Cochlear Ltd, Centennial, Colo, the world’s largest manufacturer of implantable hearing solutions, reports that an advisory committee to the US Food and Drug Administration (FDA) voted favorably on the Cochlear™ Nucleus® Hybrid™ L24 Implant System. Cochlear reports that this is a first-of-its-kind system designed for the treatment of adults with severe-to-profound sensorineural hearing loss (SNHL) in the high frequencies and normal-to-only-mild hearing loss in the low frequencies—often referred to as “ski-slope” hearing loss.
The panel, comprised of leading physicians and researchers, voted in favor of the new Hybrid device based on substantial clinical evidence demonstrating the safety and efficacy of the Nucleus Hybrid System in patients who met the candidacy criteria, says Cochlear. The FDA is not bound by the recommendations of its advisory committees, but will consider the guidance during the final review of the new Hybrid device (ie, it is not yet FDA approved).
“We are pleased with the panel’s vote for the Nucleus Hybrid System,” said Chris Smith, president of Cochlear Americas in a press statement. “The notion of hybrid hearing is truly a novel one that addresses an unmet need for people with hearing loss by bridging the gap between hearing aids and cochlear implants. This first-of-its-kind technology consists of a unique combination of solutions to overcome high frequency hearing loss, which impairs a person’s ability to hear voices clearly and understand speech in noise. This positive recommendation is an important first step to giving thousands of patients the opportunity to hear much better than was possible even with the most advanced hearing aids.”
The Nucleus Hybrid System is designed to combine the natural hearing via acoustic amplification of low frequencies with the electrical stimulation of a cochlear implant for high frequencies in one device. It is designed to deliver patients superior quality and clarity of sound in even the most difficult hearing situations, especially hearing in noisy environments.
“The Nucleus Hybrid System is a technological breakthrough when it comes to treating patients with hearing loss,” says Bruce J. Gantz, MD, head of the Department of Otolaryngology-Head and Neck Surgery at the University of Iowa Carver College of Medicine and Hybrid System clinical investigator. “This device will open the doors to a whole new way of hearing both acoustically and electrically for those patients who cannot be treated effectively today with hearing aids.”
Source: Cochlear Ltd.