Changes on clinical and participatory outcomes in people with severe-to-profound hearing loss after cochlear implantation: protocol of a multicentre prospective observational cohort study - Societal Merit of Intervention on Hearing Loss Evaluation (SMILE).

INTRODUCTION: Cochlear implantation (CI) is a (cost-)effective intervention for people with severe or profound hearing loss. Since its introduction experience increased and the technology evolved, leading to better results and relaxation of CI eligibility criteria. Meanwhile, with national healthcare costs increasing there is a need for evidence of healthcare technology's value. This protocol describes a study to investigate clinical and participatory outcomes after CI for the currently (expanded) eligible hearing impaired population. The study adds to the current evidence base through its multicentre design, long-term follow-up and use of participatory outcomes alongside standard clinical outcomes. METHODS: This multicentre prospective observational cohort study will include at least 156 adult patients with severe-to-profound hearing loss, approximately evenly divided into two groups (1, ages 18-65 years and 2, age >65 years). The measurements consist of audiometry, cognition tests, listening effort tests and multiple generic and disease specific questionnaires. Questionnaires will be administered twice before CI, soon after inclusion at CI referral and shortly before CI surgery, with an annual follow-up of 3 years after CI. The Impact on Participation and Autonomy questionnaire will be used to assess participation. Generalised models (linear, logistic, Poisson) will be used. Mixed effects models will be used to investigate changes over time while exploring differences in subgroups and the influence of covariates. ETHICS AND DISSEMINATION: The study has received ethical approval from the Medical Ethical Committee of all participating centres. The results could provide valuable insights into changes in participatory outcomes of people with severe-to-profound hearing loss after CI. Results will be disseminated through peer-reviewed journals, scientific conferences and professional and patient organisation meetings. TRIAL REGISTRATION NUMBER: NCT05525221.

Impact of Expanding Eligibility Criteria for Cochlear Implantation - Dynamic Modeling Study.

OBJECTIVES: Eligibility criteria for cochlear implantation (CI) are shifting due to technological and surgical improvements. The aim of this study was to explore the impact of further expanding unilateral CI criteria in those with severe hearing loss (HL) (61-80 dBHL) in terms of number of CI recipients, costs, quality of life, and cost-effectiveness. METHODS: A dynamic population-based Markov model was constructed mimicking the Dutch population in three age categories over a period of 20 years. Health states included severe HL (61-80 dBHL), profound HL (>81 dBHL), CI recipients, and no-CI recipients. Model parameters were based on published literature, (national) databases, expert opinion, and model calibration. RESULTS: If persons with severe HL would qualify and opt for CI similar to those with profound HL now, this would lead to a 6-7 times increase of new CI recipients and an associated increase in costs (€550 million) and QALYs (54.000) over a 20-year period (incremental cost utility ratio: 10.771 euros/QALY [2.5-97.5 percentiles: 1.252-23.171]). One-way-sensitivity analysis indicated that model outcomes were most sensitive to regaining employment, utility associated with having a CI, and costs of surgery and testing. CONCLUSION: Our findings suggest that expanding eligibility for CI to persons with severe HL could be a cost-effective use of resources. Clearly, however, it would require a significant increase in diagnostic, operative, and rehabilitative capacity. Our quantitative estimates can serve as a basis for a wider societal deliberation on the question whether such an increase can and should be pursued. LEVEL OF EVIDENCE: NA Laryngoscope, 133:924-932, 2023.

The effect of cochlear implantation on autonomy, participation and work in postlingually deafened adults: a scoping review.

PURPOSE: This scoping review examines the available evidence on the effect of unilateral cochlear implantation (CI) in adults with postlingual bilateral hearing loss on societal-related outcomes in terms of work, autonomy and participation. METHODS: Five databases were searched (Pubmed, Web of Science, Embase, PsycINFO and Cochrane Library). Publications were screened in three steps on inclusion criteria. Of the 4230 screened publications, 110 met the inclusion criteria and were assessed for data extraction regarding outcomes "work", "autonomy", "participation". Study characteristics and key findings are presented and narratively described. RESULTS: Twenty-seven publications were included and categorized into retrospective (n = 3), cross-sectional (n = 18) or prospective (n = 6) study designs. Measurement or identification of number of outcomes (no) were related to work (no = 20), participation (no = 9) and autonomy or independency (no = 10). Most studies indicated benefits of CI on these outcomes. However, some studies did not or indicated additional barriers for benefits. Eleven publications primarily aimed to study one or more of our primary outcomes. CONCLUSION: In this literature search, scientific databases are reviewed. The results indicate that there is a relatively small body of evidence regarding the effect of CI on the outcomes "work", "autonomy" and "participation". Even though there are some limitations of the current study including some overlap in outcome definitions, most included studies indicate a beneficial effect of CI on work, autonomy and participation. The lack of consensus in definitions and the small body of evidence indicates a need for additional prospective studies investigating the societal outcomes of CI in postlingually deafened adults.