News

MED-EL's Cochlear Implant System Gains FDA Approval for Expanded Candidacy and Hearing Preservation

• By John K. Waters
• 11/13/2024

MED-EL Corporation, a leader in hearing implant solutions, announced today that the U.S. Food and Drug Administration (FDA) has approved expanded indications and hearing preservation claims for its cochlear implant system, opening new avenues for treatment in the U.S. for adults with moderate-to-profound hearing loss. The updated approval broadens candidacy for MED-EL’s devices, marking the industry’s most inclusive indication criteria.

The new approval applies to adults with bilateral sensorineural hearing loss who score 50% or lower in word recognition in the ear to be implanted, and 60% or less in the other ear, as measured by a challenging single-word test.

"This landmark change in criteria is a crucial step in addressing the underutilization of cochlear implants and ensuring that more individuals with hearing loss can benefit from these life-changing devices," said Dr. Meredith Holcomb, Director of the Hearing Implant Program at the University of Miami and a lead investigator in the supporting clinical trial, in a statement.

The FDA also approved MED-EL’s claim of hearing preservation, making it the first and only cochlear implant manufacturer in the U.S. with this designation. Research shows that the majority of patients with MED-EL’s FLEX electrode array retain functional residual hearing post-implantation, with many preserving this hearing for at least two years.

"The recent approval of expanded indications for the MED-EL Cochlear Implant System permits application of their uniquely suitable FLEX electrode arrays for preserving low-frequency hearing in this distinctive patient population," said Kevin Brown, Chief of the Division of Otology and Neurotology at the University of North Carolina-Chapel Hill, also a study investigator, in a statement. "This allows patients to reap all the benefits of combined electrical and acoustic hearing in the same ear."

The FLEX electrode is designed to reduce cochlear trauma, a critical factor in preserving residual hearing. Available in varied lengths to accommodate individual cochlear anatomy, the electrode array also enables Anatomy-Based Fitting (ABF), which aligns sound pitches with electrode placement, providing a richer and more natural hearing experience.

"Today’s announcement is an important step forward for patients as we continue our work to utilize the full potential of the natural cochlea,” said Ingeborg Hochmair, Founder and CEO of MED-EL, in a statement.

This FDA approval reinforces MED-EL’s commitment to expanding hearing access and preserving the auditory experience for individuals with hearing loss, she said. The expanded candidacy guidelines and hearing preservation claims enable a broader range of patients to benefit from the technology, underscoring MED-EL’s dedication to enhancing quality of life through innovative hearing solutions.