Survey Uncovers ‘Off-Label’ CI Surgery More than three-quarters of U.S. physicians responding to a recent survey perform cochlear implantation for a number of conditions that are considered “off-label” of the current Food and Drug Administration (FDA) indications for implantation. In a study published in ENT Today, researchers anonymously surveyed 81 members of the American Neurotology ... News in Brief
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News in Brief  |   June 01, 2018
Survey Uncovers ‘Off-Label’ CI Surgery
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Hearing Aids, Cochlear Implants & Assistive Technology / News in Brief
News in Brief   |   June 01, 2018
Survey Uncovers ‘Off-Label’ CI Surgery
The ASHA Leader, June 2018, Vol. 23, 15. doi:10.1044/leader.NIB6.23062018.15
The ASHA Leader, June 2018, Vol. 23, 15. doi:10.1044/leader.NIB6.23062018.15
More than three-quarters of U.S. physicians responding to a recent survey perform cochlear implantation for a number of conditions that are considered “off-label” of the current Food and Drug Administration (FDA) indications for implantation.
The study found many physicians use cochlear implants (CIs) for patients with varying degrees of hearing loss in one or both ears. FDA guidelines—which date back nearly two decades—indicate CI implantation for adults and children who have severe hearing loss and do not benefit from conventional hearing aids.
A total of 78 percent of survey respondents performed cochlear implantation for at least one of the following conditions within the last two years: profound hearing loss in children younger than 12 months (43 percent), children with asymmetrical hearing loss in which at least one ear was better than performance cutoff for age (31 percent), adults with asymmetrical hearing in which at least one ear was better than the performance cutoff (61 percent), single-sided deafness (46 percent), and ipsilateral vestibular schwannoma (35 percent).
The survey also found that clinics with a higher volume of CI surgeries were more likely to have performed off-label surgeries.
The researchers hope that current FDA labeling will eventually expand to provide a better reflection of today’s clinical landscape. “The high percentage of surgeons performing implantations for off-label or nontraditional indications reflects the overly restrictive and dated status of current implant guidelines,” the researchers conclude.
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June 2018
Volume 23, Issue 6