Electric-Acoustic Stimulation Extended Follow-up Post Approval Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hearing Loss, Sensorineural

Intervention / Treatment
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* Device: Electric-Acoustic Stimulation (EAS) Cochlear Implant System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study procedures<br> | Device: Electric-Acoustic Stimulation (EAS) Cochlear Implant System<br>* Combination of a cochlear implant and a hearing aid<br>* Other names: EAS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Words Correct As Assessed by CUNY Sentence Test. | Long-term effectiveness of the Electric-Acoustic System will be assessed by speech perception testing in noise with CUNY sentences completed through five years post-implantation. | Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE. | The HEARRING Scale was developed by the HEARRING Research Group, a collaboration of surgeons and audiologists in the hearing implant field who work together to develop consensus statements. The Scale was published in 2013 by Skarzynski et al. as means to classify post-operative residual hearing thresholds. Residual hearing is classified as complete (100-76%), partial (26-75%), minimal (1-25%), or none (0%) according to an equation which takes into account pre-operative thresholds, post-operative thresholds, and the limits of the audiometer. | Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial | 
| Percentage of Words Correct as Assessed by CNC Words in Quiet. | Long-term effectiveness of the Electric-Acoustic System will be assessed by speech perception testing in quiet with CNC words completed through five years post-implantation. | Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial | 
| Subjective Benefit From EAS Through 5 Years Post Implantation Measured on the APHAB (Abbreviated Profile Hearing Aid Benefit) Questionnaire. | The APHAB Questionnaire measures percentage of listening difficulty on a scale from 100% (very difficult) to 0% (not difficult at all). Results are reported as the average listening difficulty across subjects. | Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial |