Adaptation of the Cochlear Implant Quality of Life-35 Profile Into German.

PURPOSE: The adaptation of existing questionnaires is a valuable method to make instruments available in multiple languages. It is necessary to assure the quality of an adaptation by following adaptation guidelines. The Cochlear Implant Quality of Life-35 Profile (CIQOL-35 Profile) was developed and validated to measure the functional abilities in English-speaking adult CI users but is not yet available in German. In this study, we performed a cross-cultural adaptation of this instrument to make it applicable in research and rehabilitation with German-speaking patients. METHOD: This study followed established practice guidelines for translating and adapting hearing-related questionnaires. Professional translators and health care professionals with experience with patients with hearing loss translated all items forward and backward multiple times. A committee reviewed the process and decided when a satisfactory consensus was achieved. Next, we examined the intelligibility of the German version using cognitive interviews with 15 adult CI users. RESULTS: For most items, there was no difficulty with direct translation. In items that turned out to be more difficult to translate, it proved to be very helpful to compare the back translation to the original version, discuss the wording in the committee, and ask the source-language questionnaire developer. During the interviews, issues of comprehension for some phrases were identified. These phrases were changed according to the participant's questions and suggestions. CONCLUSIONS: The CIQOL-35 Profile was successfully adapted into German. The German version of the questionnaire is now available for research and clinical practice. Further validation of the German CIQOL-35 Profile is in progress. SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.25386571.

Computer-based Auditory Training by New Adult Cochlear Implant Recipients Is Associated With Durable Improvements in Cochlear Implant Quality of Life.

OBJECTIVE: The process of adapting to communicate with a cochlear implant (CI) is complex. The use of auditory training after cochlear implantation may help to facilitate improvements in postoperative speech recognition and quality-of-life outcomes in new adult CI recipients. However, the effectiveness of auditory training remains uncertain and long-term effects have not been examined in a large sample of new adult CI users. As such, the objective of this study was to examine the influence of common forms of auditory training on speech recognition and CI-related quality-of-life (CI-related QOL) outcomes at 1 year after cochlear implantation. We hypothesized that patients who reported use of computer-based auditory training (CBAT) would show improved speech and CIQOL-35 Profile scores at 1 year after activation of their implant, compared with their peers. DESIGN: This study was designed as a prospective study and was undertaken at a tertiary academic CI center. Participants included 114 adults undergoing cochlear implantation for bilateral hearing loss. Patients serially self-reported use of the following types of post-CI auditory training over their first-year postactivation: (1) face-to-face training (e.g., speech-language pathologist), (2) passive home-based training (e.g., listening to audiobooks), and (3) CBAT (e.g., self-directed software). Outcomes measures for this study included change in Consonant-Nucleus-Consonant phoneme (CNCp), CNC word (CNCw), AzBio sentences in quiet, and CIQOL-35 Profile global and domain scores from pre-CI to 12-mo post-CI. RESULTS: Of 114 patients, 94 (82.5%) used one or more auditory training resources. Of these, 19.3% used face-to-face training, 67.5% passive home-based training, and 46.5% CBAT. Of 114 patients, 73 had complete CIQOL data. At 12 mo, only CBAT use was associated with significantly greater improvements in global and all domain-specific CIQOL scores (d-range = 0.72-0.87), compared with those not using CBAT. Controlling for demographics and use of multiple training resources, CBAT remained the strongest positive predictor of CIQOL improvement, with significant associations with global score (ß = 12.019[4.127,19.9]) and all domain scores at 12-mo post-CI: communication (ß = 11.937[2.456,21.318), emotional (ß = 12.293[1.827,22.759), entertainment (ß = 17.014[5.434,28.774), environment (ß = 13.771[1.814,25.727]), listening effort (ß = 12.523[2.798,22.248]), and social (ß = 18.114[7.403,28.826]). No significant benefits were noted with use of CBAT or any other form of auditory training and speech recognition scores at 12-mo post-CI (d-range = -0.12-0.22). CONCLUSIONS: Auditory training with CBAT was associated with improved CI-related QOL outcomes at 12-mo post-CI. Given its availability and low cost, this study provides evidence to support using CBAT to improve real-world functional abilities in new adult CI recipients.

Short Postoperative Length of Stay After Lateral Cerebrospinal Fluid Leak Repair.

OBJECTIVE: To characterize the short-term outcomes of patients undergoing surgical repair of lateral skull base cerebrospinal fluid (CSF) leaks followed by a shortened length of stay (LOS) protocol. STUDY DESIGN: Retrospective study. SETTING: Tertiary medical center. METHODS: A total of 156 adult patients from July 2016 to December 2022 who underwent repair of CSF leaks via transmastoid (TM), middle cranial fossa (MCF), or combined (TM/MCF) approaches were included. Data collected included: LOS, presentation to the emergency department (ED), need for readmission, major neurologic complications (stroke, seizure, and meningitis), and CSF leak recurrence. RESULTS: Approximately half of patients underwent a TM repair (49.4%), whereas the other half underwent either an MCF (3.8%) or combined TM/MCF repair (46.8%). No peri-/postoperative lumbar drains were used and only 2 (1.3%) patients were admitted to the intensive care unit after surgery. Mean LOS for the cohort was 1.1 ± 0.7 days and was longer for surgeries involving MCF (1.3 ± 0.6) compared to TM (0.8 ± 0.7). Ninety-two percent of TM cases were discharged within 24 hours (32% on the same day) while for cases involving an MCF approach, 72.2% of patients were discharged within 24 hours. Of the patients in the study, 6 (3.8%) presented to an ED for minor complications and no patient required readmission. Revision surgery was required for 3 (1.9%) patients for recurrent CSF leak. CONCLUSION: Our findings suggest that short LOS after surgical repair of lateral skull base defects in the treatment of CSF leak is safe and effective.

Frequency-to-Place Mismatch Impacts Cochlear Implant Quality of Life, But Not Speech Recognition.

OBJECTIVE: To retrospectively compare frequency-place mismatch among adult cochlear implant (CI) recipients with lateral wall (LW) and perimodiolar/Mid Scala (PM/MS) arrays, and to quantify the impact of these factors on early post-activation (3 months) speech recognition abilities and CI-specific quality of life. METHODS: One hundred and twenty-six adult participants were separated into two groups: (1) 83 participants who underwent CI with a PM/MS array and 43 patients who underwent CI with a LW array. All participants completed the Cochlear Implant Quality of Life Profile (CIQOL-35 Profile) instrument. Angular insertion depth and semitone mismatch, which contribute to frequency-place mismatch, were assessed using post-operative CT scans. Word and speech recognition in quiet were determined using the Consonant-Nucleus-Consonant (CNC) and the AzBio tests, respectively (n = 82 patients). RESULTS: LW arrays were more deeply inserted and exhibited less semitone mismatch compared to PM/MS arrays. No significant relationship was found between semitone mismatch and early post-operative speech perception scores for either PM/MS or LW arrays. However, greater degrees of semitone mismatch were associated with lower CIQOL-35 profile scores for PM/MS arrays. CONCLUSIONS AND RELEVANCE: The results of this study indicate that both the degree of frequency-place mismatch, and its impact on CI-specific quality of life, vary by CI array design. LEVEL OF EVIDENCE: 4 Laryngoscope, 2024.

Systematic Review of Auditory Training Outcomes in Adult Cochlear Implant Recipients and Meta-Analysis of Outcomes.

Objective: to review evidence on the efficacy of auditory training in adult cochlear implant recipients. Data Sources: PRISMA guidelines for a systematic review of the literature were followed. PubMed, Scopus, and CINAHL databases were queried on 29 June 2023 for terms involving cochlear implantation and auditory training. Studies were limited to the English language and adult patient populations. Study Selection: Three authors independently reviewed publications for inclusion in the review based on a priori inclusion and exclusion criteria. Inclusion criteria encompassed adult cochlear implant populations, an analysis of clinician- or patient-directed auditory training, and an analysis of one or more measures of speech recognition and/or patient-reported outcome. Exclusion criteria included studies with only pediatric implant populations, music or localization training in isolation, and single-sample case studies. Data Extraction: The data were collected regarding study design, patient population, auditory training modality, auditory training timing, speech outcomes, and data on the durability of outcomes. A quality assessment of the literature was performed using a quality metric adapted from the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group guidelines. Data Synthesis and Meta-Analysis: Data were qualitatively summarized for 23 studies. All but four studies demonstrated significant improvement in at least one measured or patient-reported outcome measure with training. For 11 studies with sufficient data reporting, pre-intervention and post-intervention pooled means of different outcome measures were compared for 132 patients using meta-analysis. Patient-direct training was associated with significant improvement in vowel-phoneme recognition and speech recognition in noise (p < 0.05 and p < 0.001, respectively), and clinician-directed training showed significant improvement in sentence recognition in noise (p < 0.001). Conclusions: The literature on auditory training for adult cochlear implant recipients is limited and heterogeneous, including a small number of studies with limited levels of evidence and external validity. However, the current evidence suggests that auditory training can improve speech recognition in adult cochlear implant recipients.

Item Level Psychometrics of the Dizziness Handicap Inventory in Vestibular Migraine and Meniere's Disease.

OBJECTIVES: Evaluate the measurement properties of the Dizziness Handicap Inventory (DHI) using item response theory in patients diagnosed with vestibular migraine (VM) and Meniere's disease (MD). DESIGN: One hundred twenty-five patients diagnosed with VM and 169 patients diagnosed with MD by a vestibular neurotologist according to the Bárány Society criteria in two tertiary multidisciplinary vestibular clinics and who completed the DHI at their initial visit, were included in the study. The DHI (total score and individual items) was analyzed using the Rasch Rating Scale model for patients in each subgroup, VM and MD, and as a whole group. The following categories were assessed: rating-scale structure, unidimensionality, item and person fit, item difficulty hierarchy, person-item match, and separation index, standard error of measurement, and minimal detectable change (MDC). RESULTS: Patients were predominantly female (80% of the VM subgroup and 68% of the MD subgroup) with a mean age of 49.9 ± 16.5 years and 54.1 ± 14.2 years, respectively. The mean total DHI score for the VM group was 51.9 ± 22.3 and for the MD group was 48.5 ± 26.6 ( p > 0.05). While neither all items nor the separate constructs met all criteria for unidimensionality (i.e., items measuring a single construct), post hoc analysis showed that the all-item analysis supported a single construct. All analyses met the criterion for showing a sound rating scale and acceptable Cronbach's alpha (≥0.69). The all-item analysis showed the most precision, separating the samples into three to four significant strata. The separate-construct analyses (physical, emotional, and functional) showed the least precision, separated the samples into less than three significant strata. Regarding MDC, the MDC remained consistent across the analyses of the different samples; approximately 18 points for the full analyses and approximately 10 points for the separate construct (physical, emotional, and functional). CONCLUSIONS: Our evaluation of the DHI using item response theory shows that the instrument is psychometrically sound and reliable. The all-item instrument fulfills criteria for essential unidimensionality but does seem to measure multiple latent constructs in patients with VM and MD, which has been reported in other balance and mobility instruments. The current subscales did not show acceptable psychometrics, which is in line with multiple recent studies favoring the use of the total score. The study also shows that the DHI is adaptable to episodic recurrent vestibulopathies. The total score shows better precision and separation of subjects in up to four strata compared to the separate construct that separate subjects into less than three strata. The measurement error smallest detectable change was found in our analysis to be 18 points, which means any change in the DHI of less than 18 points is not likely to be clinically significant. The minimal clinically important difference remains indeterminate.

Determinants of Cochlear Implant Satisfaction and Decisional Regret in Adult Cochlear Implant Users.

OBJECTIVE: Determine associations expected and actual cochlear implant (CI) outcomes, decisional regret, and satisfaction in experienced adult CI users. STUDY DESIGN: Cross-sectional cohort study. SETTING: Tertiary medical center. PATIENTS: Thirty-nine adult CI users meeting traditional bilateral hearing loss indications with ≥12 months CI experience. INTERVENTIONS/MAIN OUTCOME MEASURES: Patients completed the validated Satisfaction with Amplification in Daily Living and Decisional Regret instruments. Pre- and post-CI outcomes (CI Quality of Life [CIQOL]-Expectations; CIQOL-35 Profile; CNC words, AzBio Sentences) were obtained from a prospectively maintained clinical database. RESULTS: Using established cutoff scores, 29% of patients reported a substantial degree of post-CI decisional regret. For each CIQOL domain, patients without decisional regret obtained post-CI outcome scores closer to pre-CI expectations compared with patients with decisional regret ( d = 0.34 to 0.91); similar results were observed with higher CI user satisfaction ( d = 0.17-0.83). Notably, the degree of pre- to post-CI improvement in CNC or AzBio scores did not differ between patients with and without decisional regret or with lower and higher satisfaction. Finally, greater pre-/postimprovement in CIQOL-35 Profile domain scores demonstrated far stronger associations with lower decisional regret and higher satisfaction than changes in speech recognition scores. CONCLUSIONS: Patients with better alignment of their pre-CI expectations and post-CI outcomes and greater pre-/post-CIQOL improvement had lower decisional regret and higher satisfaction. This emphasizes the importance of evidence-based pre-CI counseling regarding real-world CI benefits and caution against assuming that improvements in speech recognition are related to patient satisfaction.

Discrepancies Between Expected and Actual Cochlear Implant-Related Functional Outcomes.

OBJECTIVE: Previous research has demonstrated that realistic patient expectations are a critical factor in determining cochlear implant (CI) candidacy. The current study uses the validated Cochlear Implant Quality of Life-Expectations (CIQOL-Expectations) instrument to determine expectations of potential CI users and the degree to which their pre-CI expectations are met after implantation. STUDY DESIGN: Prospective cohort study. SETTING: Tertiary medical center. PATIENTS: Sixty adult CI patients. INTERVENTIONS/MAIN OUTCOME MEASURES: Pre-CI aided and post-CI consonant-nucleus-consonant word and AzBio sentence scores, pre-CI CIQOL-Expectations, and pre-CI and 3/6/12-month post-CI CIQOL-35 Profile scores. RESULTS: Mean pre-CI CIQOL-Expectations exceeded 12-month mean CIQOL-35 Profile scores for the global measure and the communication, environment, and listening effort domains ( d = 0.65-0.97). The communication and listening effort domain scores had the largest discrepancy between expected and actual post-CI improvement (actual scores, 15.1 and 16.3 points lower than expected [ d = 0.93-0.97], respectively). For 42% of patients, pre-CI global expectations exceeded 12-month post-CI CIQOL-35 Profile global scores, 49% met their expectations, and actual scores exceeded expectations for only 10% of patients. Similar patterns were seen for all CIQOL domains except emotional. CONCLUSIONS: Post-CI functional abilities seem to fall short of pre-CI expectations for a substantial percentage of CI users, which was most apparent for the communication and listening effort CIQOL domains. These results may help clinicians direct personalized counseling toward common misconceptions, which can aid shared decision making and potentially minimize the mismatch between expected and realized outcomes.Level of Evidence: III.IRB Pro00073019, approved December 20, 2017 (Medical University of South Carolina).

Development and Chinese Cross-Cultural Adaptation of the Cochlear Implant Quality-of-Life Survey.

OBJECTIVE: To conduct the Chinese cross-cultural adaptation of the Cochlear Implant Quality of Life-10 Global (CIQOL-10 Global) instrument. PATIENTS: Bilingual Chinese American cochlear implant users. INTERVENTION: Chinese cross-cultural adaptation of the CIQOL-10 Global. MAIN OUTCOME MEASURE: Description of the process of Chinese cross-cultural adaptation of the CIQOL-10 Global and pilot testing of the Chinese CIQOL-10 Global in the target patient population. RESULTS: The CIQOL-10 Global was cross-culturally adapted into Chinese. Ten participants were recruited for pilot testing. There was wide representation from across the target population in terms of age (mean, 44.8 yr; range, 20.2-80.3 yr), sex (5 were male, 5 were female), education, and socioeconomic factors. All participants were able to easily read, comprehend, and fill out the Chinese CIQOL-10 Global. CONCLUSIONS: The Chinese version of the CIQOL-10 Global is now available to provide an overall assessment of quality of life of Chinese-speaking cochlear implant users.

Impact of Patient Frailty on Speech Recognition and Quality of Life Outcomes in Adult Cochlear Implant Users.

OBJECTIVE: The process of cochlear implantation (CI) and subsequent post-cochlear implant care is extensive and can be difficult to navigate for patients considered medically frail. This study investigates potential impact of patient frailty on speech recognition and quality of life outcomes after CI. STUDY DESIGN: Retrospective review of a prospectively maintained database. SETTING: Tertiary cochlear implant center. PATIENTS: Three hundred seventy adults undergoing CI for traditional bilateral hearing loss indication. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Comparison of pre-CI to 12-month post-CI change in consonant-nucleus-consonant phoneme/words, AzBio sentences in quiet/+10SNR, and Cochlear Implant Quality of Life (CIQOL)-35 Profile domain and global scores based on degree of patient frailty as assessed using the five-factor modified frailty index and Charlson Comorbidity Index. RESULTS: The average age at implantation was 65.4 years (±SD, 15.7; 19-94 years). Overall, there were minimal to absent and nonsignificant differences in speech recognition outcomes (consonant-nucleus-consonant phoneme/words, and AzBio sentences +10SNR) based on pre-CI patient frailty. The exception was less improvement in AzBio quiet sentence score in patients noted to be severely frail based on Charlson Comorbidity Index (57.1% vs. 35.2%, d = 0.7 [0.3, 1]). Similar findings were observed for CIQOL-35 Profile domain and global scores where no associations were found other than decreased improvement in the social domain in patients noted to be severely frail (21.7 vs. -0.3, d = 1 [0.4, 1.7]). CONCLUSIONS: Although some differences in outcomes were noted based on cochlear implant user frailty, these were small and isolated to only a few outcome measures. Therefore, assuming the patient is medically safe for surgery, preoperative frailty should not dissuade clinicians from recommending CI.

Conditional Minimal Detectable Change for the Cochlear Implant Quality of Life-35 Profile Associated With Improved Functional Abilities 12 Months After Cochlear Implantation.

Importance: It is essential to measure an individual patient's baseline and follow-up abilities to demonstrate changes in clinical outcomes over time. Inherent in this strategy is interpreting whether the measured change is clinically significant and beyond measurement error. Conditional minimal detectable change (cMDC) values are widely used in many disciplines but have rarely been established for outcome measures in otolaryngology or hearing research, and never in cochlear implantation. Objective: To determine cMDC values for the Cochlear Implant Quality of Life-35 (CIQOL-35) Profile instrument to enhance our understanding of the initial and ongoing changes in functional abilities from cochlear implants (CIs). Design, Setting, and Participants: Item response theory analyses of responses from a multi-institutional cohort of 705 CI users at a tertiary CI center were used to derive standard error (SE) values for each possible CIQOL-35 domain score. Using an iterative approach, these SE values were used to calculate cMDC values for every possible pre-CI and post-CI domain score combination. We then compared pre-CI to 12-month post-CI CIQOL-35 domains scores in an independent cohort of 65 adult CI users to determine whether the measured change exceeded error to be clinically significant. The analysis took place on December 14, 2022. Interventions: The CIQOL-35 Profile instrument and cochlear implantation. Results: The cMDC values were smaller for the communication domain, and global measure and cMDC values for all domains were larger at the extremes of the measurement scale. Overall, 60 CI users (92.3%) demonstrated improvement beyond cMDC at 12 months post-CI for at least 1 CIQOL-35 domain, and no patients' scores declined beyond cMDC for any domain. The percentage of CI users demonstrating improvement beyond cMDC varied by domain, with communication (53 [81.5%]) showing the largest number of CI users improving, followed by global (42 [64.6%]) and entertainment (40 [60.9%]). In general, CI users who demonstrated improvement in CIQOL-35 domains had greater improvement in speech recognition scores than patients who did not, but the strength and significance of these associations greatly varied by domain and speech material. Conclusions and Relevance: This multistep cohort study found that cMDC values for the CIQOL-35 Profile provided personalized thresholds for detecting real changes in patient self-reported functional abilities over time across multiple domains, which may inform clinical decision-making. Moreover, these longitudinal results reveal the domains with more or less improvement, which may aid in patient counseling.

Impact of auditory environments on language outcomes in children with a cochlear implant.

OBJECTIVES: To analyse the effects of auditory environments on receptive and expressive language outcomes in children with a CI. DESIGN: A single-institution retrospective review was performed. The auditory environments included Speech-Noise, Speech-Quiet, Quiet, Music, and Noise. Hearing Hour Percentage (HHP) and percent total hours were calculated for each environment. Generalised Linear Mixed Models (GLMM) analyses were used to study the effects of auditory environments on PLS Receptive and Expressive scores. STUDY SAMPLE: Thirty-nine children with CI. RESULTS: On GLMM, an increase in Quiet HHP and Quiet percent total hours were positively associated with PLS Receptive scores. Speech-Quiet, Quiet, and Music HHP were positively associated with PLS Expressive scores, with only Quiet being significant for percent total hours. In contrast, percent total hours of Speech-Noise and Noise had a significant negative association with PLS Expressive scores. CONCLUSIONS: This study suggests that more time spent in a quiet auditory environment positively influences PLS Receptive and Expressive scores and that more time listening to speech in quiet and music positively influences PLS Expressive scores. Time spent in environments recognised as Speech-Noise and Noise might negatively impact a child's expressive language outcomes with a CI. Future research is needed to better understand this association.

Why Do Candidates Forgo Cochlear Implantation?

OBJECTIVE: Identify barriers and facilitating factors in cochlear implant (CI) utilization by comparing functional measures between CI candidates who undergo or forgo implantation. METHODS: Forty-three participants were separated into two groups: (1) 28 participants who underwent CI and (2) 15 participants who elected not to proceed with CI despite meeting eligibility criteria (no-CI). Prior to implantation, all participants completed the CI Quality of Life (CIQOL)-35 Profile and CIQOL-Expectations instrument. They were also surveyed on factors contributing to their decision to either undergo or forgo CI. Word and speech recognition were determined using the Consonant-Nucleus-Consonant (CNC) and the AzBio tests, respectively. RESULTS: CIQOL-Expectations scores were indistinguishable between groups, but there were substantial differences in baseline CIQOL-35 Profile scores. Compared to the CI group, the no-CI group exhibited higher pre-CI scores in the Emotional (Cohen's d [95% CI] = 0.8 [0.1, 1.5]) and Entertainment (Cohen's d [95% CI] = 0.8 [0.1, 1.5]) domains. Survey data revealed that the most commonly reported barriers to pursuing CI in the no-CI cohort were fear of surgical complications (85%), cost associated with implantation (85%), and perception that hearing was not poor enough for CI surgery (85%). CONCLUSIONS AND RELEVANCE: The results of this study indicate that functional outcome expectations are similar between candidates who elect to receive or forgo CI, yet those who forgo CI have higher baseline CI-specific QOL abilities. LEVEL OF EVIDENCE: 4 Laryngoscope, 133:3548-3553, 2023.

Association of Cognitive Impairment Screening Scores With Improvements in Speech Recognition and Quality of Life After Cochlear Implantation.

Importance: Many cochlear implant centers screen patients for cognitive impairment as part of the evaluation process, but the utility of these scores in predicting cochlear implant outcomes is unknown. Objective: To determine whether there is an association between cognitive impairment screening scores and cochlear implant outcomes. Design, Setting, and Participants: Retrospective case series of adult cochlear implant recipients who underwent preoperative cognitive impairment screening with the Montreal Cognitive Assessment (MoCA) from 2018 to 2020 with 1-year follow-up at a single tertiary cochlear implant center. Data analysis was performed on data from January 2018 through December 2021. Exposures: Cochlear implantation. Main Outcomes and Measures: Preoperative MoCA scores and mean (SD) improvement (aided preoperative to 12-month postoperative) in Consonant-Nucleus-Consonant phonemes (CNCp) and words (CNCw), AzBio sentences in quiet (AzBio Quiet), and Cochlear Implant Quality of Life-35 (CIQOL-35) Profile domain and global scores. Results: A total of 52 patients were included, 27 (52%) of whom were male and 46 (88%) were White; mean (SD) age at implantation was 68.2 (13.3) years. Twenty-three (44%) had MoCA scores suggesting mild and 1 (2%) had scores suggesting moderate cognitive impairment. None had been previously diagnosed with cognitive impairment. There were small to medium effects of the association between 12-month postoperative improvement in speech recognition measures and screening positive or not for cognitive impairment (CNCw mean [SD]: 48.4 [21.9] vs 38.5 [26.6] [d = -0.43 (95% CI, -1.02 to 0.16)]; AzBio Quiet mean [SD]: 47.5 [34.3] vs 44.7 [33.1] [d = -0.08 (95% CI, -0.64 to 0.47)]). Similarly, small to large effects of the associations between 12-month postoperative change in CIQOL-35 scores and screening positive or not for cognitive impairment were found (global: d = 0.32 [95% CI, -0.59 to 1.23]; communication: d = 0.62 [95% CI, -0.31 to 1.54]; emotional: d = 0.26 [95% CI, -0.66 to 1.16]; entertainment: d = -0.005 [95% CI, -0.91 to 0.9]; environmental: d = -0.92 [95% CI, -1.86 to 0.46]; listening effort: d = -0.79 [95% CI, -1.65 to 0.22]; social: d = -0.51 [95% CI, -1.43 to 0.42]). Conclusions and Relevance: In this case series, screening scores were not associated with the degree of improvement of speech recognition or patient-reported outcome measures after cochlear implantation. Given the prevalence of screening positive for cognitive impairment before cochlear implantation, preoperative screening can be useful for early identification of potential cognitive decline. These findings support that screening scores may have a limited role in preoperative counseling of outcomes and should not be used to limit candidacy.

Patient-Related Factors Do Not Predict Use of Computer-Based Auditory Training by New Adult Cochlear Implant Recipients.

OBJECTIVE: The use of computer-based auditory training (CBAT) after cochlear implantation is associated with improved speech recognition and real-world functional abilities. However, patient-related factors associated with CBAT use remain unknown. This study seeks to identify such factors and recognize those at risk for not implementing CBAT. STUDY DESIGN: Prospective natural experiment. SETTING: Tertiary academic center. PATIENTS: A total of 117 new adult cochlear implant (CI) recipients with bilateral moderate-to-profound hearing loss. INTERVENTIONS/MAIN OUTCOME MEASURES: Patient demographic and lifestyle information, preimplantation aided speech recognition scores, Cochlear Implant Quality of Life (CIQOL) domain and global scores, CIQOL-Expectations scores, and CBAT use in the first 3 months after activation. Patient-related variables included age, sex, race, duration of hearing loss before implantation, hours of CI use per day, hearing-aid use before implantation, living arrangements/marital status, annual household income, employment, technology use, and education. RESULTS: Overall, 33 new CI users (28.2%) used CBAT in the first 3 months after activation. On bivariate analysis of the pre-CI CIQOL scores, CIQOL-Expectations score, aided speech recognition scores, and demographic/lifestyle factors examined, regular use of smartphone, tablet, or computer technology was significantly associated with an increased likelihood of CBAT use (odds ratio, 9.354 [1.198-73.020]), whereas higher CIQOL-Expectations emotional domain scores were associated with a lower likelihood of CBAT use (d = -0.69 [-1.34 to -0.05]). However, using multivariable analysis to control for potential confounding factors revealed no significant associations between CBAT use in the first 3 months after cochlear implantation and any examined factor. CONCLUSIONS: No associations between patient demographic, lifestyle, or pre-CI speech recognition and patient-reported outcome measures and CBAT use were identified. Therefore, discussions with all patients after implantation on the availability of CBAT and its potential benefits are warranted. In addition, given the limited overall use of CBAT and its association with improved CI outcomes, future studies are needed to investigate facilitators and barriers to CBAT use.

Longitudinal Speech Recognition Changes After Cochlear Implant: Systematic Review and Meta-analysis.

OBJECTIVES: To examine patterns of change and plateau in speech recognition scores in postlingually hearing impaired adult cochlear implant recipients. The study also examines variations in change patterns for different speech materials and testing conditions. STUDY DESIGN: Used systematic review with meta-analysis. METHODS: Articles in English reporting speech recognition scores of adults with postlingual hearing loss at pre-implantation and at least two post-implantation time points were included. Statistically significant changes were determined by meta-analysis and the 95% confidence interval. RESULTS: A total of 22 articles representing 1954 patients were included. Meta-analysis of mean difference demonstrated significant improvements in speech recognition score for words in quiet (37.4%; 95% confidence interval [34.7%, 40.7%]), sentences in quiet (49.4%; 95% confidence interval [44.9%, 53.9%]), and sentences in noise (30.8%; 95% confidence interval [25.2%, 36.4%]) from pre-op to 3 months. Scores continued to increase from 3 to 12 months but did not reach significance. Similarly, significant improvements from pre-op to 3 months were observed for consonant nucleus consonant (CNC) words in quiet (37.1%; 95% confidence interval [33.8%, 40.4%]), hearing in noise test (HINT) sentences in quiet (46.5%; 95% confidence interval [37.0%, 56.0%]), AzBio sentences in quiet (45.9%; 95% confidence interval [44.2%, 47.5%]), and AzBio sentences in noise (26.4%; 95% confidence interval [18.6%, 34.2%]). HINT sentences in noise demonstrated improvement from pre-op to 3 months (35.1%; 95% confidence interval [30.0%, 40.3%]) and from 3 to 12 months (15.5%; 95% confidence interval [7.2%, 23.8%]). CONCLUSIONS: Mean speech recognition scores demonstrate significant improvement within the first 3 months, with no further statistically significant improvement after 3 months. However, large individual variation should be expected and future research is needed to explain the sources of these individual differences. Laryngoscope, 133:1014-1024, 2023.

Development and Implementation of the Cochlear Implant Quality of Life (CIQOL) Functional Staging System.

OBJECTIVES: The purpose of this study is to develop and implement a functional staging system using the Cochlear Implant Quality of Life (CIQOL) framework. The CIQOL-35 Profile was developed and validated following a rigorous research design and found to be more comprehensive and psychometrically sound than previous patient-reported outcome measures (PROMs) applied to adult CI users. However, interpreting the CIQOL-35 Profile (and all PROMs) relative to real-world functioning remains difficult for patients and clinicians, which limits the capacity of PROMs to direct clinical care. To address this limitation, a functional staging system based on PROM scores was developed to provide detailed descriptions of patients' self-reported abilities (clinical vignettes) without sacrificing the inherent value of the psychometrically derived scores. The current study (1) creates an evidence-based CIQOL functional staging system using advanced psychometric techniques, (2) confirms the clarity and meaningfulness of the staging system with patients, and (3) implements the staging system to measure CIQOL stage progression using data from a longitudinal study design. METHODS: Item response theory (IRT) analyses of CIQOL-35 Profile data from 705 experienced adult CI users and expert opinion were used to determine the cut-scores that separated adjacent stages for the six CIQOL-35 domains (communication, emotional, entertainment, environment, listening effort, and social). The research team then created clinical vignettes based on item response patterns for each stage. Semi-structured key informant interviews were conducted with 10 adult CI users to determine the clarity and meaningfulness of the CIQOL stages and associated clinical vignettes. Finally, we prospectively collected CIQOL-35 Profile scores from 42 CI users prior to cochlear implantation and then at 3- and 6-months post-CI activation to measure CIQOL stage progression. RESULTS: Psychometric analyses identified five statistically distinct stages for the communication domain and three stages for all other domains. Using IRT analysis results for guidance, research team members independently identified the cut-scores that represented transitions between the functional stages for each domain with excellent agreement (κ = 0.98 [95% confidence interval 0.96-0.99]). Next, the key informant interviews revealed that CI users found the clinical vignettes to be clear and only minor changes were required. Participants also agreed that stage progression represented meaningful improvements in functional abilities. Finally, 88.1% of 42 patients in the prospective cohort (n = 37) improved from pre-CI functional stage by at least one functional stage in one or more domains. The communication domain had the greatest number of patients improve by one or more stages (59.5%) and the social domain the fewest (25.6%). There was also a trend for less improvement at 3- and 6-months post-CI activation for patients at higher pre-CI functional stages, even though higher stages were achievable. CONCLUSION: The new CIQOL functional staging system provides an evidence-based understanding of the real-world functional abilities of adult CI users from pre-CI to 3- to 6-months post-CI activation across multiple domains. In addition, study results provide the proportion of CI users in each stage at each timepoint. Results can be used during discussions of expectations with potential CI users to provide enhanced insight regarding realistic outcomes and the anticipated timing for improvements. The use of the CIQOL functional staging system also presents an opportunity to develop individualized goal-based rehabilitation strategies that target barriers to stage advancement faced by CI users. LEVEL OF EVIDENCE: 2 Laryngoscope, 132:S1-S13, 2022.

Understanding Patient Expectations Before Implantation Using the Cochlear Implant Quality of Life-Expectations Instrument.

Importance: Previous research suggests that clinicians view realistic patient expectations as the most important nonaudiological factor in the decision to proceed with a cochlear implant (CI). However, clinicians have few data to determine whether patients' outcome expectations are realistic. Objective: To address this unmet clinical need through the development and psychometric analysis of a new patient-reported outcome measure, the CI Quality of Life (CIQOL) Expectations. Design, Setting, and Participants: This cross-sectional study was conducted at a tertiary CI center from February 26, 2020, to August 31, 2021. First, a team comprising 2 CI audiologists, a CI surgeon, a hearing scientist, and 2 psychometricians with experience in instrument development converted all items from the CIQOL-35 Profile instrument into statements reflecting expected outcomes. Then, cognitive interviews with 20 potential CI users assessed the clarity and comprehensiveness of the new instrument. Next, responses to the CIQOL-Expectations instrument for 131 potential adult CI candidates were psychometrically analyzed using confirmatory factor analysis and item response theory. Finally, degree to which patient expectations changed from before to after and their CI evaluation appointments was measured. Intervention: The CIQOL-Expectations instrument. Results: Of 178 participants, 85 (47.8%) were female, and there was 1 (0.6%) Asian, 26 (14.6%) Black or African American, 1 (0.6%) Latinx, and 150 (84.3%) White individuals. No major content or grammar changes were identified during the cognitive interviews. Overall, all CIQOL domains demonstrated adequate to strong psychometric properties. Several domains did not meet all a priori established indicators of model fit or ability to separate CI users based on response patterns, but all met most indicators. Potential CI users demonstrated the highest mean (SD) expectation scores for the environment (70.2 [20.8]) and social (68.4 [18.0]) domains. In addition, the entertainment (20 [15.3%]) and environment (31 [24.4%]) domains had the highest percentage of patients with expectation scores of 100. Yet, normative CIQOL-35 Profile data from experienced CI users suggested few patients obtain this high degree of functional benefit after implant. Conclusions and Relevance: The results of this cross-sectional study suggest that the CIQOL-Expectations instrument may provide an opportunity to assess potential CI users' expected outcomes using modification of an established CIQOL instrument and a patient-centered framework. The included items and domains reflect real-world functional abilities valued by CI users and may provide opportunities for an evidence-based shared decision-making approach to the CI evaluation process. With this instrument, clinicians can compare individual patients' pre-CI outcome expectations with established normative data and provide appropriate counseling.

Normative Cochlear Implant Quality of Life (CIQOL)-35 Profile and CIQOL-10 Global Scores for Experienced Cochlear Implant Users from a Multi-Institutional Study.

OBJECTIVE: Although adult cochlear implant (CI) outcomes have primarily focused on speech recognition scores, the rigorous development of a CI-specific patient-reported outcome measure provides an opportunity for a more comprehensive and ecologically valid approach to measure the real-world functional abilities of adult CI users. Here, we report for the first time normative Cochlear Implant Quality of Life (CIQOL)-35 Profile and global scores and variance for a large, multi-institutional sample of adult CI users. STUDY DESIGN: Cross-sectional study design. SETTING: CI centers in the United States. PATIENTS: Seven hundred five adults with bilateral moderate to profound hearing loss with at least 1 year of CI use. INTERVENTIONS: Cochlear implantation. MAIN OUTCOME MEASURES: CIQOL-35 Profile and CIQOL-10 Global scores. RESULTS: During the development of the CIQOL instruments, 1,000 CI users from all regions of the United States were invited to participate in studies. Of these, 705 (70.5%) completed all portions of the study, and their data are reported here. Mean CIQOL domain scores were highest (indicating better function) for the emotional and social domains and lowest for listening effort. The entertainment and social domains demonstrated the widest distribution of scores and largest standard deviations, indicating greatest variability in function. Overall, there were minimal ceiling and floor effects for all domains. CONCLUSION: Normative scores from a large sample of experienced adult CI users are consistent with clinical observations, showing large differences in functional abilities and large variability. Normative CIQOL data for adult CI users have the potential to enhance preoperative discussions with CI candidates, improve post-CI activation monitoring, and establish standards for CI centers.

Pathogenesis and Etiology of Ménière Disease: A Scoping Review of a Century of Evidence.

IMPORTANCE: Ménière disease is a rare chronic benign disorder of the inner ear with a natural history of multiple clinical phenotypes of variable severity and a tendency to burnout with time. Although multiple treatment modalities have been shown to improve the disease process-some adversely affecting cochleovestibular function-it remains uncertain whether one, several separate, or a combination of pathophysiologic mechanisms affect the disease process. A scoping review of the evidence underlying proposed pathophysiologic mechanisms of Ménière disease is needed to determine which processes are most likely to be etiopathogenic factors. OBSERVATIONS: Of the 4602 relevant articles found through Embase, Ovid, and PubMed, 444 met inclusion criteria. The most common reported causes of Ménière disease were autoimmune or immune-mediated, genetic, or structural dysfunction of the inner ear. During the study period from inception to March 2021, etiologic theories shifted from structural dysfunction to autoimmune and genetic causes of Ménière disease. CONCLUSIONS AND RELEVANCE: This scoping review found that Ménière disease is a multifactorial disease with lifelong comorbidities and loss of quality-associated life-years whose most commonly reported causes were structural dysfunction, immunologic damage, and genetic susceptibility. Recent studies have examined how autoinflammatory processes and vestibular migraine may be associated with Ménière disease. Large heterogeneity among studies may be explained by historical differences in the clinical understanding of the disease, as well as evolving intervention methodologies and practitioner expertise. Ménière disease is a multifactorial disease with lifelong comorbidities and loss of quality-associated life-years; therefore, future studies of reliable biomarkers of endolymphatic hydrops and real-time imaging are warranted to improve understanding and treatment.