Development and validation of a surgical planning tool for bone-conduction implants.

Background: The BONEBRIDGE® (Med-El GmbH) is a bone-conduction device comprising an external audio processor and an internal Bone Conduction-Floating Mass Transducer (BC-FMT) surgically anchored to the temporal bone. Due to the implant's size, its placement may be challenging in certain anatomies, necessitating thorough surgical planning. Manual planning methods are laborious, time-intensive, and prone to errors. This study aimed to develop and validate an automated algorithm for determining skull thickness, aiding in the surgical planning of the BONEBRIDGE and other devices requiring similar bone thickness estimations. Materials and methods: Twelve cadaveric temporal bones underwent clinical computed tomography (CT). A custom Python algorithm was developed to automatically segment bone from soft tissue, generate 3D models, and perform ray-tracing to estimate bone thickness. Two thickness colormaps were generated for each sample: the cortical thickness to the first air cell and the total thickness down to the dura. The algorithm was validated against expert manual measurements to achieve consensus interpretation. Results: The algorithm estimated bone-to-air thicknesses (mean = 4.7 mm, 95% Confidence Interval [CI] of 4.3-5.0 mm) that closely matched the expert measurements (mean = 4.7 mm, CI of 4.4-5.0 mm), with a mean absolute difference (MAD) of 0.3 mm. Similarly, the algorithm's estimations to the dura (6.0 mm, CI of 5.4-6.5 mm) were comparable to the expert markings (5.9 mm, CI of 5.4-6.5 mm), with a MAD of 0.3 mm. Conclusions: The first automated algorithm to calculate skull thickness to both the air cells and dura in the temporal bone was developed. Colormaps were optimized to aid with the surgical planning of BONEBRIDGE implantation, however the tool can be generalized to aid in the surgical planning of any bone thickness application. The tool was published as a freely available extension to the open-source 3D Slicer software program (www.slicer.org).

Morphologic Analysis of the Scala Tympani Using Synchrotron: Implications for Cochlear Implantation.

OBJECTIVES: To use synchrotron radiation phase-contrast imaging (SR-PCI) to visualize and measure the morphology of the entire cochlear scala tympani (ST) and assess cochlear implant (CI) electrode trajectories. METHODS: SR-PCI images were used to obtain geometric measurements of the cochlear scalar diameter and area at 5-degree increments in 35 unimplanted and three implanted fixed human cadaveric cochleae. RESULTS: The cross-sectional diameter and area of the cochlea were found to decrease from the base to the apex. This study represents a wide variability in cochlear morphology and suggests that even in the smallest cochlea, the ST can accommodate a 0.4 mm diameter electrode up to 720°. Additionally, all lateral wall array trajectories were within the anatomically accommodating insertion zone. CONCLUSION: This is the first study to use SR-PCI to visualize and quantify the entire ST morphology, from the round window to the apical tip, and assess the post-operative trajectory of electrodes. These high-resolution anatomical measurements can be used to inform the angular insertion depth that can be accommodated in CI patients, accounting for anatomical variability. LEVEL OF EVIDENCE: N/A. Laryngoscope, 134:2889-2897, 2024.

Surgical Considerations in Inner Ear Gene Therapy from Human Temporal Bone Anatomy.

OBJECTIVE(S): Recently directed methods of inner ear drug delivery underscore the necessity for understanding critical anatomical dimensions. This study examines anatomical measurements of the human middle and inner ear relevant for inner ear drug delivery studied with three different imaging modalities. METHODS: Post-mortem human temporal bones were analyzed using human temporal bone histopathology (N = 24), micro computerized tomography (µCT; N = 4), and synchrotron radiation phase-contrast imaging (SR-PCI; N = 7). Nine measurements involving the oval and round windows were performed when relevant anatomical structures were visualized for subsequent age-controlled analysis, and comparisons were made between imaging methods. RESULTS: Combined human temporal bone histopathology showed the mean distance to the saccule from the center of the stapes footplate (FP) was 2.07 ± 0.357 mm and the minimum distance was 1.23 mm. The mean distance from the round window membrane (RWM) to the osseous spiral lamina (OSL) was 1.75 ± 0.199 mm and the minimum distance was 1.43 mm. Instruments inserted up to 1 mm past the center of the FP are unlikely to cause saccular damage, provided there are no endolymphatic hydrops. Similarly, instruments inserted up to 1 mm through the RWM in the trajectory toward the OSL are unlikely to cause OSL damage. CONCLUSION: The combined analyses of inner-ear dimensions of age-controlled groups and imaging modalities demonstrate critical dimensions of importance to consider when inserting delivery vehicles into the human cochlea. LEVEL OF EVIDENCE: N/A Laryngoscope, 134:2879-2888, 2024.

Virtual Reality Simulation for the Middle Cranial Fossa Approach: A Validation Study.

BACKGROUND AND OBJECTIVES: Virtual reality (VR) surgical rehearsal is an educational tool that exists in a safe environment. Validation is necessary to establish the educational value of this platform. The middle cranial fossa (MCF) is ideal for simulation because trainees have limited exposure to this approach and it has considerable complication risk. Our objectives were to assess the face, content, and construct validities of an MCF VR simulation, as well as the change in performance across serial simulations. METHODS: Using high-resolution volumetric data sets of human cadavers, the authors generated a high-fidelity visual and haptic rendering of the MCF approach using CardinalSim software. Trainees from Neurosurgery and Otolaryngology-Head and Neck Surgery at two Canadian academic centers performed MCF dissections on this VR platform. Randomization was used to assess the effect of enhanced VR interaction. Likert scales were used to assess the face and content validities. Performance metrics and pre- and postsimulation test scores were evaluated. Construct validity was evaluated by examining the effect of the training level on simulation performance. RESULTS: Twenty trainees were enrolled. Face and content validities were achieved in all domains. Construct validity, however, was not demonstrated. Postsimulation test scores were significantly higher than presimulation test scores ( P < .001 ). Trainees demonstrated statistically significant improvement in the time to complete dissections ( P < .001 ), internal auditory canal skeletonization ( P < .001 ), completeness of the anterior petrosectomy ( P < .001 ), and reduced number of injuries to critical structures ( P = .001 ). CONCLUSION: This MCF VR simulation created using CardinalSim demonstrated face and content validities. Construct validity was not established because no trainee included in the study had previous MCF approach experience, which further emphasizes the importance of simulation. When used as a formative educational adjunct in both Neurosurgery and Otolaryngology-Head and Neck Surgery, this simulation has the potential to enhance understanding of the complex anatomic relationships of critical neurovascular structures.

Finite element modelling of the human middle ear using synchrotron-radiation phase-contrast imaging.

Finite element (FE) models of the middle ear often lack accurate geometry of soft tissue structures, such as the suspensory ligaments, as they can be difficult to discern using conventional imaging modalities, such as computed tomography. Synchrotron-radiation phase-contrast imaging (SR-PCI) is a non-destructive imaging modality that has been shown to produce excellent visualization of soft tissue structures without the need for extensive sample preparation. The objectives of the investigation were to firstly use SR-PCI to create and evaluate a biomechanical FE model of the human middle ear that includes all soft tissue structures, and secondly, to investigate how modelling assumptions and simplifications of ligament representations affect the simulated biomechanical response of the FE model. The FE model included the suspensory ligaments, ossicular chain, tympanic membrane, the incudostapedial and incudomalleal joints, and the ear canal. Frequency responses obtained from the SR-PCI-based FE model agreed well with published laser doppler vibrometer measurements on cadaveric samples. Revised models with exclusion of the superior malleal ligament (SML), simplification of the SML, and modification of the stapedial annular ligament were studied, as these revised models represented modelling assumptions that have been made in literature.

Improving Nasopharyngeal Swab Technique via Simulation for Frontline Workers.

OBJECTIVES/HYPOTHESIS: Nasopharyngeal swabs currently remain the gold standard for COVID-19 sample collection. A surge in testing volume has resulted in a large number of health care workers who are unfamiliar with nasal anatomy performing this test, which can lead to improper collection practices culminating in false-negative results and complications. Therefore, we aimed to assess the accuracy and educational potential of a realistic 3D-printed nasal swab simulator to expedite health care workers' skill acquisition. STUDY DESIGN: Prospective pre-post interventional study. METHODS: A nasal swab task trainer (NSTT) was developed to scale from computed tomography data with a deviated septum. Frontline workers at COVID-19 testing sites in Ontario, Canada, were recruited to use the NSTT for nasopharyngeal swab training. Integrated video recording capability allowed participants to self-evaluate procedure accuracy. A five-point Likert scale was collected regarding the NSTT's educational value and procedural fidelity. RESULTS: Sixty-two frontline workers included in the study were primarily registered nurses (52%) or paramedics (16%). Following simulator use, self-assessed accuracy improved in 77% of all participants and 100% of participants who expressed low confidence before training. Ninety-four percent reported that the NSTT provided a complete educational experience, and 82% regarded the system as a more effective training approach than what is currently available. Eighty-one indicated that the simulator should be used at all COVID-19 testing sites, with 77% stating province-wide implementation was warranted. CONCLUSIONS: The nasal swab task trainer is an effective educational tool that appears well-suited for improved skill acquisition in COVID-19 testing and may be useful for training other nasal swab applications. LEVEL OF EVIDENCE: 3 Laryngoscope, 133:38-42, 2023.

High-Fidelity Virtual Reality Simulation for the Middle Cranial Fossa Approach-Modules for Surgical Rehearsal and Education.

BACKGROUND: Virtual reality simulation has gained prominence as a valuable surgical rehearsal and education tool in neurosurgery. Approaches to the internal auditory canal, cerebellopontine angle, and ventral brainstem region using the middle cranial fossa are not well explored by simulation. OBJECTIVE: We hope to contribute to this paucity in simulation tools devoted to the lateral skull base, specifically the middle cranial fossa approach. METHODS: Eight high-resolution microcomputed tomography scans of human cadavers were used as volumetric data sets to construct a high-fidelity visual and haptic rendering of the middle cranial fossa using CardinalSim software. Critical neurovascular structures related to this region of the skull base were segmented and incorporated into the modules. RESULTS: The virtual models illustrate the 3-dimensional anatomic relationships of neurovascular structures in the middle cranial fossa and allow a realistic interactive drilling environment. This is facilitated by the ability to render bone opaque or transparent to reveal the proximity to critical anatomy allowing for practice of the virtual dissection in a graduated fashion. CONCLUSION: We have developed a virtual library of middle cranial fossa approach models, which integrate relevant neurovascular structures with aims to improve surgical training and education. A ready extension is the potential for patient-specific application and pathology.

Machine learning approaches used to analyze auditory evoked responses from the human auditory brainstem: A systematic review.

BACKGROUND: The application of machine learning algorithms for assessing the auditory brainstem response has gained interest over recent years with a considerable number of publications in the literature. In this systematic review, we explore how machine learning has been used to develop algorithms to assess auditory brainstem responses. A clear and comprehensive overview is provided to allow clinicians and researchers to explore the domain and the potential translation to clinical care. METHODS: The systematic review was performed based on PRISMA guidelines. A search was conducted of PubMed, IEEE-Xplore, and Scopus databases focusing on human studies that have used machine learning to assess auditory brainstem responses. The duration of the search was from January 1, 1990, to April 3, 2021. The Covidence systematic review platform (www.covidence.org) was used throughout the process. RESULTS: A total of 5812 studies were found through the database search and 451 duplicates were removed. The title and abstract screening process further reduced the article count to 89 and in the proceeding full-text screening, 34 articles met our full inclusion criteria. CONCLUSION: Three categories of applications were found, namely neurologic diagnosis, hearing threshold estimation, and other (does not relate to neurologic or hearing threshold estimation). Neural networks and support vector machines were the most commonly used machine learning algorithms in all three categories. Only one study had conducted a clinical trial to evaluate the algorithm after development. Challenges remain in the amount of data required to train machine learning models. Suggestions for future research avenues are mentioned with recommended reporting methods for researchers.

Achondroplasia and severe sensorineural hearing loss: The role of active bone conduction implants.

The BONEBRIDGE is a partially implantable, transcutaneous bone conduction device that can be used to treat conductive or mixed mild-to-moderate hearing loss in patients who do not attain sufficient improvement from conventional hearing aids. The following case report describes sequential bilateral BONEBRIDGE implantation in a 25-year-old patient with achondroplasia and bilateral mixed-hearing loss with a significant sensorineural component in the setting of chronic suppurative otitis media. Although the patient did not meet the approved BONEBRIDGE criteria, implantation was successful with improvements in audiological outcomes and self-reported quality of life. There were no reported complications at 5-years post-implantation.

Comprehensive metrics for evaluating surgical microscope use during tympanostomy tube placement.

PURPOSE: Learning to use a surgical microscope is a fundamental step in otolaryngology training; however, there is currently no objective method to teach or assess this skill. Tympanostomy tube placement is a common otologic procedure that requires skilled use of a surgical microscope. This study was designed to (1) implement metrics capable of evaluating microscope use and (2) establish construct validity. STUDY DESIGN: This was a prospective cohort study. METHODS: Eight otolaryngology trainees and three otolaryngology experts were asked to use a microscope to insert a tympanostomy tube into a cadaveric myringotomy in a standardized setting. Microscope movements were tracked in a three-dimensional space, and tracking metrics were applied to the data. The procedure was video-recorded and then analyzed by blinded experts using operational metrics. Results from both groups were compared, and discriminatory metrics were determined. RESULTS: The following tracking metrics were identified as discriminatory between the trainee and expert groups: total completion time, operation time, still time, and jitter (movement perturbation). Many operational metrics were found to be discriminatory between the two groups, including several positioning metrics, optical metrics, and procedural metrics. CONCLUSIONS: Performance metrics were implemented, and construct validity was established for a subset of the proposed metrics by discriminating between expert and novice participants. These discriminatory metrics could form the basis of an automated system for providing feedback to residents during training while using a myringotomy surgical simulator. Additionally, these metrics may be useful in guiding a standardized teaching and evaluation methodology for training in the use of surgical microscopes.

Micro-CT of the human ossicular chain: Statistical shape modeling and implications for otologic surgery.

The ossicular chain is a middle ear structure consisting of the small incus, malleus and stapes bones, which transmit tympanic membrane vibrations caused by sound to the inner ear. Despite being shown to be highly variable in shape, there are very few morphological studies of the ossicles. The objective of this study was to use a large sample of cadaveric ossicles to create a set of three-dimensional models and study their statistical variance. Thirty-three cadaveric temporal bone samples were scanned using micro-computed tomography (µCT) and segmented. Statistical shape models (SSMs) were then made for each ossicle to demonstrate the divergence of morphological features. Results revealed that ossicles were most likely to vary in overall size, but that more specific feature variability was found at the manubrium of the malleus, the long process and lenticular process of the incus, and the crura and footplate of the stapes. By analyzing samples as whole ossicular chains, it was revealed that when fixed at the malleus, changes along the chain resulted in a wide variety of final stapes positions. This is the first known study to create high-quality, three-dimensional SSMs of the human ossicles. This information can be used to guide otological surgical training and planning, inform ossicular prosthesis development, and assist with other ossicular studies and applications by improving automated segmentation algorithms. All models have been made publicly available.

Comparison of machine learning models to classify Auditory Brainstem Responses recorded from children with Auditory Processing Disorder.

INTRODUCTION: Auditory brainstem responses (ABRs) offer a unique opportunity to assess the neural integrity of the peripheral auditory nervous system in individuals presenting with listening difficulties. ABRs are typically recorded and analyzed by an audiologist who manually measures the timing and quality of the waveforms. The interpretation of ABRs requires considerable experience and training, and inappropriate interpretation can lead to incorrect judgments about the integrity of the system. Machine learning (ML) techniques may be a suitable approach to automate ABR interpretation and reduce human error. OBJECTIVES: The main objective of this paper was to identify a suitable ML technique to automate the analysis of ABR responses recorded as a part of the electrophysiological testing in the Auditory Processing Disorder clinical test battery. METHODS: ABR responses recorded during routine clinical assessment from 136 children being evaluated for auditory processing difficulties were analyzed using several common ML algorithms: Support Vector Machines (SVM), Random Forests (RF), Decision Trees (DT), Gradient Boosting (GB), Extreme Gradient Boosting (Xgboost), and Neural Networks (NN). A variety of signal feature extraction techniques were used to extract features from the ABR waveforms as inputs to the ML algorithms. Statistical significance testing and confusion matrices were used to identify the most robust model capable of accurately identifying neurological abnormalities present in ABRs. RESULTS: Clinically significant features in the time-frequency representation of the signal were identified. The ML model trained using the Xgboost algorithm was identified as the most robust model with an accuracy of 92% compared to other models. CONCLUSION: The findings of the present study demonstrate that it is possible to develop accurate ML models to automate the process of analyzing ABR waveforms recorded at suprathreshold levels. There is currently no ML-based application to screen children with listening difficulties. Therefore, it is expected that this work will be translated into an evaluation tool that can be used by audiologists in the clinic. Furthermore, this work may aid future researchers in exploring ML paradigms to improve clinical test batteries used by audiologists in achieving accurate diagnoses.

PWD-3DNet: A Deep Learning-Based Fully-Automated Segmentation of Multiple Structures on Temporal Bone CT Scans.

The temporal bone is a part of the lateral skull surface that contains organs responsible for hearing and balance. Mastering surgery of the temporal bone is challenging because of this complex and microscopic three-dimensional anatomy. Segmentation of intra-temporal anatomy based on computed tomography (CT) images is necessary for applications such as surgical training and rehearsal, amongst others. However, temporal bone segmentation is challenging due to the similar intensities and complicated anatomical relationships among critical structures, undetectable small structures on standard clinical CT, and the amount of time required for manual segmentation. This paper describes a single multi-class deep learning-based pipeline as the first fully automated algorithm for segmenting multiple temporal bone structures from CT volumes, including the sigmoid sinus, facial nerve, inner ear, malleus, incus, stapes, internal carotid artery and internal auditory canal. The proposed fully convolutional network, PWD-3DNet, is a patch-wise densely connected (PWD) three-dimensional (3D) network. The accuracy and speed of the proposed algorithm was shown to surpass current manual and semi-automated segmentation techniques. The experimental results yielded significantly high Dice similarity scores and low Hausdorff distances for all temporal bone structures with an average of 86% and 0.755 millimeter (mm), respectively. We illustrated that overlapping in the inference sub-volumes improves the segmentation performance. Moreover, we proposed augmentation layers by using samples with various transformations and image artefacts to increase the robustness of PWD-3DNet against image acquisition protocols, such as smoothing caused by soft tissue scanner settings and larger voxel sizes used for radiation reduction. The proposed algorithm was tested on low-resolution CTs acquired by another center with different scanner parameters than the ones used to create the algorithm and shows potential for application beyond the particular training data used in the study.

The BONEBRIDGE active transcutaneous bone conduction implant: effects of location, lifts and screws on sound transmission.

BACKGROUND: The BONEBRIDGE (MED-EL, Innsbruck, Austria) is a bone-conduction implant used in the treatment of conductive and mixed hearing loss. The BONEBRIDGE consists of an external audio processor and a bone-conduction floating mass transducer that is surgically implanted into the skull in either the transmastoid, retrosigmoid or middle fossa regions. The manufacturer includes self-tapping screws to secure the transducer; however, self-drilling screws have also been used with success. In cases where the skull is not thick enough to house the transducer, lifts are available in a variety of sizes to elevate the transducer away from the skull. The objective of the present study was to investigate the effects of screw type, lift thickness, and implant location on the sound transmission of the BONEBRIDGE. METHOD: Six cadaveric temporal bones were embalmed and dried for use in this study. In each sample, a hole was drilled in each of the three implant locations to house the implant transducer. At the middle fossa, six pairs of screw holes were pre-drilled; four pairs to be used with self-tapping screws and lifts (1, 2, 3, and 4 mm thick lifts, respectively), one pair with self-tapping screws and no lifts, and one pair with self-drilling screws and no lifts. At the transmastoid and retrosigmoid locations, one pair of screw holes were pre-drilled in each for the use of the self-tapping screws. The vibration of transmitted sound to the cochlea was measured using a laser Doppler vibrometry technique. The measurements were performed on the cochlear promontory at eight discrete frequencies (0.5, 0.75, 1, 1.5, 2, 3, 4 and 6 kHz). Vibration velocity of the cochlear wall was measured in all samples. Measurements were analyzed using a single-factor ANOVA to investigate the effect of each modification. RESULTS: No significant differences were found related to either screw type, lift thickness, or implant location. CONCLUSIONS: This is the first known study to evaluate the effect of screw type, lift thickness, and implant location on the sound transmission produced by the BONEBRIDGE bone-conduction implant. Further studies may benefit from analysis using fresh cadaveric samples or in-vivo measurements.

Publisher Correction: Vascular Supply of the Human Spiral Ganglion: Novel Three-Dimensional Analysis Using Synchrotron Phase-Contrast Imaging and Histology.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Correction to: Assessment of a virtual reality temporal bone surgical simulator: a national face and content validity study.

Following publication of the original article [1], the authors identified incorrect ordering and incorrect files being used for Figs. 1, 2 and 3.

Vascular Supply of the Human Spiral Ganglion: Novel Three-Dimensional Analysis Using Synchrotron Phase-Contrast Imaging and Histology.

Human spiral ganglion (HSG) cell bodies located in the bony cochlea depend on a rich vascular supply to maintain excitability. These neurons are targeted by cochlear implantation (CI) to treat deafness, and their viability is critical to ensure successful clinical outcomes. The blood supply of the HSG is difficult to study due to its helical structure and encasement in hard bone. The objective of this study was to present the first three-dimensional (3D) reconstruction and analysis of the HSG blood supply using synchrotron radiation phase-contrast imaging (SR-PCI) in combination with histological analyses of archival human cochlear sections. Twenty-six human temporal bones underwent SR-PCI. Data were processed using volume-rendering software, and a representative three-dimensional (3D) model was created to allow visualization of the vascular anatomy. Histologic analysis was used to verify the segmentations. Results revealed that the HSG is supplied by radial vascular twigs which are separate from the rest of the inner ear and encased in bone. Unlike with most organs, the arteries and veins in the human cochlea do not follow the same conduits. There is a dual venous outflow and a modiolar arterial supply. This organization may explain why the HSG may endure even in cases of advanced cochlear pathology.

Assessment of a virtual reality temporal bone surgical simulator: a national face and content validity study.

BACKGROUND: Trainees in Otolaryngology-Head and Neck Surgery must gain proficiency in a variety of challenging temporal bone surgical techniques. Traditional teaching has relied on the use of cadavers; however, this method is resource-intensive and does not allow for repeated practice. Virtual reality surgical training is a growing field that is increasingly being adopted in Otolaryngology. CardinalSim is a virtual reality temporal bone surgical simulator that offers a high-quality, inexpensive adjunct to traditional teaching methods. The objective of this study was to establish the face and content validity of CardinalSim through a national study. METHODS: Otolaryngologists and resident trainees from across Canada were recruited to evaluate CardinalSim. Ethics approval and informed consent was obtained. A face and content validity questionnaire with questions categorized into 13 domains was distributed to participants following simulator use. Descriptive statistics were used to describe questionnaire results, and either Chi-square or Fishers exact tests were used to compare responses between junior residents, senior residents, and practising surgeons. RESULTS: Sixty-two participants from thirteen different Otolaryngology-Head and Neck Surgery programs were included in the study (32 practicing surgeons; 30 resident trainees). Face validity was achieved for 5 out of 7 domains, while content validity was achieved for 5 out of 6 domains. Significant differences between groups (p-value of < 0.05) were found for one face validity domain (realistic ergonomics, p = 0.002) and two content validity domains (teaching drilling technique, p = 0.011 and overall teaching utility, p = 0.006). The assessment scores, global rating scores, and overall attitudes towards CardinalSim, were universally positive. Open-ended questions identified limitations of the simulator. CONCLUSION: CardinalSim met acceptable criteria for face and content validity. This temporal bone virtual reality surgical simulation platform may enhance surgical training and be suitable for patient-specific surgical rehearsal for practicing Otolaryngologists.

Active Transcutaneous Bone Conduction Implant: Audiometric Outcomes Following a Novel Middle Fossa Approach With Self-Drilling Screws.

OBJECTIVE: To present surgical and audiometric outcomes of patients implanted with an active transcutaneous bone conduction implant following the novel middle fossa surgical approach with self-drilling screws. STUDY DESIGN: Retrospective review. SETTING: Tertiary care center. PATIENTS: Thirty-seven adults with either conductive or mixed hearing loss that met indications for an active transcutaneous bone conduction implant were consecutively implanted from April, 2013 to May, 2018. INTERVENTION: Unilateral middle fossa implantation of an active transcutaneous bone conduction implant. MAIN OUTCOME MEASURES: Patient charts were reviewed for surgical outcomes and complications over the 6-year period. Preoperative air conduction, preoperative bone conduction, and 3-month postoperative aided thresholds were recorded. Speech perception was assessed using CNC words and AzBio sentences. Pure-tone averages (PTAs; measured at 0.5, 1.0, 2.0 and 3.0 kHz), air-bone gap, and functional gain were calculated. RESULTS: Mean air conduction and bone conduction PTAs (±standard deviation) of the implanted ear were 66.8 dB (±14.9 dB) and 21.9 dB (±14.0 dB), respectively. Mean aided PTA was 26.5 dB (± 8.5 dB). The average functional gain was 40.3 dB (±19.0 dB). Favorable speech perception outcomes were observed. No complications or instances of revision surgery were reported, with a mean follow-up time of 32 months (range, 9-71 mo). CONCLUSIONS: This is the first paper to describe outcomes of patients implanted with an active transcutaneous bone conduction implant via the middle fossa with self-drilling screws. Favorable surgical outcomes were observed with a follow-up of up to 6 years.

Characterization of the human helicotrema: implications for cochlear duct length and frequency mapping.

BACKGROUND: Despite significant anatomical variation amongst patients, cochlear implant frequency-mapping has traditionally followed a patient-independent approach. Basilar membrane (BM) length is required for patient-specific frequency-mapping, however cochlear duct length (CDL) measurements generally extend to the apical tip of the entire cochlea or have no clearly defined end-point. By characterizing the length between the end of the BM and the apical tip of the entire cochlea (helicotrema length), current CDL models can be corrected to obtain the appropriate BM length. Synchrotron radiation phase-contrast imaging has made this analysis possible due to the soft-tissue contrast through the entire cochlear apex. METHODS: Helicotrema linear length and helicotrema angular length measurements were performed on synchrotron radiation phase-contrast imaging data of 14 cadaveric human cochleae. On a sub-set of six samples, the CDL to the apical tip of the entire cochlea (CDLTIP) and the BM length (CDLBM) were determined. Regression analysis was performed to assess the relationship between CDLTIP and CDLBM. RESULTS: The mean helicotrema linear length and helicotrema angular length values were 1.6 ± 0.9 mm and 67.8 ± 37.9 degrees, respectively. Regression analysis revealed the following relationship between CDLTIP and CDLBM: CDLBM = 0.88(CDLTIP) + 3.71 (R2 = 0.995). CONCLUSION: This is the first known study to characterize the length of the helicotrema in the context of CDL measurements. It was determined that the distance between the end of the BM and the tip of the entire cochlea is clinically consequential. A relationship was determined that can predict the BM length of an individual patient based on their respective CDL measured to the apical tip of the cochlea.