FDA Approves First Telehealth-Enabled Cochlear Impact | Healthcare Informatics Magazine | Health IT | Information Technology Skip to content Skip to navigation

FDA Approves First Telehealth-Enabled Cochlear Impact

November 20, 2017
by Heather Landi
| Reprints

The U.S. Food and Drug Administration (FDA) approved the first telehealth option to program cochlear implants remotely.

A cochlear implant is an implanted electronic hearing device, designed to produce useful hearing sensations to a person with severe to profound hearing loss, by electrically stimulating nerves inside the inner ear. According to the National Institutes of Health, in the United States, roughly 58,000 cochlear implants have been implanted in adults and 38,000 in children, as of 2012.

Cochlear implants often require regular programming visits with an audiologist. During these visits, the audiologist adjusts various electronic settings that control how the implant stimulates the nerves inside the inner ear, such as adjustments in sensitivity to low-level sound or limits on loud sounds. This in turn changes how the patient perceives different sounds, such as speech or music in different environments. Generally speaking, these adjustments can improve the patient’s quality of life by improving their ability to understand speech, their comfort in loud environments or independence in performing daily tasks.

The remote programming feature for the Nucleus Cochlear Implant System is indicated for patients who have had six months of experience with their cochlear implant sound processor and are comfortable with the programming process.

“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,” Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose and Throat Devices in the FDA’s Center for Devices and Radiological Health, said in a statement.

To support the approval of the remote programming feature for the Nucleus Cochlear Implant System, the FDA evaluated data from a clinical study of 39 patients, aged 12 or older, each of whom had a cochlear implant for at least one year. Speech perception tests one month after each session showed no significant difference between in-person and remote programing. The FDA also evaluated data from patients’ self-assessment of their ability to hear speech in the presence of other sounds and sense the direction, distance and motion of sound. In addition, the FDA also assessed the cybersecurity measures for the remote interaction.

The FDA granted the approval of the Nucleus Cochlear Implant System to Cochlear Americas.

 

Get the latest information on Health IT and attend other valuable sessions at this two-day Summit providing healthcare leaders with educational content, insightful debate and dialogue on the future of healthcare and technology.

Learn More

Topics

News

Survey: Infrastructure, Interoperability Key Barriers to Global HIT Development

A new survey report from Black Book Research on global healthcare IT adoption and records systems connectivity finds nations in various phases of regional electronic health record (EHR) adoption. The survey results also reveal rapidly advancing opportunities for U.S.-based and local technology vendors.

Penn Medicine Opens Up Telehealth Hub

Philadelphia-based Penn Medicine has opened its Center for Connected Care to centralize the health system’s telemedicine activities.

Roche to Pay $1.9B for Flatiron Health

Switzerland-based pharmaceutical company Roche has agreed to pay $1.9 billion to buy New York-based Flatiron Health Inc., which has both an oncology EHR and data analytics platform.

Financial Exec Survey: Interoperability Key Obstacle to Value-Based Payment Models

Momentum continues to grow for value-based care as nearly three-quarters of healthcare executives report their organizations have achieved positive financial results from value-based payment programs, to date, according to a new study from the Healthcare Financial Management Association (HFMA).

Cerner, Children's National to Help UAE Pediatric Center with Health IT

Al Jalila Children's Specialty Hospital, the only pediatric hospital in the United Arab Emirates, has entered into an agreement with Washington, D.C.-based Children's National Health System to form a health IT strategic partnership.

Telemedicine Association Names New CEO

The American Telemedicine Association (ATA) has named Ann Mond Johnson its new CEO, replacing Jon Linkous who stepped down suddenly last August after 24 years as the organization’s CEO.