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FDA Approves Expanded Use of MED-EL Cochlear Implant System

The FDA has approved the MED-EL Cochlear Implant System for a broader range of patients, including adults with bilateral moderate to profound sensorineural hearing loss who benefit minimally from hearing aids.

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has granted approval for the expanded use of the MED-EL Cochlear Implant (CI) System. This decision allows the device to be used in a wider patient population, specifically targeting individuals with bilateral hearing loss who meet certain criteria.
  • Eligibility Criteria: The system is now indicated for individuals eighteen years of age or older with bilateral moderate to profound sensorineural hearing loss. These patients must demonstrate limited benefit from appropriately-fit hearing aids, characterized by specific hearing thresholds and test scores.
  • Hearing Aid Trial: MED-EL emphasizes the importance of a hearing aid trial before considering implantation, unless contraindicated by conditions such as cochlear ossification.
This approval marks a significant step forward in providing advanced hearing solutions to those who have not found sufficient relief through traditional hearing aids, offering a new avenue for auditory rehabilitation.
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Reference News

[1]
Premarket Approval (PMA) - FDA
accessdata.fda.gov · Nov 1, 2002

FDA's CDRH approved expanded use of MED-EL Cochlear Implant System for adults with bilateral moderate to profound hearin...

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