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1.
Otol Neurotol ; 45(7): 790-797, 2024 Aug 01.
Article in English | MEDLINE | ID: mdl-38923968

ABSTRACT

OBJECTIVES: To assess the clinical utility of spread of excitation (SOE) functions obtained via electrically evoked compound action potentials (eCAP) to 1) identify electrode array tip fold-over, 2) predict electrode placement factors confirmed via postoperative computed tomography (CT) imaging, and 3) predict postoperative speech recognition through the first year post-activation in a large clinical sample. STUDY DESIGN: Retrospective case review. SETTING: Cochlear implant (CI) program at a tertiary medical center. PATIENTS: Two hundred seventy-two ears (238 patients) with Cochlear Ltd. CIs (mean age = 46 yr, range = 9 mo-93 yr, 50% female) implanted between August 2014 and December 2022 were included. MAIN OUTCOME MEASURES: eCAP SOE widths (mm) (probe electrodes 5, 11, and 17), incidence of electrode tip fold-over, CT imaging data (electrode-to-modiolus distance, angular insertion depth, scalar location), and speech recognition outcomes (consonant-nucleus-consonant [CNC], AzBio quiet, and +5 dB SNR) through the first year after CI activation. RESULTS: 1) eCAP SOE demonstrated a sensitivity of 85.7% for identifying tip fold-over instances that were confirmed by CT imaging. In the current dataset, the tip fold-over incidence rate was 3.1% (7 patients), with all instances involving a precurved electrode array. 2) There was a significant positive relationship between eCAP SOE and mean electrode-to-modiolus distance for precurved arrays, and a significant positive relationship between eCAP SOE and angular insertion depth for straight arrays. No relationships between eCAP SOE and scalar location or cochlea diameter were found in this sample. 3) There were no significant relationships between eCAP SOE and speech recognition outcomes for any measure or time point, except for a weak negative correlation between average eCAP SOE widths and CNC word scores at 6 months post-activation for precurved arrays. CONCLUSIONS: In the absence of intraoperative CT or fluoroscopic imaging, eCAP SOE is a reasonable alternative method for identifying electrode array tip fold-over and should be routinely measured intraoperatively, especially for precurved electrode arrays with a sheath.


Subject(s)
Action Potentials , Cochlear Implantation , Cochlear Implants , Speech Perception , Humans , Female , Male , Middle Aged , Aged , Cochlear Implantation/methods , Adult , Retrospective Studies , Aged, 80 and over , Child, Preschool , Young Adult , Adolescent , Child , Infant , Speech Perception/physiology , Action Potentials/physiology , Evoked Potentials, Auditory/physiology , Tomography, X-Ray Computed
2.
Int J Med Robot ; 20(1): e2609, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38536718

ABSTRACT

BACKGROUND: Cochlear-implant electrode arrays (EAs) are currently inserted with limited feedback, and impedance sensing has recently shown promise for EA localisation. METHODS: We investigate the use of impedance sensing to infer the progression of an EA during insertion. RESULTS: We show that the access resistance component of bipolar impedance sensing can detect when a straight EA reaches key anatomical locations in a plastic cochlea and when each electrode contact enters/exits the cochlea. We also demonstrate that dual-sided electrode contacts can provide useful proximity information and show the real-time relationship between impedance and wall proximity in a cadaveric cochlea for the first time. CONCLUSION: The access resistance component of bipolar impedance sensing has high potential for estimating positioning information of EAs relative to anatomy during insertion. Main limitations of this work include using saline as a surrogate for human perilymph in ex vivo models and using only one type of EA.


Subject(s)
Cochlear Implantation , Cochlear Implants , Humans , Electric Impedance , Cochlea/surgery , Electrodes, Implanted
3.
Laryngoscope ; 2024 Mar 20.
Article in English | MEDLINE | ID: mdl-38506449

ABSTRACT

OBJECTIVES: To comprehensively examine the characteristics and prognosis of bilateral sudden sensorineural hearing loss (BSSHL) and its subtypes compared to unilateral sudden sensorineural hearing loss (USSHL). DATA SOURCES: PubMed, Scopus, and CINAHL. REVIEW METHODS: Databases were searched from inception to December 5, 2023, for studies reporting patient characteristics and audiometric outcomes for BSSHL and its simultaneous (Si-BSSHL) and sequential (Se-BSSHL) subtypes. Meta-analysis of continuous measures, proportions (%), mean differences (Δ), and odds ratio (OR) were performed. RESULTS: Eleven studies were included, consisting of 368 patients with BSSHL and 2,705 patients with USSHL. The pooled prevalence among all SSHL cases was 88.1% (95% CI: 81.2%-93.6%) for USSHL and 11.9% (95% CI: 6.4% to 18.8%) for BSSHL. PTA improvement following treatment with steroids was significantly worse in patients with BSSHL (Δ15.3 dB; 95% CI: 14.6 to 15.9; p < 0.0001) compared to patients with USSHL. There was no significant difference in post-treatment PTA improvement between the BSSHL subtypes. Patients with Si-BSSHL were significantly less likely to have an idiopathic etiology (OR: 0.4; 95% CI: 0.2 to 0.8; p = 0.01) and significantly more likely to have an autoimmune disease etiology (OR: 27.4; 95% CI: 2.2 to 336.1; p = 0.01), comorbid cardiovascular disease (OR: 2.3; 95% CI: 1.1 to 5.1; p = 0.03), and comorbid hypertension (OR: 2.5; 95% CI: 1.6 to 3.8; p < 0.0001) compared to patients with USSHL. CONCLUSIONS: BSSHL is a considerably rarer form of SSHL with worse prognosis compared to USSHL. BSSHL, and Si-BSSHL in particular, has significantly greater associations with systemic pathologies compared to USSHL. Laryngoscope, 2024.

4.
Otol Neurotol Open ; 4(1): e049, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38533347

ABSTRACT

Objective: To assess image artifact when imaging a cochlear implant (CI) with a conventional 3T MRI machine compared with a very low-field (0.064T) MRI. Patients: None. Intervention: Diagnostic study. Main Outcome Measure: Image artifact size associated with the CI affixed to an MRI phantom at very low-field 0.064T MRI versus 3T MRI. Results: The longest diameter of the image artifact was 125 mm for the 3T MRI and 86 mm for the 0.064T MRI, representing 45% longer image artifact generated in the 3T MRI. The actual volume of the imaging phantom was 1371 cm3. The volume of the image artifact was measured as 379 cm3 in the 3T MRI, representing a loss of 27.6% of the actual volume of the imaging phantom. The volume of image artifact was measured as 170 cm3 in the 0.064T MRI, representing a loss of 12.4% of the phantom volume. Conclusions: 3T MRI had better image quality. This result was not surprising given that larger magnetic field strength is known to provide higher resolution. There was 15% less image artifact generated in the very low-field MRI machine compared with a conventional 3T device. And there was also subjectively increased distortion of the imaging phantom at 3T MRI compared with the 0.064T MRI. With minimized safety concerns and a much lower cost than conventional 3T machines, very low-field scanners may find expanded clinical uses. This preclinical study explores the potential utility of very low-field MRI in scanning CI recipients.

5.
Otolaryngol Head Neck Surg ; 170(5): 1234-1245, 2024 May.
Article in English | MEDLINE | ID: mdl-38353342

ABSTRACT

OBJECTIVE: To evaluate the treatment efficacy of neuromodulation versus sham for the treatment of tinnitus. DATA SOURCES: Cochrane Library, CINAHL, PubMed, Scopus. REVIEW METHODS: The Cochrane Library, CINAHL, PubMed, and Scopus were searched from inception through May 2023 for English language articles documenting "neuromodulation" and "tinnitus" stratified by sham-controlled randomized control trials with 40 or more patients. Data collected included Beck Anxiety Inventory, Beck Depression Inventory (BDI), Tinnitus Handicap Inventory (THI), Tinnitus Questionnaire, and Visual Analog Scale. A Meta-analysis of continuous measures (mean) and proportions (%) were conducted. RESULTS: A total of 19 randomized control trials (N = 1186) were included. The mean age was 48.4 ± 5.3 (range: 19-74), mean duration of tinnitus was 3.8 ± 3.4 years, 61% [56.2-65.7] male, and 55.7% [46-65] with unilateral tinnitus. The short-term effect of transcutaneous electrical nerve stimulation and transcranial direct current stimulation on THI score is -16.2 [-23.1 to -9.3] and -19 [-30.1 to -7.8], respectively. The long-term effect of repetitive transcranial magnetic stimulation on THI score is -8.6 [-11.5 to -5.7]. Transcranial direct current stimulation decreases BDI score by -11.8 [-13.3 to -10.3]. CONCLUSION: As measured by the Tinnitus Handicap Index, our findings suggest the effects of transcutaneous electrical nerve stimulation and transcranial direct current stimulation reach significant benefit in the short term, whereas repetitive transcranial magnetic stimulation reaches significant benefit in the long term. Based on the BDI, transcranial direct current stimulation significantly reduces comorbid depression in patients with tinnitus.


Subject(s)
Tinnitus , Tinnitus/therapy , Humans , Transcutaneous Electric Nerve Stimulation/methods , Treatment Outcome , Transcranial Magnetic Stimulation/methods , Transcranial Direct Current Stimulation/methods , Randomized Controlled Trials as Topic
6.
J Clin Pharmacol ; 64(2): 145-154, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37751891

ABSTRACT

Nirmatrelvir, a novel, potent, orally bioavailable severe acute respiratory syndrome coronavirus 2 main protease inhibitor, coadministered with ritonavir for pharmacokinetic (PK) enhancement is licensed for the treatment of mild to moderate COVID-19 in individuals at increased risk of progression to severe disease. Cytochrome P450 3A4 is the primary metabolic enzyme responsible for nirmatrelvir metabolism; however, when cytochrome P450 3A4 is inhibited by ritonavir, nirmatrelvir is primarily excreted, unchanged, in urine. Because of intended use of nirmatrelvir among individuals with hepatic impairment, this Phase 1 study (NCT05005312) evaluated the effects of hepatic impairment on nirmatrelvir PK parameters to assess the potential need for any dose adjustments in this population. Participants with normal hepatic function or moderate hepatic impairment (n = 8 each) were administered a single 100-mg nirmatrelvir dose, with 100 mg of ritonavir administered 12 hours before, together with, and 12 and 24 hours after nirmatrelvir. Nirmatrelvir median plasma concentrations and systemic exposure measured by area under the plasma concentration-time curve from time zero extrapolated to infinite time and maximum observed plasma concentration values were comparable in both groups. Nirmatrelvir/ritonavir had an acceptable safety profile in both groups, and no clinically significant changes in laboratory measurements, vital signs, or electrocardiogram assessments were observed. Based on these results, no dose adjustment is deemed necessary in patients with moderate hepatic impairment and, by extension, in patients with mild hepatic impairment.


Subject(s)
COVID-19 , Liver Diseases , Humans , Ritonavir , Protease Inhibitors/therapeutic use , COVID-19 Drug Treatment , Antiviral Agents/pharmacokinetics , Liver Diseases/metabolism , Cytochrome P-450 Enzyme System
7.
Otol Neurotol ; 44(9): 903-911, 2023 10 01.
Article in English | MEDLINE | ID: mdl-37590880

ABSTRACT

OBJECTIVE: After demonstration of face validity of a surgical middle ear simulator (SMS) previously, we assessed the content validity of the simulator with otolaryngology residents. STUDY DESIGN: Multicenter randomized prospective international study. SETTING: Four academic institutions. METHODS: Novice participants were randomized into control, low-fidelity (LF), and high-fidelity (HF) groups. Control and LF produced 2 recordings from 2 attempts, and HF produced 4 recordings from 10 attempts, with trials 1, 4, 7, and 10 used for scoring. Three blinded experts graded videos of the simulated stapedectomy operation using an objective skills assessment test format consisting of global and stapedotomy-specific scales. RESULTS: A total of 152 recordings from 61 participants were included. Baseline characteristics did not differ significantly between groups. Depending on the step of the operation, inter-rater reliability ranged from 24 to 90%. For LF and HF, years of training was significantly associated with improved scores in certain objective skills assessment test subparts. HF outperformed the control group on stapes and global scores ( p < 0.05). The HF group demonstrated improvement in global score over trials, but plateaued after four trials. Scores varied greatly for participants from different institutions in certain operative steps, such as transecting incudostapedial joints, likely due to differences in instrumentation and time elapsed since manufacture. CONCLUSION: Practice with SMS led to better performance in both global and stapes-specific scores. Further studies are needed to examine construct validity and to create otology-appropriate grading systems. Variables like instrumentation and decline in flexibility of the simulator after 12 months greatly affect performance on the simulator.


Subject(s)
Ear, Middle , Ossicular Prosthesis , Humans , Prospective Studies , Reproducibility of Results , Ear, Middle/surgery , Stapes
8.
J Med Imaging (Bellingham) ; 10(4): 044003, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37476645

ABSTRACT

Purpose: Cochlear implants (CIs) have been shown to be highly effective restorative devices for patients suffering from severe-to-profound hearing loss. Hearing outcomes with CIs depend on electrode positions with respect to intracochlear anatomy. Intracochlear anatomy can only be directly visualized using high-resolution modalities, such as micro-computed tomography (µCT), which cannot be used in vivo. However, active shape models (ASM) have been shown to be robust and effective for segmenting intracochlear anatomy in large scale datasets of patient computed tomographies (CTs). We present an extended dataset of µCT specimens and aim to evaluate the ASM's performance more comprehensively than has been previously possible. Approach: Using a dataset of 16 manually segmented cochlea specimens on µCTs, we found parameters that optimize mean CT segmentation performance and then evaluate the effect of library size on the ASM. The optimized ASM was further evaluated on a clinical dataset of 134 CT images to assess method reliability. Results: Optimized parameters lead to mean CT segmentation performance to 0.36 mm point-to-point error, 0.10 mm surface error, and 0.83 Dice score. Larger library sizes provide diminishing returns on segmentation performance and total variance captured by the ASM. We found our method to be clinically reliable with the main performance limitation that was found to be the candidate search process rather than model representation. Conclusions: We have presented a comprehensive validation of the ASM for use in intracochlear anatomy segmentation. These results are critical to understand the limitations of the method for clinical use and for future development.

9.
Cochlear Implants Int ; 24(5): 273-281, 2023 09.
Article in English | MEDLINE | ID: mdl-37489512

ABSTRACT

OBJECTIVE: To investigate whether revision surgery with the same device results in a change in three key indicators of electrode positioning: scalar location, mean modiolar distance (M¯), and angular insertion depth (AID). METHODS: Retrospective analysis of a cochlear implant database at a university-based tertiary medical center. Intra-operative CT scans were obtained after initial and revision implantation. Electrode array (EA) position was calculated using auto-segmentation techniques. Initial and revision scalar location, M¯, and AID were compared. RESULTS: Mean change in M¯ for all ears was -0.07 mm (SD 0.24 mm; P = 0.16). The mean change in AID for all ears was -5° (SD 67°; P = 0.72). Three initial implantations with pre-curved EAs resulted in a translocation from Scala Tympani (ST) to Scala Vestibuli (SV). Two remained translocated after revision, while one was corrected when revised with a straight EA. An additional five translocations occurred after revision. CONCLUSIONS: In this study examining revision cochlear implantation from a single manufacturer, we demonstrated no significant change in key indicators of EA positioning, even when revising with a different style of electrode. However, the revision EA is not necessarily confined by the initial trajectory and there may be an increased risk of translocation.


Subject(s)
Cochlear Implantation , Cochlear Implants , Humans , Retrospective Studies , Cochlea , Replantation
10.
Br J Clin Pharmacol ; 89(11): 3352-3363, 2023 11.
Article in English | MEDLINE | ID: mdl-37354048

ABSTRACT

AIMS: To evaluate pharmacokinetics (PK) and safety after coadministration of nirmatrelvir/ritonavir or ritonavir alone with midazolam (a cytochrome P450 3A4 substrate) and dabigatran (a P-glycoprotein substrate). METHODS: PK was studied in 2 phase 1, open-label, fixed-sequence studies in healthy adults. Single oral doses of midazolam 2 mg (n = 12) or dabigatran 75 mg (n = 24) were administered alone and after steady state (i.e. ≥2 days) of nirmatrelvir/ritonavir 300 mg/100 mg and ritonavir 100 mg. Midazolam and dabigatran plasma concentrations and adverse events were analysed for each treatment. RESULTS: After administration of midazolam with nirmatrelvir/ritonavir (test) or alone (reference), midazolam geometric mean area under the concentration-time curve extrapolated to infinity (AUCinf ) and maximum plasma concentration (Cmax ) increased 14.3-fold and 3.7-fold, respectively. Midazolam coadministered with ritonavir (test) or alone (reference) resulted in 16.5-fold and 3.9-fold increases in midazolam geometric mean AUCinf and Cmax , respectively. After administration of dabigatran with nirmatrelvir/ritonavir (test) or alone (reference), dabigatran geometric mean AUCinf and Cmax increased 1.9-fold and 2.3-fold, respectively. Dabigatran coadministered with ritonavir (test) or alone (reference) resulted in a 1.7-fold increase in dabigatran geometric mean AUCinf and Cmax . Midazolam or dabigatran exposures were generally comparable when coadministered with nirmatrelvir/ritonavir or ritonavir alone, with a slightly higher dabigatran Cmax with nirmatrelvir/ritonavir vs. ritonavir alone. Nirmatrelvir/ritonavir was generally safe when administered with or without midazolam or dabigatran. No serious or severe adverse events were reported. CONCLUSION: Coadministration of midazolam or dabigatran with nirmatrelvir/ritonavir increased systemic exposure of midazolam or dabigatran. Midazolam exposures were comparable when coadministered with nirmatrelvir/ritonavir or ritonavir alone, suggesting no incremental effect of nirmatrelvir. Dabigatran Cmax was slightly higher when coadministered with nirmatrelvir/ritonavir compared with of ritonavir alone, suggesting a minor incremental effect of nirmatrelvir.


Subject(s)
Midazolam , Ritonavir , Adult , Humans , Midazolam/pharmacokinetics , Dabigatran/adverse effects , Dabigatran/pharmacokinetics , Healthy Volunteers , Drug Interactions , Area Under Curve , Cytochrome P-450 CYP3A/metabolism
11.
Am J Audiol ; 32(2): 403-416, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37249492

ABSTRACT

PURPOSE: This study investigated the relationship between the number of active electrodes, channel stimulation rate, and their interaction on speech recognition and sound quality measures while controlling for electrode placement. Cochlear implant (CI) recipients with precurved electrode arrays placed entirely within scala tympani and closer to the modiolus were hypothesized to be able to utilize more channels and possibly higher stimulation rates to achieve better speech recognition performance and sound quality ratings than recipients in previous studies. METHOD: Participants included seven postlingually deafened adult CI recipients with Advanced Bionics Mid-Scala electrode arrays confirmed to be entirely within scala tympani using postoperative computerized tomography. Twelve conditions were tested using four, eight, 12, and 16 electrodes and channel stimulation rates of 600 pulse per second (pps), 1,200 pps, and each participant's maximum allowable rate (1,245-4,800 pps). Measures of speech recognition and sound quality were acutely assessed. RESULTS: For the effect of channels, results showed no significant improvements beyond eight channels for all measures. For the effect of channel stimulation rate, results showed no significant improvements with higher rates, suggesting that 600 pps was sufficient for maximum speech recognition performance and sound quality ratings. However, across all conditions, there was a significant relationship between mean electrode-to-modiolus distance and all measures, suggesting that a lower mean electrode-to-modiolus distance was correlated with higher speech recognition scores and sound quality ratings. CONCLUSION: These findings suggest that even well-placed precurved electrode array recipients may not be able to take advantage of more than eight channels or higher channel stimulation rates (> 600 pps), but that closer electrode array placement to the modiolus correlates with better outcomes for these recipients.


Subject(s)
Cochlear Implantation , Cochlear Implants , Speech Perception , Adult , Humans , Speech Perception/physiology , Cochlea , Cochlear Implantation/methods , Scala Tympani/surgery
12.
Br J Clin Pharmacol ; 89(9): 2867-2876, 2023 09.
Article in English | MEDLINE | ID: mdl-37184075

ABSTRACT

AIMS: The objective of this study was to evaluate the effects of a strong cytochrome P450 family (CYP) 3A4 inhibitor (itraconazole) and inducer (carbamazepine) on the pharmacokinetics and safety of nirmatrelvir/ritonavir. METHODS: Pharmacokinetics were measured in two phase 1, open-label, fixed-sequence studies in healthy adults. During Period 1, oral nirmatrelvir/ritonavir 300 mg/100 mg twice daily was administered alone; during Period 2, it was administered with itraconazole or carbamazepine. Nirmatrelvir/ritonavir was administered as repeated doses or one dose in the itraconazole and carbamazepine studies, respectively. Nirmatrelvir and ritonavir plasma concentrations and adverse event (AE) rates in both periods were analysed. RESULTS: Each study included 12 participants. Following administration of nirmatrelvir/ritonavir with itraconazole (Test) or alone (Reference), test/reference ratios of the adjusted geometric means (90% CIs) for nirmatrelvir AUCtau and Cmax were 138.82% (129.25%, 149.11%) and 118.57% (112.50%, 124.97%), respectively. After administration of nirmatrelvir/ritonavir with carbamazepine (Test) or alone (Reference), test/reference ratios (90% CIs) of the adjusted geometric means for nirmatrelvir AUCinf and Cmax were 44.50% (33.77%, 58.65%) and 56.82% (47.04%, 68.62%), respectively. Nirmatrelvir/ritonavir was generally safe when administered with or without itraconazole or carbamazepine. No serious or severe AEs were reported. CONCLUSIONS: Coadministration of a strong CYP3A4 inhibitor with a strong CYP3A inhibitor used for pharmacokinetic enhancement (i.e., ritonavir) resulted in small increases in plasma nirmatrelvir exposure, whereas coadministration of a strong inducer substantially decreased systemic nirmatrelvir and ritonavir exposures suggesting a contraindication in the label with CYP3A4 strong inducers. Administration of nirmatrelvir/ritonavir alone or with itraconazole or carbamazepine was generally safe.


Subject(s)
Itraconazole , Ritonavir , Adult , Humans , Itraconazole/adverse effects , Ritonavir/adverse effects , Drug Interactions , Cytochrome P-450 CYP3A Inhibitors/pharmacology , Cytochrome P-450 CYP3A Inducers , Carbamazepine/adverse effects , Area Under Curve , Healthy Volunteers , Cytochrome P-450 CYP3A
13.
Otolaryngol Head Neck Surg ; 169(4): 780-791, 2023 10.
Article in English | MEDLINE | ID: mdl-37003296

ABSTRACT

OBJECTIVE: To investigate the impact of the surgical indication on posttonsillectomy bleed rates. DATA SOURCES: PubMed, Scopus, CINAHL. REVIEW METHODS: A systematic review was performed searching for articles published from the date of inception to July 6, 2022. English language articles describing posttonsillectomy hemorrhage rates in pediatric patients (age ≤ 18) stratified by indication were selected for inclusion. A meta-analysis of proportions with comparison (Δ) of weighted proportions was conducted. All studies were assessed for risk of bias. RESULTS: A total of 72 articles with 173,970 patients were selected for inclusion. The most common indications were chronic/recurrent tonsillitis (CT/RT), obstructive sleep apnea/sleep-disordered breathing (OSA/SDB), and adenotonsillar hypertrophy (ATH). Posttonsillectomy hemorrhage rates for CT/RT, OSA/SDB, and ATH were 3.57%, 3.69%, and 2.72%, respectively. Patients operated on for a combination of CT/RT and OSA/SDB had a bleed rate of 5.99% which was significantly higher than those operated on for CT/RT alone (Δ2.42%, p = .0006), OSA/SDB alone (Δ2.30%, p = .0016), and ATH alone (Δ3.27%, p < .0001). Additionally, those operated on for a combination of ATH and CT/RT had a hemorrhage rate of 6.93%, significantly higher than those operated on for CT/RT alone (Δ3.36%, p = .0003), OSA/SDB alone (Δ3.01%, p = .0014), and ATH alone (Δ3.98%, p < .0001). CONCLUSION: Patients operated on for multiple indications had significantly higher rates of posttonsillectomy hemorrhage than those operated on for a single surgical indication. Better documentation of patients with multiple indications would help further characterize the magnitude of the compounding effect described here.


Subject(s)
Sleep Apnea, Obstructive , Tonsillectomy , Tonsillitis , Child , Humans , Tonsillectomy/adverse effects , Sleep Apnea, Obstructive/surgery , Palatine Tonsil , Adenoidectomy/adverse effects , Tonsillitis/surgery , Hemorrhage , Hypertrophy/surgery
14.
Otol Neurotol ; 44(4): 324-330, 2023 04 01.
Article in English | MEDLINE | ID: mdl-36728107

ABSTRACT

HYPOTHESIS: This study evaluated the utility of the pull-back technique in improving perimodiolar positioning of a precurved cochlear implant (CI) electrode array (EA) with simultaneous insertion force profile measurement and direct observation of dynamic EA behavior. BACKGROUND: Precurved EAs with perimodiolar positioning have improved outcomes compared with straight EAs because of lowered charge requirements for stimulation and decreased spread of excitation. The safety and efficacy of the pull-back technique in further improving perimodiolar positioning and its associated force profile have not been adequately demonstrated. METHODS: The bone overlying the scala vestibuli was removed in 15 fresh cadaveric temporal bones, leaving the scala tympani unviolated. Robotic insertions of EAs were performed with simultaneous force measurement and video recording. Force profiles were obtained during standard insertion, overinsertion, and pull-back. Postinsertion CT scans were obtained during each of the three conditions, enabling automatic segmentation and calculation of angular insertion depth, mean perimodiolar distance ( Mavg ), and cochlear duct length. RESULTS: Overinsertion did not result in significantly higher peak forces than standard insertion (mean [SD], 0.18 [0.06] and 0.14 [0.08] N; p = 0.18). Six temporal bones (40%) demonstrated visibly improved perimodiolar positioning after the protocol, whereas none worsened. Mavg significantly improved after the pull-back technique compared with standard insertion (mean [SD], 0.34 [0.07] and 0.41 [0.10] mm; p < 0.01). CONCLUSIONS: The pull-back technique was not associated with significantly higher insertional forces compared with standard insertion. This technique was associated with significant improvement in perimodiolar positioning, both visually and quantitatively, independent of cochlear size.


Subject(s)
Cochlear Implantation , Cochlear Implants , Humans , Cochlea/diagnostic imaging , Cochlea/surgery , Cochlear Implantation/methods , Scala Tympani/surgery , Scala Vestibuli , Electrodes, Implanted
16.
Laryngoscope ; 133(1): 179-183, 2023 01.
Article in English | MEDLINE | ID: mdl-35546515

ABSTRACT

TITLE: Facial Paralysis in Skull Base Osteomyelitis - Comparison of Surgical and Nonsurgical Management. OBJECTIVE: To compare outcomes of surgical and nonsurgical management in cases of facial paresis secondary to skull base osteomyelitis. METHODS: A 14 patients presenting with skull base osteomyelitis complicated by facial nerve paresis at a single tertiary referral center from 2009 to 2019 were retrospectively reviewed. Patients were treated with medical therapy with or without surgical intervention, consisting of mastoidectomy and debridement with or without facial nerve decompression. House-Brackmann (HB) Grade was the main outcome measure. RESULTS: A 14 patients (average age 68 years, range 58-82 years, 71% male) were analyzed, with 5 undergoing facial nerve decompression (36%), 5 undergoing mastoidectomy without facial nerve decompression (36%), and 4 undergoing medical management alone (28%). Of the 4 patients who underwent medical therapy alone, none experienced significant improvement in facial function. Of the 5 patients who underwent facial nerve decompression, 3 patients experienced improved facial function. Of the 5 patients who underwent mastoidectomy without decompression, 4 experienced improved facial function. There was no clear link between the severity of infection and the severity of facial paresis. When comparing HB score changes before and after treatment across groups, there was no statistically significant difference seen (p = 0.47). CONCLUSIONS: Mastoidectomy and debridement with or without facial nerve decompression may improve facial nerve outcomes when compared to isolated medical management, although differences were not of statistical significance. The best facial nerve recoveries occurred in patients undergoing surgery within 14 days of the onset of paralysis. LEVEL OF EVIDENCE: 4 - Case Series Laryngoscope, 133:179-183, 2023.


Subject(s)
Facial Paralysis , Osteomyelitis , Humans , Male , Middle Aged , Aged , Aged, 80 and over , Female , Facial Paralysis/etiology , Facial Paralysis/surgery , Retrospective Studies , Facial Nerve/surgery , Skull Base/surgery , Osteomyelitis/complications , Osteomyelitis/surgery , Decompression, Surgical , Treatment Outcome
17.
Int J Comput Assist Radiol Surg ; 18(3): 413-421, 2023 Mar.
Article in English | MEDLINE | ID: mdl-36331796

ABSTRACT

PURPOSE: During traditional insertion of cochlear implant (CI) electrode arrays (EAs), surgeons rely on limited tactile feedback and visualization of the EA entering the cochlea to control the insertion. One insertion approach for precurved EAs involves slightly overinserting the EA and then retracting it slightly to achieve closer hugging of the modiolus. In this work, we investigate whether electrical impedance sensing could be a valuable real-time feedback tool to advise this pullback technique. METHODS: Using a to-scale 3D-printed scala tympani model, a robotic insertion tool, and a custom impedance sensing system, we performed experiments to assess the bipolar insertion impedance profiles for a cochlear CI532/632 precurved EA. Four pairs of contacts from the 22 electrode contacts were chosen based on preliminary testing and monitored in real time to halt the robotic insertion once the closest modiolar position had been achieved but prior to when the angular insertion depth (AID) would be reduced. RESULTS: In this setting, the open-loop robotic insertion impedance profiles were very consistent between trials. The exit of each contact from the external stylet of this EA was clearly discernible on the impedance profile. In closed-loop experiments using the pullback technique, the average distance from the electrode contacts to the modiolus was reduced without greatly affecting the AID by using impedance feedback in real time to determine when to stop EA retraction. CONCLUSION: Impedance sensing, and specifically the access resistance component of impedance, could be a valuable real-time feedback tool in the operating room during CI EA insertion. Future work should more thoroughly analyze the effects of more realistic operating room conditions and inter-patient variability on this technique.


Subject(s)
Cochlear Implantation , Cochlear Implants , Robotic Surgical Procedures , Humans , Electric Impedance , Feedback , Cochlea/surgery , Cochlear Implantation/methods , Electrodes, Implanted
18.
Med Image Comput Comput Assist Interv ; 14228: 376-385, 2023 Oct.
Article in English | MEDLINE | ID: mdl-38559808

ABSTRACT

Cochlear implants (CIs) are neuroprosthetics that can provide a sense of sound to people with severe-to-profound hearing loss. A CI contains an electrode array (EA) that is threaded into the cochlea during surgery. Recent studies have shown that hearing outcomes are correlated with EA placement. An image-guided cochlear implant programming technique is based on this correlation and utilizes the EA location with respect to the intracochlear anatomy to help audiologists adjust the CI settings to improve hearing. Automated methods to localize EA in postoperative CT images are of great interest for large-scale studies and for translation into the clinical workflow. In this work, we propose a unified deep-learning-based framework for automated EA localization. It consists of a multi-task network and a series of postprocessing algorithms to localize various types of EAs. The evaluation on a dataset with 27 cadaveric samples shows that its localization error is slightly smaller than the state-of-the-art method. Another evaluation on a large-scale clinical dataset containing 561 cases across two institutions demonstrates a significant improvement in robustness compared to the state-of-the-art method. This suggests that this technique could be integrated into the clinical workflow and provide audiologists with information that facilitates the programming of the implant leading to improved patient care.

19.
Otol Neurotol Open ; 2(2)2022 Jun.
Article in English | MEDLINE | ID: mdl-36274668

ABSTRACT

Clinics are treating a growing number of patients with greater amounts of residual hearing. These patients often benefit from a bimodal hearing configuration in which acoustic input from a hearing aid on 1 ear is combined with electrical stimulation from a cochlear implant on the other ear. The current guidelines aim to review the literature and provide best practice recommendations for the evaluation and treatment of individuals with bilateral sensorineural hearing loss who may benefit from bimodal hearing configurations. Specifically, the guidelines review: benefits of bimodal listening, preoperative and postoperative cochlear implant evaluation and programming, bimodal hearing aid fitting, contralateral routing of signal considerations, bimodal treatment for tinnitus, and aural rehabilitation recommendations.

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