Cochlear implantation has become the standard of care for the millions of adults with severe-to-profound sensorineural hearing loss. Despite advances in cochlear implant (CI) technologies, speech recognition outcomes remain highly variable.^1,2 Reasons for this variability are uncertain but likely involve several device-specific and patient-specific factors. Some of the device-specific variables that have been studied include signal processing strategies,^3-7 intracochlear electrode location,^8-15 and operative approach.^16-19 However, intrinsic patient-specific demographic and audiologic factors, including age at implantation, duration of hearing loss, preimplant audiologic measurements, and hearing aid (HA) use prior to implantation, likely affect CI outcomes independent from these device-related variables.

Objective: Determine the change in general health-related quality of life (HRQOL) after cochlear implantation and association with speech recognition. Study Design: Meta-analysis. Methods: Search was performed following the PRISMA statement using PubMed, Medline, Scopus, and CINAHL. Studies on adult cochlear implant (CI) patients measuring HRQOL before and after cochlear implantation were included. Standardized mean difference (SMD) for each measure and pooled effects were determined. A meta-analysis of correlations was also performed between all non-disease-specific patient-reported outcome measures (PROMs) and speech recognition after cochlear implantation. Results: Twenty-two articles met criteria for meta-analysis of HRQOL improvement, but 15 (65%) were excluded due to incomplete statistical reporting. From the seven articles with 274 CI patients that met inclusion criteria, pooled analyses showed a medium positive effect of cochlear implantation on HRQOL (SMD = 0.79). Subset analysis of the HUI-3 measure showed a large effect (SMD = 0.84). Nine articles with 550 CI patients met inclusion criteria for meta-analysis of correlations between non-disease specific PROMs and speech recognition after cochlear implantation. Pooled analysis showed a low correlation between non-disease-specific PROMs and word recognition in quiet (r = 0.35), sentence recognition in quiet (r = 0.40), and sentence recognition in noise (r = 0.32). Conclusion: Although regularly used, HRQOL measures are not intended to measure nor do they accurately reflect the complex difficulties facing CI patients. Only a medium positive effect of cochlear implantation on HRQOL was observed along with a low correlation between non-disease-specific PROMs and speech recognition. The use of such instruments in this population may underestimate the benefit of cochlear implantation.

Objective: Validated and reliable patient-reported outcome measures (PROMs) may provide a comprehensive and accurate assessment of the real-world experiences of cochlear implant (CI) users and complement information obtained from speech recognition outcomes. To address this unmet clinical need, the Cochlear Implant Quality of Life (CIQOL)-35 Profile instrument and CIQOL-10 Global measure were developed according to the Patient-Reported Outcomes Information System (PROMIS) and COnsensus-based Standards for the Selection of health status Measurement INstruments (COSMIN) guidelines. The CIQOL-35 Profile consists of 35 items in six domain constructs (communication, emotional, entertainment, environment, listening effort, and social) and the CIQOL-10 Global contains 10 items that provide an overall CIQOL score. The present study compares psychometric properties of the newly developed CIQOL instruments to two legacy PROMs commonly used in adult CI users. Design: Using a prospective cohort design, a sample of 334 adult CI users recruited from across the United States provided responses to (1) the CIQOL instruments; (2) a CI-specific PROM (Nijmegen Cochlear Implant Questionnaire, NCIQ); and (3) a general-health PROM (Health Utilities Index 3 [HUI-3]). Responses were obtained again after 1 mo. The reliability and validity of the CIQOL-35 Profile and CIQOL-10 Global instruments were compared with the legacy PROMs (NCIQ and HUI-3). Psychometric properties and construct validity of each instrument were analyzed using confirmatory factor analysis, item response theory (IRT), and test-retest reliability (using Pearson’s correlations), where appropriate. Results: All six CIQOL-35 Profile domains and the CIQOL-10 Global instrument demonstrated adequate to strong construct validity. The majority of the NCIQ subdomains and NCIQ total score had substantial confirmatory factor analysis model misfit, representing poor construct validity. Therefore, IRT analysis could only be applied to the basic sound performance and activity limitation subdomains of the NCIQ. IRT results showed strong psychometric properties for all CIQOL-35 Profile domains, the CIQOL-10 Global instrument, and the basic sound performance and activity limitation subdomains of the NCIQ. Test-retest reliability was strong for the CIQOL-35 Profile, CIQOL-10 Global, and NCIQ, but moderate to weak for the HUI-3; the hearing score of the HUI-3 demonstrated the weakest reliability. Conclusion: The CIQOL-35 Profile and CIQOL-10 Global are more psychometrically sound and comprehensive than the NCIQ and the HUI-3 for assessing QOL in adult CI users. Due to poor reliability, we do not recommend using the HUI-3 to measure QOL in this population. With validation and psychometric analyses complete, the CIQOL-35 Profile measure and CIQOL-10 Global instrument are now ready for use in clinical and research settings to measure QOL and real-world functional abilities of adult CI users.