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.

Bone cement repair of malleus handle fractures: Intraoperative video and case report of two patients.

Isolated malleus fractures are a rare occurrence with few reported cases in the literature. Symptoms include sudden otalgia, hearing loss, tinnitus and aural fullness. Work-up and diagnosis are based on a combination of thorough anamnesis and careful otoscopic evaluation or high-resolution computer tomography. We present two cases of isolated malleus handle fractures who were diagnosed based on a combination of pneumatic otoscopy and tympanometry. Both fractures were surgically repaired using hydroxyapatite bone cement as showcased in the supplemental video material. Post-operative audiometry showed improvement in the pure-tone-average of both patients as well as normalisation of tympanometry. Isolated malleus fracture should be suspected in cases of sudden hearing loss and tinnitus following digital manipulation of the outer ear canal together with a conductive hearing loss with a mostly high-frequent air-bone-gap and hypercompliant tympanometry with hypermobility of the tympanic membrane on pneumatic insufflation. Surgical repair of the fracture using bone cement has good hearing outcomes and leads to improvement in auditory symptoms.

The Effect of Electrode Position on Behavioral and Electrophysiologic Measurements in Perimodiolar Cochlear Implants.

BACKGROUND: The shape and position of cochlear implant electrodes could potentially influence speech perception, as this determines the proximity of implant electrodes to the spiral ganglion. However, the literature to date reveals no consistent association between speech perception and either the proximity of electrode to the medial cochlear wall or the depth of insertion. These relationships were explored in a group of implant recipients receiving the same precurved electrode. METHODS: This was a retrospective study of adults who underwent cochlear implantation with Cochlear Ltd.'s Slim Perimodiolar electrode at the Royal Victorian Eye and Ear Hospital between 2015 and 2018 (n = 52). Postoperative images were obtained using cone beam computed tomography (CBCT) and analyzed by multi-planar reconstruction to identify the position of the electrode contacts within the cochlea, including estimates of the proximity of the electrodes to the medial cochlear wall or modiolus and the angular depth of insertion. Consonant-vowel-consonant (CVC) monosyllabic phonemes were determined preoperatively, and at 3 and 12 months postoperatively. Electrically evoked compound action potential (ECAP) thresholds and impedance were measured from the implant array immediately after implantation. The relationships between electrode position and speech perception, electrode impedance, and ECAP threshold were an analyzed by Pearson correlation. RESULTS: Age had a negative impact on speech perception at 3 months but not 12 months. None of the electrode-wide measures of proximity between electrode contacts and the modiolus, nor measures of proximity to the medial cochlear wall, nor the angular depth of insertion of the most apical electrode correlated with speech perception. However, there was a moderate correlation between speech perception and the position of the most basal electrode contacts; poorer speech perception was associated with a greater distance to the modiolus. ECAP thresholds were inversely related to the distance between electrode contacts and the modiolus, but there was no clear association between this distance and impedance. CONCLUSIONS: Speech perception was significantly affected by the proximity of the most basal electrodes to the modiolus, suggesting that positioning of these electrodes may be important for optimizing speech perception. ECAP thresholds might provide an indication of this proximity, allowing for its optimization during surgery.

3-D-Printed Models for Temporal Bone Training: A Validity Study.

OBJECTIVE: 3-D printing offers convenient and low-cost mastoidectomy training; nonetheless, training benefits using 3-D-printed temporal bones remain largely unexplored. In this study, we have collected validity evidence for a low-cost, 3-D-printed temporal bone for mastoidectomy training and established a credible pass/fail score for performance on the model. STUDY DESIGN: A prospective educational study gathering validity evidence using Messick's validity framework. SETTING: Seven Danish otorhinolaryngology training institutions. PARTICIPANTS: Eighteen otorhinolaryngology residents (novices) and 11 experienced otosurgeons (experts). INTERVENTION: Residents and experienced otosurgeons each performed two to three anatomical mastoidectomies on a low-cost, 3-D-printed temporal bone model produced in-house. After drilling, mastoidectomy performances were rated by three blinded experts using a 25-item modified Welling scale (WS). MAIN OUTCOME MEASURE: Validity evidence using Messick's framework including reliability assessment applying both classical test theory and Generalizability theory. RESULTS: Novices achieved a mean score of 13.9 points; experienced otosurgeons achieved 23.2 points. Using the contrasting groups method, we established a 21/25-point pass/fail level. The Generalizability coefficient was 0.91, and 75% of the score variance was attributable to participant performance, indicating a high level of assessment reliability. Subsequent D studies revealed that two raters rating one performance or one rater rating two performances were sufficiently reliable for high-stakes assessment. CONCLUSION: Validity evidence supports using a low-cost, 3-D-printed model for mastoidectomy training. The model can be printed in-house using consumer-grade 3-D printers and serves as an additional training tool in the temporal bone curriculum. For competency-based training, we established a cut-off score of 21 of 25 WS points using the contrasting groups method.

Are Video Recordings Reliable for Assessing Surgical Performance? A Prospective Reliability Study Using Generalizability Theory.

INTRODUCTION: Reliability is pivotal in surgical skills assessment. Video-based assessment can be used for objective assessment without physical presence of assessors. However, its reliability for surgical assessments remains largely unexplored. In this study, we evaluated the reliability of video-based versus physical assessments of novices' surgical performances on human cadavers and 3D-printed models-an emerging simulation modality. METHODS: Eighteen otorhinolaryngology residents performed 2 to 3 mastoidectomies on a 3D-printed model and 1 procedure on a human cadaver. Performances were rated by 3 experts evaluating the final surgical result using a well-known assessment tool. Performances were rated both hands-on/physically and by video recordings. Interrater reliability and intrarater reliability were explored using κ statistics and the optimal number of raters and performances required in either assessment modality was determined using generalizability theory. RESULTS: Interrater reliability was moderate with a mean κ score of 0.58 (range 0.53-0.62) for video-based assessment and 0.60 (range, 0.55-0.69) for physical assessment. Video-based and physical assessments were equally reliable (G coefficient 0.85 vs. 0.80 for 3D-printed models and 0.86 vs 0.87 for cadaver dissections). The interaction between rater and assessment modality contributed to 8.1% to 9.1% of the estimated variance. For the 3D-printed models, 2 raters evaluating 2 video-recorded performances or 3 raters physically assessing 2 performances yielded sufficient reliability for high-stakes assessment (G coefficient >0.8). CONCLUSIONS: Video-based and physical assessments were equally reliable. Some raters were affected by changing from physical to video-based assessment; consequently, assessment should be either physical or video based, not a combination.

Cochlear implantation and simultaneous posterior semicircular canal plugging.

BACKGROUND: Intractable benign paroxysmal positional vertigo (BPPV) may be treated by plugging the affected semicircular canal (SCC). A cochlear implant (CI) can diminish subjective symptoms of tinnitus. We present a case with intractable BPPV and incapacitating tinnitus who underwent surgery, simultaneously plugging his posterior SCC (PSCC) and implanting an ipsilateral CI. CASE: A 50-year-old male experienced single-sided deafness (SSD) with severe ipsilateral tinnitus, and intractable BPPV related to the ipsilateral PSCC. Two years earlier, he had been treated with a bone anchored hearing system (BAHS) for his single-sided hearing loss, but his tinnitus and BPPV persisted. The patient was elected for surgical plugging of the affected SCC and was offered a simultaneous ipsilateral CI to treat his hearing loss and reduce his disabling tinnitus. The procedure was initially clinically and subjectively successful, but the tinnitus worsened, following an MRI despite regular precautions. CONCLUSION: This is the first case presentation of cochlear implantation performed concurrent to plugging of the ipsilateral PSCC. The outcome of the procedure was overall successful.

Assessing competence in cochlear implant surgery using the newly developed Cochlear Implant Surgery Assessment Tool.

PURPOSE: To develop and gather validity evidence for a novel tool for assessment of cochlear implant (CI) surgery, including virtual reality CI surgery training. METHODS: Prospective study gathering validity evidence according to Messick's framework. Four experts developed the CI Surgery Assessment Tool (CISAT). A total of 35 true novices (medical students), trained novices (residents) and CI surgeons performed two CI-procedures each in the Visible Ear Simulator, which were rated by three blinded experts. Classical test theory and generalizability theory were used for reliability analysis. RESULTS: The CISAT significantly discriminated between the three groups (p < 0.001). The generalizability coefficient was 0.76 and most of the score variance (53.3%) was attributable to the participant and only 6.8% to the raters. When exploring a standard setting for CI surgery, the contrasting groups method suggested a pass/fail score of 36.0 points (out of 55), but since the trained novices performed above this, we propose using the mean CI surgeon performance score (45.3 points). CONCLUSION: Validity evidence for simulation-based assessment of CI performance supports the CISAT. Together with the standard setting, the CISAT might be used to monitor progress in competency-based training of CI surgery and to determine when the trainee can advance to further training.

Effect of 3D-Printed Models on Cadaveric Dissection in Temporal Bone Training.

OBJECTIVE: Mastoidectomy is a cornerstone in the surgical management of middle and inner ear diseases. Unfortunately, training is challenged by insufficient access to human cadavers. Three-dimensional (3D) printing of temporal bones could alleviate this problem, but evidence on their educational effectiveness is lacking. It is largely unknown whether training on 3D-printed temporal bones improves mastoidectomy performance, including on cadavers, and how this training compares with virtual reality (VR) simulation. To address this knowledge gap, this study investigated whether training on 3D-printed temporal bones improves cadaveric dissection performance, and it compared this training with the already-established VR simulation. STUDY DESIGN: Prospective cohort study of an educational intervention. SETTING: Tertiary university hospital, cadaver dissection laboratory, and simulation center in Copenhagen, Denmark. METHODS: Eighteen otorhinolaryngology residents (intervention) attending the national temporal bone dissection course received 3 hours of mastoidectomy training on 3D-printed temporal bones. Posttraining cadaver mastoidectomy performances were rated by 3 experts using a validated assessment tool and compared with those of 66 previous course participants (control) who had received time-equivalent VR training prior to dissection. RESULTS: The intervention cohort outperformed the controls during cadaver dissection by 29% (P < .001); their performances were largely similar across training modalities but remained at a modest level (~50% of the maximum score). CONCLUSION: Mastoidectomy skills improved from training on 3D-printed temporal bone and seemingly more so than on time-equivalent VR simulation. Importantly, these skills transferred to cadaveric dissection. Training on 3D-printed temporal bones can effectively supplement cadaver training when learning mastoidectomy.

Four-point impedance as a biomarker for bleeding during cochlear implantation.

Cochlear implantation has successfully restored the perception of hearing for nearly 200 thousand profoundly deaf adults and children. More recently, implant candidature has expanded to include those with considerable natural hearing which, when preserved, provides an improved hearing experience in noisy environments. But more than half of these patients lose this natural hearing soon after implantation. To reduce this burden, biosensing technologies are emerging that provide feedback on the quality of surgery. Here we report clinical findings on a new intra-operative measurement of electrical impedance (4-point impedance) which, when elevated, is associated with high rates of post-operative hearing loss and vestibular dysfunction. In vivo and in vitro data presented suggest that elevated 4-point impedance is likely due to the presence of blood within the cochlea rather than its geometry. Four-point impedance is a new marker for the detection of cochlear injury causing bleeding, that may be incorporated into intraoperative monitoring protocols during CI surgery.

Wide diameter bone-anchored hearing system implants: a comparison of long-term follow-up data between tissue reduction and tissue preservation techniques.

OBJECTIVE: To present long-term data on the Wide Ponto implant bone-anchored hearing system (BAHS) in regards to implant stability, soft tissue reaction and implant loss for two case series undergone either the tissue reduction- or the tissue preservation surgical technique. METHODS: Comparison of two consecutive, prospective case series. Each case series enrolled 24 patients. The case series underwent one-stage implantation of the Wide Ponto implant BAHS using either a linear incision technique with subcutaneous reduction or a linear incision technique without subcutaneous reduction. Implant stability quotient (ISQ) values were measured using resonance frequency analysis and soft tissue reactions were graded according to Holgers' classification system. Follow-up visits were performed at 10 days, 6 weeks, 6 months, 12 months and annually up to 4 years (tissue preservation) or 5 years (tissue reduction) postoperatively. RESULTS: The two case series had homogenous patient populations and followed an identical postoperative scheme. The ISQ values increased consistently the first 12 months for both groups (p ≤ 0.001), and were higher in the tissue preservation case series, (p = 0.04, 9 mm abutment). More than 91% of the soft tissue observations were assessed as Holgers' grade 0 or 1. One implant (2.1%) was lost due to trauma. CONCLUSION: In both case series, the Wide Ponto implant showed increasing implant stability during the follow-up period from the time of surgery, irrespective of surgical technique, indicating good osseointegration. Soft tissue reactions were rare and of minor severity. Implant survival was high.

The Effect of a Distributed Virtual Reality Simulation Training Program on Dissection Mastoidectomy Performance.

OBJECTIVE: To investigate the effect on final-product performance of a distributed, virtual reality (VR) simulation training program on cadaveric dissection performance and learning curves compared with standard VR simulation training during a temporal bone course. STUDY DESIGN: Educational interventional cohort study. SETTING: The national Danish temporal bone courses of 2016 and 2017. SUBJECTS: Postgraduate year 2 to 5 residents in otorhinolaryngology. INTERVENTION: Nine participants volunteered for additional VR simulation training (intervention) before the temporal bone course, with training blocks distributed (i.e., separated). The remaining 28 participants received standard VR simulation training during the temporal bone course (control). MAIN OUTCOME MEASURE: VR simulation and cadaveric dissection final-product performances were analyzed by blinded raters using a 26-item modified Welling Scale. RESULTS: Distributed VR simulation training before the temporal bone course (intervention) significantly increased dissection final-product performance by 25% compared with standard VR simulation training during the course (control) (mean scores 12.8 points versus 10.3 points, p < 0.01). Distributed and repeated VR simulation practice markedly decreased drilling time. Guidance by the simulator-integrated tutor-function significantly increased final-product performance by 2.3 points compared with nontutored procedures but at the cost of increased drilling time. CONCLUSION: Skills acquired in a VR simulation environment translate to cadaveric dissection skills and repeated and distributed VR simulation can be used to further increase performance compared with standard VR simulation training during a temporal bone course. Further dissemination of inexpensive VR simulators would allow all future temporal bone course participants to train locally before attending future centralized courses.

Surgical Results and Complications of Cochlear Implantation in Far-Advanced Otosclerosis.

OBJECTIVE: To report surgical results and complications of cochlear implantation in patients with far-advanced otosclerosis (FAO). MATERIALS AND METHODS: This was a retrospective chart review of surgical results in terms of electrode insertion as well as peri- and postoperative complications. Ten cochlear implantations (CIs) were performed in eight patients with FAO. A prior stapedotomy had been performed in all cases. RESULTS: Full electrode insertion was achieved in nine of the 10 operations (90%) and partial insertion in one operation. An unintended opening of the vestibule during drilling was the only perioperative complication. Postoperative complications occurred as two cases of vertigo (one prolonged). No chorda tympani syndrome and no cases of facial nerve stimulation were noted. CONCLUSION: Although based on a limited number of cases, we conclude that full electrode insertion can be achieved in almost all cases and that major complications are infrequent in CI in patients with FAO. Postoperative vertigo appears to be the most commonly occurring complication.

Clinical Outcome of a Wide-diameter Bone-anchored Hearing Implant and a Surgical Technique With Tissue Preservation.

OBJECTIVE: To investigate the clinical outcome of a surgical technique with tissue preservation for a wide bone-anchored hearing implant concerning postoperative complications, skin reactions, implant loss, and implant stability. STUDY DESIGN: Consecutive, prospective case series. SETTING: Tertiary referral center. PATIENTS: Twenty-four adult patients with normal skin quality were enrolled. INTERVENTION(S): Implantation of bone-anchored implant was performed using a one-stage linear-incision technique with tissue preservation surgery. MAIN OUTCOME MEASURES(S): Skin and soft tissue reactions according to Holgers grading system. Pain and numbness measured according to visual analogue scale. Implant stability quotient values were recorded using resonance frequency analysis. Follow-up at 10 days, 6 weeks, 6 months, and 1 year after surgery. RESULTS: Primary implant stability was good and a significant increase in implant stability quotient occurred during the first 10 days and continued to be stable throughout the 1-year observation period. No implants were lost. Skin and soft tissue reactions were few, no reaction (Holger grade 0) was observed in 88% of the follow-up examinations and no grade 4 reactions occurred. Pain and numbness were minimal. CONCLUSION: The wide implant showed good stability initially and throughout the observation period. Skin and soft tissue reactions were rare and minor. No implants were lost.

The effect of self-directed virtual reality simulation on dissection training performance in mastoidectomy.

OBJECTIVES/HYPOTHESIS: To establish the effect of self-directed virtual reality (VR) simulation training on cadaveric dissection training performance in mastoidectomy and the transferability of skills acquired in VR simulation training to the cadaveric dissection training setting. STUDY DESIGN: Prospective study. METHODS: Two cohorts of 20 novice otorhinolaryngology residents received either self-directed VR simulation training before cadaveric dissection training or vice versa. Cadaveric and VR simulation performances were assessed using final-product analysis with three blinded expert raters. RESULTS: The group receiving VR simulation training before cadaveric dissection had a mean final-product score of 14.9 (95 % confidence interval [CI] [12.9-16.9]) compared with 9.8 (95% CI [8.4-11.1]) in the group not receiving VR simulation training before cadaveric dissection. This 52% increase in performance was statistically significantly (P < 0.0001). A single dissection mastoidectomy did not increase VR simulation performance (P = 0.22). CONCLUSIONS: Two hours of self-directed VR simulation training was effective in increasing cadaveric dissection mastoidectomy performance and suggests that mastoidectomy skills are transferable from VR simulation to the traditional dissection setting. Virtual reality simulation training can therefore be employed to optimize training, and can spare the use of donated material and instructional resources for more advanced training after basic competencies have been acquired in the VR simulation environment. LEVEL OF EVIDENCE: NA. Laryngoscope, 126:1883-1888, 2016.

[The bone-anchored hearing aid]. / Det knogleforankrede høreapparat.

The bone-anchored hearing aid (Baha) was introduced in 1977 by Tjellström and colleagues and has now been used clinically for over 30 years. Generally, the outcomes are good, and several studies have shown improved audiological- and quality of life outcomes. The principle of the Baha is, that sound vibrations are led directly to the inner ear via the mastoid bone, bypassing the middle ear. This is achieved via an osseointegrated implant and a skin-penetrating abutment. Studies report high success rates and a majority of complications as typically minor in nature.

Long-term results of 185 consecutive osseointegrated hearing device implantations: a comparison among children, adults, and elderly.

OBJECTIVE: To determine the occurrence and type of perioperative and postoperative complications in patients implanted with an osseointegrated hearing device (OHD) (also known as BAHA/BAHS) and compare results in children, adults, and elderly and for different surgical techniques. STUDY DESIGN: Retrospective case file review. SETTING: Tertiary referral center. PATIENTS: Patients implanted with an OHD between 2004 and 2012, with more than 6 months of follow-up. INTERVENTION: OHD implantation. MAIN OUTCOME MEASURES: Implant loss, adverse skin reactions (Holgers' score, ≥2), skin overgrowth, and discomfort resulting in abutment and/or implant removal. RESULTS: One hundred eighty-five implantations in 176 patients were reviewed. Overall, 3.8% of the implants were lost spontaneously after a mean of 2.5 years. Implant loss in children was 18% versus 2.5% in adults and 3.8% in elderly. Adverse skin reactions occurred in 14% of observations overall; in 10% in children compared with 16% in adults and 9% in elderly. Partial or total skin overgrowth was seen in 4% and 6% of the observations in children and adults, respectively, whereas none of the elderly experienced this problem. The abutment was removed because of discomfort and/or no benefit in 10% overall, in 13% of adults, and in 6% of the elderly; none of the children opted for removal. Linear incision technique showed fewest complications. CONCLUSION: OHD implantation is a procedure with few major complications. Adverse skin reaction is the most common complication. Children lose the implant more frequently than adults. Elderly patients have less adverse skin reactions/skin overgrowth. Discomfort leading to abutment removal is a concern especially among adults.

A new wide-diameter bone-anchored hearing implant-prospective 1-year data on complications, implant stability, and survival.

OBJECTIVE: To investigate a new wide bone-anchored hearing implant considering initial stability, stability over time, implant loss, and skin reaction. STUDY DESIGN: Consecutive, prospective case series. SETTING: Tertiary referral center. PATIENTS: Twenty adult patients were enrolled. All operations were 1-stage, single-incision technique with subcutaneous reduction. INTERVENTION(S): Measurement of implant stability. MAIN OUTCOME MEASURE(S): Implant stability quotient (ISQ) values were recorded using resonance frequency analysis at the time of implantation and at 10 days, 6 weeks, 6 months, and 1 year after surgery. Skin and soft tissue reactions according to Holgers grading system. RESULTS: Implant stability quotient measurements revealed a significant increase in ISQ during the first 10 days after operation, and the ISQ values continued to rise throughout the 1-year observation period. No implants were lost. Skin and soft tissue reactions were rare and minor, as no reaction was seen in 93% of the follow-up examinations and no grade 4 reactions occurred. CONCLUSION: The new wide implant showed good stability at surgery. Osseointegration was fast, and implant stability increased throughout the 1-year observation period. No implants were lost. Skin and soft tissue reactions were rare and minor.

Squamous cell carcinoma of the nasal vestibule 1993-2002: a nationwide retrospective study from DAHANCA.

BACKGROUND: A retrospective nationwide study of cancer of the nasal vestibule was conducted to evaluate classification systems and prognostic factors for treatment outcome. METHODS: Patients treated between 1993 and 2002 at head and neck oncology centers in Denmark were included. RESULTS: The 5-year results were locoregional control 67%, overall survival 50%, cancer-specific survival 74%. Cancer-specific survival according to Wang classification was 83%, 63%, and 39% for T1, T2, T3, respectively (p < .000). Regarding T1 tumors, 5-year locoregional control for surgery, surgery + radiotherapy (RT), or RT was 94%, 87%, or 61%, respectively (p < .000). Fifty-four Gray in 18 fractions was found comparable with 66 Gy in 33 fractions regarding T1 tumors. CONCLUSION: This national survey is the largest series of nasal vestibule cancer ever published. Wang classification is more prognostic and easier to use than the Union Internationale Contre le Cancer 2002. Surgery or hypofractionated RT can be used for T1 lesions, whereas larger lesions should be treated with combined approach.