The FDA has approved a remote programming system for patients with cochlear implants, removing the need for patients to visit specialised clinics to have their devices adjusted.
Cochlear implant concept
The programming feature is for patients who have had their cochlear implant for more than six months and are comfortable with the programming process.
The remote programming session is performed via a telemedicine meeting and is intended to reduce the burden to patients who have to travel for appointments.
Cochlear implants are designed to produce hearing sensations to those with severe to profound hearing loss by electrically stimulating nerves inside the inner ear. The devices require regular programming visits during which the audiologist adjusts various electronic settings. The tweaks to these settings, such as sensitivity to low-level sound or limits on loud sounds, changes how the patient perceives different sounds.
Speaking about the approval, Malvina Eydelman, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices in the FDA’s Center for Devices and Radiological Health, said:
“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.”
The FDA approved the remote programming feature by evaluating data from a clinical study of 39 people who had had a cochlear implant for at least one year. Each patient had one programming session in a clinic and two remote programming sessions two months apart. The patients then had speech perception tests one month after each session. Each session showed no significant difference between both types of programming appointments. The FDA also assessed the cyber-security measures for the remote interaction.