Electric-Acoustic Stimulation Extended Follow-up Post Approval Study

Office of Device Evaluation Lead-MED-EL EAS Extended f/u Study

The MED-EL EAS Extended Follow-up Study is an extended follow-up of the subjects who were enrolled in the pivotal study to assess long-term safety and device performance.

The study will be conducted as a prospective, non-controlled, non-randomized, multicenter study at the 14 sites. Up to 68 available subjects who were enrolled in the pivotal study will be invited to participate in the extended follow-up. Study subjects will be followed for a minimum of 5 years post-implantation of the device.

Inclusion Criteria:

• 18 years of age or older at the time of implantation
• Severe to profound sensorineural hearing loss for frequencies greater than 1500 Hz (i.e., threshold no better than 70 dB HL at 2000-8000 Hz)
• Low-frequency thresholds up to and including 500 Hz no poorer than 65 dB HL
• CNC word recognition score less than or equal to 60% in the ear to be implanted
• CNC word recognition score less than or equal to 60% in the contralateral ear
• English spoken as the primary language

Exclusion Criteria:

• Conductive, retrocochlear, or central auditory disorder
• Hearing loss in the ear to be implanted that has demonstrated a recent fluctuation at two or more frequencies of 15 dB in either direction in the last 2 years
• Any physical, psychological, or emotional disorder that interferes with surgery or the ability to perform on test and rehabilitation procedures
• Developmental delays or organic brain dysfunction
• Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations
• Unwillingness or inability of the candidate to comply with all investigational requirements