The Limitations of FDA Criteria: Inconsistencies with Clinical Practice, Findings, and Adult Criteria as a Barrier to Pediatric Implantation

Children require greater access to sound than adults as they are learning to communicate using hearing and spoken language. Yet when it comes to cochlear implant candidacy, currently approved Food and Drug Administration (FDA) criteria for adults are much less restrictive than those for children, allowing for greater levels of residual hearing and aided speech recognition in adults. Cochlear implant guidelines for children have changed very little in the 30 years since cochlear implants have been approved for pediatrics, and this lack of change has proven to be a barrier to implantation. Using evidence-based practice, centers have been providing off-label implantation for children who fall outside of current FDA criteria, including children with more residual hearing, children with single-side deafness younger than 5 years, and infants with bilateral profound loss younger than 9 months. The purpose of this article is to outline how these restrictions impede access to implants for children and describe the evidence supporting cochlear implantation in children who fall outside of current criteria.

Mythbusters! The Truth about Common Misconceptions in Cochlear Implantation

Cochlear implantation (CI) is the preferred method of hearing rehabilitation when patients cannot perform well with traditional amplification. Unfortunately, there are still significant misconceptions around this life-changing intervention. The goal of this article is to address some of the most common myths around CI surgery. After reading this article, the learner will be able to explain the utility of CI in patients with residual hearing and recognize that insurance coverage is widespread. The reader will be able to list common risks associated with this well-tolerated procedure including anesthetic risk and the risk of vestibular dysfunction. Additionally, the reader will be able to identify the significant positive impact of CI on patients' quality of life. Finally, the reader will identify that many patients can safely have an MRI scan after implantation, including nearly all contemporary recipients.

The Importance of Access to Bilateral Hearing through Cochlear Implants in Children

Children with hearing loss require early access to sound in both ears to support their development. In this article, we describe barriers to providing bilateral hearing and developmental consequences of delays during early sensitive periods. Barriers include late identification of hearing loss in one or both ears and delayed access to intervention with hearing devices such as cochlear implants. Effects of delayed bilateral input on the auditory pathways and brain are discussed as well as behavioral effects on speech perception and other developmental outcomes including language and academics. Evidence for these effects has supported an evolution in cochlear implant candidacy in children that was started with unilateral implantation in children with profound deafness bilaterally to bilateral implantation to implantation of children with asymmetric hearing loss including children with single-side deafness. Opportunities to enhance the developmental benefits of bilateral hearing in children with hearing loss are also discussed including efforts to improve binaural/spatial hearing and consideration of concurrent vestibular deficits which are common in children with hearing loss.

Barriers to Adult Cochlear Implant Care in the United States: An Analysis of Health Care Delivery

Persistent underutilization of cochlear implants (CIs) in the United States is in part a reflection of a lack of hearing health knowledge and the complexities of care delivery in the treatment of sensorineural hearing loss. An evaluation of the patient experience through the CI health care delivery process systematically exposes barriers that must be overcome to undergo treatment for moderate-to-severe hearing loss. This review analyzes patient-facing obstacles including diagnosis of hearing loss, CI candidate identification and referral to surgeon, CI evaluation and candidacy criteria interpretation, and lastly CI surgery and rehabilitation. Pervasive throughout the process are several themes which demand attention in addressing inequities in hearing health disparities in the United States.

Defining Disparities in Cochlear Implantation through the Social Determinants of Health

Hearing loss is a global public health problem with high prevalence and profound impacts on health. Cochlear implantation (CI) is a well-established evidence-based treatment for hearing loss; however, there are significant disparities in utilization, access, and clinical outcomes among different populations. While variations in CI outcomes are influenced by innate biological differences, a wide array of social, environmental, and economic factors significantly impact optimal outcomes. These differences in hearing health are rooted in inequities of health-related socioeconomic resources. To define disparities and advance equity in CI, there is a pressing need to understand and target these social factors that influence equitable outcomes, access, and utilization. These factors can be categorized according to the widely accepted framework of social determinants of health, which include the following domains: healthcare access/quality, education access/quality, social and community context, economic stability, and neighborhood and physical environment. This article defines these domains in the context of CI and examines the published research and the gaps in research of each of these domains. Further consideration is given to how these factors can influence equity in CI and how to incorporate this information in the evaluation and management of patients receiving cochlear implants.

The Impact of Cochlear Implantation: Cognitive Function, Quality of Life, and Frailty in Older Adults

This review examines the relationship between cochlear implantation and cognition and quality of life in older adults, as well as how frailty affects outcomes for older patients with cochlear implants. A growing body of evidence suggests that there is a strong association between hearing loss and cognitive impairment. Preliminary studies suggest that cochlear implantation in older adults may be protective against cognitive decline. While studies have observed a positive impact of cochlear implantation on quality of life, currently it is unclear what factors contribute the most to improved quality of life. Frailty, as a measurement of general health, likely plays a role in complication rates and quality-of-life outcomes after cochlear implantation, though larger prospective studies are required to further elucidate this relationship.

Determining Cochlear Implant Candidacy in Adults: Limitations, Expansions, and Opportunities for Improvement

The safety, efficacy, and success of cochlear implants (CIs) are well established and have led to changes in criteria used by clinicians to determine who should receive a CI. Such changes in clinical decision-making have out-paced the slower-occurring changes that have taken place with regulatory bodies' and insurers' indications. We review the historical development of indications for CIs, including those of the U.S. Food and Drug Administration (FDA), Medicare, Medicaid, and private insurers. We report on expansion to include patients with greater residual hearing, such as those who receive Hybrid and EAS devices, and report on recent FDA approvals that place less emphasis on the patient's best-aided condition and greater emphasis on the ear to be treated. This includes expansion of CIs to patients with single-side deafness and asymmetric hearing loss. We review changes in the test materials used to determine candidacy, including transition from sentences in quiet to sentences in noise to the recent use of monosyllabic words and cognitive screening measures. Importantly, we discuss the recent trend to recommend CIs despite a patient not meeting FDA or insurers' indications (a practice known as “off-label”), which serves as attestation that current indications need to be updated.

Functional Assessment of Hearing Aid Benefit: Incorporating Verification and Aided Speech Recognition Testing into Routine Practice

Potential cochlear implant (CI) candidates arrive to the clinic with a variety of hearing loss configurations, hearing aid history, and aided capabilities. CI candidacy is primarily determined based on aided speech recognition capability, which relies on benefit derived from use of hearing aids. Therefore, contemporary evaluation for CI candidacy should incorporate a battery of testing to determine abilities and limitations and must be predicated on appropriate verification of the hearing aid fitting. However, recent reports, including a retrospective chart review of patients presenting to Cleveland Clinic for CI evaluation, suggest that a significant subset of patients may be using inappropriately fit or programmed amplification. Thus, a combination of simulated real-ear measurements and aided speech recognition testing is essential for fully assessing the effect of amplification and ultimately determination of CI candidacy. Furthermore, waiting to incorporate these tools until CI candidacy is suspected may delay timely identification of problems or need to change technology. Utilization of evidence-based decision drivers ultimately leads clinicians to timely patient-specific interventions which may include surgical intervention or other amplification options. As audiology moves into a healthcare era in which payers consider the benefit of our services to overall health and well-being, demonstrating timely, optimal outcomes using thorough, multifactorial evaluation is essential.

Improving Speech Understanding and Monitoring Health with Hearing Aids Using Artificial Intelligence and Embedded Sensors

This article details ways that machine learning and artificial intelligence technologies are being integrated in modern hearing aids to improve speech understanding in background noise and provide a gateway to overall health and wellness. Discussion focuses on how Starkey incorporates automatic and user-driven optimization of speech intelligibility with onboard hearing aid signal processing and machine learning algorithms, smartphone-based deep neural network processing, and wireless hearing aid accessories. The article will conclude with a review of health and wellness tracking capabilities that are enabled by embedded sensors and artificial intelligence.