Factors contributing to clinically important health utility gains in cochlear implant recipients.

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.

Patient-Related Benefits for Adults with Cochlear Implantation: A Multicultural Longitudinal Observational Study.

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.

Speech understanding in noise for cochlear implant recipients using a spatial noise reduction setting in an off the ear sound processor with directional microphones.

PURPOSE: Cochlear implant (CI) recipients struggle to hear in competing background noise. ForwardFocus is a spatial noise reduction setting from Cochlear Ltd. (Sydney) that can simultaneously attenuate noise from multiple sources behind the listener. This study assessed hearing performance with ForwardFocus in an off-the-ear (OTE) sound processor. METHOD: Twenty-two experienced adult CI recipients participated. Speech reception data was collected in fixed noise acutely in the clinic. After three to five weeks take home experience, subjective impressions were recorded, and evaluations were conducted for speech reception in quiet and roving noise. RESULTS: Group mean speech reception thresholds (SRT) were below 0 dB in two spatially-separated noise test conditions when using ForwardFocus in the OTE sound processor. SRT were -8.5 dB (SD 2.9) in 4-talker babble roving in a rear hemi-field (S0Nrearhemi) and -3.9 dB (SD 3.3) in 12-talker babble presented laterally and behind (S0N3). Results in S0N3 were significantly better with ForwardFocus On (p = 0.0018). Subjective ratings with the OTE were comparable to, or better than, with their walk-in BTE or OTE sound processor. CONCLUSIONS: ForwardFocus provides significant benefits for speech recognition in competing background noise in an OTE sound processor. These results support clinicians in counselling CI recipients on potential sound processor options to consider.

Design, implementation, and management of an international medical device registry.

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.

Self-assessment of daily hearing function for implant recipients: A comparison of mean total scores for the Speech Spatial Qualities of Hearing Scale (SSQ49) with the SSQ12.

OBJECTIVE: To assess the relationship and agreement between mean total scores for the Speech Spatial Qualities of Hearing Scale (SSQ49) and the shorter SSQ12 to measure daily hearing function for a large group of auditory implant recipients. METHODS: Prospective, longitudinal self-assessment by 1013 implant recipients using the SSQ49 at preimplant and at annual post-implant intervals (one, two and three-years) via an international registry. Mean total scores were calculated for the SSQ49 and the extracted SSQ12 responses. Pearson correlation and Bland-Altman agreement were examined between the SSQ49, SSQ12 and transformed SSQ12 versions. Longitudinal mixed-effects models were used to compare changes over time. RESULTS: Very high correlation was shown between mean total scores for all versions while perfect agreement was not reached. Clinically acceptable agreement (<1.0 unit) between all versions was obtained with the transformed SSQ12 being least biased. All versions showed statistically significant improvement at one-year post-implant (>2.2 units; p < 0.001). CONCLUSIONS: All scale-versions showed comparable sensitivity to changes in self-reported hearing function over time. TheSSQ12 may be considered as a potential time-efficient self-assessment of hearing function for implant recipients in routine practice. Further research may involve independent repeated administration of each scale version.