Objectives: To assess subjectively perceived, real-world benefits longitudinally for unilateral cochlear implant (CI) recipients in a multinational population treated routinely. To identify possible predictors of self-reported benefits. Design: This was a prospective, multicenter, repeated-measures study. Self-assessment of performance at preimplantation and postimplantation at 1, 2, and 3 years using standardized, validated, local language versions of the Speech, Spatial, and Qualities of Hearing Scale (SSQ), and the Health Utilities Index Mark 3 (HUI3) was performed. Outcomes were analyzed using a longitudinal mixed-effects model incorporating country effect. Patient demographics were explored for associations with change over time. Subjects: Two hundred ninety-one routinely treated, unilateral CI recipients, aged 13-81 years, from 9 clinics across 4 countries. Results: Highly significant improvements were observed for all outcome measures (p < 0.0001). Postimplantation, mean outcome scores remained stable beyond 1 year, with notable individual variability. A significant association for one or more outcomes with preimplantation contralateral hearing aid use, telephone use, age at implantation, implantation side, preimplantation comorbidities, dizziness, and tinnitus was observed (p < 0.004). Conclusions: Longitudinal benefits of CI treatment can be measured using clinically standardized self-assessment tools to provide a holistic view of patient-related benefits in routine clinical practice for aggregated data from multinational populations. Self-reported outcomes can provide medical-based evidence regarding CI treatment to support decision-making by health service providers.

The aim of this study was to assess the qualitative and quantitative benefits for speech-recognition ability of a preprocessing strategy known as adaptive dynamic range optimization (ADRO), used in conjunction with the subject's standard MAP, in comparison with the subject's standard MAP alone, for a group of experienced German-speaking adults using the Nucleus 24 Cochlear implant. In a prospective, single-subject, comparative study design, experienced adult CI-users were asked to trial and compare both their standard MAP and the newly fitted ADRO MAP (ADRO MAP fitting - week 0) following a take-home trial period of 5 weeks. Assessment of speech recognition ability performed in quiet (at 50, 60 and 70 dB SPL) and adaptively in noise was carried out repeatedly in two test sessions in weeks 5 and 7 (ADRO MAP postfitting) using both MAPs. The order of speech tests and MAPs tested was counterbalanced across the test sessions to control for potential learning effects during the study. Subjective assessments were performed at week 0 to assess details of current usage. Comparative subjective assessments were carried out at weeks 5 and 7 to obtain impressions of loudness of environmental sounds and speech understanding in a variety of conversational situations with both MAPs and finally MAP preference judgements. Fifteen adult, German-speaking, experienced implant users wearing their body-worn SPrint processor for a minimum of six hours and up to 16 hours per day were enrolled in the study across three university clinic hospitals in Germany. On average, speech-reception thresholds (SRT) were significantly improved with the ADRO MAP compared to using the standard MAP for all speech materials in quiet. The mean advantage for SRT values with the ADRO MAP was 2.9 dB, sigma +/- 2.8 dB (p = 0.002) for the Freiburger Numbers test and 3.3 dB, sigma +/- 3.2 dB (p = 0.008) for the Freiburger Monosyllabic Words test. In noise, the ADRO MAP led to a significant improvement for the group for the mean signal-to-noise ratio required for a 50% speech recognition score (SNR 50) for the Oldenburger sentences of 1.74 dB, sigma +/- 3.2 dB (p = 0.048). Comparison of subjective impressions of loudness of environmental sounds revealed no significant difference in the ratings observed with either MAP. For speech understanding in a variety of listening situations, 35% of subjects preferred the ADRO MAP, 29% preferred the standard MAP whereas 36% reported no difference. Statistically the MAP preferences for the groups were not significant, however a significant MAP preference was noted in four subjects for the ADRO MAP and in two subjects for the standard MAP. Our study results demonstrate significant benefits of ADRO for speech recognition ability in quiet and in noise for both soft and conversational levels of speech. For the majority of subjects, both the ADRO and standard MAPs were found to be useful on a daily basis. No reductions in performance were noted for speech recognition or loudness scaling judgements of environmental sounds when usi...

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Background Registries are powerful clinical investigational tools. Although in hospitals registries may be mandated, industry-sponsored, international registries are voluntary and therefore can require clearer objectives and more planning. The registry also needs sufficient resources and appropriate measurement tools to motivate long-term participation and ensure success. Methods We summarize our learnings from 10 years of running a medical device registry that surveys patient-reported benefits of hearing implants. Results We enlisted 77 participating clinics globally, who actively recruited a total of more than 1500 hearing implant users. We identified the stages in developing a registry specific to hearing loss. Furthermore, we report the challenges and successes in design and implementation and make recommendations for future registries. Conclusions Data collection infrastructure needs to be kept up to date throughout the defined registry lifetime, and it is essential to oversee data quality and completeness. Compliance at registry sites is important for data quality and needs to be weighed against the cost of site monitoring. To motivate sites to enter data accurately and expeditiously, we facilitated easy access to their own data which helped to support their clinical routine. Trial registration ClinicalTrials.gov NCT02004353. 9th December 2013.

Purpose Cochlear implantation can restore access to sound and speech understanding in subjects with substantial hearing loss. The Health Utilities Index Mark III (HUI3) measures the impact of an intervention on the patient’s quality of life and is sensitive to changes in hearing. In the current study we used factor analysis to predict a clinically important gain in HUI3 scores in adult cochlear implant recipients. Methods Data were collected in an observational study for 137 adult recipients from a single center who had at least 1-year HUI3 follow-up. Demographic and other baseline parameters were retrospectively analyzed for their association with a clinically important HUI3 scale gain, defined as at least 0.1 points. Data were also collected for the speech spatial qualities (SSQ) scale. Results Baseline telephone use and HUI3 hearing, speech and emotion attribute levels were significantly associated with clinically important gains in HUI3 scores. However, SSQ scores increased significantly with or without clinically important HUI3 gains. Conclusion Those subjects who were unhappy or experienced difficulties communicating with strangers or in a group were twice as likely to obtain a clinically important gain in health utility compared to those who were happy or had less difficulty communicating. Subjects who were unable to use the telephone prior to cochlear implantation were one and a half times more likely to obtain a clinically important gain. The SSQ scale was more sensitive to hearing improvements due to cochlear implantation. An inability to use the telephone is an easy to assess biomarker for candidacy for cochlear implantation.