MED-EL Wins Expanded FDA-Approved Indications for its Cochlear Implant System

The U.S. Food and Drug Administration (FDA) has approved new indications and hearing preservation outcomes for MED-EL Corporation’s hearing implants.

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, according to the company.

“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 a clinical trial investigator. “The 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.”

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, which shows the FLEX electrode design provides the best opportunity to preserve a patient’s remaining hearing ability.

Hearing preservation results were based on research demonstrating that most 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 compelling because they reflect broad experience in the real world with various surgeons and hospitals. Residual hearing results had to meet strict criteria in order to be considered preservation of “functional” hearing.*

“The 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.”

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, MED-EL claims. 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.

“With our FLEX electrode design, MED-EL has engineered the only cochlear implants proven to preserve residual hearing in many recipients,” MED-EL Founder/CEO Ingeborg Hochmair “This 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.”

MED-EL Medical Electronics develops implantable hearing solutions. The Austrian-based, privately owned business was co-founded by industry pioneers Ingeborg and Erwin Hochmair, whose research led to the development of the world’s first micro-electronic multi-channel cochlear implant (CI). That device was successfully implanted in 1977 and was the basis for the modern CI. The firm hired its first employees in 1990 and to date has more than 2,800 employees from about 80 nations and 30 locations worldwide.

The company offers a wide 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. 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.

*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.