This is an informative, but ultimately flawed, story about the use of the auditory brainstem implant (ABI). The story’s main focus is an ongoing clinical trial that’s testing the device in children — a relatively new use for the device. However, the device has already been used for many years in adults, and at least one center in Italy has also been implanting the device in young children. The story doesn’t doesn’t provide any detail about what that experience has shown us. Instead, the story relies mainly on the comments of the study investigators, the parent of a subject in the study, and an expert from the NIH — all of whom may be invested, to some extent, in the success of the device. Their comments don’t stand up without a foundation of quantifiable evidence.
Hearing loss and deafness can limit a child’s ability to develop communication, language, and social skills, according to the CDC. Cochlear implants (CIs) provide a significant quality of life enhancement to those who are eligible for the device. Unfortunately, as the story tells us, not all children and adults are helped by CIs. A clinical trial to determine the safety of an auditory brainstem implant in children is an important first step toward finding a suitable alternative to CIs.
At this stage, the costs of the implant and the necessary surgery are not truly known. However, since the device is implanted in older children and adults, the approximate cost should be identifiable. We would have welcomed a brief statement about the approximate cost.
The story rightly points out that the ABI implant is in clinical trials in children, so any definitive assessment of benefit is premature. Still, the story passed up several opportunities to help readers understand the extent of the benefits as they are currently understood.
For example, the reader is told, “Then about a decade ago, an Italian surgeon started trying the ABI in deaf children, whose younger brains are more flexible and might better adapt to this artificial way of delivering sound. Now, spurred by some successes abroad, the first U.S. studies in young children are underway at a handful of hospitals. Hearing specialists are watching the work closely.” How successful were the implants in the Italian pediatric patients? How was it measured?
The story also notes, “The Food and Drug Administration approved the device in 2000 specifically for adults and teenagers whose hearing nerves had been destroyed by surgery for a rare type of tumor. It doesn’t restore normal hearing, but can help to varying degrees.” Again, how much did the implant help and how was this measured?
The comments from Dr. Eisenburg are helpful to understand the potential benefits. “The children don’t magically understand and use those sounds. It’s going to take a lot of work.”
Overall, however, there is not enough quantification or explanation of benefits to merit a satisfactory grade.
The story addresses harms, but doesn’t quite meet our threshold for a satisfactory rating. One of the experts quoted, Dr. Schwartz, noted: “We’re talking about real surgery to go into a deep area of the brain” and “This is a precise operation that requires exacting technique.” So, we are told that this is not a trivial surgical procedure. We are also told that complications appear to be rare, but from one of the developers of the device: “Post-surgery, stimulator complications can include non-auditory sensations such as tingling of the face or throat.”
The ongoing study referenced in the article is in reality a safety study (A safety Study of the Auditory Brainstem Implant for Pediatric Profoundly Deaf Patients). The harms from the implantation of the ABI will not be known until the study is completed and then in only a small handful of patients. However, one small published study saw two of five pediatric patients suffer from leaks of spinal fluid and resulting in a “…cascade of co-morbidities and elongated hospitalization.” We think these serious and potentially common (two out of five patients) harms, which were easily identified in our literature search, could have and should have been mentioned.
The story does not provide much in the way of evidence. The ABI has been in use in the US and in Europe for a number of years, so we assume the there is a body of evidence to refer to in the story. The reader is provided only with nonspecific statements on the value of the implants.
The story is clear as to how rare the use of an ABI is based on the very limited number of potential candidates: adults and teenagers whose hearing nerves had been destroyed by surgery for a rare type of tumor, and infants born without working auditory nerves.
The sources for this story include the parent of a subject enrolled in the clinical trial as well as two of the investigators, one of whom was a developer of the device. Another source — Dr. Hughes, of the NIH — is not directly involved in the study, but his agency funded the research. This relationship may influence his perspective. We’re grateful that the story discloses these potential conflicts, and we’ll award a satisfactory rating to acknowledge the variety of perspectives offered. But in an ideal world, we’d prefer to see comments from experts who are not associated with the study, its funding, or the development of the implant.
We are told right up front that there is no real alternative to the implant at this time. Children eligible to participate in the trial must have failed or are not eligible for the “more routine” cochlear implants.
The story makes it clear that access to the device is available only to a small number of children participating in the clinical trial and that the device is investigational in this population. It would had been helpful and perhaps more complete to provide readers with information on how to find the trial information. For such information, follow this link: https://clinicaltrials.gov/ct2/show/NCT02102256?term=auditory+brainstem+implant&rank=5
The novelty of the implant’s use in this population is made clear along with a few comments about the precedents for its use.
The story does not appear to rely on a news release.