text_1: UNC Hearing Loss Experts Lead Clinical Trials of FDA-Approved Hearing Implant
text_2: Synchrony EAS (electric acoustic stimulation) hearing implant. Image credit: Med-El USA, the device manufacturerThis news release from the University of North Carolina purports to advise journalists and the public about clinical research from the university that helped gain recent FDA approval for an implantable hearing device designed for adults with a form of moderate to severe hearing loss. But this news release is a not-very-thinly veiled infomercial for the device’s maker, and a promotional piece for and by the head of the university department whose faculty members clearly stand to benefit from marketing it. The release is full of hyperbolic praise for the device (“The technology is remarkable and so were the results…”) and the university’s role in the clinical trials. But it is very light on quantitative data and information about costs, complications and side effects that would help readers judge the pros and cons of an invasive cochlear implant. The release offers no links or references to published, peer-reviewed data; to the manufacturer’s website; or notes on potential conflicts of interest. There is some useful information about the prevalence of hearing loss in the U.S. and about what is novel about the implant. But this releases reads more like a commercial brochure than an informative and educational summary for public awareness. Hearing loss is indeed a significant and growing problem and a threat to an aging population. In recent years, hearing loss has been tied by research to cognitive loss (as described in this 2013 study published in JAMA Internal Medicine), as well as social isolation, traffic accidents and a host of other physical, emotional and social ills. Because Medicare, Medicaid and other insurers do not cover the cost of hearing aids — which can run into the thousands of dollars for state-of-the-art devices — most adults who need them don’t have them. For the most severe, disabling forms of “sensorineural”  hearing loss, cochlear implants can be life-changing, and the device described in this release could have novelty and benefits in addressing both high and low frequency hearing problems. Significantly, most insurance, including Medicare, covers the cost of the device and implant surgery. But the benefits of the implants come with risks, including the need for general anesthesia, damage to facial nerves, infections, tinnitus, and numbness. Adjustment to the devices can take months of habilitative services — and removal rates remain high in some populations. Long-term effects, moreover, still are largely unknown. For all these reasons, news releases and stories about surgical implants should offer context about the benefits, risks, costs and alternatives.