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Two-eared Hearing No Longer Experimental

Gifford, René H.

doi: 10.1097/01.HJ.0000582424.19700.6f
Editorial
Free

Dr. Gifford is a professor of hearing and speech sciences at Vanderbilt University Medical Center and the director of the Cochlear Implant Program at the Vanderbilt Bill Wilkerson Center in Nashville, TN.

Cochlear implantation for individuals with single-sided deafness (SSD) has garnered considerable attention over the past several years. SSD is a special case of asymmetric hearing loss where an individual has one ear with normal or near-normal hearing. In the December 2017 issue of The Hearing Journal, I discussed the evidence in peer-reviewed literature on cochlear implantation for individuals with SSD for improving speech recognition in noise, spatial hearing, qualities of hearing, and even tinnitus suppression. In the article, I explained that despite the growing literature base demonstrating the efficacy of cochlear implantation in adults and children with SSD, considerable disagreement remained among hearing care professionals over whether this is a viable intervention.

Much of the historical practice differences and hesitation of professionals to recommend cochlear implants (CIs) for individuals with SSD was due to the fact that SSD was not an approved indication for cochlear implantation requiring insurance authorization for off-label use. However, this is no longer the case. In July 2019, MED-EL announced that the U.S. Food and Drug Administration (FDA) approved their CI system for individuals with SSD and asymmetric hearing loss aged 5 years and older. While this is a revolutionary step forward in providing two-eared hearing for individuals with SSD, this is not the first instance of regulatory approval for cochlear implantation in cases of SSD. In 2013, MED-EL received CE marking granting approval to market CIs for individuals with SSD in the European Economic Area. Thus, this indication and routine clinical practice for SSD CI has been in place for over six years in Europe—and much longer when considering off-label usage.

Though we now have FDA approved indications for cochlear implantation in individuals with SSD aged 5 years and older, it is important for us to recognize what regulatory approval means for our entire patient population. Clinicians working in the CI space recognize that all three FDA-approved CI systems have their own FDA-approved indications. Each manufacturer's CI indication specifies different configurations and severities of hearing loss as well as different levels of speech recognition with appropriately fitted hearing aids.

In addition to the cross-manufacturer differences in labeled indications, the Centers for Medicare and Medicaid Services (CMS) has its own set of candidacy criteria for cochlear implantation—referred to as national coverage determination (NCD) 50.3—which explicitly specifies “bilateral moderate-to-profound sensorineural hearing impairment” (CMS, 2005; https://go.cms.gov/2Mv6Eyj). Given that CMS specifies cochlear implantation for individuals with bilateral hearing loss, we are not yet approved to recommend cochlear implantation for adults aged 65 years and older for whom Medicare is the primary insurer. This is a critical issue for clinicians and hospitals since CMS does not require preauthorization for surgical procedures yet requires that medical institutions adhere to CMS NCDs. This point is raised not to serve as the proverbial wet blanket to an otherwise transformational event in the history of auditory implants; rather, I hope to encourage clinicians and scientists to get involved and advocate for efficacious interventions at the state, regional, and national level. Those of us who have worked with CI patients who have SSD and have witnessed the benefits our patients exhibited in speech understanding, spatial hearing, and quality of life can help move this cause forward. Patient advocacy is at the heart of what hearing health care providers do each day. Professional advocacy, which is needed to drive policy change, may not come as naturally. We can all drive change within our field by presenting SSD CI data at our state hearing/audiology association meetings, getting involved with clinical research at our institution, joining evidence-based practice committees (e.g., ASHA, AAA), and continuing to press appeals and peer-to-peer reviews when CI coverage may be denied for our SSD patients.

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