Electric-Acoustic Stimulation Extended Follow-up Post Approval Study

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