FDA Approves Remote Programming of Cochlear Implants The U.S. Food and Drug Administration recently approved a remote feature for follow-up programming sessions for a specific cochlear implant through a telemedicine platform. The approval was granted to Cochlear Americas for its Nucleus Cochlear Implant System. Remote programming may be appropriate for people with at least six months’ experience ... News in Brief
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News in Brief  |   February 01, 2018
FDA Approves Remote Programming of Cochlear Implants
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Hearing Aids, Cochlear Implants & Assistive Technology / Regulatory, Legislative & Advocacy / News in Brief
News in Brief   |   February 01, 2018
FDA Approves Remote Programming of Cochlear Implants
The ASHA Leader, February 2018, Vol. 23, 14. doi:10.1044/leader.NIB1.23022018.14
The ASHA Leader, February 2018, Vol. 23, 14. doi:10.1044/leader.NIB1.23022018.14
The approval was granted to Cochlear Americas for its Nucleus Cochlear Implant System.
Remote programming may be appropriate for people with at least six months’ experience with their cochlear implant and who are comfortable with the programming process.
“Being able to have a qualified audiologist program the device via telemedicine from a remote location can greatly reduce the burden to patients and their families, especially those who must travel great distances or need frequent adjustments,” says Malvina Eydelman, director of the Division of Ophthalmic and Ear, Nose and Throat Devices in the FDA’s Center for Devices and Radiological Health.
Approval of the remote programming feature follows FDA review of data from a clinical study of 39 patients, age 12 or older, each of whom had a cochlear implant for at least a year. Each patient had one in-person programming session and two remote programming sessions, all approximately two months apart. Speech-perception tests one month after each session showed no significant difference between in-person and remote programing.
Audiologists are required to comply with all relevant state laws and confirm with private payers on reimbursement for telepractice services. The FDA ruling does not dictate Medicare’s or insurance companies’ payment policies nor does it affect state laws related to telepractice.
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February 2018
Volume 23, Issue 2