The FDA recently approved a telehealth option that will allow providers to remotely program cochlear implants.
The FDA recently approved a feature of the Nucleus Cochlear Implant System that allows physicians to remotely program the devices through a telemedicine platform, according to a press release.
The remote feature is indicated for patients who have had a cochlear implant for at least 6 months and are comfortable with programming the device.
Cochlear implants are implanted devices used for patients with hearing loss. The devices produce hearing sensations by stimulating inner ear nerves, according to the release. More than 58,000 adults and 38,000 children have cochlear implants, the National Institutes of Health estimates.
The devices require programming visits, in which audiologists adjust electronic settings that control how the implant stimulates the nerves. Physicians may adjust the sensitivity to low sounds or place a limit on high sounds, according to the release.
These changes alter how patients perceive different sounds and can improve quality of life by enhancing their ability to understand speech, comfort in loud environments, and independence in performing tasks, according to the FDA.
The new approval was due to positive findings from a clinical trial including 39 patients who had a cochlear implant for at least 1 year. Each patient received 1 in-person programming session and 2 remote sessions.
The investigators found that speech perception 1 month after each session indicated no differences between the approaches, according to the release.
The authors also analyzed self-reported patient data regarding their ability to hear speech and their ability to sense the direction, distance, and motion of sound.
Additionally, the FDA evaluated cybersecurity concerns to ensure that remote access was secure, according to the release.
“Programming adjustments to a cochlear implant are performed at specialized cochlear implant centers or at clinics by audiologists with expertise in cochlear implants. 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,” said Malvina Eydelman, MD, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices in the FDA Center for Devices and Radiological Health.