The Esteem is totally implantable, removing the social stigma of a visible device.
Explore This IssueFebruary 2012
“The technology really has matured to the point where it’s a reasonable alternative,” Dr. Arriaga said. “The outcomes really are quite positive in the majority of patients,” he said. “It really does seem like a reasonable option for an unsatisfied hearing aid user.”
Peter Weisskopf, MD, FACS, head of the neurotology section at the Barrow Neurological Institute in Phoenix, Ariz., argued that what is left unsaid in marketing materials is that 44 percent of Esteem users had WRS scores worse than or equal to their hearing with a hearing aid, according to manufacturer Envoy Medical’s own published results, posted on envoymedical.com.
He called into question the ethics involved in the use of the devices, noting that companies spend up to $10 million a year on advertising, that patients’ first point of contact is the company itself and that implants are done on a cash basis.
“Can you get a second opinion? Is there a second opinion?” he said. “I don’t feel qualified to give one. I haven’t been trained by the Esteem company to tell what all the pros and cons are. So what is a patient to do?”
He also said there was an inherent bias at the centers that did the research leading to approvals, because the research was supported by the manufacturer. With little long-term data available, a cost that can reach $30,000 and the risk of a surgical procedure, he said, “Why take the risk?”
Managing Oropharyngeal Cancer
Randal Weber, MD, FACS, chair of head and neck surgery at the University of Texas M.D. Anderson Cancer Center in Houston, argued for a non-surgical approach to oropharyngeal cancer.
Among the data he cited were 102 patients at his own center who received unilateral irradiation for T1 and T2 tonsil cancer, with a five-year locoregional control rate of 100 percent, 95 percent overall survival and excellent functional outcome with no patients requiring a long-term G-tube or tracheostomy.
A 2006 study (N Engl J Med. 354;6) found that radiotherapy plus Cetuximab was superior to radiation alone for locoregionally advanced squamous cell carcinoma of the head and neck, resulting in 49 months of locoregional control among those with oropharyngeal cancer, he noted.
But he also said a non-surgical approach might not be best for those with high-risk oropharyngeal tumors, defined by T4 tumors and advanced neck disease, and for HPV-negative tumors, based on the RTOG 0129 trial recently published in the New England Journal of Medicine.