Medical Device Network

MED-EL bags expanded clearances for hearables system

Alongside expanded indications, the clearance allows for more people to MED-EL cochlear implant at earlier stages of hearing loss.

North Carolina-based hearables company, MED-EL Corporation, has secured clearance from the US Food and Drug Administration (FDA) for a range of new indications alongside the approval of hearing preservation outcomes that expand access to the company’s MED-EL hearing implants.

The new expanded indication covers 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. As a result, now more people will have access to the company’s cochlear implant.

Alongside the approval, the company has also said that it is now the first and only cochlear implant manufacturer to receive FDA approval to make marketing claims related to the preservation of functional residual hearing after implantation. Part of the MED-EL implant, the company is adamant that its Flex electrode system can preserve patient hearing, citing results from an anonymised registry that showed that many patients have functionally preserved hearing for at least two years after receiving a FLEX electrode.

Ingeborg Hochmair, founder and CEO of MED-EL, said: “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.”

The global hearables market is set to reach sales of $131bn by the end of 2030, having grown at a compound annual growth rate (CAGR) of 15.7% from 2023, according to GlobalData analysis. In 2022, the FDA relaxed hearing aid regulations allowing for the sale of over-the-counter hearing aids for adults aged over 18 years with perceived mild to moderate hearing loss. As a result, technology giants such as Apple have already made moves into the market.

Kevin Brown, chief of the division of otology and neurotology at the University of North Carolina, said: “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. This allows patients to reap all the benefits of combined electrical and acoustic hearing in the same ear.”