DURHAM, N.C.--(BUSINESS WIRE)--Hearing implant leader MED-EL Corporation announced today the U.S. Food and Drug Administration (FDA) approval of new indications along with the first-ever approval of hearing preservation outcomes that definitively set MED-EL hearing implants apart. A new, expanded indication is now approved in the United States for adults with bilateral moderate-to-profound sensorineural hearing loss, who have aided word recognition scores of 50% or less in the ear to be implanted, and 60% or less in the non-implant ear. This new indication allows more patients to qualify for a MED-EL cochlear implant and represents the widest candidacy indication in the industry, using a more challenging single word test (CNC) as the qualifying speech recognition measure, rather than 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.”
“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.”
In addition to broadening the candidacy criteria, 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, confirming that the FLEX electrode design provides the best opportunity to preserve what remaining hearing the candidate has. Hearing preservation results were based on research demonstrating that the majority of recipients with FLEX electrode arrays maintain some degree of functional residual hearing, which can often be maintained 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,” 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.”
The FLEX electrode design, which is available in varying lengths to fit each individual cochlea, is the only electrode design proven to reduce cochlear trauma, which is critical for preserving residual hearing. The company recently added the capability for 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 unique sound coding that offers a richer, fuller hearing experience and more natural sound quality for music. These innovative technologies, when combined with the proven ability to preserve functional natural hearing in many implant recipients, suggest that candidates who meet the new indication criteria should not wait for their hearing to worsen before obtaining a MED-EL cochlear implant.
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.
