Regulatory authority confirms: MED-EL FLEX electrodes preserve residual hearing in cochlear implant recipients.

Previously, this was considered to be certain: with a cochlear implantation, the patient loses any hearing debris that still exists. This often deterred individuals with progressive hearing loss from undergoing cochlear implantation, even when conventional hearing aids had long since failed to provide adequate speech comprehension.

But in 50 years of CI development, technology and surgical technology have greatly improved. As early as 2006, MED-EL introduced the particularly thin and atraumatic FLEX technology: even with medium-length and long FLEX electrode arrays, hearing can be preserved. Even the world's longest CI electrode array is offered in a hearing-preserving design as FLEX 34.

The FLEX design also makes it easier for CI candidates with residual hearing to decide on prompt implantation as soon as speech is no longer understandable even with hearing aids.

Audience receipt confirmed by strictest licensing authority

The U.S. Food and Drug Administration, or FDA for short, is considered the strictest regulatory authority among insiders when it comes to international medical technology. In October 2024, it approved the use of MED-EL cochlear implants with FLEX electrode arrays also for adults with moderate to severe inner ear hearing loss, provided they benefit only to a limited extent from hearing aids. This primarily applies to individuals with significant high-frequency hearing loss, whose low-frequency hearing ability is not sufficient for electrical-acoustic stimulation (EAS).¹

Currently, MED-EL FLEX electrode arrays are the only CI electrode arrays with this approval. In Austria, implantation in this indication was possible before. However, the FDA approval provides impressive confirmation that FLEX electrode arrays can preserve existing hearing in a truly unique way.

Scientifically proven

The authorisation was based on extensive scientific studies. Anonymised data from users of MED-EL cochlear implants with FLEX electrodes, recorded in a Europe-wide CI register, were analysed according to the Vienna Consensus. This was developed in 2023 by 24 surgeons from different countries. The results of the analysis reflect the practical experiences of various surgeons and hospitals under differing conditions. The CI users also did not meet any special selection criteria and were not implanted using any particular surgical technique. Nevertheless, in the majority of cases, residual hearing without the CI was still preserved two years after implantation.²

Similar outcomes were reported in analyses conducted according to the standards of the American Academy of Otolaryngology³, as well as in a dedicated multicenter study on hearing preservation. The latter also showed that even individuals whose natural hearing could not be preserved achieved better speech understanding with their CI after only six months than they had previously with hearing aids — both in quiet and in noisy environments.

FDA approval proves experience

"The FDA’s expanded criteria better reflect current clinical practice and improve patient access to this incredible technology," explains Prof. Meredith Holcomb, AuD, director of the hearing implant programme at the Medical University of Miami. Kevin D. Brown, MD, PhD, Head of the Department of Otology and Neurootology at the University of North Carolina-Chapel Hill, adds, "If we use the uniquely suited FLEX electrode arrays to preserve low-frequency hearing for these patients, they too can take advantage of all the benefits of combined electrical and acoustic hearing in the same ear."

With any cochlear implantation, there remains a residual risk of loss of existing hearing, but those who do not achieve satisfactory hearing with hearing aids should not delay the implantation. “With our FLEX electrode design, MED-EL has developed the only cochlear implants that have been proven to preserve residual hearing in many recipients,” explains Ingeborg Hochmair, founder and CEO of MED-EL. Because, as MED-EL emphasizes: “Patients have always been our top priority.”

The MED-EL cochlear implants are the first and so far the only ones approved by the FDA for adults with residual hearing in the low-frequency range. This evidence—combined with MED-EL’s unique anatomically based Adapted Base Feature (ABF)—is intended to encourage CI candidates to proceed with implantation sooner, even if they still have some useful residual hearing.

References

1. [1] https://blog-medel-pro/EN-US/Cochlear-Implants/FDA-Expands-med-el-criteria-for-adults-with-residual-hearing/
2. [2] Completely obtained according to Vienna consensus: maximum 15 decibels change at 125, 250 and 500 hertz; partially obtained: maximum 30 decibels change.
3. [3] 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.: at 125, 250 and 500 Hertz maximum 80 decibels hearing loss.