Systematic Review and Meta-Analysis of a New Active Transcutaneous Bone Conduction Implant.

OBJECTIVE: This review aims to quantify the pooled functional gain (FG) in different types of hearing loss with the transcutaneous hearing device, Osia (Cochlear, Sydney, Australia) in comparison with the unaided state. Secondary outcomes are patient-reported outcomes measures (PROMs) and complication rates. DATA SOURCES: Medline, Embase, SCOPUS, Cochrane CENTRAL, PROSPERO and Cochrane Library. REVIEW METHODS: Systematic review and meta-analysis of indexed search terms relating to "Osia," "Osseointegration," "Cochlear Implant," and "Bone-Anchored Prosthesis" was performed from database inception to September 20, 2022. RESULTS: Of the 168 studies identified, 14 studies with 15 patient cohorts (n = 314) met inclusion criteria for meta-analysis. Pooled overall mean FG for all types of hearing loss was 35.0 dB sound pressure level (SPL) (95% confidence interval [CI] 29.12-40.97) compared against unaided hearing. Pooled FG for conductive/mixed hearing loss was 37.7 dB SPL (95% CI 26.1-49.3). Pooled single-sided deafness (SSD) FG could not be calculated due to the small patient cohort for whom SSD data was reported. There is a trend toward improvements in speech receptiveness threshold, signal to noise ratio, and some PROMs compared with baseline hearing. Early complication rates demonstrate risks similar to other transcutaneous implants, with a low predicted explantation (0.11%, 95% CI 0.00%-1.90%) and wound infection rate (1.92% [95% CI 0.00%-6.17%]). No articles directly comparing transcutaneous devices were identified. CONCLUSION: The Osia devices demonstrate clear audiologic benefits and a good safety profile for the included patient population. Our study results indicate that frequency-specific gain, PROMs, and the audiological benefit in single-sided deafness may be areas for future prospective research. Laryngoscope, 134:1531-1539, 2024.

Systematic Review of Intracochlear Measurements and Effect on Postoperative Auditory Outcomes after Cochlear Implant Surgery.

OBJECTIVE: Quality and adequacy of the electrode neuron interface (ENI) is postulated to be a determining factor in affecting auditory outcomes after cochlear implantation. This study aims to review radiological parameters affecting ENI, including angular insertion (AngI), wrapping factor (WF), scalar translocation (ScaT), and electrode-modiolar distance (EMD) and their effect on auditory outcomes. DATABASES REVIEWED: PubMed, MEDLINE, Embase, Scopus, OpenGrey, and Google Scholar from inception to 01 September 2022. METHODS: Inclusion criteria were (i) all humans with any cochlear implant (CI); (ii) postoperative cross-sectional imaging with electrode position factors of AngI, ScaT, EMD, and/or WF; and (iii) associated auditory outcomes. Search was restricted to English-language literature. Two independent reviewers performed title and abstract screening, data extraction, and ROBINS-I risk of bias assessment. Formal statistical analysis not performed due to data heterogeneity. PROSPERO (CRD42022359198). RESULTS: Thirty-one studies (n = 2,887 patients, 3,091 electrodes) underwent qualitative synthesis. Higher AngI (n = 1921 patients) demonstrated positive correlation in 11 studies, no correlation in eight studies, and negative correlation in four studies. ScaT (n = 2,115 patients) demonstrated negative correlation in 12 studies, none in six studies, and one unclear correlation. Larger EMD (n = 240 patients) showed negative correlation in two studies, no correlation in one, and unclear correlation in one study. Smaller WF (n = 369 patients) demonstrated no correlation in three studies and positive correlation in one study. CONCLUSIONS: Our study finds variable reported relationship between AngI and auditory outcomes. CI electrodes with a ScaT or larger EMD are more likely to exhibit poorer outcomes, and WF does not correlate with outcomes.

Inter-rater agreement between 13 otolaryngologists to diagnose otitis media in Aboriginal and Torres Strait Islander children using a telehealth approach.

INTRODUCTION: Telehealth programs are important to deliver otolaryngology services for Aboriginal and Torres Strait Islander children living in rural and remote areas, where distance and access to specialists is a critical factor. OBJECTIVE: To evaluate the inter-rater agreement and value of increasing levels of clinical data (otoscopy with or without audiometry and in-field nurse impressions) to diagnose otitis media using a telehealth approach. DESIGN: Blinded, inter-rater reliability study. SETTING: Ear health and hearing assessments collected from a statewide telehealth program for Indigenous children living in rural and remote areas of Queensland, Australia. PARTICIPANTS: Thirteen board-certified otolaryngologists independently reviewed 80 telehealth assessments from 65 Indigenous children (mean age 5.7 ± 3.1 years, 33.8% female). INTERVENTIONS: Raters were provided increasing tiers of clinical data to assess concordance to the reference standard diagnosis: Tier A) otoscopic images alone, Tier B) otoscopic images plus tympanometry and category of hearing loss, and Tier C) as B plus static compliance, canal volume, pure-tone audiometry, and nurse impressions (otoscopic findings and presumed diagnosis). For each tier, raters were asked to determine which of the four diagnostic categories applied: normal aerated ear, acute otitis media (AOM), otitis media with effusion (OME), and chronic otitis media (COM). MAIN OUTCOME MEASURES: Proportion of agreement to the reference standard, prevalence-and-bias adjusted κ coefficients, mean difference in accuracy estimates between each tier of clinical data. RESULTS: Accuracy between raters and the reference standard increased with increased provision of clinical data (Tier A: 65% (95%CI: 63-68%), κ = 0.53 (95%CI: 0.48-0.57); Tier B: 77% (95%CI: 74-79%), 0.68 (95%CI: 0.65-0.72); C: 85% (95%CI: 82-87%), 0.79 (95%CI: 0.76-0.82)). Classification accuracy significantly improved between Tier A to B (mean difference:12%, p < 0.001) and between Tier B to C (mean difference: 8%, p < 0.001). The largest improvement in classification accuracy was observed between Tier A and C (mean difference: 20%, p < 0.001). Inter-rater agreement similarly improved with increasing provision of clinical data. CONCLUSIONS: There is substantial agreement between otolaryngologists to diagnose ear disease using electronically stored clinical data collected from telehealth assessments. The addition of audiometry, tympanometry and nurse impressions significantly improved expert accuracy and inter-rater agreement, compared to reviewing otoscopic images alone.

Implantation and long-term assessment of the stability and biocompatibility of a novel 98 channel suprachoroidal visual prosthesis in sheep.

Severe visual impairment can result from retinal degenerative diseases such as retinitis pigmentosa, which lead to photoreceptor cell death. These pathologies result in extensive neural and glial remodelling, with survival of excitable retinal neurons that can be electrically stimulated to elicit visual percepts and restore a form of useful vision. The Phoenix99 Bionic Eye is a fully implantable visual prosthesis, designed to stimulate the retina from the suprachoroidal space. In the current study, nine passive devices were implanted in an ovine model from two days to three months. The impact of the intervention and implant stability were assessed using indirect ophthalmoscopy, infrared imaging, and optical coherence tomography to establish the safety profile of the surgery and the device. The biocompatibility of the device was evaluated using histopathological analysis of the tissue surrounding the electrode array, with a focus on the health of the retinal cells required to convey signals to the brain. Appropriate stability of the electrode array was demonstrated, and histological analysis shows that the fibrotic and inflammatory response to the array was mild. Promising evidence of the safety and potential of the Phoenix99 Bionic Eye to restore a sense of vision to the severely visually impaired was obtained.

Risk Factors for Facial Nerve and Other Nonauditory Side Effects Following Cochlear Implantation.

OBJECTIVE: The purpose of this study was to characterize a cohort of patients with nonauditory side-effects (NASx) following cochlear implant (CI) surgery. STUDY DESIGN: Retrospective case review. SETTING: Tertiary referral center. PATIENTS: One hundred twenty three multichannel CI recipients with intraoperative facial nerve stimulation (FNS). INTERVENTIONS: Intraoperative electrical auditory brainstem responses (eABR) during CI surgery. MAIN OUTCOME MEASURES: Nonauditory side effects post-CI activation. RESULTS: Intraoperative FNS was identified in 2.26% of patients (123/5441), of whom, 34% (42/123) experienced VII stimulation on CI activation. Pain was experienced by 22% (27/123) and vestibular dysfunction was experienced by 4% (5/123) of cases. All case who experienced pain and/or vestibular NASx also experienced VII stimulation. The majority of cases were managed by CI remapping or observation and habituation.Significant relationships were found between etiology of hearing loss and presence of FNS upon initial activation (p < 0.05). No significance was found between FNS intraoperatively and at initial activation for all assumed mechanisms of hearing loss (p > 0.05) with the exceptions of acquired hearing loss of undetermined etiology and toxic etiology group (p < 0.05).There was no significant impact of implant array design (p > 0.05). CONCLUSIONS: This study has characterized patients with NASx in a large cohort of CI patients. One third of cases identified with FNS intraoperatively, developed NASx post-CI activation. Risk factors for NASx postactivation include high-risk etiologies and intraoperative objective measures (i.e., eABR). This may assist surgeons and audiologists to identify at-risk patients who may need modifications in CI program planning.

Composite gelfoam/fascia graft: a novel technique in tympanoplasty surgery.

BACKGROUND: Traditional tympanoplasty techniques require graft placement and then supporting material (GelFoam) as a two-step process. Both steps potentially disrupt accurate graft placement leading to failure and persistence of the perforation. METHODS: We demonstrate a novel technique for graft preparation and placement using composite gelfoam/fascia in which the gelfoam and fascia are compressed into a common layer and applied to the perforation and drum remnant in a single step. Placement is ergonomically efficient and effective. CONCLUSION: This novel modification of traditional graft preparation and placement is simple and ergonomically efficient.

Validation of a 3D-printed human temporal bone model for otology surgical skill training.

HYPOTHESIS: Three-dimensional (3D) printed temporal bones are comparable to cadaveric temporal bones as a training tool for otologic surgery. BACKGROUND: Cadaveric temporal bone dissection is an integral part of otology surgical training. Unfortunately, availability of cadaveric temporal bones is becoming much more limited and concern regarding chemical and biological risks persist. In this study, we examine the validity of 3D-printed temporal bone model as an alternative training tool for otologic surgery. METHODS: Seventeen otolaryngology trainees participated in the study. They were asked to complete a series of otologic procedures using 3D-printed temporal bones. A semi-structured questionnaire was used to evaluate their dissection experience on the 3D-printed temporal bones. RESULTS: Participants found that the 3D-printed temporal bones were anatomically realistic compared to cadaveric temporal bones. They found that the 3D-printed temporal bones were useful as a surgical training tool in general and also for specific otologic procedures. Overall, participants were enthusiastic about incorporation of 3D-printed temporal bones in temporal bone dissection training courses and would recommend them to other trainees. CONCLUSION: 3D-printed temporal bone model is a viable alternative to human cadaveric temporal bones as a teaching tool for otologic surgery.

Safety and biocompatibility of a bionic eye: Imaging, intraocular pressure, and histology data.

The data presented here are related and supplementary data to the research article "Implantation and long-term assessment of the stability and biocompatibility of a novel 98 channel suprachoroidal visual prosthesis in sheep" [1]. In Eggenberger et al., nine sheep of the Suffolk (N=2) and Dorper (N=7) breeds were implanted in the left eye with an electrically inactive, suprachoroidal retinal stimulator (Bionic Eye) for durations of up to 100 days. The surgical safety, implant stability and device biocompatibility were assessed. Intraocular pressure measurements, indirect and infrared ophthalmoscopy and optical coherence tomography were performed at fixed time points to evaluate the clinical effects of the surgery and device implantation. Post-mortem eye tissue collection and histology was performed to measure the effects of the intervention at the cellular level. The data, including a comprehensive collection of fundus, infrared, optical coherence tomography and histology images can be used as a reference for comparison with other research, for example, active retinal stimulators. Furthermore, these data can be used to evaluate the suitability of the sheep model, in particular Dorper sheep, for future research.

Assessing Cochlear Length Using Cone Beam Computed Tomography in Adults With Cochlear Implants.

: Developing a clinically viable technique for measuring cochlear length could enhance future electrode design of cochlear implants and surgical skills to improve clinical outcomes. While computed tomography (CT) has been used, metal artifact and the exposure to higher levels of radiation limits its use. More recently, cone beam CT (CBCT) has been used to assess the integrity of the implant array in situ, exposing implantees to lower levels of radiation while retaining image quality. The current study aims to develop a technique for measuring cochlear length in implanted adults, using CBCT images combined with known dimensions of implant arrays and lengths of cochlear structures from cadaveric human temporal bones. STUDY DESIGN: One hundred CBCT temporal bone images of ears implanted with Cochlear straight or perimodiolar arrays were reviewed by two independent examiners. RESULTS: Outer-wall length, based on the position of the straight array within the cochlea and the reported average length of the organ of Corti, was 27.44 to 35.91 mm (mean = 32.24 mm). Inner-wall length, based on the position of the perimodiolar array and the reported average length of the spiral ganglion, ranged from 17.8 to 22.24 mm (mean = 19.43 mm). CONCLUSION: A novel method for calculating outer- and inner-wall cochlear length using CBCT images has been developed which is feasible in clinical settings.

Speech Recognition Outcomes After Cochlear Reimplantation Surgery.

This study compares speech recognition outcomes before and after cochlear reimplantation surgery, in relation to clinical factors known before and at time of surgery. Between 2006 and 2015, 2,055 adult cochlear implant surgeries were conducted at this center, of which 87 were reimplantation surgeries (4.2%). Speech recognition scores (SRS) assessed before and after reimplantation were available for 54 adults. Overall, SRS measured after reimplantation were similar to the best SRS obtained by the patient and greater than the last SRS measured before surgery. Additional complications were noted in the clinical files of all patients for which reimplantation was considered unsuccessful (16%).

Neuroendocrine Adenoma of the Middle Ear: A Rare Histopathological Diagnosis.

Neuroendocrine tumours occur throughout the body but are rare in the head and neck region and particularly rare in the middle ear. Clinical findings are often nonspecific and therefore pose a diagnostic challenge. Furthermore, the nomenclature of neuroendocrine tumours of the middle ear is historically controversial. Herein a case is presented of a middle ear adenoma in a 33-year-old patient who presented with otalgia, hearing loss, and facial nerve palsy. A brief discussion is included regarding the histopathological features of middle ear adenomas and seeks to clarify the correct nomenclature for these tumours.

Growth Rate Analysis of an Untreated Glomus Vagale on MRI.

Paragangliomas are slow growing, hypervascular neuroendocrine tumors that develop in the extra-adrenal paraganglion tissues. Paraganglioma involving the vagus nerve ganglia is termed glomus vagale. The slow growth of head and neck paragangliomas especially in the absence of symptom may obviate the necessity for any active intervention, in which case, a "wait and scan" policy is implemented involving long-term clinical and radiologic follow-ups. We present a case of a 71-year-old female with an untreated left glomus vagale who underwent a conservative "wait and rescan" plan of management and the tumor was observed with 8 serial MRI scans over a period of 7.4 years. A growth rate analysis was conducted which demonstrated a slow growth. A literature review of radiologic studies examining the natural history of head and neck paragangliomas was also performed.

Outcomes in Stapedotomy Surgery: The Learning Curve Redefined.

OBJECTIVE: The aim of this study is to determine if the cumulative summation test for the learning curve (LC-CUSUM) and the cumulative summation graph (CUSUM) can be used to demonstrate landmark points of competence and maintenance of proficiency in stapes surgery over a continuous time period. STUDY DESIGN: Retrospective review from January 1999 until August 2014. SETTING: Tertiary referral hospital. PATIENTS: All adult patients with confirmed otosclerosis. INTERVENTION(S): Two-hundred and four primary and revision stapedotomy. MAIN OUTCOME MEASURE(S): Learning curves were constructed using the CUSUM and LC-CUSUM. Failure was defined as closure of the ABG >10 dB in less than 10% of patients to demonstrate the landmark point of competency and to highlight any fluctuations over a prolonged period. RESULTS: When the failure rate was defined as closure of the ABG >10 dB, it was not possible to create useful LC-CUSUM and CUSUM graphs, but by redefining the failure rate as > 15 dB, competency was reached at case 43 and maintained with natural fluctuations occurring between cases 137 and 149 and again at case 196. CONCLUSIONS: LC-CUSUM and CUSUM are a more robust analytical method of illustrating the learning curve and suggest that the traditional benchmark of closure of the ABG ≤10 dB in more than 90% of patients may need reconsideration. It can also be used as standardized audit tools when monitoring results and used to plan future training programs as they clearly define a point when novice trainees become competent.

The semi-lunar meatoplasty.

Stenosis of the external auditory meatus is known to be problematic for the otolaryngologist. Establishment of an adequate meatoplasty is important to restore normal otologic physiologic function, whether the meatoplasty is performed as a primary operation or as an adjuvant procedure. Numerous techniques have been devised for performing a meatoplasty. A new technique to create a large and patent meatoplasty is described using a semi-lunar incision in the conchal bowl.

Rates of revision and device failure in cochlear implant surgery: a 30-year experience.

OBJECTIVES/HYPOTHESIS: To characterize revision cochlear implant surgery and quantify rates of revision and device failure. STUDY DESIGN: Retrospective review of 235 cases of revision cochlear implant surgery performed at the Sydney Cochlear Implant Center over a period of 30 years, between January 1982 and June 2011. METHODS: Patient demographics and characteristics of revision surgery were retrospectively extracted from a centralized database. Analyses of overall and cumulative rates were performed. RESULTS: During the study period, 2,827 primary cochlear implantations were performed in 2,311 patients, with 201 primary implants in 191 patients of this cohort (109 children and 82 adults) undergoing 235 revision surgeries. The most common indication for revision surgery was device failure (57.8%), followed by migration/extrusion (23.4%), infection/wound complication (17.0%), and poor outcome/secondary pathology (6.4%). The majority of revision surgeries were reimplantations. Overall revision and device failure rates were 8.3% and 4.8%, respectively. The cumulative revision rate for primary implants at all ages increased linearly by 1% per year. The cumulative revision rate was significantly higher in children, and decreased with more recently performed implantations and with newer generations of implants. CONCLUSIONS: The cumulative revision rate for primary implants suggests an ongoing linear relationship between the time of postprimary implantation and the need for revision surgery. We have formed an evidence base that characterizes the nature and frequency of revision surgery in a high-volume setting, allowing clinicians to effectively counsel prospective patients and clinics to understand the burden of revision surgery and device failure.

The vestibular schwannoma surgery learning curve mapped by the cumulative summation test for learning curve.

OBJECTIVE: To demonstrate and quantify the learning curve for microsurgical excision of vestibular schwannoma in a newly formed neurootologic team by using the cumulative summation test for learning curve (LC-CUSUM). To secondarily identify the factors influencing postoperative facial nerve outcome. STUDY DESIGN: Retrospective review. SETTING: Tertiary referral center. PATIENTS: Between 1999 and 2011, 153 consecutive cases of vestibular schwannoma excision. INTERVENTION: One-hundred and fifty-three patients underwent excision of vestibular schwannoma. MAIN OUTCOME MEASURES: Facial nerve outcomes were assessed using the House-Brackmann (HB) facial nerve grading system. Postoperative facial nerve outcomes at 12 months were analyzed using the LC-CUSUM method with HB Grades I to III being defined as successful outcomes. The factors that influence postoperative facial nerve outcome were analyzed. RESULTS: The constructed learning curve shows a gradual improvement in facial nerve outcomes. The learning curve crossed the derived LC-CUSUM barrier at the 56th procedure, indicating that sufficient evidence had accumulated to demonstrate that the surgeon had achieved optimal outcomes at this point. Tumor size (p = 0.008) and surgical approach (p = 0.005) were 2 additional significant factors influencing postoperative facial nerve outcome. CONCLUSION: The learning curve is evident in this series of microsurgical excisions of vestibular schwannoma. A newly formed team needs to perform at least 56 cases to gain sufficient experience to accomplish optimal results. Position along the learning curve, tumor size, and familiarity with a preferred surgical approach are the factors, which dominated facial nerve outcome. We recommend the use of LC-CUSUM test for learning curve analysis.

Cochlear implants and magnetic resonance scans: A case report and review.

OBJECTIVE AND IMPORTANCE: Traditionally, magnetic resonance imaging (MRI) was contraindicated for patients with cochlear implants (CIs), due to concern about device displacement, overheating of the device or tissues, or direct damage to the device electrode. In addition, image artifact from the device magnet gave poor imaging information in the cranial and upper cervical spine region. Today, MRI is increasingly required in patients who have undergone cochlear implantation, and CI design and MRI protocols have therefore changed to allow implanted patients to safely enter the MRI field, in some cases without removal of the CI internal magnet. CLINICAL PRESENTATION: We present a patient with bilateral CIs who required MRI to investigate new neurological symptoms. Despite tight head bandaging applied according to our protocol, MRI at 1.5 T led to bilateral skin reactions and displacement of the magnet on the left. Both magnets were subsequently removed to allow the skin reactions to settle and for further imaging without artifact. The functioning of the patient's implants was not affected. CONCLUSION: The final decision to recommend that a patient with a CI undergoes MRI, with or without removal of the internal magnet, requires close cooperation between the CI team, the physician requiring the scan, and the radiology team involved in the patient's care. The case study we present highlights the need for patients to be fully informed of the risks involved.

Pseudogout mimicking an infratemporal fossa tumor.

BACKGROUND: The infratemporal fossa is a well-concealed, complex anatomical space. Neoplasms arising in this area are heterogenous in nature and have an insidious onset and usually present late. METHODS AND RESULTS: We present a case of a 71-year-old woman who presented with worsening facial pain, trismus, and a large mass in her infratemporal fossa with minimal associated temporomandibular joint destruction. She underwent a surgical excision of the mass, which revealed a pseudogout deposit. CONCLUSION: The clinical and radiological features of patients with tophaceous pseudogout frequently mimic those of a benign or malignant neoplasm of the infratemporal fossa, often resulting in more radical surgery.