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Completed

NCT Number: NCT03031678

Electric-Acoustic Stimulation Extended Follow-up Post Approval 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.

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Key information

Conditions

Hearing Loss, Sensorineural Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Unversity, Palo Alto, California, United States

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About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electric-Acoustic Stimulation (EAS) Cochlear Implant System

Device

Combination of a cochlear implant and a hearing aid

Other names: EAS

Primary outcomes

  1. Percentage of Words Correct As Assessed by CUNY Sentence Test.

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

    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.

Secondary outcomes

  1. Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE.

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

    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.

  2. Percentage of Words Correct as Assessed by CNC Words in Quiet.

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

    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.

  3. Subjective Benefit From EAS Through 5 Years Post Implantation Measured on the APHAB (Abbreviated Profile Hearing Aid Benefit) Questionnaire.

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

    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.

Sponsors and collaborators

Lead sponsor

Med-El Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 25, 2017
Registry last updated
Sep 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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