In a first for the agency, the U.S. Food and Drug Administration (FDA) has approved the use of a cochlear implant system that can be remotely programmed via a telemedicine platform.
Cochlear implants are used to produce hearing sensations in people who are experiencing severe hearing loss. However, to optimize their functionality, such implants usually need frequent adjustments by an audiologist to more precisely meet a patient’s unique hearing requirements. Until now, such adjustments and device reprogramming required a visit to the audiologist’s office, imposing a significant burden on many patients.
In a press release issued in mid-November, the FDA announced its approval of the Nucleus Cochlear Implant System by Cochlear Americas. In its announcement, the FDA noted that clinical studies submitted by the company in support of its application for approval showed “no significant difference” between in-person and remote programming in the operation of the devices.
The FDA also noted that it assessed cybersecurity measures for such remote reprogramming as part of its review.