Status:
UNKNOWN
Anatomy Based Selection of CI Array for SSD Patients
Lead Sponsor:
Nova Scotia Health Authority
Collaborating Sponsors:
Med-El Corporation
Conditions:
Single-Sided Deafness
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the study is to evaluate cochlear implant speech outcomes and subjective benefit for cochlear implant recipients with single-sided deafness using patient-specific, anatomy-based array s...
Detailed Description
To determine the effectiveness of Anatomy-Based Electrode selection versus Standard of Care Electrode selection in SSD listeners a prospective, single-blinded study design will be used to evaluate the...
Eligibility Criteria
Inclusion
- 18 years of age or older at the time of implantation
- Unilateral severe to profound sensorineural hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 70 dB HL or greater
- Normal hearing mild hearing loss in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 40 dB or less
- Deemed an appropriate candidate by the 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 using appropriate imaging modality to be determined by the investigator
- Other retrocochlear hearing loss
- Evidence of severe cochlear malformation (i.e., common cavity or ossification)
- External or middle ear infection
- Suspected developmental or cognitive concern
- Other medical contraindication for surgery or anesthesia
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06189274
Start Date
April 1 2024
End Date
December 1 2025
Last Update
January 3 2024
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