of percutaneous system. Audiometries, speech recognition with and without the system, Glasgow Benefit Inventory (GBI) and Hearing Device Satisfaction Scale (HDSS) surveys tools. Results: With transcutaneous system, conductive mixed hearing loss group, achieved postoperatory mean gain of 33 dB SPL (Standard error [SE] ±3, 95% confidence interval [95% CI] 26-40, p>0.00001); with percutaneous system 38 dB SPL (SE ±6) 5% CI 25-51, p>0.00001); difference 5 dB SPL (SE ±3, 95% CI 1-11, p = 0.09). Postoperative speech discrimination, transcutaneous system 100% @63 dB (Standard deviation [SD] ±2 dB, 95% CI 61-65); percutaneous system 100% @58 dB (SD ±7 dB, 95% CI 51-65); difference 5 dB (SE ±3 dB, 95% CI -2 – 12, p = 0.12). In Single Sided Deafness (SSD), postoperative, transcutaneous system 82 dB SPL (SE ±4, 95% CI 72-92); percutaneous system 92 dB SPL (SE ±7, 95% CI 76-108); difference of 10 dB SPL (SE ±4, 95% CI 0.1-20, p = 0.047). Speech discrimination, postoperative, transcutaneous system 100% @66 dB SPL (SD ±7, 95% CI 55-77), percutaneous system 100% @64 dB (SD ±5, 95% CI 56-72); difference 2 dB (SE ±4, 95% CI -9-13, p = 0.7). For benefit perception with the devices, for transcutaneous system mean total scored 33 (SD ±18, 95% CI 20-46); for percutaneous system, 22 (SD ±12, 95% CI 13-31); difference 11 points (EE ±7, 95% CI -3-25, p = 0.12). Satisfaction with the device survey scored similarly except for the Comfort sub-item in the General Aspects favorable to the transcutaneous system. Conclusions: Audiological, satisfaction and –quality of life benefits identified in patients with Bonebridge® system are evident and comparable to those achieved by patients with the BAHA® system...