Summary: Med-El Corporation’s cochlear implants received FDA approval for expanded adult indications and hearing preservation outcomes, allowing more patients to benefit from advanced hearing technology.
Takeaways:
- Expanded Candidacy: The FDA’s new approval broadens eligibility for Med-El cochlear implants to adults with moderate-to-profound sensorineural hearing loss, enabling more individuals to qualify.
- Hearing Preservation Technology: The FLEX electrode design, now FDA-approved for hearing preservation claims, allows many recipients to retain some functional natural hearing post-implantation.
- Enhanced Sound Quality: Med-El’s cochlear implants feature innovative sound coding and Anatomy-Based Fitting, offering recipients a more natural and enriched hearing experience.
Hearing implant provider Med-El Corporation announced U.S. Food and Drug Administration (FDA) approval of new indications along with approval of hearing preservation outcomes for its hearing implants.
Expanded Indication for Cochlear Implant
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, 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. “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 FLEX Electrode Design
In addition to broadening the candidacy criteria, Med-El also received 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.
“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,” says 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.”
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.*
Further reading
“With our FLEX electrode design, MED-EL has engineered the only cochlear implants proven to preserve residual hearing in many recipients,” says 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 an electrode design that reduces 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.
Featured image: The Synchrony 2 Cochlear Implant with Sonnet 2 and Rondo 3. Photo: Med-El
*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.
