Credit: Photo courtesy UNC School of Medicine.
Newswise — CHAPEL HILL, NC – For patients whose hearing is considered “too good” for traditional cochlear implants, but whose hearing loss is too advanced to benefit from hearing aids, there hasn’t been a device to meet their needs.
But a hearing implant system that just received FDA approval will now meet that previously unmet need and benefit those patients, according to Harold C. Pillsbury, MD, chair of the Department of Otolaryngology/Head and Neck Surgery at the UNC School of Medicine.
SYNCHRONY EAS (Electric Acoustic Stimulation) Hearing Implant System, which is manufactured by Durham-based MED-EL Corporation, received FDA approval on September 16.
UNC participated in the EAS System clinical trials and implanted the device in more patients than any other hearing center that participated.
“Our clinical trial participants were overwhelmingly receptive to this new technology,” Pillsbury said. “The technology is remarkable and so were the results.”
The implant relies on two auditory technologies – the SYNCHRONY cochlear implant that stimulates the auditory nerve for high-frequency hearing loss and the EAS audio processor, which has a built-in acoustic amplification for low-frequency hearing loss.
The SYNCHRONY EAS implant best assists people whose hearing loss is referred to as “ski-slope” hearing loss, based on the steeply sloping image that appears on an audiogram when a patient has more trouble hearing higher-frequency sounds. Using traditional hearing aids, those patients often have difficulty understanding speech above the din of background noise.
Ninety-seven percent of patients participating in the MED-EL EAS clinical trial reported a benefit from EAS within the first year. Ninety-two percent of participants reported an improvement in their ability to hear even among background noise, one of the most challenging listening environments for people with hearing loss. And 90 percent reported satisfaction with the device overall.
“On average, patients performed more than twice as well on tests of speech understanding with EAS than they did with their hearing aids preoperatively, which speaks to the benefits of this technology,” Pillsbury said.
The National Institute on Deafness and Other Communication Disorders estimates that 26 million Americans between the ages of 20 and 69 have high-frequency hearing loss. While 2 percent of adults aged 45 to 54 have disabling hearing loss, the rate increases to 8.5 percent for adults aged 55 to 64. Nearly 25 percent of those ages 65 to 74 and 50 percent of those who are 75 and older have disabling hearing loss.
The EAS System FDA approval is for candidates who are 18 years old and older who have normal to moderate sensorineural hearing loss in the low frequencies, sloping to a severe-to-profound hearing loss in the high frequencies.
MED-EL expects that the SYNCHRONY EAS Hearing Implant System will be available in the coming months.
This 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.
Neither the release nor a company web site, nor a Google search turned up information about the cost of the approved device. There are almost always out-of-pocket costs associated with implants, even when insurance coverage is good.
The release claims that 97 percent of participants in the clinical trial at UNC “reported a benefit” from the device within the first year and 90 percent reported overall satisfaction. It says “on average, patients performed more than twice as well on tests of speech understanding” compared to those without the implant.
It is not clear if the benefit experienced by 97 percent of participants translated into clinical (real-life) significance for patients. What exactly does “satisfaction” represent in this context? The release doesn’t specify. And how big a benefit is performing “twice as well” as patients who didn’t get the device? The answer depends on what the baseline hearing losses were for each group of participants — something not discussed in the release. There are no data at all on failures, removals, infections, etc. They are not mentioned.
The release has zero information about harms, actual or potential.
Readers of this release never learn anything about the age, gender, socioeconomic status, educational background, or race of participants. Nothing is learned about the implant procedure, evaluation of the patients, how participants were selected, or how they were followed in after-implant care. In short, the release doesn’t offer any particulars about the clinical research protocol that the university treated “more of” than any other participating hearing center. We can assume that the study involved multiple sites but not much more.
There is no mongering and to its credit, the release provides concrete statistics on the prevalence of hearing loss. But there is some evidence of “benefits mongering.”
The release needed information about funding sources for the clinical trials. In addition, the release does not explain the quoted source’s relationship to the study (although it is implied that he is helping to lead it).
Although the release makes some distinction between the type of hearing loss most likely to benefit from this FDA approved device; and it explains in some detail how the device is an improvement over other cochlear implants, it isn’t clear about the overlapping benefits of newer digital hearing aids and the implants for people in the “moderate” sensorineural hearing loss category.
The release notes that the device received FDA approval on September 16.and that it will be available “in coming months.”
The release does a good job of explaining what is different about this device compared to other cochlear implants, notably that it is combines two technologies to address both high frequency and low frequency hearing loss. But the release would have been strengthened by noting that newer “open fit” hearing aids also try to tackle the dual hearing loss problem for many people.
The release doesn’t rely heavily sensational language.