Uncovering Vulnerable Phases in Cochlear Implant Electrode Array Insertion: Insights from an In Vitro Model.

OBJECTIVES: The aim of this study is to improve our understanding of the mechanics involved in the insertion of lateral wall cochlear implant electrode arrays. DESIGN: A series of 30 insertion experiments were conducted by three experienced surgeons. The experiments were carried out in a previously validated artificial temporal bone model according to established soft surgery guidelines. The use of an in vitro setup enabled us to comprehensively evaluate relevant parameters, such as insertion force, intracochlear pressure, and exact electrode array position in a controlled and repeatable environment. RESULTS: Our findings reveal that strong intracochlear pressure transients are more frequently caused during the second half of the insertion, and that regrasping the electrode array is a significant factor in this phenomenon. For choosing an optimal insertion speed, we show that it is crucial to balance slow movement to limit intracochlear stress with short duration to limit tremor-induced pressure spikes, challenging the common assumption that a slower insertion is inherently better. Furthermore, we found that intracochlear stress is affected by the order of execution of postinsertion steps, namely sealing the round window and posterior tympanotomy with autologous tissue and routing of the excess cable into the mastoid cavity. Finally, surgeons' subjective estimates of physical parameters such as speed, smoothness, and resistance did not correlate with objectively assessed measures, highlighting that a thorough understanding of intracochlear mechanics is essential for an atraumatic implantation. CONCLUSION: The results presented in this article allow us to formulate evidence-based surgical recommendations that may ultimately help to improve surgical outcome and hearing preservation in cochlear implant patients.

The acute vestibular syndrome: prevalence of new hearing loss and its diagnostic value.

OBJECTIVES: To assess the prevalence of new hearing losses in patients with acute vestibular syndrome (AVS) and to start to evaluate its diagnostic value for the differentiation between peripheral and central causes. DESIGN: We performed a cross-sectional prospective study in AVS patients presenting to our Emergency Department (ED) from February 2015 to November 2020. All patients received an MRI, Head-impulse test, Nystagmus test and Test of skew ('HINTS'), caloric testing and a pure-tone audiometry. RESULTS: We assessed 71 AVS patients, 17 of whom had a central and 54 a peripheral cause of dizziness. 12.7% had an objective hearing loss. 'HINTS' had an accuracy of 78.9% to diagnose stroke, whereas 'HINTS' plus audiometry 73.2%. 'HINTS' sensitivity was 82.4% and specificity 77.8% compared to 'HINTS' plus audiometry showing a sensitivity of 82.4% and specificity of 70.4%. The four patients with stroke and minor stroke had all central 'HINTS'. 55% of the patients did not perceive their new unilateral hearing loss. CONCLUSIONS: We found that almost one-eighth of the AVS patients had a new onset of hearing loss and only half had self-reported it. 'HINTS' plus audiometry proved to be less accurate to diagnose a central cause than 'HINTS' alone. Audiometry offered little diagnostic accuracy to detect strokes in the ED but might be useful to objectify a new hearing loss that was underestimated in the acute phase. Complete hearing loss should be considered a red flag, as three in four patients suffered from a central cause.

Vestibular function, subjective complaints, perceived disability in daily life, and sports activities in patients with cochlear implants performed during childhood: a prospective cross-section study.

BACKGROUND: Vestibular function (VF) in patients with cochlear implantation (CI) performed during childhood is underinvestigated. OBJECTIVE: To study VF in patients receiving CI during childhood. MATERIAL & METHODS: Sixty patients (22 females) from 7-34 years old, unilaterally (n = 21) and bilaterally (n = 39) implanted, were included. Deafness was congenital (n = 45), consequential to meningitis (n = 3), skull fracture (n = 1), perinatal CMV infection (n = 1), ototoxic drugs (n = 1), unknown etiology (n = 9). VF was measured between 1 to 22 years after implantation, including calorics, v-HIT, c-VEMPS. Dizziness handicap inventory (DHI), age at independent walking(IW), sport activities were also investigated. RESULTS: Nine CI-patients (15%) reported dizziness/vertigo either prior or months to years after surgery. Comparison between symptomatic (15%), asymptomatic (85%), uni-bilaterally CI-patients showed no significant difference on VF's impairment for calorics (p = .603) and v-HIT (p = 1). Symptoms were not related to vestibular impairment. Age at implantation (p = 0.956), uni- bilateral (p = .32), simultaneous versus sequential (p = .134) did not influence IW age. DHI showed a tendency for being symptomatic at higher implantation age. Interval between CI, IWage, current age between surgery and vestibular evaluation did not have a significant effect on symptomatology. CONCLUSION & SIGNIFICANCE: This first middle to long-term evaluation of the VF in CI-patients, implanted in childhood, pointed out that 85% of patients were asymptomatic, with a mean time of >10 years after surgery. Vestibular impairment and symptoms seem to be mainly due to the underlying inner ear's disease rather than surgery.

Comparison of auditory brainstem response and electrocochleography to assess the coupling efficiency of active middle ear implants.

Aim: This study aimed to compare the effectiveness of auditory brainstem response (ABR) and extracochlear electrocochleography (ECochG) in objectively evaluating the coupling efficiency of floating mass transducer (FMT) placement during active middle ear implant (AMEI) surgery. Methods: We enrolled 15 patients (mean age 58.5 ± 19.4 years) with mixed hearing loss who underwent AMEI implantation (seven ossicular chain and eight round window couplings). Before the surgical procedure, an audiogram was performed. We utilized a clinical measurement system to stimulate and record intraoperative ABR and ECochG recordings. The coupling efficiency of the VSB was evaluated through ECochG and ABR threshold measurements. Postoperatively, we conducted an audiogram and a vibrogram. Results: In all 15 patients, ABR threshold testing successfully determined intraoperative coupling efficiency, while ECochG was successful in only eight patients. In our cohort, ABR measurements were more practical, consistent, and robust than ECochG measurements. Coupling efficiency, calculated as the difference between vibrogram thresholds and postoperative bone conduction thresholds, was found to be more accurately predicted by ABR measurements (p = 0.016, R2 = 0.37) than ECochG measurements (p = 0.761, R2 = 0.02). We also found a non-significant trend toward better results with ossicular chain coupling compared to round window coupling. Conclusion: Our findings suggest that ABR measurements are more practical, robust, and consistent than ECochG measurements for determining coupling efficiency during FMT placement surgery. The use of ABR measurements can help to identify the optimal FMT placement, especially with round window coupling. Finally, we offer normative data for both techniques, which can aid other clinical centers in using intraoperative monitoring for AMEI placement.

Postoperative Impedance-Based Estimation of Cochlear Implant Electrode Insertion Depth.

OBJECTIVES: Reliable determination of cochlear implant electrode positions shows promise for clinical applications, including anatomy-based fitting of audio processors or monitoring of electrode migration during follow-up. Currently, electrode positioning is measured using radiography. The primary objective of this study is to extend and validate an impedance-based method for estimating electrode insertion depths, which could serve as a radiation-free and cost-effective alternative to radiography. The secondary objective is to evaluate the reliability of the estimation method in the postoperative follow-up over several months. DESIGN: The ground truth insertion depths were measured from postoperative computed tomography scans obtained from the records of 56 cases with an identical lateral wall electrode array. For each of these cases, impedance telemetry records were retrieved starting from the day of implantation up to a maximum observation period of 60 mo. Based on these recordings, the linear and angular electrode insertion depths were estimated using a phenomenological model. The estimates obtained were compared with the ground truth values to calculate the accuracy of the model. RESULTS: Analysis of the long-term recordings using a linear mixed-effects model showed that postoperative tissue resistances remained stable throughout the follow-up period, except for the two most basal electrodes, which increased significantly over time (electrode 11: ~10 Ω/year, electrode 12: ~30 Ω/year). Inferred phenomenological models from early and late impedance telemetry recordings were not different. The insertion depth of all electrodes was estimated with an absolute error of 0.9 mm ± 0.6 mm or 22° ± 18° angle (mean ± SD). CONCLUSIONS: Insertion depth estimations of the model were reliable over time when comparing two postoperative computed tomography scans of the same ear. Our results confirm that the impedance-based position estimation method can be applied to postoperative impedance telemetry recordings. Future work needs to address extracochlear electrode detection to increase the performance of the method.

A Sleeve-Based, Micromotion Avoiding, Retractable and Tear-Opening (SMART) Insertion Tool for Cochlear Implantation.

OBJECTIVE: In conventional cochlear implantation, the insertion of the electrode array is strongly affected by the local anatomy and human kinematics. Herein, we present a concept for an insertion tool that allows to optimize the insertion trajectory beyond anatomical constraints and stabilizes the electrode array in manual implantation. A novel sleeve-based design allows the instrument to be compliant and potentially protective to intracochlear structures, while a tear-open mechanism allows it to be removed after insertion by simply retracting the tool. METHODS: Conventional and tool-guided manual insertions were performed by expert cochlear implant surgeons in an analog temporal bone model that allows to simultaneously record intracochlear pressure, insertion forces and electrode array deformation. RESULTS: Comparison between conventional and tool-guided insertions demonstrate a substantial reduction of maximum insertion forces, force variations, transverse intracochlear electrode array movement, and pressure transients. CONCLUSION: The presented tool can be utilized in manual cochlear implantation and significantly improves key metrics associated with intracochlear trauma. SIGNIFICANCE: The instrument may ultimately help improve hearing outcomes in cochlear implantation. The versatile design may be used in both manual cochlear implantation and motorized and robotic insertion, as well as image-guided surgery.

Vestibular Schwannoma: Long-term Outcome of the Vestibular Function After Stereotactic Radiosurgery.

Objective: Evaluation at long term of the impact of the stereotactic surgery (SRS) on the vestibular function in vestibular schwannoma (VS) patients. Study design and setting: Retrospective study in a tertiary referral center. Patients: Fifty-one VS patients were included (34 females;17 males), aged from 41 to 78 years treated exclusively with SRS. Intervention: Vestibular function was assessed before SRS and with median time interval of 14 (FU1) and 25 (FU2) months after treatment. Vestibular evaluation included: history, clinical vestibular examination, videonystagmography, head impulse test (v-HIT) and cervical vestibular evoked myogenic potentials (c-VEMPS). Results: Before SRS, caloric testing (Caloric) was impaired in 77%; after treatment, in 92% (FU1) and 77% (FU2). Lateral HIT was decreased in 22% before SRS, in 39% at FU1 and FU2. C-VEMPS were absent in 50% before SRS, in 76% at FU1 and, FU2. Before SRS, no statistically significant association was found between asymptomatic and symptomatic patients with respect to the results of Caloric, v-HIT and c-VEMPS. This lack of association was also seen after SRS, at FU1 and FU2. Conclusion: Our study showed that the impairment of the vestibular function might be attributed to the VS itself as well as to the radiation of the inner ear during SRS. The lateral SSC at low frequencies and the saccular function seem to be more involved with the time.

Endoscopic resection of Intralabyrinthine Schwannoma followed by Cochlear implantation.

We present the case of a 65 years old patient who developed a complete, sensorineural hearing loss on the right side due to an intravestibular schwannoma. Our video shows a transcanal, endoscopic approach with complete schwannoma removal on the right side, subsequent e-BERA recordings, and cochlear implantation.

Robotic Cochlear Implantation for Direct Cochlear Access.

Robot-assisted systems offer great potential for gentler and more precise cochlear implantation. In this article, we provide a comprehensive overview of the clinical workflow for robotic cochlear implantation using a robotic system specifically developed for a minimally invasive, direct cochlear access. The clinical workflow involves experts from various disciplines and requires training to ensure a smooth and safe procedure. The protocol briefly summarizes the history of robotic cochlear implantation. The clinical sequence is explained in detail, beginning with the assessment of patient eligibility and covering surgical preparation, preoperative planning with the special planning software, drilling of the middle ear access, intraoperative imaging to confirm the trajectory, milling of the inner ear access, insertion of the electrode array, and implant management. The steps that require special attention are discussed. As an example, the postoperative outcome of robotic cochlear implantation in a patient with advanced otosclerosis is presented. Finally, the procedure is discussed in the context of the authors' experience.

Cochlear base length as predictor for angular insertion depth in incomplete partition type 2 malformations.

INTRODUCTION: The preoperative determination of suitable electrode array lengths for cochlear implantation in inner ear malformations is a matter of debate. The choice is usually based on individual experience and the use of intraoperative probe electrodes. The purpose of this case series was to evaluate the applicability and precision of an angular insertion depth (AID) prediction method, based on a single measurement of the cochlear base length (CBL). METHODS: We retrospectively measured the CBL in preoperative computed tomography (CT) images in 10 ears (8 patients) with incomplete partition type 2 malformation. With the known electrode length (linear insertion depth, LID) the AID at full insertion was retrospectively predicted for each ear with a heuristic equation derived from non-malformed cochleae. Using the intra- or post-implantation cone beam CT images, the actual AID was assessed and compared. The deviations of the predicted from the actual insertion angles were quantified (clinical prediction error) to assess the precision of this single-measure estimation. RESULTS: Electrode arrays with 15 mm (n = 3), 19 mm (n = 2), 24 mm (n = 3), and 26 mm (n = 2) length were implanted. Postoperative AIDs ranged from 211° to 625°. Clinical AID prediction errors from -64° to 62° were observed with a mean of 0° (SD of 44°). In two ears with partial insertion of the electrode, the predicted AID was overestimated. The probe electrode was intraoperatively used in 9/10 cases. CONCLUSION: The analyzed method provides good predictions of the AID based on LID and CBL. It does not account for incomplete insertions, which lead to an overestimation of the AID. The probe electrode is useful and well established in clinical practice. The investigated method could be used for patient-specific electrode length selection in future patients.

The Microscopic Transcanal Approach in Stapes Surgery Revisited.

The microscopic transcanal (aka transmeatal) surgical approach was first described in the 60s, offering a minimally invasive means of reaching the external auditory canal, the middle ear, and epitympanon. Such an approach avoids a retroauricular or endaural skin incision; however, working through a narrow space needs angled microsurgical instruments and specific training in otologic surgery. The transcanal approach restricts the working space; however, it offers a binocular microscopic vision into the middle ear without extended skin incisions and thus, reducing post-operative pain and bleeding. In addition, this minimally invasive approach avoids scar tissue complications, hypoesthesia of the auricle, and potential protrusion of the pinna. Despite its numerous advantages, this method is still not routinely performed by otologic surgeons. Since this minimally invasive technique is more challenging, there is a need for extensive training in order for it to be widely adopted by otologic surgeons. This article provides step-by-step surgical instructions for stapes surgery and reports possible indications, pitfalls, and limitations using this microscopic transcanal technique.

Performing Intracochlear Electrocochleography During Cochlear Implantation.

Electrocochleography (ECochG) measures inner ear potentials generated in response to acoustic stimulation of the ear. These potentials reflect the residual function of the cochlea. In cochlear implant candidates with residual hearing, the implant electrode can directly measure ECochG responses during the implantation process. Various authors have described the ability to monitor the inner ear function by continuous ECochG measurements during the surgery. The measurement of ECochG signals during surgery is not trivial. There are no interpretable signals in up to 20% of cases. For a successful recording, a standardized procedure is recommended to achieve the highest measurement reliability and avoid possible pitfalls. Therefore, seamless collaboration between the CI surgeon and CI technician is key. This video consists of an overview of the system setup and a stepwise procedure of performing intracochlear ECochG measurements during CI surgery. It shows the surgeon's and the CI technician's roles in the process, and how a smooth collaboration between the two is made possible.

Endoscopic Cholesteatoma Surgery.

Implementation of endoscopes in cholesteatoma surgery resulted in considerable changes in the management of cholesteatoma in the last two decades. Compared to the microscopic approach with an excellent but straight-line view and limited illumination, the introduction of endoscopes provides a wide-angled panoramic view. Moreover, angled lenses allow the surgeon to visualize the middle ear and its hidden recesses through a transcanal, minimally-invasive approach. The endoscope enables the surgeon to remove limited cholesteatoma of the middle ear and its recesses using an exclusive endoscopic technique by taking advantage of these benefits. This reduces the rate of residual disease and sparing external incisions and excessive temporal bone drilling as in a transmastoid approach. Since transcanal endoscopic access is mainly a one-handed technique, it implies the need for specific procedures and technical refinements. This article describes a step-by-step guide as a surgical manual for endoscopic removal of epitympanic cholesteatoma. Different techniques for cholesteatoma dissection and bone removal for epitympanectomy, including curettage and powered instruments such as drills and ultrasonic devices with their outcomes, are discussed. This may offer ear surgeons insight into technical refinements and the latest technological developments and open the horizon for different techniques.

Influence of head orientation and implantation site of a novel transcutaneous bone conduction implant on MRI metal artifact reduction sequence.

PURPOSE: The use of magnetic resonance imaging (MRI) is often limited in patients with auditory implants because of the presence of metallic components and magnets. The aim of this study was to evaluate the clinical usefulness of a customized MRI sequence for metal artifact suppression in patients with BONEBRIDGETM BCI 602 implants (MED-EL, Innsbruck, Austria), the successor of the BCI 601 model. METHODS: Using our in-house developed and customized metal artifact reduction sequence (SEMAC-VAT WARP), MRI artifacts were evaluated qualitatively and quantitatively. MRI sequences were performed with and without artifact reduction on two whole head specimens with and without the BCI 602 implant. In addition, the influence of two different implantation sites (mastoid versus retrosigmoid) and head orientation on artifact presence was investigated. RESULTS: Artifact volume was reduced by more than the 50%. Results were comparable with those obtained with the BCI 601, showing no significant differences in the dimensions of artifacts caused by the implant. CONCLUSION: SEMAC-VAT WARP was once more proved to be efficient at reducing metal artifacts on MR images. The dimensions of artifacts associated with the BCI 602 are not smaller than those caused by the BCI 601.

Automated alternate cover test for 'HINTS' assessment: a validation study.

OBJECTIVE: The alternate cover test (ACT) in patients with acute vestibular syndrome is part of the 'HINTS' battery test. Although quantitative, the ACT is highly dependent on the examiner's experience and could theoretically vary greatly between examiners. In this study, we sought to validate an automated video-oculography (VOG) system based on eye tracking and dedicated glasses. METHODS: We artificially induced a vertical strabismus to simulate a skew deviation on ten healthy subjects, aged from 26 to 66, using different press-on Fresnel prisms on one eye while recording eye position with VOG of the contralateral eye. We then compared the system's performance to that of a blinded trained orthoptist using conventional, semi-quantitative method of skew measurement known as the alternate prism cover test (APCT) as a gold standard. RESULTS: We found a significant correlation between the reference APCT and the Skew VOG (Pearson's R2 = 0.606, p < 0.05). There was a good agreement between the two tests (intraclass correlation coefficient 0.852, 95 CI 0.728-0.917, p < 0.001). The overall accuracy of the VOG was estimated at 80.53% with an error rate of 19.46%. There was no significant difference in VOG skew estimations compared with the gold standard except for very small skews. CONCLUSIONS: VOG offers an objective and quantitative skew measurement and proved to be accurate in measuring vertical eye misalignment compared to the ACT with prisms. Precision was moderate, which mandates a sufficient number of tests per subject.

Freehand Stereotactic Image-Guidance Tailored to Neurotologic Surgery.

Hypothesis: The use of freehand stereotactic image-guidance with a target registration error (TRE) of µTRE + 3σTRE < 0.5 mm for navigating surgical instruments during neurotologic surgery is safe and useful. Background: Neurotologic microsurgery requires work at the limits of human visual and tactile capabilities. Anatomy localization comes at the expense of invasiveness caused by exposing structures and using them as orientation landmarks. In the absence of more-precise and less-invasive anatomy localization alternatives, surgery poses considerable risks of iatrogenic injury and sub-optimal treatment. There exists an unmet clinical need for an accurate, precise, and minimally-invasive means for anatomy localization and instrument navigation during neurotologic surgery. Freehand stereotactic image-guidance constitutes a solution to this. While the technology is routinely used in medical fields such as neurosurgery and rhinology, to date, it is not used for neurotologic surgery due to insufficient accuracy of clinically available systems. Materials and Methods: A freehand stereotactic image-guidance system tailored to the needs of neurotologic surgery-most importantly sub-half-millimeter accuracy-was developed. Its TRE was assessed preclinically using a task-specific phantom. A pilot clinical trial targeting N = 20 study participants was conducted (ClinicalTrials.gov ID: NCT03852329) to validate the accuracy and usefulness of the developed system. Clinically, objective assessment of the TRE is impossible because establishing a sufficiently accurate ground-truth is impossible. A method was used to validate accuracy and usefulness based on intersubjectivity assessment of surgeon ratings of corresponding image-pairs from the microscope/endoscope and the image-guidance system. Results: During the preclinical accuracy assessment the TRE was measured as 0.120 ± 0.05 mm (max: 0.27 mm, µTRE + 3σTRE = 0.27 mm, N = 310). Due to the COVID-19 pandemic, the study was terminated early after N = 3 participants. During an endoscopic cholesteatoma removal, a microscopic facial nerve schwannoma removal, and a microscopic revision cochlear implantation, N = 75 accuracy and usefulness ratings were collected from five surgeons each grading 15 image-pairs. On a scale from 1 (worst rating) to 5 (best rating), the median (interquartile range) accuracy and usefulness ratings were assessed as 5 (4-5) and 4 (4-5) respectively. Conclusion: Navigating surgery in the tympanomastoid compartment and potentially in the lateral skull base with sufficiently accurate freehand stereotactic image-guidance (µTRE + 3σTRE < 0.5 mm) is feasible, safe, and useful. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03852329.

Vestibular dose correlates with dizziness after radiosurgery for the treatment of vestibular schwannoma.

BACKGROUND: Stereotactic radiosurgery (SRS) has been recognized as a first-line treatment option for small to moderate sized vestibular schwannoma (VS). Our aim is to evaluate the impact of SRS doses and other patient and disease characteristics on vestibular function in patients with VS. METHODS: Data on VS patients treated with single-fraction SRS to 12 Gy were retrospectively reviewed. No dose constraints were given to the vestibule during optimization in treatment planning. Patient and tumor characteristics, pre- and post-SRS vestibular examination results and patient-reported dizziness were assessed from patient records. RESULTS: Fifty-three patients were analyzed. Median follow-up was 32 months (range, 6-79). The median minimum, mean and maximum vestibular doses were 2.6 ± 1.6 Gy, 6.7 ± 2.8 Gy, and 11 ± 3.6 Gy, respectively. On univariate analysis, Koos grade (p = 0.04; OR: 3.45; 95% CI 1.01-11.81), tumor volume (median 6.1 cm3; range, 0.8-38; p = 0.01; OR: 4.85; 95% CI 1.43-16.49), presence of pre-SRS dizziness (p = 0.02; OR: 3.98; 95% CI 1.19-13.24) and minimum vestibular dose (p = 0.033; OR: 1.55; 95% CI 1.03-2.32) showed a significant association with patient-reported dizziness. On multivariate analysis, minimum vestibular dose remained significant (p = 0.02; OR: 1.75; 95% CI 1.05-2.89). Patients with improved caloric function had received significantly lower mean (1.5 ± 0.7 Gy, p = 0.01) and maximum doses (4 ± 1.5 Gy, p = 0.01) to the vestibule. CONCLUSIONS: Our results reveal that 5 Gy and above minimum vestibular doses significantly worsened dizziness. Additionally, mean and maximum doses received by the vestibule were significantly lower in patients who had improved caloric function. Further investigations are needed to determine dose-volume parameters and their effects on vestibular toxicity.

Surgical implications of 3D vs 2D endoscopic ear surgery: a case-control study.

PURPOSE: To compare 3D to 2D technology in endoscopic ear surgery (EES); to report surgeons' feedback on the use of 3D in EES; to describe the operative setting for 3D EES. METHODS: A case-control study on EES was performed at a tertiary university center. All consecutive cases of 3D EES (case group) were matched to a control group operated with the standard 2D technique. Data on surgical approach, type of surgery, operative time, outcomes, and complications were compared between the two groups. After each surgery, the operating surgeons were asked to give a feedback on the use of 3D endoscopy, filling in a questionnaire based on 5-point Likert scales. RESULTS: None of the 3D procedures was switched to 2D. Nor intraoperative or long-term complications were recorded. The operative time was similar in both groups. Postoperative hearing function did not show any statistically significant difference between 3 and 2D patients. Ninety-six percent of participants agreed or strongly agreed on better views of anatomy and pathology with the 3D technique. Discomfort induced by 3D vision was rarely reported. CONCLUSION: Surgical and functional results from EES respectively performed with 3D and 2D systems are overall similar, suggesting that both techniques are safe and effective. According to the surgeons' feedback, 3D provides better depth perception and improved view of anatomy and pathology. Several surgeons are willing to use the 3D system for future EES. To guarantee the best 3D EES experience, the setting in the operating room plays a crucial role.

Cochlear implants in single-sided deafness - clinical results of a Swiss multicentre study.

AIM OF THE STUDY: The aim of this multicentre, prospective, open, nonrandomised clinical trial was to demonstrate the clinical efficiency and outcomes of cochlear implants (CIs) in adult patients with post-lingual single-sided deafness (SSD). METHODS: A group of five left and five right SSD participants were investigated with various clinical tests and questionnaires before and 12 months after CI activation. Changes in hearing thresholds, speech understanding in noise, sound localisation, tinnitus (Tinnitus Handicap Inventory; THI), subjective hearing ability (Speech, Spatial and Qualities of Hearing Scale; SSQ), and quality of life (WHOQOL-BREF) were assessed. In addition, the pre- and postoperative results of the SSD patients were compared with an age- and gender-matched normal hearing control group. RESULTS: Surgery was uncomplicated in all patients. Two years after implantation, 9 of the 10 patients used their CI regularly for an average of more than 11 hours a day. A significant improvement in speech understanding in noise measured in the sound field using the Oldenburg sentence test could be demonstrated in the two situations in which patients with SSD experience the greatest difficulty: speech from the front and noise at the healthy ear, and speech to the implanted ear and noise from the front. The sound localisation test showed significant improvement of the mean localisation error and the root mean square error after CI activation. Furthermore, a significant reduction of the THI was measured, and the SSQ showed a significant improvement in the subscale speech comprehension and in the subscale spatial hearing. Also, quality of life measured with the WHOQOL-BREF showed a general improvement, which was significant in the global subscale. For this questionnaire, there was no significant difference between the normal-hearing control group and the patients after 12 months of CI use. CONCLUSION: This study confirmed the clinical benefit of cochlear implantation in patients with SSD. The significant improvement of speech understanding in noise, sound localisation, tinnitus perception, subjective hearing ability, and in particular the improved quality of life support the recommendation that patients with recently acquired SSD should be offered a CI. (Clinical trial registration number on clinicaltrial.gov: NCT01749592).

Robotic middle ear access for cochlear implantation: First in man.

To demonstrate the feasibility of robotic middle ear access in a clinical setting, nine adult patients with severe-to-profound hearing loss indicated for cochlear implantation were included in this clinical trial. A keyhole access tunnel to the tympanic cavity and targeting the round window was planned based on preoperatively acquired computed tomography image data and robotically drilled to the level of the facial recess. Intraoperative imaging was performed to confirm sufficient distance of the drilling trajectory to relevant anatomy. Robotic drilling continued toward the round window. The cochlear access was manually created by the surgeon. Electrode arrays were inserted through the keyhole tunnel under microscopic supervision via a tympanomeatal flap. All patients were successfully implanted with a cochlear implant. In 9 of 9 patients the robotic drilling was planned and performed to the level of the facial recess. In 3 patients, the procedure was reverted to a conventional approach for safety reasons. No change in facial nerve function compared to baseline measurements was observed. Robotic keyhole access for cochlear implantation is feasible. Further improvements to workflow complexity, duration of surgery, and usability including safety assessments are required to enable wider adoption of the procedure.