MED-EL Cochlear Implant System Receives FDA Approval for Expanded Indications and Hearing Preservation
核心洞察
The FDA has approved expanded indications for the MED-EL Cochlear Implant System (搜索), allowing more adults with bilateral moderate-to-profound sensorineural hearing loss (搜索) to qualify.
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.
The FLEX electrode design by MED-EL has been proven to reduce cochlear trauma, which is critical for preserving residual hearing in cochlear implant recipients.
MED-EL Corporation has announced FDA approval for expanded candidacy indications for its cochlear implant system, along with the first-ever approval of hearing preservation outcomes. The approval signifies a major advancement in hearing implant technology, potentially benefiting a wider range of patients with hearing loss.
The FDA has approved a new indication 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-implanted ear. This expanded indication broadens the eligibility criteria for MED-EL cochlear implants, using a single word test (CNC) as the qualifying speech recognition measure.
Expert Commentary
"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."
Kevin Brown, M.D., PhD, Chief of the Division of Otology and Neurotology, University of North Carolina-Chapel Hill, also a study investigator, added, "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. This allows patients to reap all the benefits of combined electrical and acoustic hearing in the same ear."
Hearing Preservation
MED-EL is now the first and only cochlear implant manufacturer to receive FDA approval to make marketing claims related to preservation of functional residual hearing after implantation. This approval confirms that the FLEX electrode design offers the best opportunity to preserve any remaining hearing the candidate possesses. Research has demonstrated that a majority of recipients with FLEX electrode arrays maintain some degree of functional residual hearing, often maintained over time. An anonymized registry showed that many patients have functionally preserved hearing for at least two years after receiving a FLEX electrode. To be considered preservation of “functional” hearing, residual hearing results had to meet strict criteria.
FLEX Electrode Design and Anatomy-Based Fitting
The FLEX electrode design, available in varying lengths, is proven to reduce cochlear trauma, which is critical for preserving residual hearing. The company recently added Anatomy-Based Fitting (ABF), which allows 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.
Company Statement
"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."