The following post was revised on November 15 to include portions of the FDA Medical Devices Advisory Committee’s position regarding the Nucleus® Hybrid™ L24 Implant System.
SILVER SPRING, MD—A public advisory panel of the U.S. Food and Drug Administration (FDA) Medical Devices Advisory Committee has given a favorable vote to a new implant system from Cochlear Americas. At a public meeting held November 8 in Silver Spring, the Ear, Nose and Throat Devices Panel gave its go-ahead to the Nucleus® Hybrid™ L24 Implant System.
The Nucleus Hybrid L24 is the first implant designed for the treatment of adults with severe to profound sensorineural hearing loss in the high frequencies and normal hearing to mild loss in the low frequencies. This configuration, often referred to as “ski-slope” hearing loss, is especially difficult to address with traditional hearing aids.
The 14-member panel’s decision, which was nearly unanimous, is advisory only, so while the FDA will consider its guidance during final review of the new hybrid device, the agency may reject the panel’s advice and not approve use of the system. However, a favorable recommendation from the panel of respected physicians and researchers generally carries considerable weight.
PANEL’S STATEMENT
A statement released after the November 8 hearing reported:
“The Panel voted 14-0-0 (yes-no-abstain) that the data show there is reasonable assurance that the Nucleus® Hybrid™ L24 Implant System is safe for use in patients who meet the criteria specified in the proposed indication.
“The Panel voted 14-0-0 (yes, no, abstain) that there is reasonable assurance that the Nucleus® Hybrid™ L24 Implant System is effective for use in patients who meet the criteria specified in the proposed indication.
The Panel voted 13-0-1 (yes, no, abstain) that the benefits of the Nucleus® Hybrid™ L244 Implant System do outweigh the risks for use in patients who meet the criteria specified in the proposed indication.
PART HEARING AID, PART COCHLEAR IMPLANT
The Nucleus Hybrid System combines the natural hearing via acoustic amplification of low frequencies with the electrical stimulation of a cochlear implant for high frequencies in a single device. It is designed to deliver superior quality and clarity of sound even in noisy environments and other difficult hearing situations.
Bruce J. Gantz, MD, who is the hybrid system’s clinical investigator, called it “a technological breakthrough when it comes to treating patients with hearing loss.” Gantz, who is head of the Department of Otolaryngology — Head and Neck Surgery at the University of Iowa Carver College of Medicine, added, “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.”
Chris Smith, president of Cochlear Americas, said, “We are pleased with the panel’s vote for the Nucleus Hybrid System. [It] 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.”
More about the Nucleus Hybrid L24 is available in the sponsor’s executive summary.
