Electric-Acoustic Stimulation Extended Follow-up Post Approval Study
Office of Device Evaluation Lead-MED-EL EAS Extended f/u Study
1 other identifier
interventional
50
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2016
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 13, 2017
CompletedFirst Posted
Study publicly available on registry
January 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedResults Posted
Study results publicly available
September 10, 2020
CompletedSeptember 10, 2020
August 1, 2020
3 years
January 13, 2017
August 6, 2020
August 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Classification of Residual Hearing at 5 Years Post Operatively as a Function of the HEARRING SCALE.
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.
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.
Five years (60 months) post-implantation for subjects implanted under the original EAS clinical trial
Study Arms (1)
Study procedures
OTHERInterventions
Combination of a cochlear implant and a hearing aid
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Stanford Unversity
Palo Alto, California, 94303, United States
University of Miami
Miami, Florida, 33136, United States
University of Kansas University Medical Center
Kansas City, Kansas, 66160, United States
University of North Carolina
Chapel Hill, North Carolina, 27517, United States
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 24328756BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Allison Racey
- Organization
- MED-EL Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2017
First Posted
January 25, 2017
Study Start
December 1, 2016
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
September 10, 2020
Results First Posted
September 10, 2020
Record last verified: 2020-08