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Importance: Current indications for Medicare beneficiaries to receive a cochlear implant are outdated.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.

Oral steroids for the resolution of otitis media with effusion (OME) in children (OSTRICH): study protocol for a randomised controlled trial.

BACKGROUND: Otitis media with effusion (OME) is an accumulation of fluid in the middle ear affecting about 80 % of children by the age of 4 years. While OME usually resolves spontaneously, it can affect speech, behaviour and development. Children with persistent hearing loss associated with OME are usually offered hearing aids or insertion of ventilation tubes through the tympanic membrane. Oral steroids may be a safe and effective treatment for OME, which could be delivered in primary care. Treatment with oral steroids has the potential to benefit large numbers of children and reduce the burden of care on them and on health services. However, previous trials have either been too small with too short a follow-up period, or of too poor quality to give a definite answer. The aim of the Oral Steroids for the Resolution of Otitis Media with Effusion in Children (OSTRICH) trial is to determine if a short course of oral steroids improves the hearing of children with OME in the short and longer term. METHODS/DESIGN: A total of 380 participants (children of 2 to 8 years of age) are recruited from Hospital Ear, Nose and Throat departments in Wales and England. A trained clinician seeks informed consent from parents of children with symptoms for at least 3 months that are attributable to OME and with confirmed bilateral hearing loss at study entry. Participants are randomised to a course of oral steroid or a matched placebo for 1 week. Outcomes include audiometry, tympanometry and otoscopy assessments; symptoms; adverse effects; functional health status; quality of life; resource use; and cost effectiveness. Participants are followed up at 5 weeks, and at 6 and 12 months after the day of randomisation. The primary outcome is audiometry-confirmed satisfactory hearing at 5 weeks. DISCUSSION: An important evidence gap exists regarding the clinical and cost effectiveness of short courses of oral steroid treatment for OME. Identifying an effective, safe, nonsurgical intervention for OME in children for use in primary care would be of great benefit to children, their families and the NHS. ISRCTN: ISRCTN49798431 (Registered 7 December 2012).

Cost-utility analysis of bilateral cochlear implantation in adults: a health economic assessment from the perspective of a publicly funded program.

OBJECTIVES/HYPOTHESIS: To determine the cost-effectiveness of bilateral cochlear implantation (CI) in deaf adults. STUDY DESIGN: Cost-utility analysis. METHODS: Ninety patients and 52 health professionals served as proxies to estimate the benefit of bilateral cochlear implantation, utilizing the Health Utility Index. Three scenarios were created to reflect 1) deafness without intervention, 2) unilateral CI, and 3) bilateral CI. Cost evaluation reflected the burden on a publicly funded healthcare system. The base case included 25 years of service provision, processor upgrades every 5 years, 50% price reduction for second side, and 15% failure rate. Discounting and sensitivity analyses were applied. RESULTS: Costs were $63,632 (unilateral CI), $111,764 (bilateral CI), and $48,132 (incremental cost of second CI). The health preference gained from no intervention to unilateral CI, and to bilateral CI were 0.270 and 0.305. Incremental utility gained by the second implant was 11.5% of total. The incremental cost-utility ratio (ICUR) was $14,658/quality-adjusted life year (QALY) for bilateral CI compared to no intervention. It was stable regardless of discounting or sensitivity analyses. ICUR was $55,020/QALY from unilateral to bilateral CI with higher uncertainties. It improved with differential discounting, further second-side price reduction, and reduced frequency of processor upgrades. ICUR worsened with reduced length of use and higher failure rates. CONCLUSIONS: Sequential bilateral CI was cost-effective when compared to no intervention, although gains were made mostly by the first implant. Cost-effectiveness compared to unilateral implantation was borderline but improved through base case variations to reflect long-term gains or cost-saving measures. LEVEL OF EVIDENCE: 2C.

[Cochlear implant in children: rational, indications and cost/efficacy]. / L'impianto cocleare nel bambino: razionale, indicazioni, costo/efficacia.

A cochlear implant (CI) is a partially implanted electronic device that can help to provide a sense of sound and support speech to severely to profoundly hearing impaired patients. It is constituted by an external portion, that usually sits behind the ear and an internal portion surgically placed under the skin. The external components include a microphone connected to a speech processor that selects and arranges sounds pucked up by the microphone. This is connected to a transmitter coil, worn on the side of the head, which transmits data to an internal receiver coil placed under the skin. The received data are delivered to an array of electrodes that are surgically implanted within the cochlea. The primary neural targets of the electrodes are the spiral ganglion cells which innervate fibers of the auditory nerve. When the electrodes are activated by the signal, they send a current along the auditory nerve and auditory pathways to the auditory cortex. Children and adults who are profoundly or severely hearing impaired can be fitted with cochlear implants. According to the Food and Drug Administration, approximately 188,000 people worldwide have received implants. In Italy it is extimated that there are about 6-7000 implanted patients, with an average of 700 CI surgeries per year. Cochlear implantation, followed by intensive postimplantation speech therapy, can help young children to acquire speech, language, and social skills. Early implantation provides exposure to sounds that can be helpful during the critical period when children learn speech and language skills. In 2000, the Food and Drug Administration lowered the age of eligibility to 12 months for one type of CI. With regard to the results after cochlear implantation in relation to early implantation, better linguistic results are reported in children implanted before 12 months of life, even if no sufficient data exist regarding the relation between this advantage and the duration of implant use and how long this advantage persists in the subsequent years. With regard to cochlear implantation in children older than 12 months the studies show better hearing and linguistic results in children implanted at earlier ages. A sensitive period under 24-36 months has been identified over which cochlear implantation is reported to be less effective in terms of improvement in speech and hearing results. With regard to clinical effectiveness of bilateral cochlear implantation, greater benefits from bilateral implants compared to monolateral ones when assessing hearing in quiet and in noise and in sound localization abilities are reported to be present in both case of simultaneous or sequential bilateral implantation. However, with regard to the delay between the surgeries in sequential bilateral implantation, although benefit is reported to be present even after very long delays, on average long delays between surgeries seems to negatively affect the outcome with the second implant. With regard to benefits after cochlear implantation in children with multiple disabilities, benefits in terms of speech perception and communication as well as in quality of the daily life are reported even if benefits are slower and lower in comparison to those generally attained by implanted children without additional disabilities. Regarding the costs/efficacy ratio, the CI is expensive, in particular because of the cost of the high technological device, long life support, but even if healthcare costs are high, the savings in terms of indirect costs and quality of life are important. The CI, in fact, has a positive impact in terms of quality of life.

An economic evaluation of screening 60- to 70-year-old adults for hearing loss.

BACKGROUND: Hearing loss is common among older adults and has consequences for sufferers, families and society, but there is substantial unmet need for intervention. Screening could expedite intervention and improve outcomes. METHODS: We use Markov models to estimate the incremental cost-effectiveness ratio (ICER) of potential screening programmes compared with current provision (GP-referral), from a health service perspective. Alternative options are investigated through scenario analysis. One-way and probabilistic sensitivity analyses are undertaken. RESULTS: All modelled screens are cost-effective and reduce unmet need for hearing aids. The most cost-effective option identified is a one-stage audiometric screen for bilateral hearing loss ≥30 dB hearing level (HL) at age 60, repeated at ages 65 and 70. This option has an ICER of £1461 compared to GP-referral and would mean an additional 15 437 adults benefiting from hearing intervention per 100 000 population aged 60. The cost-effectiveness acceptability curve shows that screening is more cost-effective than GP-referral provided a Quality Adjusted Life Year is valued at £2000 or more. CONCLUSIONS: Adult hearing screening would provide a cost-effective way to improve quality of life for older adults. We recommend piloting an audiometric screen offered to all adults age 60, 65 and 70 years to identify bilateral hearing loss of at least 30 dB HL.

Bone-anchored hearing aids (BAHAs) for people who are bilaterally deaf: a systematic review and economic evaluation.

BACKGROUND: A bone-anchored hearing aid (BAHA) consists of a permanent titanium fixture, which is surgically implanted into the skull bone behind the ear, and a small detachable sound processor that clips onto the fixture. BAHAs are suitable for people with conductive or mixed hearing loss who cannot benefit fully from conventional hearing aids. OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of BAHAs for people who are bilaterally deaf. DATA SOURCES: Nineteen electronic resources, including MEDLINE, EMBASE and The Cochrane Library (inception to November 2009). Additional studies were sought from reference lists and clinical experts. REVIEW METHODS: Inclusion criteria were applied by two reviewers independently. Data extraction and quality assessment were undertaken by one reviewer and checked by a second. Prospective studies of adults or children with bilateral hearing loss were eligible. Comparisons were BAHAs versus conventional hearing aids [air conduction hearing aid (ACHA) or bone conduction hearing aid (BCHA)], unaided hearing and ear surgery; and unilateral versus bilateral BAHAs. Outcomes included hearing measures, validated measures of quality of life (QoL), adverse events and measures of cost-effectiveness. For the review of cost-effectiveness, full economic evaluations were eligible. RESULTS: Twelve studies were included (seven cohort pre-post studies and five cross-sectional 'audiological comparison' studies). No prospective studies comparing BAHAs with ear surgery were identified. Overall quality was rated as weak for all included studies and meta-analysis was not possible due to differences in outcome measures and patient populations. There appeared to be some audiological benefits of BAHAs compared with BCHAs and improvements in speech understanding in noise compared with ACHAs; however, ACHAs may produce better audiological results for other outcomes. The limited evidence reduces certainty. Hearing is improved with BAHAs compared with unaided hearing. Improvements in QoL with BAHAs were identified by a hearing-specific instrument but not generic QoL measures. Studies comparing unilateral with bilateral BAHAs suggested benefits of bilateral BAHAs in many, but not all, situations. Prospective case series reported between 6.1% and 19.4% loss of implants. Most participants experienced no or minor skin reactions. A decision analytic model was developed. Costs and benefits of unilateral BAHAs were estimated over a 10-year time horizon, applying discount rates of 3.5%. The incremental cost per user receiving BAHA, compared with BCHA, was £ 16,409 for children and £ 13,449 for adults. In an exploratory analysis the incremental cost per quality-adjusted life-year (QALY) gained was between £ 55,642 and £ 119,367 for children and between £ 46,628 and £ 100,029 for adults for BAHAs compared with BCHA, depending on the assumed QoL gain and proportion of each modelled cohort using their hearing aid for ≥ 8 or more hours per day. Deterministic sensitivity analysis suggested that the results were highly sensitive to the assumed proportion of people using BCHA for ≥ 8 hours per day, with very high incremental cost-effectiveness ratio values (£ 500,000-1,200,000 per QALY gained) associated with a high proportion of people using BCHA. More acceptable values (£ 15,000-37,000 per QALY gained) were associated with a low proportion of people using BCHA for ≥ 8 hours per day (compared with BAHA). LIMITATIONS: The economic evaluation presented in this report is severely limited by a lack of robust evidence on the outcome of hearing aid provision. This has lead to a more restricted analysis than was originally anticipated (limited to a comparison of BAHA and BCHA). In the absence of useable QoL data, the cost-effectiveness analysis is based on potential utility gains from hearing, that been inferred using a QoL instrument rather than measures reported by hearing aid users themselves. As a result the analysis is regarded as exploratory and the reported results should be interpreted with caution. CONCLUSIONS: Exploratory cost-effectiveness analysis suggests that BAHAs are unlikely to be a cost-effective option where the benefits (in terms of hearing gain and probability of using of alternative aids) are similar for BAHAs and their comparators. The greater the benefit from aided hearing and the greater the difference in the proportion of people using the hearing aid for ≥ 8 hours per day, the more likely BAHAs are to be a cost-effective option. The inclusion of other dimensions of QoL may also increase the likelihood of BAHAs being a cost-effective option. A national audit of BAHAs is needed to provide clarity on the many areas of uncertainty surrounding BAHAs. Further research into the non-audiological benefits of BAHAs, including QoL, is required.

The economic costs of congenital bilateral permanent childhood hearing impairment.

OBJECTIVE: The objective of this study was to estimate the economic costs of bilateral permanent childhood hearing impairment (PCHI) in the preceding year of life for children aged 7 to 9 years. METHODS: A cost analysis was conducted by using a birth cohort of children born between 1992 and 1997 in 8 districts of Southern England, of which half had been born into populations exposed to universal newborn screening (UNS). Unit costs were applied to estimates of health, social, and broader resource use made by 120 hearing-impaired children and 63 children in a normally hearing comparison group. Associations between societal costs per child and severity of hearing impairment, language ability score, exposure to UNS, and age of confirmation were analyzed, including adjustment for potential confounders in a linear regression model. RESULTS: The mean societal cost in the preceding year of life at 7 to 9 years of age was 14092.5 pound sterling for children with PCHI, compared with 4206.8 pound sterling for the normally hearing children, a cost difference of 9885.7 pound sterling. After adjusting for severity and other potential confounders in a linear regression model, mean societal costs among children with PCHI were reduced by 2553 pound sterling for each unit increase in the z score for receptive language. Using similar regression models, exposure to a program of UNS was associated with a smaller cost reduction of 2213.2 pound sterling, whereas costs were similar between children whose PCHI was confirmed at <9 or >9 months. CONCLUSIONS. The study provides rigorous evidence of the annual health, social, and broader societal cost of bilateral PCHI in the preceding year of life at 7 to 9 years of age and shows that it is related to its severity and has an inverse relationship with language abilities after adjustment for severity.

Advantages of a new miniature hearing aid for mild to moderate hearing loss.

OBJECTIVES/HYPOTHESIS: To evaluate the performance of a new, miniature, behind-the-ear hearing aid designed for individuals with mild to moderate high-frequency hearing loss who need an aid but are reluctant to try one. The aid is essentially invisible, leaves the ear canal open, and can be fit in less than 30 minutes without an ear impression. The cost is less than $500. STUDY DESIGN: A 4-week trial of the aid in 63 ears (62 subjects) with mild to moderate bilateral hearing loss. METHODS: A questionnaire was completed at the end of the study by each subject asking them to evaluate several features of the aid (cosmesis, comfort, understanding speech, amplification, and so forth) and to compare their unaided performance in quiet and in noise with the test hearing aid. A rating scale of 1 to 10 was used, with 10 being excellent and 1 poor. RESULTS: Subjective improvement in understanding speech in both quiet (5.8-->7.3) and noise (4.6-->5.9) occurred with the aid. Cosmesis, comfort, and appearance were highly rated (mean scores, > 8). CONCLUSIONS: This aid appears to have several features (comfort, cost, performance, and cosmesis) that make it ideal as a first aid for patients with mild to moderate losses.