The clinical efficacy of cochlear implants (CIs) for patients with bilateral severe-to-profound hearing loss for whom hearing aids provide limited benefit is well documented. However, estimates suggest that approximately 90 percent of patients who could benefit do not have CIs.1 Despite continued inability to substantially increase this number, hearing care providers who work in CI programs routinely see the benefit, and have continued to advocate for CI utilization using increasingly less restrictive candidacy criteria, including asymmetric hearing loss (AHL) and even single-sided deafness (SSD). In SSD, one ear is completely within normal limits while the other ear exhibits sensorineural hearing loss (SNHL) that cannot benefit from amplification, whereas in AHL, the better ear exhibits some degree of hearing loss better than that historically considered for CI candidacy. In other words, if both ears demonstrated the degree of SNHL in the poorer ear, the individual would be a clear-cut candidate for CI.
However, the U.S. FDA labeling has been based on bilateral, not unilateral, severe-to-profound SNHL, thereby denying the latter patient population access to CIs. In recent years, a series of clinical trials have demonstrated that CI in SSD may help “restore binaural functionality, improve quality of life, facilitate reversal of neuroplasticity related to auditory deprivation,”2 effectively attenuate tinnitus, and improve localization and speech recognition abilities.3-5 As a result, CI in SSD has been CE-marked in Europe since 2013, and has gradually become more clinically acceptable in the United States, where it is the standard of care in some progressive programs. In fact, in July 2019, the FDA approved the labeling of one manufacturer's CI system for use in candidates >5 years old with AHL or SSD, defined as profound SNHL and aided word recognition scores of less than five percent in the ear to be implanted.
Although the introduction of this new indication was a meaningful step forward for CI candidates, recognizing the benefits of a device and convincing the health care system to embrace its application are two distinct issues. Adoption and utilization of a management option require demonstration of clinical and cost-effectiveness, regulatory support, adoption by referring providers, and coverage by payers. While the clinical effectiveness of CI in SSD/AHL is well known and regulatory progress has been made, the discussion must extend to the practical logistics of access. Specifically, three primary barriers to clinical progress for this population remain: (1) paucity of data regarding cost-effectiveness, (2) reticence of payers to align policies with best practices, and (3) subscription of referring providers to newly redefined candidacy criteria.
The two most viable arguments against CI in SSD are that (1) only one ear is necessary to achieve optimal hearing, and that (2) introduction of a CI could be detrimental to the better hearing ear, both of which have been disproved. Much of the impact of SSD, such as increased cognitive load, cortical reorganization, listening fatigue, and tinnitus reduction, is invisible and difficult to quantify. As a result, it is frequently assumed that normal hearing in one ear is adequate. However, SSD has been shown to affect music appreciation, speech understanding in noise, speech and language acquisition in pre- and peri-lingual children, performance in the classroom/workplace, and quality of life due to deficits that can be attributed to the loss of binaural hearing, including binaural squelch, binaural summation, and the head shadow effect.2
In children, any degree of unilateral hearing loss has been shown to lead to impaired educational progress, including “higher rates of grade failure, higher incidence of individualized education programming (IEP), and increased need for educational resources and attention in the classroom.”2 Unilateral sound deprivation during the development of auditory pathways in childhood has been shown to lead to cortical reorganization,6,7 and older children and adults may suffer from social and mental anxieties subsequent to the abrupt loss of a sense that is often taken for granted. Diminished easy awareness of social cues, need for selective positioning in groups, and reduced ability to multitask (e.g., have environmental awareness while talking on the phone) can all negatively impact one's quality of life and cognitive load.
Second, it is well documented that earlier implantation and shorter duration of deafness before implantation result in improved outcomes.8 Yet access to CI is often delayed or denied to individuals with substantial hearing loss in one ear despite known advantages of bilateral hearing, including spatial hearing and localization, quality of speech sounds, quality of life, and speech perception in noisy environments9 that cannot be achieved with alternative treatments. Specifically, contralateral routing of signal (CROS) and bone-anchored implantation (BAI), whereby a microphone ipsilateral to the unaidable ear reroutes the signal to the normally functioning side, fail to restore binaural benefits, improve localization, or reduce tinnitus—factors that improve with use of CI.3 Most importantly, studies suggest that the addition of an electrically driven stimulus to normal contralateral hearing does not interfere with speech understanding capabilities nor result in the non-use of the device. On the contrary, a systematic review of the literature reported ongoing device utilization by 96.5 percent of CI recipients.10 SSD patients who choose CI feel “that they made the right decision, albeit the impossibility to restore normal hearing” and not being able to try the device before undergoing surgery.11
Cost-effectiveness analysis (CEA) of CI requires consideration of not only the costs of providing the service but also the cost-savings in the form of downstream health-related costs and increased health-related quality of life.12 Factors beyond clinical effectiveness include the patient's physical and emotional function, vitality, interpersonal communication, independence in daily living, overall satisfaction with life, and mental health.13 Costs associated with CI include not only the initial surgery and implant but also external equipment and audiologic services, including programming and rehabilitative services.14 These factors often result in the perception that CI places a greater burden on the health care system and should be reserved as a last resort. In reality, “cochlear implantation is a high cost intervention, but one which the evidence demonstrates makes a dramatic positive impact on peoples’ lives in a range of domains.”15 While there is no significant difference in quality of life between CI recipients and their normally hearing peers, there is lower quality of life in CI candidates using hearing aids and those with less CI experience, older age at implantation, and lower auditory perception.13
A 2012 cost-utility study comparing individuals who have CIs with those who use hearing aids for profound SNHL found an economic cost differential of $204,000 in favor of CI, with CI delivering a return on investment of $2.07 for each dollar invested.16 Other practical implications have also been reported, including an increase in median annual salary ($42,672 vs. $30,432), the degree of which exceeded the cost of the CI itself.17 Choi, et al.,18 concluded that “clinical strategies and public policies promoting earlier rather than later cochlear implantation in older candidates are likely to lead to more favorable long-term outcomes and cost-effectiveness of cochlear implantation in older adults.”
The literature is understandably more limited in terms of capturing cost-benefit data for patients with a normal or at least very aidable better ear. Due to the lack of economic data for this intervention, two study protocols on this topic have been registered in recent years,19,20 with the intention of defining the economic value of this intervention. These studies aim to answer the question of whether the additional risks and “costs of CI are justified by increased benefits, when compared to current treatment strategies”19 by considering reduction in tinnitus and improvements in speech understanding, localization, and quality of life. In the meantime, practicing clinicians must determine how to incorporate recommendation for CI into their practices.
OPPORTUNITY FOR CLINICIANS
Although cost-effectiveness data in this population are lacking, treatment effectiveness has been well established. However, demonstrating the effectiveness of a technology is inadequate without adoption into clinical practice, a process reported to take an average of 17 years, which even then is inconsistently applied.21,22 Regarding CI, there is an established track record of a lack of confidence in identifying appropriate CI candidates even when they meet the more traditional candidacy criteria. This lack of awareness has been cited as a key reason that potential candidates have limited access to CI. Realistically, in addition to being unfamiliar or uncomfortable with CI candidacy criteria, especially the more expanded indications, providers may feel threatened by rapidly encroaching new indications for devices that can be implanted or obtained over the counter, and may worry about loss of practice revenue from the delivery of non-implantable alternatives such as a CROS system or traditional hearing aids. To best serve patients, providers must be clinically, ethically, and financially comfortable with recommending CI as an alternative treatment option.
In CI programs with in-house surgical services, CI is often financially preferable to hearing aids, and may generate revenue approximately 10 times that of hearing aid evaluation and fitting. However, many referrals for CI can be expected to be generated by private practices, university programs, or other clinics unaffiliated with surgical services. There is a paucity of data to evaluate the potential financial burden of “losing an ear,” for which a hearing aid could be dispensed to implantation, but one could extrapolate that revenues may be reduced by 50 to 100 percent per patient, depending on whether the patient continued to follow up at the referring practice for management of the non-implanted ear. However, less tangible, harder-to-quantify benefits to the practice secondary to recommending CI consistently include building patient trust, giving an impression of practicing on the cutting edge, and building collaborative relationships with referring providers and surgical centers—all of which have the potential to actually increase revenues by referring more patients to the program. Additionally, offering CI programming services creates a potential for a new service line that diversifies an audiology practice and could create another revenue stream.
A primary component of the successful incorporation of new technology into clinical practice is adequate coverage by insurance. Without adoption of a technology into a coverage policy, even if clinicians recognize and recommend a device, CI candidates may not be able to proceed with surgery unless they can depend on the financial security of insurance coverage. Thus, the insurer's determination of whether to cover a new indication and how it will be reimbursed is a key step in the process. Different payers manage this process in different ways—some subscribe to an external technology assessment organization that evaluates the scientific evidence and provides recommendations, while others perform their own analyses. Each insurer determines its own tolerance for how restrictive the plan will be. The decision is then reflected in plan policies, typically in one of three ways: a requirement that a treatment be of proven benefit (i.e., not experimental or investigational), medically necessary, and not a specific exclusion (excluded despite medical evidence because it is viewed as discretionary).21
Some payer coverage decisions include a requirement that patients have tried other technologies first, including a hearing aid or a CROS system, which may delay or prevent access. This process helps explain why even though short electrode arrays have been FDA-approved since 2014, some insurers refuse to cover them, insisting they are still experimental. In some cases, when newer, proven technology with expectations for better long-term outcomes is approved, its reimbursement rates are set higher so as to encourage providers to recommend that option over the traditional choice, even when the newer option is more expensive.21 Because CIs are more invasive, require more frequent reprogramming, and represent substantially increased costs from a non-surgical, often non-covered option (i.e., CROS) or even a more minor surgical procedure (i.e., BAI), more work will need to be done to reinforce the comparative effectiveness of CI from clinical and cost outcome perspectives and to drive coverage. There is evidence that “not addressing hearing loss early dramatically increases the economic burden to society through the additional costs for health services, loss of independence and additional care costs in treating the consequences of hearing loss.”23 It is necessary to quantify the burden that is lessened with CI use to optimize hearing in various populations.
CIs offer substantial benefits to patients over traditional interventions, including reduction in tinnitus, improved speech understanding, and increased localization ability. The challenge lies not in acknowledging the positive outcomes, but rather in convincing the health care system to act upon them. Recent expansion of CI candidacy to include patients with SSD and AHL represents an important step toward increasing access, but there must be a larger paradigm shift for patients to enjoy the benefits of such expanded candidacy. Cost-benefit analyses for CI candidates with more residual hearing than traditional candidates are needed to justify recommendation for CIs. Referring providers must be willing to embrace the advantages of CIs and inform their patients of the option. For practices offering surgical services, the positive financial returns can be quantified, and should support the desire of clinical teams to encourage expanded utilization of these devices. Further research is needed to understand the implications for independent audiology practices, although there are intangible benefits to a practice that may minimize or negate lost revenue. For payers, expanding coverage to include unilateral severe-to-profound hearing loss would likely reflect an increased expenditure, although the savings from expenses not incurred due to untreated hearing loss may actually negate some of these anticipated losses. More analysis is needed to fully understand this complex interaction. Regardless, sometimes financial management can't be the driving factor. Health care organizations and providers are morally and ethically obligated to do the right thing, and in this case, the right thing is to provide patients with access to the best hearing outcome possible.
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