Oct 2019The Hearing Journal
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. 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 utilisation 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 labelling 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,” effectively attenuate tinnitus, and improve localisation and speech recognition abilities. 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 labelling 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, recognising the benefits of a device and convincing the health care system to embrace its application are two distinct issues. Adoption and utilisation 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.