Is the answer to your hearing loss a non-cochlear middle ear implant? I see lots of interest in the Esteem and the Maxum, and have myself thought about getting one or the other. In fact my audiologist strongly recommends the Esteem for me, and would refer me to a clinic who could do the job for “only about 30thousand dollars”…not covered by Medicare and NOTHING GUARANTEED. If I add in the cost of travel to Orange County where this clinic is located and the month or so I would have to go without hearing in the implanted side, the Esteem is not a shoe-in solution to me. So what are the FACTS about these implants? Not a lot on the web that I can google up to find out. What kind of risk is involved in these surgeries. How long on average before they have to open you up to change the battery, for example? Not a lot of data available yet. I did find an interesting but 2-year old debate online:
New Hearing Devices
Moisés Arriaga, MD, MBA, FACS, director of otology-neurotology and professor of otolaryngology and neurosurgery at Louisiana State University Health Sciences Center in New Orleans, took the side of implantable hearing devices in the next mini-debate.
Dr. Arriaga, who has participated in clinical trials of several models of middle ear implants, said the approved devices, the Vibrant Soundbridge, the Maxum and the Esteem, have all resulted in better hearing improvement compared to traditional hearing aids. With the Esteem, for example, patients had an overall 21-point improvement in word recognition scores (WRS) compared to their scores with a hearing aid, according to results in the clinical trial leading to its approval.
One of the main reasons for their success is that the canal isn’t blocked with those devices as it is with hearing aids. They also involve direct vibration of the anatomy of the ear.
The Esteem is totally implantable, removing the social stigma of a visible device.
“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?” Source: http://www.enttoday.org/details/arti…pharyngea.html
Is this the last word on the subject? Are there now published reviews of outcomes for these implants: particularly bad outcomes? What are the bad things that can happen with these implants? Every surgery is risky…should I take the risk? We need some science here, impartial reviews. Where are we to turn for the truth?
FED UP with the paucity of impartial evidence on this. Why doesn’t Medicare cover these devices if they are so good? I am inclined to agree with Dr. Weisskopf at this time.