Status:
COMPLETED
Single-Sided Deafness in the Medicare Population
Lead Sponsor:
Med-El Corporation
Conditions:
Hearing Loss, Unilateral
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of cochlear implantation in adults 65 years of age and older.
Detailed Description
The study will be conducted as a single-subject, repeated measures, multi center study at 3 sites. Fifteen subjects will be enrolled in this study. Three centers in the United States and Canada will r...
Eligibility Criteria
Inclusion
- 65 years of age or older at the time of implantation
- Unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 90 dB or greater in the ear to be implanted
- Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap less than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and 4000 Hz
- Normal or near-normal hearing in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 30 dB or less
- Word recognition in the ear to be implanted of 5% or less on CNC word score in quiet
- Previous experience with an appropriately-fit CROS, BI-CROS, bone conduction, or traditional hearing aid, as deemed appropriate by investigator
- Fluent in English
Exclusion
- Duration of profound hearing loss of 10 years or more
- Sudden onset of hearing loss within six months of implantation
- Evidence of non-functional cochlear nerve or other retrocochlear hearing loss
- Evidence of severe cochlear malformation (i.e., common cavity or ossification)
- External or middle ear infection
- Suspected cognitive concern
- Other medical contraindication for surgery or anesthesia
Key Trial Info
Start Date :
June 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05250414
Start Date
June 27 2022
End Date
August 11 2025
Last Update
September 29 2025
Active Locations (3)
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1
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
2
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
3
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5