In November, the FDA issued a ruling that will make life easier for cochlear implant recipients living in rural areas.
Implant surgery and immediate follow-up for mapping and programming must be done at a medical center or specialized clinic, but the new FDA ruling would allow remote programming for later adjustments. The audiologist and patient communicate via two-way video, with the audiologist programming the implant via computer just as he or she would in person.
The new ruling applies to Cochlear America’s Nucleus Cochlear Implant System, but other implant companies will probably follow with similar features. The ruling may eventually apply to programming hearing aids as well.
The FDA approved remote programming for patients age 12 and over who have had their implant for at least six months and who are comfortable with the programming process.
The FDA based its ruling on a clinical study of 39 patients, each of whom had had an implant for at least one year. The study included one in-person programming and two remote programming sessions for each patient. “Speech perception tests one month after each session showed no significant difference between in-person and remote programing,” the FDA said.
This comes to about 62 million Americans, for whom access to affordable healthcare is a major concern, according to an earlier article in Health Data Management. David Schmitz, M.D., president of the National Rural Health Association, testified to a congressional committee last July. He added that broadband providers must invest in the necessary technological infrastructure to make telemedicine possible.
Audiologists in rural areas are even rarer than physicians. Telemedical programming allows qualified audiologists to reach far more patients than they would ordinarily be able to do.
Speaking of the November FDA ruling, Malvina Eydelman, MD, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices in the FDA’s Center for Devices and Radiological Health, said that telemedicine can “reduce the burden to patients and their families, especially those who must travel great distances or need frequent adjustments.” Cochlear implants need adjustments not only as the user’s hearing adjusts to the implant, but as new technology becomes available. Since programming is done via the external processor, telemedicine is an easy and appropriate tool.