Electric-Acoustic Stimulation Extended Follow-up Post Approval Study

Med-El Corporation50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hearing Loss, Sensorineural

Interventions

Electric-Acoustic Stimulation (EAS) Cochlear Implant SystemDEVICE

Combination of a cochlear implant and a hearing aid

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Stanford Unversity

Palo Alto, California, United States

University of Miami

Miami, Florida, United States

University of Kansas University Medical Center

Kansas City, Kansas, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial

Data from ClinicalTrials.gov

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