FDA Expands Indications for MED-EL Cochlear Implants, Approves Hearing Preservation Claims
核心洞察
The FDA has broadened the indications for MED-EL cochlear implants, allowing more adults with moderate-to-profound sensorineural hearing loss (搜索) to qualify for the device.
MED-EL received FDA approval for hearing preservation claims, highlighting the FLEX electrode design's ability to maintain functional residual hearing post-implantation.
The expanded criteria utilize a single-word test (CNC) for speech recognition, representing a more challenging measure and the widest candidacy indication in the industry.
The U.S. Food and Drug Administration (FDA) has approved expanded indications and hearing preservation outcomes for MED-EL Corporation's cochlear implant system, offering new treatment options for adults with hearing loss. This decision broadens the candidacy for MED-EL's devices and acknowledges the potential for hearing preservation post-implantation.
Expanded Candidacy for Cochlear Implants
The FDA's new approval extends eligibility to 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. This expanded indication uses a more rigorous single-word test (CNC) as the qualifying speech recognition measure, potentially allowing more individuals to benefit from cochlear implantation.
"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 Meredith Holcomb, AuD, 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.
Hearing Preservation with FLEX Electrode Design
MED-EL also secured 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 any remaining hearing the candidate possesses. Research indicates that a majority of recipients with FLEX electrode arrays maintain some degree of functional residual hearing, often sustained over time. An anonymized registry demonstrated that many patients functionally preserved hearing for at least two years post-implantation.
"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," stated Kevin Brown, MD, 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."
Functional hearing preservation was determined using strict criteria, including postoperative low-frequency pure tone averages at 125/250/500 Hz of ≤80 dB HL, or a change from pre- to post-operative low-frequency pure tone average of ≤ 30dB HL for ‘partial’ preservation and ≤15 dB HL for ‘complete’ preservation, according to the Vienna Consensus Protocol.
Technology and Innovation
The FLEX electrode design is available in various lengths to accommodate individual cochlear anatomy and is engineered to minimize cochlear trauma, which is crucial for preserving residual hearing. MED-EL has also incorporated Anatomy-Based Fitting (ABF), enabling audiologists to align the pitch of sounds with the placement of each individual’s electrode array. This complements MED-EL’s sound coding, designed to provide 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. "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."