New research concludes that U.S. physicians are performing cochlear implantation for a variety of conditions that are off-label of the current FDA labeling.
The FDA indications for cochlear implantation date back to 2000 and cover implantation for adults and children who have advanced hearing loss and do not benefit from conventional hearing aids. In a study led by Matthew L. Carlson, MD, an associate professor of otolaryngology and the medical director of the cochlear implant program at the Mayo Clinic in Rochester, Minn., researchers found that many U.S. providers use cochlear implants for patients with varying degrees of hearing loss in one or both ears.
Researchers anonymously surveyed 81 members of the American Neurotology Society who regularly performed cochlear implantation. The results: Within the past two years, 78% of respondents performed cochlear implantation for expanded indications outside current FDA labeling. These include implantation in infants younger than 12 months old (43% of respondents), both children (31%) and adults (61%) who had asymmetrical hearing loss with hearing better than the cutoffs for age, single-sided deafness (46%), and ipsilateral vestibular schwannoma (35%).
The conclusions may clinicians see what others are doing within the field and understand how they compare. “It’s valuable to evaluate and understand your practice in the context of the greater surgical community,” said Dr. Carlson. “We all want to be sure we are on the cutting edge of care in order to maximize outcomes for our patients.”
The work also shows how the field of cochlear implantation has advanced.
“Our surgical techniques have become increasingly refined and the devices have undergone substantiation innovation over the last several decades, however we are still stuck with the older guidelines,” Dr. Carlson said.
“We’ve realized that, in many cases, we are forced to withhold a phenomenal technology that will benefit many patients if we don’t work to expand the guidelines,” he added.
Ultimately, Dr. Carlson said that he and his colleagues hope that FDA labeling will expand to better reflect the current clinical landscape.