DURHAM, NORTH CAROLINA – MED-EL Corporation announced that the U.S. Food and Drug Administration (FDA) has approved new indications for its cochlear implant system, including the first-ever approval related to hearing preservation outcomes. The updated indication in the United States now includes adults with bilateral moderate-to-profound sensorineural hearing loss and aided word recognition scores of 50% or less in the ear to be implanted, and 60% or less in the non-implant ear.
This expansion broadens eligibility for MED-EL cochlear implants and utilizes a more stringent single word test (CNC) as the qualifying measure for speech recognition, rather than sentence-based assessments.
Expert Support for Expanded Candidacy Criteria
“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.”
“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, 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.”
Hearing Preservation Achievements and FLEX Electrode Technology
In addition to the expanded candidacy criteria, MED-EL has become the first cochlear implant manufacturer to receive FDA approval for marketing claims related to the preservation of functional residual hearing following implantation. Research indicates that the majority of recipients with FLEX electrode arrays retain some level of functional residual hearing, which may be preserved over time.
In fact, results from an anonymized registry showed that many patients have functionally preserved hearing for at least two years after receiving a FLEX electrode. Registry results are especially compelling because they reflect broad experience in the real world with a variety of surgeons and hospitals. Residual hearing results had to meet strict criteria in order to be considered preservation of “functional” hearing.*
“With our FLEX electrode design, MED-EL has engineered the only cochlear implants proven to preserve residual hearing in many recipients. 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.”
–Ingeborg Hochmair, Founder and CEO, MED-EL
The FLEX electrode design is available in different lengths to accommodate the unique anatomy of each individual cochlea and has been shown to reduce cochlear trauma, which is important for preserving residual hearing.
The company has also introduced Anatomy-Based Fitting (ABF), a feature that enables audiologists to match sound pitch to the specific placement of a patient’s electrode array. ABF works alongside MED-EL’s sound coding technology, which aims to provide a fuller and more natural auditory experience, particularly for music. These advancements, combined with evidence supporting the preservation of natural hearing, may encourage eligible candidates to consider implantation earlier.
About MED-EL
MED-EL Medical Electronics, a leader in implantable hearing solutions, is driven by a mission to overcome hearing loss as a barrier to communication and quality of life. The Austrian-based, privately owned business was co-founded by industry pioneers Ingeborg and Erwin Hochmair, whose ground-breaking research led to the development of the world’s first micro-electronic multi-channel cochlear implant (CI), which was successfully implanted in 1977 and was the basis for what is known as the modern CI today. This laid the foundation for the successful growth of the company in 1990, when they hired their first employees. To date, MED-EL has more than 2,800 employees from around 80 nations and 30 locations worldwide.
The company offers the widest range of implantable and non-implantable solutions to treat all types of hearing loss, enabling people in 137 countries to enjoy the gift of hearing with the help of a MED-EL device. MED-EL’s hearing solutions include cochlear and middle ear implant systems, a combined electric acoustic stimulation hearing implant system, as well as surgical and non-surgical bone conduction devices. www.medel.com
*The criteria for functional hearing preservation meets the specifications outlined in one of these two methods: 1) Adunka OF, Gantz BJ, Dunn C, Gurgel RK, Buchman CA. Minimum Reporting Standards for Adult Cochlear Implantation. Otolaryngol Head Neck Surg. 2018 Aug;159(2):215-219. In this approach, the post-operative low-frequency pure tone average of 125/250/500 Hz had to be ≤80 dB HL. 2) Vienna Consensus Protocol, International Surgical Advisory Board, Feb 2023, Vienna. In this method, the change from pre- to post-operative low-frequency pure tone average of 125/250/500 Hz had to be ≤ 30dB HL for ‘partial’ preservation, and ≤15 dB HL for ‘complete’ preservation.
Source: MED-EL
