A Critique of the National Academies of Sciences, Engineering, and Medicine Report (2021) and the Diagnostic Accuracy of Measurements of Functional Hearing Ability.

PURPOSE: The Social Security Administration (SSA) asked the National Academies of Sciences, Engineering, and Medicine (NASEM, 2021) to make recommendations for tests of functional hearing ability. These tests include speech perception measures administered in quiet and in background noise. Such tests are required to make disability determinations for adults and children following cochlear implantation. The test review required an evaluation of the diagnostic accuracy of the speech perception measures. Following a review of the literature, NASEM wrote that the evidence needed to support such a recommendation was lacking. They resorted to "professional judgment" and recommended a monosyllabic word recognition test, presumably in quiet, along with a measure of self-report or parent report. The primary purpose of this article was to critically review the committee's report. The secondary purpose was to critique the committee's recommendation of a monosyllabic word test as a measure of functional hearing ability for disability determinations. The third purpose was to provide a review of diagnostic accuracy studies not included in NASEM (2021) with an emphasis on speech recognition in noise (SRN) tests. CONCLUSIONS: In contrast to the committee's recommendation, studies have shown that a monosyllabic word test is a poor predictor of SRN ability. Contrary to the conclusion of NASEM (2021), diagnostic accuracy studies have been conducted for a few SRN tests. The Hearing in Noise Test and the AzBio SRN test have published data demonstrating their ability to correctly identify the presence and absence of an SRN disorder.

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.

A Five-Year Update on the Profile of Adults Undergoing Cochlear Implant Evaluation and Surgery-Are We Doing Better?

OBJECTIVE: To characterize the influence of expanding indications on the profile of adults undergoing cochlear implantation (CI) at a high-volume CI center. STUDY DESIGN: Retrospective review. SETTING: Tertiary referral center. PATIENTS: 774 adults undergoing CI evaluation from August 2015 to August 2020. MAIN OUTCOME MEASURES: Demographics; audiometry; speech recognition; speech, spatial, and qualities of hearing scale (SSQ-12). RESULTS: Of 745 (96.3%) patients qualifying for implantation, 642 (86.6%) pursued surgery. Median age at evaluation was 69 years; 56.3% were men; 88.2% were Caucasian. Median distance to our center was 95 miles. The majority (51.8%) had public insurance (Medicare, Medicaid), followed by private (47.8%) and military (0.4%). Mean PTA, CNC, and AzBio in quiet and noise for the ear to be implanted were 85.2 dB HL, 15.0%, and 19.2% and 3.5%, respectively. Hybrid/EAS criteria were met by 138 (18.5%) CI candidates, and 436 (77.0%) unilateral CI recipients had aidable contralateral hearing for bimodal hearing configurations. Younger age (odds ratio [OR], 0.96; 95% confidence interval, 0.93-0.99) and non-Caucasian race (OR, 6.95; 95% confidence interval, 3.22-14.98) predicted candidacy. Likelihood of surgery increased for Caucasian (OR, 8.08; 95% confidence interval, 4.85-13.47) and married (OR, 2.28; 95% confidence interval, 1.50-3.47) patients and decreased for those with public insurance (OR, 0.45; 95% confidence interval, 0.29-0.69). A lower SSQ-12 score predicted both candidacy and surgery. CONCLUSION: Despite expansions in criteria, speech understanding remained extremely low at CI evaluation. Younger age and non-Caucasian race predicted candidacy, and Caucasian, married patients with private insurance and lower SSQ scores were more likely to pursue surgery.

American Cochlear Implant Alliance Task Force Guidelines for Clinical Assessment and Management of Adult Cochlear Implantation for Single-Sided Deafness.

The indications for cochlear implantation have expanded to include individuals with profound sensorineural hearing loss in the impaired ear and normal hearing (NH) in the contralateral ear, known as single-sided deafness (SSD). There are additional considerations for the clinical assessment and management of adult cochlear implant candidates and recipients with SSD as compared to conventional cochlear implant candidates with bilateral moderate to profound sensorineural hearing loss. The present report reviews the current evidence relevant to the assessment and management of adults with SSD. A systematic review was also conducted on published studies that investigated outcomes of cochlear implant use on measures of speech recognition in quiet and noise, sound source localization, tinnitus perception, and quality of life for this patient population. Expert consensus and systematic review of the current literature were combined to provide guidance for the clinical assessment and management of adults with SSD.

Association of Socioeconomic Characteristics With Receipt of Pediatric Cochlear Implantations in California.

Importance: Earlier cochlear implantation among children with bilateral severe to profound sensorineural hearing loss is associated with improved language outcomes. More work is necessary to identify patients at risk for delayed cochlear implantation and understand targets for interventions to improve cochlear implantation rates among children. Objective: To describe the demographics among children receiving cochlear implantations and variability in implantation rates in California and to investigate sociodemographic and parental factors associated with early pediatric cochlear implantation. Design, Setting, and Participants: This retrospective cross-sectional study was conducted using data from the Healthcare Cost and Utilization Project California State Ambulatory Surgery Database in calendar year 2018. Included patients were children aged 9 years old or younger undergoing cochlear implantation. Sociodemographic factors, location of treatment, and parental factors were collected. Data were analyzed from March through August 2021. Main Outcomes and Measures: Binary logistic regression was performed to investigate sociodemographic factors associated with early cochlear implantation (ie, before age 2 years). Geographic variability in pediatric cochlear implantation across hospital referral regions in California was described, and various parental factors associated with implantation before age 2 years were analyzed. Results: Among 182 children receiving cochlear implantations, the median (IQR) age was 3 (1-5) years and 58 children (31.9%) received implantations at ages 2 years or younger. There were 90 girls (49.5%) and 92 boys (50.5%), and among 170 children with race and ethnicity data, there were 27 Asian or Pacific Islander children (15.9%), 63 Hispanic children (37.1%), and 55 White children (32.4%). The risk of CI was significantly decreased among Black children compared with Asian or Pacific Islander children (relative risk [RR], 0.18 [95% CI, 0.07-0.47]; P = .001) and White children (RR, 0.24 [95% CI, 0.10-0.59]; P = .002) and among Hispanic children compared with Asian or Pacific Islander children (RR, 0.32 [95% CI, 0.21-0.50]; P < .001) and White children (RR, 0.42 [95% CI, 0.29-0.59; P < .001). Compared with private insurance, Medicaid insurance was associated with decreased odds of implantation at ages 2 years or younger (odds ratio [OR], 0.19 [95% CI, 0.06-0.64]; P = .007), and every 1 percentage point increase in maternal high school completion percentage in a given California hospital referral region was correlated with a 5-percentage point increase in percentage of cochlear implants performed at age 2 years or younger (b = 5.18 [95% CI, 1.34-9.02]; P = .008). There were no significant differences in rates of early implantation by race or ethnicity. Conclusions and Relevance: This study found significant variability in pediatric cochlear implantation rates in California. These findings suggest that socioeconomic and parental factors may be associated with differences in access to early cochlear implantation and suggest the need to invest in initiatives to address barriers to appropriate and timely access to care.

Cost-Utility Analysis of Bilateral Cochlear Implantation in Adults With Severe to Profound Sensorineural Hearing Loss in Poland.

OBJECTIVE: The aim of the study was to develop a Markov model and apply it for the evaluation of three different treatment scenarios for adult patients with severe to profound bilateral sensorineural hearing loss. STUDY DESIGN: Prospective Observational Study. SETTINGS: Hospital. PATIENTS: A clinical group of 22 adult patients (59.1% men, 40.9% women) aged from 59.13 ±â€Š8.9 years were included in the study. The study comprised two arms: patients in group 1 received the second cochlear implant one to three months after the first implant; while patients in group 2 got the second cochlear implant approximately one year after the first implant. MAIN OUTCOME MEASURES: All participants were first asked to complete an AQoL-8D questionnaire. For the cost-effectiveness analyses, a Markov model analyzed as microsimulation was developed to compare the different treatment options. RESULTS: The analyses show that bilateral cochlear implantation strategies are cost-effective compared to the 'no treatment' alternative when having a 10-year model time horizon. When all three model scenarios are compared, the bilateral simultaneous cochlear implantation strategy (Scenario 3) compared to the 'no treatment' option is even more cost-effective than the Scenarios 1 and 2, compared with the 'no treatment' alternative. CONCLUSIONS: The model results summarize that bilateral (sequential and simultaneous) cochlear implantation that are represented in the model scenarios, are cost-effective strategies for Polish adult patients with bilateral severe to profound sensorineural hearing loss.

Utility and value of pre-operative CT and MRI for cochlear implantation in the elderly.

PURPOSE: To determine the utility and value of pre-operative imaging among the elderly population ≥70 y.o. with bilateral progressive sensorineural hearing loss undergoing cochlear implantation. MATERIALS AND METHODS: A retrospective, cross-sectional review was performed at a tertiary referral center between 2010 and 2018 including patients ≥70 y.o. with bilateral presbycusis who underwent preoperative imaging and cochlear implantation. Primary outcome was whether pre-operative imaging changed the surgeon's surgical plan such as side of implant or abort procedure entirely. Patient characteristics including age, sex, side of implant, imaging modality, whether imaging changed surgical plan, and surgical complications were reviewed. One-way analysis of variance with post-hoc tests using the Bonferroni and Fisher's exact test were used to examine differences between groups. Secondary outcome was cost of preoperative imaging. RESULTS: One hundred thirty-three patients (mean age 79.38 [5.51 SD]) who underwent a total of 142 surgical cases and 147 total scans. There were 92, 27, and 14 patients who underwent CT, MRI, or both, respectfully (n=133). Of the 142 implants that were placed, preoperative imaging did not reveal a contraindication to placing implant on one side over another. Total cost of imaging was $29,694. Estimated cost if 20% of cochlear implant eligible patients ≥70 y.o. underwent imaging is $7,763,490. CONCLUSION: Decreasing unnecessary preoperative imaging can potentially decrease cost in cochlear implantation. In this sample, preoperative imaging did not affect the surgeon's choice of which side to operate on. However, imaging may provide an anatomic roadmap and contribute to either surgical confidence or caution. With the increasing amount of cochlear implant eligible elderly adults, preoperative imaging needs to be more clearly defined in this unique population.

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.

Quantitative assessment of temporal skin elasticity using shear wave elastography in pediatric cochlear implant users.

OBJECTIVE: To evaluate temporal skin thicknesses and stiffness values using shear wave elastography (SWE) in asymptomatic pediatric patients who underwent cochlear implantation. SUBJECTS AND METHODS: Sixty-four deafened pediatric patients with unilateral cochlear implant (CI) who had no complications were enrolled. The age, sex, weight, height, body mass index (BMI), CI side, duration of CI use and CI device brand of all participants were noted. Temporal skin thickness and stiffness values were measured from implanted and contralateral unimplanted sides using SWE. RESULTS: The mean skin thickness measurements of implanted and unimplanted sides were 11.87 ± 3.42 and 5.34 ± 1.56 mm, respectively. The mean skin stiffness measurements of implanted and unimplanted sides were 3.08 ± 0.7 and 1.29 ± 0.26 m/s, respectively. There were statistically significant differences in skin thickness and stiffness between implanted and unimplanted sides (P < .001, P < .001). The mean skin thickness and stiffness measurements did not differ among types of CI devices (P = .948, P = .362). Age had positive correlation with implanted (P < .001, P = .019) and unimplanted sides (P < .001, P < .001) skin thickness and stiffness. BMI had positive correlation with implanted (P < .001, P = .023) and unimplanted sides (P < .001, P < .001) skin thickness and stiffness. Duration of CI use had positive correlation with implanted side skin thickness (P < .001) and stiffness (P = .031). CONCLUSION: Temporal skin thickness and stiffness increase after CI surgery. SWE has the potential to improve diagnostic accuracy, and our results may provide important data for evaluation of clinical entities that affect temporal skin structures.

Assessment of Cochlear Implants for Adult Medicare Beneficiaries Aged 65 Years or Older Who Meet Expanded Indications of Open-Set Sentence Recognition: A Multicenter Nonrandomized Clinical Trial.

Importance: Current indications for Medicare beneficiaries to receive a cochlear implant are outdated. Multichannel cochlear implant systems may be effective when provided to Medicare beneficiaries using expanded indications. Objective: To examine the effectiveness of cochlear implants, as measured by improvement on the AzBio Sentence Test, for newly implanted Medicare beneficiaries who meet the expanded indications of an AzBio Sentence Test score of 41% to 60% in their best-aided condition. Design, Setting, and Participants: A multicenter nonrandomized trial examined preoperative and postoperative speech recognition, telephone communication, hearing device benefit, health utility, and quality of life for 34 participants enrolled at 8 different centers who received a cochlear implant between September 17, 2014, and July 10, 2018. All participants were 65 years or older, had bilateral moderate to profound hearing loss, and had a best-aided preoperative AzBio Sentence Test score in quiet of 41% to 60%. Analysis was performed on an intention-to-treat basis. Statistical analysis of final results took place from July 29 to October 1, 2019. Intervention: Multichannel cochlear implants. Main Outcomes and Measures: The study examined the a priori hypothesis that the cochlear implant would improve the AzBio Sentence Test score in the best-aided condition by 25% or more and in the implanted ear-alone condition by 30% or more. The study additionally examined word and telephone recognition and examined device benefit, health utility, and quality of life. Results: A total of 34 participants received a cochlear implant; 31 (23 men [74%]; median age, 73.6 years [range, 65.7-85.1 years]) completed testing through the 6-month evaluation, and 29 completed testing through the 12-month evaluation. Median preoperative AzBio Sentence Test scores were 53% (range, 26%-60%) for the best-aided condition and 24% (range, 0%-53%) for the cochlear implant-alone condition; median scores 12 months after implantation improved to 89% (range, 36%-100%) for the best-aided condition and 77% (range, 13%-100%) for the cochlear implant-alone condition. This outcome represents a median change of 36% (range, -22% to 75%) for the best-aided condition (lower bound of 1-sided 95% CI, 31%) and a median change of 53% (range, -15% to 93%) for the cochlear implant-alone condition (lower bound of 1-sided 95% CI, 45%). Conclusions and Relevance: Intervention with a cochlear implant was associated with improved sentence, word, and telephone recognition in adult Medicare beneficiaries whose preoperative AzBio Sentence Test scores were between 41% and 60%. These findings support expansion of the Center for Medicare & Medicaid current indications for cochlear implants. Trial Registration: ClinicalTrials.gov Identifier: NCT02075229.

Assessment of Speech Understanding After Cochlear Implantation in Adult Hearing Aid Users: A Nonrandomized Controlled Trial.

Importance: Cochlear implants were approved for use in adults in the 1980s, but use remains low owing to a lack of awareness regarding cochlear implantation candidacy criteria and expected outcomes. There have been limited, small series examining the safety and effectiveness of cochlear implantation in adult hearing aid (HA) users with and without mild cognitive impairment (MCI). Objective: To investigate the safety and effectiveness of a single-ear cochlear implant in a group of optimized adult HA users with and without MCI across a variety of domains. Design, Setting, and Participants: In this nonrandomized controlled trial, a multicenter, prospective, repeated-measures investigation was conducted at 13 US institutions. The setting was academic and community-based cochlear implant programs. Eligible participants were 100 adults (aged >18 years) with postlinguistic onset of bilateral moderate sloping to profound or worse sensorineural hearing loss (≤20 years' duration). Fluent English speakers underwent an optimized bilateral HA trial for at least 30 days. Individuals with aided Consonant-Vowel Nucleus-Consonant (CNC) word score in quiet of 40% or less correct in the ear to be implanted and 50% or less correct in the contralateral ear were offered cochlear implants. The first participant was enrolled on February 20, 2017, and the last participant was enrolled on May 3, 2018. The final follow-up was on December 21, 2018. Interventions: Participants received the same cochlear implant system and contralateral HA. Main Outcomes and Measures: The primary outcome measure was speech understanding in quiet (CNC word score) using both the cochlear implant and opposite ear HA. Secondary outcome measures included the following: adverse events; speech understanding in noise (AzBio signal-to-noise ratio of +10 db [+10 SNR]) Health Utilities Index Mark 3 (HUI3); Speech, Spatial, and Qualities of Hearing Questionnaire 49 (SSQ49); and Montreal Cognitive Assessment (MoCA). Results: The median age at cochlear implantation of the 96 patients included in the trial was 71 years (range, 23-91 years), and 62 patients (65%) were male. Three serious adverse events requiring revision surgery occurred, and all resolved without sequelae. By 6 months after activation, the absolute marginal mean change in CNC word score and AzBio +10 SNR was 40.5% (95% CI, 35.9%-45.0%) and 24.1% (95% CI, 18.9%-29.4%), respectively. Ninety-one percent (87 of 96) of participants had a clinically important improvement (>15%) in the CNC word score in the implant ear. Mild cognitive impairment (MoCA total score ≤25) was observed in 48 of 81 study participants (59%) at baseline. Speech perception marginal mean improvements were similar between individuals with and without baseline MCI, with values of 40.9% (95% CI, 35.2%-46.6%) and 39.6% (95% CI, 31.8%-47.4%), respectively, for CNC word score and 27.5% (95% CI, 21.0%-33.9%) and 17.8% (95% CI, 9.0%-26.6%), respectively, for AzBio +10 SNR. Statistically significant and clinically important improvements in the HUI3 and SSQ49 were evident at 6 months. Conclusions and Relevance: The findings of this nonrandomized controlled trial seem to indicate that cochlear implants are safe and effective in restoring speech understanding in both quiet and noise and improve quality of life in individuals with and without MCI. Trial Registration: ClinicalTrials.gov Identifier: NCT03007472.

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.

Identifying Disadvantaged Groups for Cochlear Implantation: Demographics from a Large Cochlear Implant Program.

OBJECTIVE: To identify demographic predictors of patients undergoing cochlear implantation evaluation and surgery. METHODS: Consecutive adult patients between 2009 and 2018 who underwent cochlear implantation evaluation at a university cochlear implantation program were retrospectively identified to determine (1) cochlear implantation qualification rate and (2) pursuit of surgery rate with respect to age, gender, race, primary spoken language, marital status, insurance type, and distance to the cochlear implantation center. RESULTS: A total of 823 cochlear implantation evaluations were analyzed. Overall, 76.3% of patients qualified for cochlear implantation and 61.5% of these patients pursued surgery. Age was the only independent predictor for cochlear implantation qualification, such that, for each year younger, the odds of qualifying for cochlear implantation increased by 2.5% (OR 0.98; 95% CI: 0.96-0.99). Age, race, marital status, and insurance type were each independent predictors of the decision to pursue surgery. The odds of pursuing surgery increased by 2.8% for each year younger (OR 1.03; 95% CI: 1.01-1.05). Compared to White patients, non-Whites were half as likely to pursue surgery (OR 0.47; 95% CI: 0.25-0.88). Single (OR 0.49; 95% CI: 0.26-0.94) and widowed patients (OR 0.46; 95% CI: 0.23-0.95) were about half as likely to pursue surgery as compared to married patients. Patients with military insurance were 13 times more likely to pursue surgery as compared to patients with Medicare (OR 13.0; 95% CI: 1.67-101.4). CONCLUSION: Younger age is an independent predictor for a higher cochlear implantation qualification rate, suggesting the possibility for delayed candidacy referral. Rate of surgical pursuit in qualified cochlear implantation candidates is lower for racial minorities, single and widowed patients, and older patients.

Cost-effectiveness analysis of bilateral cochlear implants for children with severe-to-profound sensorineural hearing loss in both ears in Singapore.

A cochlear implant is a small electronic device that provides a sense of sound for the user, which can be used unilaterally or bilaterally. Although there is advocacy for the benefits of binaural hearing, the high cost of cochlear implant raises the question of whether its additional benefits over the use of an acoustic hearing aid in the contralateral ear outweigh its costs. This cost-effectiveness analysis aimed to separately assess the cost-effectiveness of simultaneous and sequential bilateral cochlear implantations compared to bimodal hearing (use of unilateral cochlear implant combined with an acoustic hearing aid in the contralateral ear) in children with severe-to-profound sensorineural hearing loss in both ears from the Singapore healthcare payer perspective. Incremental quality-adjusted life year (QALYs) gained and costs associated with bilateral cochlear implants over the lifetime horizon were estimated based on a four-state Markov model. The analysis results showed that, at the 2017 mean cost, compared to bimodal hearing, patients receiving bilateral cochlear implants experienced more QALYs but incurred higher costs, resulting in an incremental cost-effectiveness ratio (ICER) of USD$60,607 per QALY gained for simultaneous bilateral cochlear implantation, and USD$81,782 per QALY gained for sequential bilateral cochlear implantation. The cost-effectiveness of bilateral cochlear implants is most sensitive to utility gain associated with second cochlear implant, and cost of bilateral cochlear implants. ICERs increased when the utility gain from bilateral cochlear implants decreased; ICERs exceeded USD$120,000 per QALY gained when the utility gain was halved from 0.03 to 0.015 in both simultaneous and sequential bilateral cochlear implantations. The choice of incremental utility gain associated with the second cochlear implant is an area of considerable uncertainty.

Bilateral Cochlear Implantation: A Health Technology Assessment.

BACKGROUND: Sensorineural hearing loss occurs as a result of damage to the hair cells in the cochlea, or to the auditory nerve. It negatively affects learning and development in children, and employment and economic attainment in adults. Current policy in Ontario is to provide unilateral cochlear implantation for patients with bilateral severe to profound sensorineural hearing loss. However, hearing with both ears as a result of bilateral cochlear implantation may offer added benefits. METHODS: We completed a health technology assessment, which included an evaluation of clinical benefits and harms, value for money, budget impact, and patient preferences related to bilateral cochlear implantation. We performed a systematic literature search for studies on bilateral cochlear implantation in adults and children from inception to March 2017. We conducted a cost-utility analysis with a lifetime horizon from a public payer perspective and analyzed the budget impact of publicly funding bilateral cochlear implantation in adults and children in Ontario for the next 5 years. Finally, we conducted interviews with adults who have sensorineural hearing loss and unilateral or bilateral cochlear implants, and with parents of children with bilateral cochlear implants. RESULTS: We included 24 publications (10 in adults, 14 in children) in the clinical evidence review. Compared with unilateral cochlear implantation, bilateral cochlear implantation improved sound localization, speech perception in noise, and subjective benefits of hearing in adults and children with severe to profound sensorineural hearing loss (GRADE: moderate to high). Bilateral cochlear implantation also allowed for better language development and more vocalization in preverbal communication in children (GRADE: moderate). The safety profile was acceptable.Bilateral cochlear implantation was more expensive and more effective than unilateral cochlear implantation. The incremental cost-effectiveness ratio was $48,978/QALY in adults and between $27,427/QALY and $30,386/QALY in children. Cost-effectiveness was highly dependent on the quality-of-life values used. We estimated that the net budget impact of publicly funding bilateral cochlear implantation for adults in Ontario would be between $510,000 and $780,000 per year for the next 5 years.Patients described the social and emotional effects of hearing loss, and the benefits and challenges of using cochlear implants. CONCLUSIONS: Based on evidence of moderate to high quality, we found that bilateral cochlear implantation improved hearing in adults and children with severe to profound sensorineural hearing loss. Bilateral cochlear implantation was potentially cost-effective compared to unilateral cochlear implantation in adults and children. Patients with sensorineural hearing loss reported the positive effects of cochlear implants, and patients with unilateral cochlear implants generally expressed a desire for bilateral implants.

Preoperative Assessment of Cervical Vestibular Evoked Myogenic Potentials (cVEMPs) Help in Predicting Hearing Preservation After Removal of Vestibular Schwannomas Through a Middle Fossa Craniotomy.

OBJECTIVE: To determine whether cervical vestibular evoked myogenic potentials (cVEMPs) are predictive of hearing preservation in patients undergoing vestibular schwannoma removal through middle fossa craniotomy approach. STUDY DESIGN: Retrospective case study. SETTING: Tertiary referral center. PATIENTS: Eighteen patients who underwent a middle fossa craniotomy for vestibular schwannoma (stage I or II of Koos classification) with attempted hearing preservation from January 2008 to February 2016 were retrospectively reviewed. INTERVENTION: Pre-surgical cVEMPs test, videonystagmography (caloric test), and magnetic resonance imaging (MRI) as well as a pre- and post-surgical audiometry test. MAIN OUTCOME MEASURES: cVEMPs parameters including amplitude asymmetry ratio (AR), P13, and N23 latencies and peak-to-peak amplitude between P13 and N23 waves were calculated. Hearing data were classified according to the AAO-HNS hearing classes. The nerve of origin of the tumor was specified during surgery and the largest tumor diameter was measure on MRI axial plane on T2-CISS weighed images. RESULTS: Preoperative amplitude asymmetry ratio was lower (n = 15, Mann-Whitney U test, p < 0.001) in the group with postoperative hearing preservation (n = 11) compared with the group with postoperative hearing preservation failure (n = 4). The positive predictive value of an AR less than 24% to assess postoperative hearing preservation is 91.6%. Tumor size and localization were not correlated with cVEMPs, nor with caloric testing in this group of small-sized intracanalicular vestibular schwannomas. CONCLUSIONS: Our data suggest that cVEMPs may help predict hearing preservation outcome in vestibular schwannoma surgery via the middle fossa craniotomy approach.

Satisfaction with Life among Mothers of Pediatric Cochlear Implant Candidates: The Impact of Implant Operation and Sociodemographic Factors.

OBJECTIVES: To evaluate the satisfaction with life among mothers of pediatric cochlear implant candidates regarding implant surgery and sociodemographic factors. MATERIALS AND METHODS: Mothers of 160 pediatric patients with profound sensorineural hearing loss who underwent unilateral cochlear implant surgery were included. A questionnaire form with items on sociodemographic-familial characteristics and Satisfaction with Life Scale (SWLS) was employed via face-to-face interview method before and 12 months after the implant surgery. RESULTS: The SWLS scores significantly improved after the implant surgery [from 19.1 (7.0) to 28.9 (4.0), p<0.000]. Being unemployed vs. employed [17.9 (6.9) vs. 24.0 (5.3), p=0.000], having another child with hearing disability [13.5 (5.7) vs. 19.7 (6.9), p=0.001], younger (12-24 months) vs. older (>24 months) age of the child at the time of implant surgery [7.1 (0.4) vs. 19.7 (6.6), p=0.001], absence vs. presence of regular follow-up visits [13.0 (0.0) vs. 19.4 (7.1), p=0.002], and presence vs. absence of change in social life after the diagnosis of disease [17.3 (6.5) vs. 20.9 (7.1), p=0.001] were associated with significantly lower SWLS scores among mothers. SWLS scores were positively correlated with patient's age at the time of implant surgery (r=0.206, p=0.009), whereas negatively correlated with the number of household members (r=-0.406, p=0.000) and number of children (r=-0.310, p=0.000). CONCLUSION: In conclusion, our findings revealed the association of cochlear implantation with a significant increase in mother's life satisfaction, despite the unemployment, presence of another child with hearing disability, and crowded household. Our findings emphasize on the consideration of family systems with special attention to mother's emotional experiences and occupational competence in the intervention programs.

Computed tomography versus magnetic resonance imaging in paediatric cochlear implant assessment: a pilot study and our experience at Great Ormond Street Hospital.

BACKGROUND: To date, there is a lack of consensus regarding the use of both computed tomography and magnetic resonance imaging in the pre-operative assessment of cochlear implant candidates. METHODS: Twenty-five patients underwent high-resolution computed tomography and magnetic resonance imaging. 'Control scores' describing the expected visualisation of specific features by computed tomography and magnetic resonance imaging were established. An independent radiological review of all computed tomography and magnetic resonance imaging scan features was then compared to the control scores and the findings recorded. RESULTS: Agreement with control scores occurred in 83 per cent (20 out of 24) of computed tomography scans and 91 per cent (21 out of 23) of magnetic resonance imaging scans. Radiological abnormalities were demonstrated in 16 per cent of brain scans and 18 per cent of temporal bone investigations. CONCLUSION: Assessment in the paediatric setting constitutes a special situation given the likelihood of congenital temporal bone abnormalities and associated co-morbidities that may be relevant to surgery and prognosis following cochlear implantation. Both computed tomography and magnetic resonance imaging contribute valuable information and remain necessary in paediatric cochlear implant pre-operative assessment.