FDA Approves Expanded Use of MED-EL Cochlear Implant System
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.