“That really would be unfortunate,” Dr. Papsin told ENT Today. “Dr. Colletti is a very experienced, talented surgeon who has access to a team of equally experienced pediatric audiologists and anesthesiologists, working at a top-notch center. So he can do this. But can most surgeons in North American and Europe achieve the same results? I’m just not sure. Yet my fear is that some will be emboldened to try this, based on the preliminary data in this study.”
Explore this issue:August 2012
Dr. Colletti told ENT Today: “We are sure that some researchers in the field will, in the very near future, try to replicate our study to confirm or contest our results on the basis of their own personal experience.”
Even if other clinicians could achieve similar outcomes, Dr. Papsin said, the initial benefits achieved may not hold up over time. Most children reach a normal speech acquisition curve by age two years, he explained. Implanting them at an age younger than six months “may move that up to around 18 months, maybe a bit better than that,” he said. “For that, you’re going to risk the downsides of doing this procedure in infants, such as the risks of anesthesia, a missed diagnosis, etc.? I don’t think that’s a good risk-benefit tradeoff.”
Bruce Gantz, MD, professor and head at the University of Iowa Department of Otolaryngology—Head and Neck Surgery, University of Iowa Hospitals and Clinics in Iowa City, said he also doubts the lasting power of the differences in speech acquisition documented in the study. “We just submitted a manuscript [to a leading scientific journal] showing that children who are implanted as late as four years have the ability to catch up to those implanted before the age of two, and that the ‘leveling out’ of some speech and language scores occurs at about age eight,” he told ENT Today.
Dr. Gantz said he also had some concerns about the design of the study by Colletti and colleagues. For example, he questioned why, after implanting nearly 400 children, the investigators included only a small group of older children in the study. Given the small size of the cohorts, he said, “I am not comfortable saying there really is a significant difference between the age groups. And I am certainly not comfortable concluding anything without longer-term follow-up.”
But for Dr. Gantz, there is a potentially larger issue at stake when one considers implanting infants who are younger than six months of age. “I very strongly disagree that you can implant a child before obtaining a behavioral audiogram, which you can usually do between seven and 10 months of age,” he said. Such tests, Dr. Gantz added, can detect the presence of residual low-frequency hearing, which can then be amplified with a hearing aid on one ear and a cochlear implant in the other ear. “That’s a far better way to manage these patients, because that dual approach preserves the patient’s ability to appreciate music and other important aspects of sound that cannot be reproduced by a cochlear implant alone,” he said.