MED-EL Cochlear Implant Receives FDA Approval for Expanded Indications and Hearing Preservation Claims
核心洞察
MED-EL's cochlear implant system secures FDA approval for expanded use in adults with moderate-to-profound sensorineural hearing loss (搜索), setting a new industry standard.
The approval includes the first-ever FDA endorsement for marketing claims related to the preservation of functional residual hearing after cochlear implantation.
MED-EL's FLEX electrode design is proven to minimize cochlear trauma, aiding in the preservation of residual hearing, as demonstrated in clinical research and registry data.
MED-EL Corporation announced FDA approval for expanded indications of its cochlear implant system and the first approval for hearing preservation outcomes. The approval expands the candidacy for adults with bilateral moderate-to-profound sensorineural hearing loss (搜索), specifically those with aided word recognition scores of 50% or less in the ear to be implanted and 60% or less in the non-implant ear.
Broadening Access to Cochlear Implants
The expanded indication allows more patients to qualify for a MED-EL cochlear implant, representing the widest candidacy indication in the industry. This expansion uses a more stringent single-word test (CNC) for speech recognition assessment, moving beyond sentence understanding.
"I am thrilled to support the FDA's expanded criteria for MED-EL cochlear implants, which not only aligns more closely with current clinical practices but also enhances patient access to this incredible technology," said Meredith Holcomb, Au.D., Associate Professor of Clinical Otolaryngology, Director of the Hearing Implant Program at the University of Miami Miller School of Medicine and an investigator in the clinical trial. "The 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."
Hearing Preservation Approval
MED-EL is the first cochlear implant manufacturer to receive FDA approval for marketing claims related to the preservation of functional residual hearing after implantation. This approval confirms that the FLEX electrode design offers the best opportunity to preserve remaining hearing.
Research demonstrated that most recipients with FLEX electrode arrays maintain some degree of functional residual hearing, often sustained over time. An anonymized registry showed that many patients functionally preserved hearing for at least two years post-implantation. Strict criteria were met to define "functional" hearing preservation.
"The recent approval of expanded indications for the MED-EL Cochlear Implant System (搜索) permits application of their uniquely suitable FLEX electrode arrays for preserving low-frequency hearing in this distinctive patient population," said Kevin Brown, M.D., PhD, Chief of the Division of Otology and Neurotology, University of North Carolina-Chapel Hill, also a study investigator. "This allows patients to reap all the benefits of combined electrical and acoustic hearing in the same ear."
FLEX Electrode Design and Anatomy-Based Fitting
The FLEX electrode design, available in various lengths, reduces cochlear trauma, crucial for preserving residual hearing. The company recently added Anatomy-Based Fitting (ABF), allowing audiologists to align the pitch of sounds to the placement of each individual’s electrode array. ABF complements MED-EL’s sound coding, offering a richer, fuller hearing experience and more natural sound quality for music.
"With our FLEX electrode design, MED-EL has engineered the only cochlear implants proven to preserve residual hearing in many recipients," said Ingeborg Hochmair, Founder and CEO, MED-EL. "At MED-EL, we have put patients first since day one. Today’s announcement is an important step forward for patients as we continue our work to utilize the full potential of the natural cochlea with our technology aligned to the individual."
These technologies suggest that candidates meeting the new indication criteria should not delay obtaining a MED-EL cochlear implant, even if their hearing has not yet severely deteriorated.