Actively Recruiting
Single-Sided Deafness and Asymmetric Hearing Loss
Led by Med-El Corporation · Updated on 2025-09-24
65
Participants Needed
6
Research Sites
301 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to evaluate the long-term safety and effectiveness of cochlear implantation of the approved population in adults and children with single-sided deafness and asymmetric hearing loss.
CONDITIONS
Official Title
Single-Sided Deafness and Asymmetric Hearing Loss
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Five years of age or older at the time of implantation
- Unilateral profound hearing loss with a pure-tone average of 90 dB or greater in the ear to be implanted
- Sensorineural hearing loss in the ear to be implanted with an air-bone gap less than or equal to 10 dB at two or more frequencies
- Normal hearing or mild to moderate hearing loss in the non-implanted ear with a pure-tone average of 55 dB or less
- Word recognition score of 5% or less on CNC word test in quiet in the ear to be implanted
- Previous experience with an appropriately-fit CROS hearing aid, BI-CROS hearing aid, bone conduction, or traditional hearing aid
- Fluent in English
You will not qualify if you...
- Duration of profound hearing loss of 10 years or more
- Absence of cochlear development or non-functionality of cochlear nerve
- Other retrocochlear hearing loss
- Evidence of severe cochlear malformation such as common cavity or ossification
- External or middle ear infection
- Suspected developmental or cognitive concern
- Other medical contraindication for surgery or anesthesia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Withdrawn
2
University of Iowa
Iowa City, Iowa, United States, 52242-1078
Actively Recruiting
3
New York Eye and Ear Infirmary
New York, New York, United States, 10003
Actively Recruiting
4
University of North Carolina
Chapel Hill, North Carolina, United States, 27517
Active, Not Recruiting
5
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Actively Recruiting
6
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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