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Electric-Acoustic Stimulation Extended Follow-up Post Approval Study

Primary Purpose

Hearing Loss, Sensorineural

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electric-Acoustic Stimulation (EAS) Cochlear Implant System
Sponsored by
Med-El Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hearing Loss, Sensorineural

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stanford Unversity
  • University of Miami
  • University of Kansas University Medical Center
  • University of North Carolina
  • The Hospital of the University of Pennsylvania
  • University of Texas Southwestern Medical Center
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study procedures

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 13, 2017
Last Updated
August 24, 2020
Sponsor
Med-El Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03031678
Brief Title
Electric-Acoustic Stimulation Extended Follow-up Post Approval Study
Official Title
Office of Device Evaluation Lead-MED-EL EAS Extended f/u Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Med-El Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study procedures
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Electric-Acoustic Stimulation (EAS) Cochlear Implant System
Other Intervention Name(s)
EAS
Intervention Description
Combination of a cochlear implant and a hearing aid
Primary Outcome Measure Information:
Title
Percentage of Words Correct As Assessed by CUNY Sentence Test.
Description
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 Outcome Measure Information:
Title
Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE.
Description
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
Title
Percentage of Words Correct as Assessed by CNC Words in Quiet.
Description
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
Title
Subjective Benefit From EAS Through 5 Years Post Implantation Measured on the APHAB (Abbreviated Profile Hearing Aid Benefit) Questionnaire.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Stanford Unversity
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
The Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24328756
Citation
Skarzynski H, van de Heyning P, Agrawal S, Arauz SL, Atlas M, Baumgartner W, Caversaccio M, de Bodt M, Gavilan J, Godey B, Green K, Gstoettner W, Hagen R, Han DM, Kameswaran M, Karltorp E, Kompis M, Kuzovkov V, Lassaletta L, Levevre F, Li Y, Manikoth M, Martin J, Mlynski R, Mueller J, O'Driscoll M, Parnes L, Prentiss S, Pulibalathingal S, Raine CH, Rajan G, Rajeswaran R, Rivas JA, Rivas A, Skarzynski PH, Sprinzl G, Staecker H, Stephan K, Usami S, Yanov Y, Zernotti ME, Zimmermann K, Lorens A, Mertens G. Towards a consensus on a hearing preservation classification system. Acta Otolaryngol Suppl. 2013;(564):3-13. doi: 10.3109/00016489.2013.869059.
Results Reference
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Electric-Acoustic Stimulation Extended Follow-up Post Approval Study

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