Electric-Acoustic Stimulation Extended Follow-up Post Approval Study

MED-EL

Status: Completed

Conditions: Hearing Loss, Sensorineural

Treatments: Device: Electric-Acoustic Stimulation (EAS) Cochlear Implant System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03031678

P000025/PAS001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Study procedures

Other group

Treatment:

Device: Electric-Acoustic Stimulation (EAS) Cochlear Implant System