Electric-Acoustic Stimulation Extended Follow-up Post Approval Study



Status:Enrolling by invitation
Conditions:Other Indications, Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:6/22/2018
Start Date:December 2016
End Date:December 2019

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

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.

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
We found this trial at
7
sites
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Chapel Hill, NC
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Dallas, TX
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3901 Rainbow Boulevard
Kansas City, Kansas 66160
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Kansas City, KS
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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Palo Alto, California 94303
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Palo Alto, CA
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