A country-wide health policy in Chile for deaf adults using cochlear implants: Analysis of health determinants and social impacts.

BACKGROUND: Post-lingual deafness represents a critical challenge for adults' well-being with substantial public health burdens. One treatment of choice has been cochlear implants (CI) for people with severe to profound hearing loss (HL). Since 2018, Chile has implemented a high-cost policy to cover CI treatment, the "Ley Ricarte Soto" (LRS) health policy. However, wide variability exists in the use of this device. To date, no related study has been published on policy evaluation in Chile or other Latin American countries. OBJECTIVES: This study aimed to evaluate the impact of the LRS policy on the treatment success and labour market inclusion among deaf or hard of hearing (DHH) adults using CI. We examined and characterised outcomes based on self-reports about treatment success and occupation status between 2018 and 2020. DESIGN: We performed a prospective study using hospital clinical records and an online questionnaire with 76 DHH adults aged >15 who had received CIs since the introduction of the LRS policy in 2018. Using univariate and multivariate regression models, we investigated the relationship between demographic, audiological, and social determinants of health and outcomes, including treatment success for social inclusion (International Outcome inventory for Hearing Aids and CIs assessment: IOI-HA) and occupation status for labour market inclusion. RESULTS: Our study showed elevated levels of treatment success in most of the seven sub-scores of the IOI-HA assessment. Similarly, around 70% of participants maintained or improved their occupations after receiving their CI. We found a significant positive association between treatment success and market inclusion. Participants diagnosed at younger ages had better results than older participants in both outcomes. Regarding social determinants of health, findings suggested participants with high social health insurance and a shorter commute time to the clinic had better results in treatment success. For labour market inclusion, participants with high education levels and better pre- CI occupation had better post-CI occupation status. CONCLUSIONS: In evaluating the LRS policy for providing CIs for DHH adults in Chile, we found positive effects relating to treatment success and occupation status. Our study supports the importance of age at diagnosis and social determinants of health, which should be assessed by integrating public services and bringing them geographically closer to each beneficiary. Although evidence-based guidelines for candidate selection given by the LRS policy might contribute to good results, these guidelines could limit the policy access to people who do not meet the requirements of the guidelines due to social inequalities.

Evolution of the candidacy requirements and patient perioperative assessment protocols for cochlear implantation.

Cochlear implantation as an approved clinical therapy ushered in an exciting era of innovation for the treatment of hearing loss. The U.S. Food and Drug Administration approved the use of cochlear implants as a treatment option for adults with profound sensorineural hearing loss in 1985. The landscape for treating adults and children with significant hearing loss has changed dramatically over the last three decades. The purpose of this paper is to examine the evolving regulatory process and changes to clinical care. A significant emerging trend in cochlear implantation is the consideration of steroids to preserve hearing during and following surgery. This parallels the quest for hearing preservation in noise-induced hearing disorders, especially considering the current interest in biological drug therapies in this population. The future will likely usher in an era of combination therapeutics utilizing drugs and cochlear implantation. For over 30+ years and following regulatory compliance, the Rocky Mountain Ear Center has developed an extensive candidacy and outcome assessment protocol. This systematic approach evaluates both unaided and aided auditory performance during candidacy stages and post-implantation. Adjunctive measures of cognition and quality-of-life augment the auditory assessment in specific populations. Practical insights into lessons learned have directed further clinical research and have resulted in beneficial changes to clinical care.

The Effects of Virtual Assessment on Capturing Skill Growth in Children With Hearing Loss.

PURPOSE: The purpose of this study is to evaluate the effects of switching from in-person assessment to virtual assessment during the COVID-19 pandemic on the growth trajectories of children with hearing loss who are learning spoken language. METHOD: Sixty-eight children with typical hearing, 44 children with cochlear implants, and 47 children with hearing aids were assessed with a norm-referenced measure of receptive vocabulary, a criterion-referenced measure of phonological awareness, and a criterion-referenced measure of conceptual print knowledge at least 4 times, at 6-month intervals, between the ages of 4 and 6 years. Of those participants, 26 children with typical hearing, 13 children with cochlear implants, and 13 children with hearing aids entered virtual testing as a result of the COVID-19 pandemic. The slopes of growth for children who entered virtual testing were compared to their own slopes prepandemic and to the growth slopes of children who completed all testing in-person, prepandemic. RESULTS: Within-subject comparisons across all measures did not show a change in growth slopes prepandemic to postpandemic. For the measure of conceptual print knowledge, children who were tested during the pandemic showed slower overall growth than children who were tested prepandemic. No effects of hearing status were found across growth on any measure. CONCLUSION: These preliminary data support the use of virtual assessment to measure growth in receptive vocabulary, phonological awareness, and conceptual print knowledge in children with hearing loss learning spoken language.

Assessment of Receptive and Expressive Language Skills Among Young Children With Prelingual Single-Sided Deafness Managed With Early Cochlear Implantation.

Importance: Pediatric single-sided deafness (SSD) can seriously affect development, causing impaired spatial hearing skills, speech-language delays, and academic underachievement. Early cochlear implantation likely improves hearing-related outcomes, but its association with language development remains unclear. Objective: To investigate whether early cochlear implantation is associated with language outcomes for children with prelingual SSD. Design, Setting, and Participants: The Cochlear Implant for Children and One Deaf Ear study was initiated in 2015 and recruited participants at 4 academic hospitals in Flanders, Belgium, through 2019. This cohort study included 3 groups of children aged 2 to 5 years: children with SSD and a cochlear implant, children with SSD without a cochlear implant, and a control group with normal hearing. Language and hearing skills were assessed 1 to 2 times per year until the age of 10 years. Study completion rates were high (82%). Data analysis was performed from October to December 2020. Exposure: Unilateral cochlear implant. Main Outcomes and Measures: Longitudinal vocabulary, grammar, and receptive language scores. The implanted group was hypothesized to outperform the nonimplanted group on all language tests. Results: During the recruitment period, 47 children with prelingual SSD without additional disabilities were identified at the participating hospitals. Fifteen of the 34 children with an intact auditory nerve received a cochlear implant (44%, convenience sample). Sixteen of the remaining children were enrolled in the SSD control group (50%). Data from 61 children (mean [SD] age at the time of enrollment, 2.08 [1.34] years; 26 girls [42%]) were included in the analysis: 15 children with SSD and a cochlear implant, 16 children with SSD without a cochlear implant, and 30 children with normal hearing. Children with SSD and a cochlear implant performed in line with their peers with normal hearing with regard to grammar. In contrast, children with SSD without a cochlear implant had worse grammar scores than the group with implants (-0.76; 95% CI, -0.31 to -1.21; P = .004) and the group with normal hearing (-0.53; 95% CI, -0.91 to -0.15; P = .02). The 3 groups had similar vocabulary and receptive language abilities. Conclusions and Relevance: These findings suggest that early cochlear implantation is associated with normal grammar development in young children with prelingual SSD. Although further follow-up will reveal the long-term outcomes of the cochlear implant for other skills, the current results will help clinicians and policy makers identify the best treatment option for these children.

Cost Effectiveness of Cochlear Implantation in Single-Sided Deafness.

OBJECTIVE: To analyze the cost effectiveness of cochlear implantation (CI) for the treatment of single-sided deafness (SSD). STUDY DESIGN: Cost-utility analysis in an adapted Markov model. SETTING: Adults with single-sided deafness in a high-income country. INTERVENTION: Unilateral CI was compared with no intervention. MAIN OUTCOME MEASURE: Incremental cost-effectiveness ratios were compared with different cost-effectiveness thresholds ($10,000 to $150,000) for different age, sex, and cost combinations. The calculations were based on the quality-adjusted life year (QALY), national life expectancy tables, and different cost settings. The health utility values for the QALY were either directly collected from published data, or, derived from published data using a regression model of multiple utility indices (regression estimate). RESULTS: The regression estimate showed an increase of the health utility value from 0.62 to 0.74 for SSD patients who underwent CI. CI for SSD was cost effective for women up to 64 years ($50,000 per-QALY threshold), 80 years ($100,000 per-QALY threshold), and 86 years ($150,000 per-QALY threshold). For men, these values were 58, 77, and 84, respectively. Changing the discount rate by up to 5% further increased the cutoff ages up to 5 years. A detailed cost and age sensitivity analysis is presented and allows testing for cost effectiveness in local settings worldwide. CONCLUSIONS: CI is a cost-effective option to treat patients with SSD.

Objective electroencephalography-based assessment for auditory rehabilitation of pediatric cochlear implant users.

The cochlear implant (CI) has an effective habilitation modality for hearing-impaired children by promoting sound perception, vocalization, and language ability. However, the major challenge that remained was the lack of assessment standards for pediatric CI users, especially prelingually deaf children, to evaluate hearing rehabilitation effectiveness. In the present study, we conducted an oddball paradigm with stimuli varying in pure-tone, syllable, and tonal sounds. After implantation, we utilized cortical auditory evoked potential (CAEP) and mismatch negativity (MMN) to obtain time-domain analysis; meanwhile, the source localization was investigated to obtain spatial accuracy of the plasticity in the auditory cortex. P1 started to emerge at the third month after implantation, but its peak level was not significant until the sixth month. The temporal lobe was activated between the third and sixth months after implantation. The MMN waveform was basically normal approximately after 12 months. These results suggest that the auditory system goes through a critical period of rapid development between three and six months and enters a maturation period after 12 months. This work indicates that CAEPs are more suitable for assessing the early auditory system reconstruction, while MMN performs better in evaluating the advanced auditory function. Furthermore, source localization has proven to be an efficient tool in exploring auditory cortex plasticity, especially for pediatric CI users.

Cost-utility Analysis of Cochlear Implantation in Adults With Single-sided Deafness: Austrian and German Perspective.

BACKGROUND: Single-sided deafness (SSD) is associated with a loss of binaural hearing. Major limitations of such patients are poor speech understanding in noisy environments and a lack of spatial hearing. To date, cochlear implantation is the most promising approach to overcome these deficits in this group of patients. OBJECTIVE: Cost-effectiveness analyses of cochlear implantation in patients with unilateral deafness. The model targets Austrian and German SSD patients who can either opt for treatment with a cochlear implant (CI) or decide against a CI and stay without any treatment. METHODS: A Markov model analyzed as microsimulation was developed using TreeAge Pro 2019 software. Pre- and postoperative utility values generated with HUI-3 were used to populate the model. Costs covered by the national insurance were considered. Costs and utilities were discounted by 3%. A model time horizon of 20 years was set. RESULTS: According to Austrian base-case analysis, the incremental cost-utility ratio (ICUR) was €34845.2 per quality-adjusted life year gained when comparing the "CI strategy" to the "no treatment strategy." The ICUR is marginally lower when adapting a German cost perspective-it was €31601.25 per quality-adjusted life year gained. Sensitivity analyses showed that the cost-effectiveness results are stable. Analyses also showed that the longer the time horizon is set, the more favorable the cost-effectiveness result is. CONCLUSIONS: Based on currently available data, the Markov microsimulation model suggests that cochlear implantation is cost-effective in Austrian and German patients with SSD if no other treatment option is considered within the model.

A prospective study on the feasibility of cochlear implantation during the coronavirus disease 2019 crisis and trends of assessment: experience in a UK centre.

OBJECTIVES: To demonstrate the feasibility of continuing cochlear implantation during the coronavirus disease 2019 crisis and to report on trends of referrals via the neonatal hearing screening programme. METHODS: A prospective case series was conducted on children who underwent cochlear implantation during the coronavirus disease 2019 crisis in the UK and a sample of referrals via the neonatal hearing screening programme. A step-by-step description of peri-operative management is included. RESULTS: Regionally, between February and May 2020, 106 babies were referred via the neonatal hearing screening programme to paediatric audiology. Eleven children were operated on during the coronavirus disease 2019 study period. None of the 11 children developed coronavirus symptoms. DISCUSSION: It is widely recognised that the demands of managing the current pandemic may compromise screening, clinical assessment and elective surgery. Time-sensitive issues such as cancer management have gained prominence, but a similar need exists for timely paediatric cochlear implantation. CONCLUSION: Implantation in the paediatric population during the coronavirus disease 2019 pandemic is feasible with careful planning.

Cochlear implant indications: a review of third-party payers' policies for standard and expanded indications.

As cochlear implant (CI) candidacy has expanded, commercial payers in the United States have varied in their adoption of new indications, potentially confusing providers' knowledge about appropriate patients for referral. We reviewed how third-party payers classify the medical necessity of cochlear implants for a variety of indications across the lifespan.We compared policies of the six largest commercial payers in our region, focusing on clinical scenarios for which many centers experience difficulty obtaining pre-authorization. These include: (1) CI in children under 12 months, (2) audiometric and speech perception criteria in children, (3) sequential bilateral CI, (4) electro-acoustic stimulation, (5) impending cochlear ossification, and (6) single-sided deafness (SSD).Of the more notable findings for the clinical scenarios half of commercial payers have a pediatric age requirement of greater than 12 months. Generally, audiologic and speech perception criteria are more stringent for children than adults across all policies. SSD is considered investigational by most policies.Third-party payers employ variable criteria regarding the medical necessity of CI, many of which are not contemporaneous with clinical knowledge and best practices. This may impact referral patterns among audiologists. More methodologically rigorous clinical trials may help shift such restrictive policies to benefit a greater number of patients.

A narrative review of the logistic and economic feasibility of cochlear implants in lower-income countries.

Objectives: Globally, less than 1% of people who could benefit from a cochlear implant have one and the problem is particularly acute in lower-income countries. Here we give a narrative review of the economic and logistic feasibility of cochlear implant programmes in lower-income countries and discuss future developments that would enable better healthcare. We review the incidence and aetiology of hearing loss in low- and middle-income countries, screening for hearing loss, implantation criteria, issues concerning imaging and surgery, and the professional expertise required. We also review the cost of cochlear implantation and ongoing costs. Findings: The cost effectiveness of cochlear implants in lower-income countries is more limited by the cost of the device than the cost of surgery, but there are also large ongoing costs that will deter many potential users. Conclusions: We conclude that the main barriers to the future uptake of cochlear implants are likely to be logistical rather than technical and cochlear implant provision should be considered as part of a wider programme to improve the health of those with hearing loss.

Quality of life assessment in paediatric cochlear implant recipients in South India: Parental assessment and correlation with rehabilitation scores using a bilingual quality of life assessment questionnaire.

Objectives: To assess the quality of life (QoL) of prelingually deaf paediatric population after Cochlear implantation (CI), using a bilingual questionnaire and to correlate with rehabilitation scores; to validate the questionnaire and recommend its use in future studies.Methods: This was a questionnaire based cross-sectional study. Parents of 151 paediatric prelingual CI recipients filled the questionnaire using a 5-point rating scale, with a score of 1-5. These scores were correlated with the CAP and SIR scores.Results and discussion: There was a positive correlation of QoL score with rehabilitation outcomes (r = 0.4638 and P ≤ 0.00001 for CAP; r = 0.3563 and P ≤ 0.00001 for SIR scores). The maximum scores (≥4.0) were given by parents for integration into educational system (4.86), response to environmental sounds (4.12) and overall parental satisfaction about child's performance (4.09). Minimum scores were given for ability to speak in sentences (2.9) and response to verbal sounds at a distance (3.23).Conclusion: The QoL of these children as assessed by the institutional questionnaire have correlated with the rehabilitation outcomes. These QoL results have a positive impact in counselling for early CI as well as for rehabilitation.

Bilateral cochlear implantation: an assessment of language sub-skills and phoneme recognition in school-aged children.

PURPOSES: The main purpose of this study is to investigate whether there is a difference in phoneme recognition and school-age language skills in children with bilateral and unilateral cochlear implants (CI). The second aim of the study is to examine language-based skills in bilateral cochlear implanted children with the first implant, second implant and in the bilateral listening situations. METHOD: 60 to 108-month-old children with similar demographic and audiological features were included. Of the 64 participants in total, 30 are bilateral cochlear implant users and 34 of them use unilateral cochlear implants. Turkish version of "Test of Language Development-Primary: Fourth edition (TOLD-P:4)" and "Phoneme Recognition Test (PRT)" were implemented for the evaluation of the language sub-components skills and auditory perception. In addition, the PRT test audio file was presented directly to the implant with connection cables via the fitting program methodologically. RESULTS: Children with bilateral cochlear implants were more successful in all language-based skills than children with unilateral cochlear implants (p < 0.05). In the PRT test, the most successful scores were obtained in the bilateral listening conditions, the second with the experienced implant side, and the most unsuccessful scores in the listening conditions with second implant. CONCLUSION: Bilateral cochlear implants are very useful in terms of language-based skills in children with severe/profound hearing loss. This can positively affect even the future academic and social skills of children.

Auditory Brainstem Implantation for Adults With Neurofibromatosis 2 or Severe Inner Ear Abnormalities: A Health Technology Assessment.

BACKGROUND: Neurofibromatosis 2 (NF2) is a rare genetic disorder that causes vestibular schwannomas to develop in both eighth cranial nerves. Almost all people with NF2 eventually become completely deaf as a result of progressive tumour enlargement or following surgical or radiotherapy treatment. Other rare abnormal conditions in the inner ears can also cause complete deafness. For people with either indication who are not candidates for cochlear implantation, auditory brainstem implantation is the only treatment option to restore some functional hearing. We conducted a health technology assessment of auditory brainstem implantation for adults with NF2 and severe inner ear abnormalities, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding auditory brainstem implantation, and patient preferences and values. METHODS: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Risk of Bias in Non-randomized Studies-of Interventions (ROBINS-I) tool and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search. We did not conduct a primary economic evaluation because the outcomes identified in our clinical evidence review were difficult to translate into measures appropriate for health economic modelling. We also analyzed the net budget impact of publicly funding auditory brainstem implantation over the next 5 years in Ontario, including the device, presurgical assessment, surgical procedure, and postsurgical rehabilitation. To contextualize the potential value of auditory brainstem implants, we spoke with six people with lived experience of NF2 and severe inner ear abnormalities. RESULTS: We included 22 publications (16 in NF2, five in severe inner ear abnormalities, and one in complications of auditory brainstem implantation) in the clinical evidence review. In adults with NF2, auditory brainstem implantation when compared with no intervention allows any degree of improvement in sound recognition (GRADE: High), allows any degree of improvement in speech perception when used in conjunction with lip-reading (GRADE: High), and provides subjective benefits of hearing (GRADE: High). It likely allows any degree of improvement in speech perception when using the implant alone (GRADE: Moderate) and may improve quality of life (GRADE: Low). In adults with severe inner ear abnormalities, auditory brainstem implantation when compared with no intervention likely allows any degree of improvement in sound recognition (GRADE: Moderate) and in any speech perception when using the implant alone (GRADE: Moderate). It may allow any degree of improvement in speech perception when used in conjunction with lip-reading (GRADE: Low), provide subjective benefits of hearing (GRADE: Low), and improve quality of life (GRADE: Low).We did not identify any economic studies on auditory brainstem implantation for adults with NF2 or adults with deafness due to severe inner ear abnormalities. We estimated that the annual net budget impact of publicly funding auditory brainstem implantation in Ontario over the next 5 years would range from about $130,000 in year 1 for two procedures to about $260,000 in year 5 for four procedures.People with whom we spoke who had received an auditory brainstem implant reported that it restored some hearing ability and improved their quality of life, though they also reported ongoing challenges in using the device or side effects from the procedure. CONCLUSIONS: When compared with no intervention, auditory brainstem implantation provides some benefit for completely deaf adults with NF2 or severe inner ear abnormalities who are not candidates for cochlear implantation. Based on evidence of moderate to high quality, auditory brainstem implants allow any degree of improvement in sound recognition and in speech perception when used in conjunction with lip-reading for people with NF2. The quality of evidence on these outcomes was low to moderate for people with severe inner ear abnormalities. These functional outcomes lead to subjective benefits of hearing which are consistently reported in the literature and in interviews with patients. We were unable to determine the cost-effectiveness of this treatment. We estimate that publicly funding auditory brainstem implantation in Ontario would result in additional costs of about $130,000 to $260,000 annually over the next 5 years.

Implantable Devices for Single-Sided Deafness and Conductive or Mixed Hearing Loss: A Health Technology Assessment.

BACKGROUND: Single-sided deafness refers to profound sensorineural hearing loss or non-functional hearing in one ear, with normal or near-normal hearing in the other ear. Its hallmark is the inability to localize sound and hear in noisy environments. Conductive hearing loss occurs when there is a mechanical problem with the conduction of sound vibrations. Mixed hearing loss is a combination of sensorineural and conductive hearing loss. Conductive and mixed hearing loss, which frequently affect both ears, create additional challenges in learning, employment, and quality of life. Cochlear implants and bone-conduction implants may offer objective and subjective benefits of hearing for people with these conditions who are deemed inappropriate candidates for standard hearing aids and do not meet the current indication (i.e., bilateral deafness) for publicly funded cochlear implants in Canada. METHODS: We conducted a health technology assessment, which included an evaluation of clinical benefits and harms, cost-effectiveness, budget impact, and patient preferences and values related to implantable devices for single-sided deafness and conductive or mixed hearing loss. We performed a systematic literature search for systematic reviews and cost-effectiveness studies of cochlear implants and bone-conduction implants, compared to no interventions, for these conditions in adults and children. We conducted cost-utility analyses and budget impact analyses from the perspective of the Ontario Ministry of Health to examine the impact of publicly funding both types of hearing implants for the defined populations. We also interviewed 22 patients and parents of children about their experience with hearing loss and hearing implants. RESULTS: We included 20 publications in the clinical evidence review. For adults and children with single-sided deafness, cochlear implantation when compared with no treatment improves speech perception in noise (% correct responses: 43% vs. 15%, P < .01; GRADE: Moderate), sound localization (localization error: 14° vs. 41°, P < .01; GRADE: Moderate), tinnitus (Visual Analog Scale, loudness: 3.5 vs. 8.5, P < .01; GRADE: Moderate), and hearing-specific quality of life (Speech Spatial and Qualities of Hearing Scale, speech: 5.8 vs. 2.6, P = .01; spatial: 5.7 vs. 2.3, P < .01; GRADE: Moderate); for children, speech and language development also improve (GRADE: Moderate). For those with single-sided deafness in whom cochlear implantation is contraindicated, bone-conduction implants when compared with no intervention provide clinically important functional gains in hearing thresholds (36-41 dB improvement in pure tone audiometry and 38-56 dB improvement in speech reception threshold, P < .05; GRADE: Moderate) and improve speech perception in noise (signal-to-noise ratio -2.0 vs. 0.6, P < .05 for active percutaneous devices; signal-to-noise ratio improved by 1.3-2.5 dB, P < .05 for active transcutaneous devices; GRADE: Moderate) and hearing-specific quality of life (Abbreviated Profile for Hearing Aid Benefit, ease of communication: 12%-53% vs. 24%-59%; background noise: 18%-48% vs. 33%-79%; listening in reverberant condition: 26%-55% vs. 41%-65%, P < .05 [active percutaneous devices]; ease of communication: 7% vs. 20%; background noise: 46% vs. 69%; listening in reverberant condition: 27% vs. 43%; P < .05 [active transcutaneous devices]; Children's Home Inventory for Listening Difficulties score 7.3 vs. 3.4; P < .05 [passive transcutaneous devices]; GRADE: Moderate). For those with conductive or mixed hearing loss, bone-conduction implants when compared with no intervention improve hearing thresholds (improved 19-45 dB [active percutaneous devices], improved 24-37 dB [active transcutaneous devices], improved 31 dB [passive transcutaneous devices], and improved 21-49 dB [active transcutaneous middle-ear implants]; GRADE: Moderate), speech perception (% correct: 77%-93% vs. < 25%; P < .05 [active transcutaneous devices], % speech recognition: 55%-98% vs. 0-72%; P < .05 [active transcutaneous middle-ear implants]; GRADE: Moderate), and hearing-specific quality of life and subjective benefits of hearing (GRADE: Moderate).In the cost-utility analyses, cochlear implants for adults and children with single-sided deafness provided greater health gains for an incremental cost, compared with no intervention. On average, the incremental cost-effectiveness ratio (ICER) was between $17,783 and $18,148 per quality-adjusted life-year (QALY). At a willingness-to-pay of $100,000 per QALY, 70% of the simulations were considered cost-effective. For the same population, bone-conduction implants were not likely to be cost-effective compared with no intervention (ICER: $402,899-$408,350/QALY). Only 38% of simulations were considered cost-effective at a willingness-to-pay of $100,000 per QALY. For adults and children with conductive or mixed hearing loss, bone-conduction implants may be cost-effective compared with no intervention (ICER: $74,155-$87,580/QALY). However, there was considerable uncertainty in the results. At a willingness-to-pay of $100,000 per QALY, only 50% to 55% of simulations were cost-effective. In sensitivity analyses, results were most sensitive to changes in health-related utilities (measured using generic quality-of-life tools), highlighting the limitations of currently published data (i.e., small sample sizes and short follow-up).For people with single-sided deafness, publicly funding cochlear implants in Ontario would result in an estimated additional cost of $2.8 million to $3.6 million in total over the next 5 years, and an additional $0.8 million would be required for bone-conduction implants for this population. For people with conductive or mixed hearing loss, publicly funding bone-conduction implants would cost an estimated additional $3.1 million to $3.3 million in total over the next 5 years.In interviews, people with single-sided deafness and conductive or mixed hearing loss reported that standard hearing aids did not meet their expectations; therefore, they chose to undergo surgery for an implantable device. Most participants with experience of a cochlear implant or bone-conduction implant spoke positively about being able to hear better and enjoy a better quality of life. People with a cochlear implant reported additional benefits: binaural hearing, better sound localization, and better hearing in noisy areas. Cost and access were barriers to receiving an implantable device. CONCLUSIONS: Based on evidence of moderate quality, cochlear implantation and bone-conduction implants improve functional and patient-important outcomes in adults and children with single-sided deafness and conductive or mixed hearing loss. Qualitative results of interviews with patients are consistent with the findings of the systematic reviews we examined.Among people with single-sided deafness, cochlear implants may be cost-effective compared with no intervention, but bone-conduction implants are unlikely to be. Among people with conductive or mixed hearing loss, bone-conduction implants may be cost-effective compared with no intervention. Results and uncertainty are mainly driven by changes in health utilities associated with having a hearing implant. Hence, further research on utility values in this population is warranted with larger sample sizes and longer follow-up.The 5-year cost of publicly funding both types of hearing implant for single-sided deafness and conductive or mixed hearing loss in Ontario is estimated to be $6.7 million to $7.8 million.

Cochlear Implants in Congenitally Deaf Children: A Discussion Built on Rights-Based Arguments.

The author discusses rights-based arguments for and against cochlear implants in congenitally deaf children and analyzes whether CIs should be required by law or left to parental discretion. Positions for and against CIs are analyzed in light of two rights-based arguments: Griffin's theory on personhood as a solution to a conflict of rights and his theory on quality of life as a solution to a conflict between rights and welfare (Griffin, 2008). The question of whether CIs should be required by law is then discussed in light of Nickel's theories on the justification of specific rights and on the avoidance of conflicts (Nickel, 2007). In this discussion, the author's aim is not to propose definitive answers, but to apply philosophical theories to the debate and introduce tools for analyzing arguments for and against CIs in children and for regulating cochlear implantation.

Cost-effective analysis of unilateral cochlear implantation under the Taiwan national healthcare insurance.

Objective: The value of cochlear implantation (CI) has not been established in Taiwan. The purpose of this study was to evaluate the cost-effectiveness of paediatric CI within the context of Taiwan's national health insurance (NHI) programme.Design: A Markov model-based cost-utility analysis (CUA) was conducted to evaluate the cost-effectiveness of a unilateral CI (UCI) with a contralateral acoustic hearing aid (UCI-HA) compared with a bilateral HA. We performed one-way sensitivity analyses to identify the cost variables that affected the incremental cost-effectiveness ratio (ICER) the most. Monte Carlo simulation was used to explore the simultaneous effect of all uncertain parameters on cost-effectiveness.Study sample: Not applicable.Results: Compared with bilateral HAs, the ICER for UCI-HA was $6487 per quality-adjusted life year (QALY) gained. The ICERs were consistently below $7000 per QALY gained and were most sensitive to the selling price of the external CI device. When this selling price increased by 10%, the ICER of UCI-HA would increase to $6954 per QALY gained. UCI-HA has a probability greater than 50% of being cost-effective if the cost-effectiveness threshold exceeds approximately $10,000 per QALY.Conclusions: Our analysis suggested that within the context of Taiwan's NHI programme, UCI is highly cost-effective for deaf children.

Audiology Practices in the Preoperative Evaluation and Management of Adult Cochlear Implant Candidates.

Importance: Currently, no clear guidelines exist regarding clinical testing methods for identifying adult cochlear implant (CI) candidates. Indications provided by the US Food and Drug Administration, Medicare, and private insurers are ambiguous concerning test materials and the level and mode of test presentation. This could lead to wide variability in clinical assessment and, potentially, unequal access to CIs for individuals with clinically significant hearing loss. Objective: To examine the preoperative testing methods used by audiologists in evaluating adult CI candidates across the United States. Design, Setting, and Participants: A survey assessing audiology practice patterns was created using a Research Electronic Data Capture system hosted at the University of Miami. A link to a survey (65 questions in multiple-choice or rank-order format was distributed electronically along with a request for completion to members of the American Cochlear Implant Alliance and to the Institute for Cochlear Implant Training forum. Responses were collected from January 17 to June 4, 2018. Participation was limited to audiologists who evaluate adult CI candidates, and respondents who do not provide adult CI care were excluded. Collected demographic information included work setting, years of experience, and highest level of education attained. Main Outcomes and Measures: Percentages, medians, and interquartile ranges were from aggregated responses concerning hearing aid verification methods; testing methods, materials, and practices; nonauditory factors that might affect CI candidacy; audiology practice patterns; and expanded indications for CIs. Results: Anonymized surveys were returned by 99 respondents; because surveys were available electronically, the number of audiologists who viewed the survey but did not respond was not available. Seven respondents identified themselves as pediatric specialists and were excluded, resulting in a total of 92 surveys available for analysis (denominators vary because respondents could complete the survey without answering all questions). Seventy percent of respondents (51 of 72) were doctors of audiology, and nearly 50% (33 of 74) were employed at universities and academic centers performing more than 50 CIs per year. When assessing adult candidacy for implant, most respondents reported using test materials from the Minimum Speech Test Battery: 96% (51 of 53), using AzBio sentences in quiet; 89% (47 of 53), AzBio sentences in noise; and 100% (53 of 53), the consonant-vowel nucleus-consonant, monosyllabic words test. However, these tests were applied inconsistently, with 39 of 53 respondents (74%) reporting use of a sound pressure level scale and the other 14 (26%) a hearing level scale at various decibel levels, and with some using a single signal-to-noise ratio and others using multiple ratios for sound-in-noise tests. Respondents' definitions of the best aided listening condition for assessing implant candidates also varied widely. Among the nonauditory factors ranked most important for assessing CI candidacy were patient's level of cognition and expectations of CI; yet, few respondents reported including cognitive or psychological tests in the assessment protocol. Conclusions and Relevance: Findings of this study reveal considerable variability in preoperative testing methods and practices across health care professionals assessing adult candidates for CI. This lack of standardization in the delivery of care may increase the risk for health care inequities, specifically in access to care for adults with clinically significant hearing loss.