The effect of percutaneous and transcutaneous BAHA on hearing and subjective auditory abilities: A comparative study.

Hearing loss significantly affects communication, social interactions, and the overall quality of life. The bone-anchored hearing aid (BAHA) is an implantable system that bypasses the outer and middle ear to directly stimulate the cochlea through bone conduction. This study aimed to compare hearing performance and subjective auditory ability improvements between transcutaneous and percutaneous BAHA devices using audiological assessments and Speech, Spatial and Qualities of Hearing Scale. This cross-sectional prospective study included 29 participants aged 14 to 69 years who had used BAHA for at least 6 months. Both Cochlear Baha System's percutaneous (connect) and transcutaneous (attract) implants were evaluated. Audiological assessments involved pure-tone audiometry, speech recognition threshold, and free-field (FF) audiometry, while subjective auditory ability was measured using the Turkish Speech, Spatial and Qualities of Hearing scale (Tr-SSQ). Significant improvements in FF audiometry averages and speech recognition thresholds were observed with BAHA compared to without BAHA (P < .001). Both implant types provided similar FF averages, speech audiometry results, and Tr-SSQ outcomes, with no significant differences between them. Tr-SSQ scores showed substantial satisfaction, indicating significant improvements in speech perception, spatial perception, and hearing quality with BAHA (P < .001). The findings align with previous research, demonstrating that BAHA is a reliable and effective solution for hearing rehabilitation. The study also emphasized the importance of using both audiological test results and daily hearing function scales to comprehensively evaluate the benefits of hearing rehabilitation in real-world environments. In conclusion, BAHA, regardless of the implant type, can provide predictable and lasting improvements in hearing thresholds and daily hearing abilities, making it a valuable option for patients with conductive hearing loss.

Feasibility and Outcomes of an Active Osseointegrated Bone Conduction Implant in Children as Young as 5 Years of Age.

INTRODUCTION: This study reviews the feasibility of implanting active osseointegrated bone conduction devices in young children, below the prior age for FDA indication (<12 years), which has recently been reduced to 5 years. Outcomes included differences in adverse event rates and operative time between two groups (<12 and 12 years or older). MATERIALS AND METHODS: This study is a retrospective review of children receiving active osseointegrated bone conduction devices at a tertiary referral center academic hospital. One hundred and twenty-four children received 135 active osseointegrated bone conduction devices (May 2018-March 2024). RESULTS: Of 135 devices, 77 (57%) were in children <12 years (mean age (SD) = 7.9 (2.0) years, range = 4.9-11.9 years) and 58 (43%) were in 12 years or older (mean age (SD) = 15.1 (1.7) years, range = 12-18 years). Adverse events were significantly higher in the older group, occurring in 8 (10%) of 77 devices in children <12 years and 15 (26%) of 58 devices in children 12 years and older (26%) (Fisher's exact test = 0.0217 at p < 0.05). Major adverse events occurred in 5/124 (4%) patients, with 2 in patients <12 years (2/73, 3%) and 3 in children 12 and older (3/51, 6%). The proportion of major events between groups was not significantly different (Fisher's exact test = 0.4, p < 0.05). Mean surgical time was significantly less (t = -2.8799, df = 120.26, p = 0.005) in the children <12 years (mean (SD) = 66.5 (22.4) min) compared to those 12 and over (mean (SD) = 78.32 (23.1) min). CONCLUSIONS: Implantation of active osseointegrated bone conduction devices is feasible in children as young as 5 years and demonstrates low rates of complication. Further miniaturization may allow even earlier safe intervention.

Bonebridge implants versus atresiaplasty in children with unilateral congenital aural atresia: A comparison study of audiological outcomes.

OBJECTIVES: To evaluate and compare audiological outcomes of atresiaplasty and Bonebridge (BB) implantation in patients with unilateral congenital aural atresia (UCAA), to guide clinical decision-making. METHODS: Twenty-seven subjects diagnosed with UCAA were included in the study. Thirteen were implanted with the BB, while 14 undergone atresiaplasty. All patients underwent pre-and post-surgery examinations, including pure-tone audiometry, sound field threshold (SFT), speech reception threshold (SRT), word recognition score (WRS), and horizontal sound source localization tests. RESULTS: (1) Postoperatively, the average SFT decreased by 11.79 ± 5.93 dB HL in the atresiaplasty group and by 24.46 ± 9.36 dB HL in the BB group, with a significantly greater decrease in the BB group compared to the atresiaplasty group (P < 0.05). (2) Both groups demonstrated a significant improvement in average disyllabic WRS postoperatively under normal ear-masking conditions, with the BB group showing a significantly higher improvement than the atresiaplasty group. (3) When the speech signal was presented from the CAA side with noise from the normal hearing side, both surgical groups exhibited a significant decrease in postoperative signal-to-noise ratio compared to preoperative levels, with improvements of 2.14 ± 2.95 dB SNR in the atresiaplasty group and 4.92 ± 5.83 dB SNR in the BB group (P < 0.05). (4) The average minimum audible angle preoperative in the atresiaplasty group was 29.71 ± 18.42°, which decreased to 18.1 ± 10.07° at 6 months postoperatively, showing a statistically significant improvement (P < 0.05). CONCLUSION: We concluded that both atresiaplasty and Bonebridge implantation can significantly improve speech perception under both quiet and noisy conditions in children with UCAA. BoneBridge implantation appears to provide better audiological outcomes than atresiaplasty. Atresiaplasty can significantly improve the accuracy of sound localization. No significant improvement in sound localization accuracy was observed in the short period after Bonebridge implantation. Further research should be conducted with a larger sample size and longer follow-up time.

Cognitive load in individuals with a transfemoral amputation during single- and dual-task walking: a pilot study of brain activity in people using a socket prosthesis or a bone-anchored prosthesis.

OBJECTIVE: To explore cognitive load in people with transfemoral amputations fitted with socket or bone-anchored prostheses by describing activity in the left and right dorsolateral prefrontal cortices during single- and dual-task walking. DESIGN: Cross-sectional pilot study. PATIENTS: 8 socket prosthesis users and 8 bone-anchored prosthesis users. All were fitted with microprocessor-controlled prosthetic knees. METHODS: Participants answered self-report questionnaires and performed gait tests during 1 single-task walking condition and 2 dual-task walking conditions. While walking, activity in the dorsolateral prefrontal cortex was measured using functional near-infrared spectroscopy. Cognitive load was investigated for each participant by exploring the relative concentration of oxygenated haemoglobin in the left and right dorsolateral prefrontal cortex. Symmetry of brain activity was investigated by calculating a laterality index. RESULTS: Self-report measures and basic gait variables did not show differences between the groups. No obvious between-group differences were observed in the relative concentration of oxygenated haemoglobin for any walking condition. There was a tendency towards more right-side brain activity for participants using a socket prosthesis during dual-task conditions. CONCLUSIONS: This pilot study did not identify substantial differences in cognitive load or lateralization between socket prosthesis users and bone-anchored prosthesis users.

Beyond the surface: exploring contributing factors to bone anchored hearing implant complications.

INTRODUCTION: Bone anchored hearing implants (BAHI) are considered for conductive and mixed hearing loss, relying on osseointegration of a titanium implant. Limitations relate to constant skin contact, with resultant percutaneous infections and granulation. This study investigates whether patient characteristics and implant-specifications contribute to BAHIs' skin complications in a cohort with a uniform surgical approach. METHODS: A 10 year (2014-2024) retrospective cohort study was conducted on BAHI procedures that were undertaken using a tissue-preserving 'punch' technique. Data on patient demographics, co-morbidities, implant type, surgical approach, and complications were collected. Poisson regression analysis was used to identify predictors of complications. RESULTS: A total of 53 patients undergoing 55 BAHI surgeries by three ENT consultants were included. Factors that greatly increased implant-related percutaneous infections included the Cochlear™ BIA400 implant when compared to the Ponto™ BHX implant (twofold, CI 2.03-2.16), abutment sizes ≤ 10 mm (fourfold, CI 3.99-4.12) and male gender (9%, CI 1.07-1.12). Granulation episodes were affected by cardiovascular disease (CVD) status (1.5-fold, CI 0.26-0.78), BIA400 implant (threefold, CI 8.8.-9.2) and abutment sizes ≤ 10 mm (fourfold, CI 3.6-3.73). Revision surgery episodes increased with diabetic status (1.2-fold, CI 0.06-0.37) and abutment sizes ≤ 10 mm (threefold, 3.303-3.304). CONCLUSIONS: Larger cohort studies are required to confirm findings, particularly for implant and abutment size contributions. However, the findings suggest that using a larger abutment size when skin thickness meassuremets are borderline, improved hygiene education in male patients, pre-operative optimisation of CVD and diabetes, and adjusted patient follow-up based on risk stratification of the contributing factors to complication rates could reduce complication rates.

Advantages of customization of osseointegrated implants in transfemoral amputees: a comparative analysis of surgical planning.

BACKGROUND: Commercially available osseointegrated devices for transfemoral amputees are limited in size and thus fail to meet the significant anatomical variability in the femoral medullary canal. This study aimed to develop a customized osseointegrated stem to better accommodate a variety of femoral anatomies in transfemoral amputees than off-the-shelf stems. Customization is expected to enhance cortical bone preservation and increase the stem-bone contact area, which are critical for the long-term stability and success of implants. METHODS: A customized stem (OsteoCustom) was designed based on the statistical shape variability of the medullary canal. The implantability of the OsteoCustom stem was tested via 70 computed tomography (CT) images of human femurs and compared to that of a commercial device (OFI-C) for two different resection levels. The evaluations included the volume of cortical bone removed and the percentage of stem-bone contact area for both resection levels. Statistical significance was analyzed using paired and unpaired t tests. RESULTS: The OsteoCustom stem could be virtually implanted in all 70 femurs, while the OFI-C was unsuitable in 19 cases due to insufficient cortical thickness after implantation, further emphasizing its adaptability to varying anatomical conditions. The OsteoCustom stem preserved a greater volume of cortical bone than did the OFI-C. In fact, 42% less bone was removed at the proximal resection level (3.15 cm³ vs. 5.42 cm³, p ≤ 0.0001), and 33% less at the distal resection level (2.25 cm³ vs. 3.39 cm³, p = 0.003). The stem-bone contact area was also greater for the OsteoCustom stem, particularly at the distal resection level, showing a 20% increase in contact area (52.3% vs. 32.2%, p = 0.002) compared to that of the OFI-C. CONCLUSIONS: The OsteoCustom stem performed better than the commercial stem by preserving more cortical bone and achieving a greater stem-bone contact area, especially at distal resection levels where the shape of the medullary canal exhibits more inter-subject variability. Optimal fit in the distal region is of paramount importance for ensuring the stability of osseointegrated implants. This study highlights the potential benefits of customized osseointegrated stems in accommodating a broader range of femoral anatomies, with enhanced fit in the medullary canal.

Tissue Classification After Bone-Anchored Hearing Implant Surgery: A Machine Learning Approach to Monitoring Skin Response.

HYPOTHESIS: Here, we aim to 1) expand the available evidence for the use of machine learning techniques for soft tissue classification after BCD surgery and 2) discuss the implications of such approaches toward the development of classification applications to aid in tissue monitoring. BACKGROUND: The application of machine learning techniques in the soft tissue literature has become a large field of study. One of the most commonly reported outcomes after percutaneous bone-conduction device (BCD) surgery is soft tissue health. Unfortunately, the classification of tissue around the abutment as healthy versus not healthy is a subjective process, even though such decisions can have implications for treatment (i.e., topical steroid versus surgical revision) and resources (e.g., clinician time). METHODS: We built and tested a convolutional neural network (CNN) model for the classification of tissues that were rated as "green" (i.e., healthy), "yellow" (i.e., unhealthy minor), and "red" (i.e., unhealthy severe). METHODS: Representative image samples were gathered from a regional bone-conduction amplification site (N = 398; 181 samples of green; 144 samples of yellow; 73 samples of red). The image samples were cropped, zoomed, and normalized. Feature extraction was then implemented and used as the input to train an advanced CNN model. RESULTS: Accuracy of image classification for the healthy ("green") versus not healthy ("yellow" and "red") model was approximately 87%. Accuracy of image classification for the unhealthy ("yellow") versus unhealthy ("red") model was approximately 94%. CONCLUSIONS: Monitoring tissue health is an ongoing challenge for BCD users and their clinicians not trained in soft tissue management (e.g., audiologists). If machine learning can aid in the classification of tissue health, this would have significant implications for stakeholders. Here we discuss how machine learning can be applied to tissue classification as a potential technological aid in the coming years.

Validation of IMU against optical reference and development of open-source pipeline: proof of concept case report in a participant with transfemoral amputation fitted with a Percutaneous Osseointegrated Implant.

BACKGROUND: Systems that capture motion under laboratory conditions limit validity in real-world environments. Mobile motion capture solutions such as Inertial Measurement Units (IMUs) can progress our understanding of "real" human movement. IMU data must be validated in each application to interpret with clinical applicability; this is particularly true for diverse populations. Our IMU analysis method builds on the OpenSim IMU Inverse Kinematics toolkit integrating the Versatile Quaternion-based Filter and incorporates realistic constraints to the underlying biomechanical model. We validate our processing method against the reference standard optical motion capture in a case report with participants with transfemoral amputation fitted with a Percutaneous Osseointegrated Implant (POI) and without amputation walking over level ground. We hypothesis that by using this novel pipeline, we can validate IMU motion capture data, to a clinically acceptable degree. RESULTS: Average RMSE (across all joints) between the two systems from the participant with a unilateral transfemoral amputation (TFA) on the amputated and the intact sides were 2.35° (IQR = 1.45°) and 3.59° (IQR = 2.00°) respectively. Equivalent results in the non-amputated participant were 2.26° (IQR = 1.08°). Joint level average RMSE between the two systems from the TFA ranged from 1.66° to 3.82° and from 1.21° to 5.46° in the non-amputated participant. In plane average RMSE between the two systems from the TFA ranged from 2.17° (coronal) to 3.91° (sagittal) and from 1.96° (transverse) to 2.32° (sagittal) in the non-amputated participant. Coefficients of Multiple Correlation (CMC) results between the two systems in the TFA ranged from 0.74 to > 0.99 and from 0.72 to > 0.99 in the non-amputated participant and resulted in 'excellent' similarity in each data set average, in every plane and at all joint levels. Normalized RMSE between the two systems from the TFA ranged from 3.40% (knee level) to 54.54% (pelvis level) and from 2.18% to 36.01% in the non-amputated participant. CONCLUSIONS: We offer a modular processing pipeline that enables the addition of extra layers, facilitates changes to the underlying biomechanical model, and can accept raw IMU data from any vendor. We successfully validate the pipeline using data, for the first time, from a TFA participant using a POI and have proved our hypothesis.

Cumulative loading increases and loading asymmetries persist during walking for people with a transfemoral bone-anchored limb.

BACKGROUND: A bone-anchored limb (BAL) is an alternative to a traditional socket-type prosthesis for people with transfemoral amputation. Early laboratory-based evidence suggests improvement in joint and limb loading mechanics during walking with a BAL compared to socket prosthesis use. However, changes in cumulative joint and limb loading measures, which may be predictive of degenerative joint disease progression, remain unknown. RESEARCH QUESTION: Do cumulative total limb and hip joint loading during walking change using a BAL for people with unilateral transfemoral amputation, compared to prior socket prosthesis use? METHODS: A case-series cohort of eight participants with prior unilateral transfemoral amputation who underwent BAL hardware implantation surgery were retrospectively analyzed (4 M/4 F; BMI: 27.7 ± 3.1 kg/m2; age: 50.4 ± 10.2 years). Daily step count and whole-body motion capture data were collected before (using socket prosthesis) and one-year after BAL hardware implantation. Cumulative total limb and hip joint loading and between-limb loading symmetry metrics were calculated during overground walking at both time points and compared using Cohen's d effect sizes. RESULTS: One year after BAL hardware implantation, participants demonstrated bilateral increases in cumulative total limb loading (amputated: d = -0.65; intact: d = -0.72) and frontal-plane hip moment (amputated: d = -1.29; intact: d = -1.68). Total limb loading and hip joint loading in all planes remained asymmetric over time, with relative overloading of the intact limb in all variables of interest at the one-year point. SIGNIFICANCE: Despite increases in cumulative total limb and hip joint loading, between-limb loading asymmetries persist. Habitual loading asymmetry has been implicated in contributing to negative long-term joint health and onset or progression of degenerative joint diseases. Improved understanding of methods to address habitual loading asymmetries is needed to optimize rehabilitation and long-term joint health as people with transfemoral amputation increase physical activity when using a BAL.

Resonance Frequency Analysis Identifies Implant- and Host-Related Factors Associated With Bone-Anchored Hearing Implant Stability.

HYPOTHESIS: Resonance frequency analysis (RFA) is a reliable, noninvasive method to assess the stability of bone-anchored hearing implants (BAHIs), although surgical-, implant-, and host-related factors can affect its outcome. BACKGROUND: BAHI plays an important role in restoring hearing function. However, implant- and host-related factors contribute to premature implant extrusion. To mitigate this, noninvasive methods to assess implant stability, along with a better understanding of factors contributing to BAHI failure, are needed. METHODS: We evaluated the utility of RFA to quantify implant stability in sawbone (bone mimicking material), 29 human cadaveric samples, and a prospective cohort of 29 pediatric and 27 adult participants, and identified factors associated with implant stability. To validate the use of RFA in BAHI, we compared RFA-derived implant stability quotient (ISQ) estimates to peak loads obtained from mechanical push-out testing. RESULTS: ISQ and peak loads were significantly correlated (Spearman rho = 0.48, p = 0.0088), and ISQ reliably predicted peak load up to 1 kN. We then showed that in cadaveric samples, abutment length, internal table bone volume, and donor age were significantly associated with implant stability. We validated findings in our prospective patient cohort and showed that minimally invasive Ponto surgery (MIPS; versus linear incision), longer implantation durations (>16 wk), older age (>25 yr), and shorter abutment lengths (≤10 mm) were associated with better implant stability. Finally, we characterized the short-term reproducibility of ISQ measurements in sawbone and patient implants. CONCLUSIONS: Together, our findings support the use of ISQ as a measure of implant stability and emphasize important considerations that impact implant stability, including surgical method, implant duration, age, and abutment lengths.

[Implant anchorage: In vivo and in vitro analyses : Clusters for implant anchorage and safety]. / Implantatverankerung: In-vivo- und In-vitro-Analysen : Cluster Implantatverankerung und -sicherheit.

Aseptic implant loosening is the primary cause of revisions in arthroplasty. Various in vitro and in vivo methods are available for assessing implant fixation and stability. The aim of the Musculoskeletal Biomechanics Research Network (MSB-NET) is to continuously improve or develop these methods. In vitro analyses are often conducted using static and dynamic ISO and ASTM standards, while RSA, DXA, and EBRA analyses are established in vivo methods for evaluating implant fixation. Primary stability analyses, as well as acoustical methods, provide additional opportunities to detect loosening early and precisely evaluate implant stability. The cluster serves as a link between basic research, clinical practice, and end users to promote in vitro and in vivo methods to improve implant safety.

Dynamic gait stability and stability symmetry for people with transfemoral amputation: A case-series of 19 individuals with bone-anchored limbs.

For some individuals with severe socket-related problems, prosthesis osseointegration directly connects a prosthesis to the residual limb creating a bone-anchored limb (BAL). We compared dynamic gait stability and between-limb stability symmetry, as measured by the Margin of Stability (MoS) and the Normalized Symmetry Index (NSI), for people with unilateral transfemoral amputation before and one-year after BAL implantation. The MoS provides a mechanical construct to assess dynamic gait stability and infer center of mass and limb control by relating the center of mass and velocity to the base of support. Before and one-year after BAL implantation, 19 participants walked overground at self-selected speeds. We quantified dynamic gait stability anteriorly and laterally at foot strike and at the minimum lateral MoS value. After implantation, we observed decreased lateral MoS at foot strike for the amputated (MoS mean(SD) %height; pre: 6.6(2.3), post: 5.9(1.3), d = 0.45) and intact limb (pre: 6.2(1.2), post: 5.8(1.0), d = 0.38) and increased between-limb MoS symmetry at foot strike (NSI mean(SD) %; anterior-pre: 10.3(7.3), post: 8.4(3.6), d = 0.23; lateral-pre: 18.8(12.4), post: 12.4(4.9), d = 0.47) and at minimum lateral stability (pre: 28.1(18.1), post: 19.2(6.8), d = 0.50). Center of mass control using a BAL resulted in dynamic gait stability more similar between limbs and may have reduced the adoption of functional asymmetries. We suggest that improved between-limb MoS symmetry after BAL implantation is likely due to subtle changes in individual limb MoS values at self-selected walking speeds resulting in an overall positive impact on fall risk through improved center of mass and prosthetic limb control.

Evaluation of a super powerful bone-anchored hearing system and its users: A retrospective study.

INTRODUCTION: Although the Baha 5SP has been commercially available for six years, very few studies have been performed on the device's efficacy. The current study aims to evaluate the characteristics and audiological results in patients with severe-to-profound mixed hearing loss fitted with this superpower sound processor. METHODS: This retrospective evaluation was conducted at a tertiary referral centre where a series of 82 adult patients with severe-to-profound mixed hearing loss were implanted with a percutaneous bone-anchored hearing system and fitted with a superpower sound processor between 2016 and 2019. Patients with incomplete or unreliable audiological data (n = 24) were excluded, resulting in 58 data sets for analysis. The main outcome measures were unaided and aided pure-tone thresholds and aided free-field speech perception in quiet. RESULTS: The median unaided air conduction (AC) threshold averaged across 0.5, 1 and 2 kHz (PTA0.5-2kHz) of all patients was 75 dB hearing loss (HL); the median unaided AC averaged across 1, 2 and 4 kHz (PTA1-4kHz) was 84 dB HL. For bone conduction and direct bone conduction, the median PTA0.5-2kHz was 52 and 47 dB HL, respectively. With the superpower device, the median free-field speech reception threshold was 54 dB sound pressure level (SPL), and the median speech perception score at 65 dB SPL was 80%. CONCLUSIONS: At least 75% of the patients reached a maximum phoneme score of 70%. For patients with lower scores, the superpower device still provides a substantial hearing benefit. This makes the superpower device particularly suitable for patients with severe-to-profound mixed hearing loss with a contraindication for conventional hearing aids and/or cochlear implants.

Very Early Loading of a Bone-Anchored Hearing System Is Safe.

OBJECTIVE: To investigate the feasibility of early sound processor loading with two separate bone-anchored hearing aid implants 1 to 2 weeks after implantation. Secondary endpoints included registration of any postoperative complications, skin reactions, and any adverse events. STUDY DESIGN: Prospective, nonrandomized, noncontrolled, multicenter clinical trial. SETTING: Tertiary referral center. PATIENTS: Sixty adult patients, eligible for bone-anchored hearing aid surgery, were enrolled. INTERVENTION: Implantation of the bone-anchored hearing aid implants were done using minimally invasive surgery with tissue preservation. MAIN OUTCOME MEASURE: Implant stability quotient (ISQ) values were recorded using resonance frequency analysis. Follow-ups were scheduled 5 to 12 days, 4 to 8 weeks, 6 months, and 12 months postoperatively. Differences between the lowest ISQ values (ISQ low) over time were analyzed by paired-samples t test with a significance level of 0.05. Skin and soft tissue reactions were assessed according to Holger's classification. RESULTS: Loading time of the Ponto Wide implant was 11.6 ± 1.4 days (SD) in average (median, 12 d; range, 7-19 d). Loading of the Ponto BHX implant was done 9.7 ± 3.5 days (SD) postoperatively (median, 9 d; range, 5-19 d). The implant stability increased significantly during the 12-month study period with both implants. One Ponto BHX implant was lost. Skin and soft tissue reactions were few in both groups. Across all planned follow-up visits, no skin and soft tissue reactions were observed in 86% (Ponto BHX implant) and 85% (Ponto Wide implant). CONCLUSION: Very early loading of sound processors after percutaneous bone-anchored hearing system surgery is safe already 1 to 2 weeks postoperatively.

Staged implantation of active transcutaneous bone conduction hearing devices (BCHD) after explantation of older generation bone anchored hearing aids (BAHAs): Surgical outcomes and approach to management.

PURPOSE: To evaluate outcomes following explantation of percutaneous or transcutaneous bone conduction implants (pBCIs or tBCIs) and subsequent implantation of transcutaneous active bone conduction hearing devices (BCHDs); to provide guidance regarding staging of surgery and adjunctive procedures. MATERIALS AND METHODS: Retrospective chart review of eight adult subjects (ten ears) with pBCIs or tBCIs who underwent explantation of their device and subsequent implantation with a BCHD [MED-EL BONEBRIDGE™ (n = 7, 70 %) or Cochlear™ Osia® (n = 3, 30 %)]. RESULTS: Reasons for pBCI or tBCI explantation were pain (60 %, 6/10), infection (60 %, 6/10), skin overgrowth (50 %, 5/10), and inability to obtain new processors (20 %, 2/10). Median time between pBCI or tBCI removal and BCHD staged implant was 4.7 (IQR 2.2-8.1) months. Two subjects developed complications following BCHD implantation. One had a persistent wound overlying the osseointegrated screw after removal of the pBCI abutment, requiring removal and temporalis rotational flap. Staged Osia® implantation was performed, but ultimately wound dehiscence developed over the device. The second subject experienced an infection after BONEBRIDGE™ implantation (32 days after pBCI explant), necessitating washout and treatment with intravenous antibiotics. There was subsequent device failure. CONCLUSION: The transition from a pBCI or tBCI to a novel transcutaneous device is nuanced. Staged pBCI or tBCI explantation and novel BCHD implantation with sufficient time for wound healing is vital. Adjunctive procedures to augment soft tissue in cases of prior attenuation may be required to avoid complications with larger internal devices.

Long-Term Outcomes of a Percutaneous Wide-Diameter Bone-Anchored Hearing Implant: A Clinical Evaluation of More than 800 Implants.

OBJECTIVE: This study evaluates the clinical outcomes of 807 percutaneous wide-diameter bone-anchored hearing implants (BAHIs) in 701 patients. In addition, it compares patient groups and examines bone conduction device (BCD) usage. STUDY DESIGN: Retrospective cohort study. Mean follow-up period of 3.8 years. SETTING: Tertiary referral center. PATIENTS: All patients implanted with a percutaneous wide-diameter BAHI until December 2020 were included. Patients were divided into age groups, "loading-time" groups, and, if applicable, specific subgroups thought to be at risk for complications postsurgery, e.g., intellectual disability and comorbidities. MAIN OUTCOME MEASURES: Soft tissue reaction, implant survival, revision surgery, and BCD usage. RESULTS: In 9.1% of the 5,188 observations of 807 implants, an adverse soft tissue reaction was reported according to the Holgers' scale. Significantly more (adverse) soft tissue reactions were observed in children and intellectually disabled (ID) patients (p < 0.05). Comorbidity subgroups showed no significant differences in soft tissue reactions. Implant loss percentage, including explantations, was 6.2%. Implant survival was significantly worse in patients with ID (14.1%; p = 0.021). Pediatric age, early loading, or comorbidities did not significantly influence implant survival. At least 592 implants (73.4%) were used for bone conduction hearing, of which 65.4% were used daily. CONCLUSION: Both children and ID patients are more prone to (adverse) soft tissue reactions, ID patients only have a higher risk of implant loss. The rate of implant loss in children seemed to be reduced compared to previous studies and thus more comparable to adults since using wide-diameter implants.

The biomechanical influence of transtibial Bone-Anchored limbs during walking.

Individuals with unilateral transtibial amputation (TTA) using socket prostheses demonstrate asymmetric joint biomechanics during walking, which increases the risk of secondary comorbidities (e.g., low back pain (LBP), osteoarthritis (OA)). Bone-anchored limbs are an alternative to socket prostheses, yet it remains unknown how they influence multi-joint loading. Our objective was to determine the influence of bone-anchored limb use on multi-joint biomechanics during walking. Motion capture data (kinematics, ground reaction forces) were collected during overground walking from ten participants with unilateral TTA prior to (using socket prostheses) and 12-months after bone-anchored limb implantation. Within this year, each participant completed a rehabilitation protocol that guided progression of loading based on patient pain response and optimized biomechanics. Musculoskeletal models were developed at each testing timepoint (baseline or 12-months after implantation) and used to calculate joint kinematics, internal joint moments, and joint reaction forces (JRFs). Analyses were performed during three stance periods on each limb. The between-limb normalized symmetry index (NSI) was calculated for joint moments and JRF impulses. Discrete (range of motion (ROM), impulse NSI) dependent variables were compared before and after implantation using paired t-tests with Bonferroni-Holm corrections while continuous (ensemble averages of kinematics, moments, JRFs) were compared using statistical parametric mapping (p < 0.05). When using a bone-anchored limb, frontal plane pelvic (residual: pre = 9.6 ± 3.3°, post = 6.3 ± 2.5°, p = 0.004; intact: pre = 10.2 ± 3.9°, post = 7.9 ± 2.6°, p = 0.006) and lumbar (residual: pre = 15.9 ± 7.0°, post = 10.6 ± 2.5°, p = 0.024, intact: pre = 17.1 ± 7.0°, post = 11.4 ± 2.8°, p = 0.014) ROM was reduced compared to socket prosthesis use. The intact limb hip extension moment impulse increased (pre = -11.0 ± 3.6 Nm*s/kg, post = -16.5 ± 4.4 Nm*s/kg, p = 0.005) and sagittal plane hip moment impulse symmetry improved (flexion: pre = 23.1 ± 16.0 %, post = -3.9 ± 19.5 %, p = 0.004, extension: pre = 29.2 ± 20.3 %, post = 8.7 ± 22.9 %, p = 0.049). Residual limb knee extension moment impulse decreased compared to baseline (pre = 15.7 ± 10.8 Nm*s/kg, post = 7.8 ± 3.9 Nm*s/kg, p = 0.030). These results indicate that bone-anchored limb implantation alters multi-joint biomechanics, which may impact LBP or OA risk factors in the TTA population longitudinally.

The influence of prosthetic suspension on gait and cortical modulations is persons with a transfemoral amputation: socket-suspended versus bone-anchored prosthesis.

BACKGROUND: Persons with a transfemoral amputation (TFA) often experience difficulties in daily-life ambulation, including an asymmetrical and less stable gait pattern and a greater cognitive demand of walking. However, it remains unclear whether this is effected by the prosthetic suspension, as eliminating the non-rigid prosthetic connection may influence stability and cortical activity during walking. Spatiotemporal and stability-related gait parameters, as well as cortical activity during walking, were evaluated between highly active individuals (MFC-level K3-4) with a TFA and able-bodied (AB) persons, and between persons with a bone-anchored prosthesis (BAP) and those with a socket-suspended prosthesis (SSP). METHODS: 18 AB persons and 20 persons with a unilateral TFA (10 BAP-users, 10 SSP-users) walked on a treadmill at their preferred speed. Spatiotemporal and margin of stability parameters were extracted from three-dimensional movement recordings. In addition, 126-channel electroencephalogram (EEG) was recorded. Brain-related activity from several cortical areas was isolated using independent component analysis. Source-level data were divided into gait cycles and subjected to time-frequency analysis to determine gait-cycle dependent modulations of cortical activity. RESULTS: Persons with TFA walked with smaller and wider steps and with greater variability in mediolateral foot placement than AB subjects; no significant differences were found between BAP- and SSP-users. The EEG analysis yielded four cortical clusters in frontal, central (both hemispheres), and parietal areas. No statistically significant between-group differences were found in the mean power over the entire gait cycle. The event-related spectral perturbation maps revealed differences in power modulations (theta, alpha, and beta bands) between TFA and AB groups, and between BAP- and SSP-users, with largest differences observed around heel strike of either leg. CONCLUSIONS: The anticipated differences in gait parameters in persons with TFA were confirmed, however no significant effect of the fixed suspension of a BAP was found. The preliminary EEG findings may indicate more active monitoring and control of stability in persons with TFA, which appeared to be timed differently in SSP than in BAP-users. Future studies may focus on walking tasks that challenge stability to further investigate differences related to prosthetic suspension.

Mechanical load applied by Intraosseous Transcutaneous Amputation Prosthesis (ITAP) during walking on level and sloped treadmill: A case study.

This proof of concept study presents a method to collect and analyse kinetic data from one participant with a transfemoral amputation fitted with a percutaneous osseointegrated implant walking on a level and sloped treadmill. We describe the construction of and results from a bespoke wireless six axis load cell built into one participant's prosthetic assembly. The load cell does not clinically compromise the participant in any way and is an initial milestone in the development of a light-weight wireless load cell for use with percutaneous osseointegrated implants. In this case, it is the first time that kinetic data from a participant fitted with an Intraosseous Transcutaneous Amputation Prosthesis has been published. We propose that the data can be used to model the load transfer to the host bone, with several clinically significant applications. The raw dynamic data are made available and quasi-static load cases for each functional phase of gait are presented. Peak forces obtained in the medio-lateral (X), cranio-caudal (Y) and antero-posterior (Z) axes over level ground respectively were -243.8 N (0.24 BW), 1321.5 N (1.31 BW) and -421.8 N (0.42 BW); uphill were -141.0 N (0.14 BW), 1604.2 N (1.59 BW), -498.1 N (0.49 BW); downhill were -206.0 N (0.20 BW), 1103.9 N (1.09 BW), -547.2 N (0.54 BW). The kinetics broadly followed able bodied gait patterns with some gait strategies consistent in participants with other implant designs or prosthetic socket connections, for example offloading the artificial limb downhill.

The gait1415+2 OpenSim musculoskeletal model of transfemoral amputees with a generic bone-anchored prosthesis.

This short communication presents the gait1415+2 musculoskeletal model, that has been developed in OpenSim to describe the lower-extremity of a human subject with transfemoral amputation wearing a generic lower-limb bone-anchored prosthesis. The model has fourteen degrees of freedom, governed by fifteen musculotendon units (placed at the contralateral and residual limbs) and two generic actuators (one placed at the knee joint and one at the ankle joint of the prosthetic leg). Even though the model is a simplified abstraction, it is capable of generating a human-like walking gait and, specifically, it is capable of reproducing both the kinematics and the dynamics of a person with transfemoral amputation wearing a bone-anchored prosthesis during normal level-ground walking. The model is released as support material to this short communication with the final goal of providing the scientific community with a tool for performing forward and inverse dynamics simulations, and for developing computationally-demanding control schemes based on artificial intelligence methods for lower-limb prostheses.