ISRCTN34622173Suspended未知
Round window versus cochleostomy electrode array insertion with lateral wall atraumatic electrode: a prospective randomised clinical study
niversity College London0 sites54 target enrollmentStarted: February 15, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Suspended
- Sponsor
- Enrollment
- 54
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. >18 years old undergoing cochlear implantation.
- •2. Able and willing to give valid consent to the study.
- •3. Able to undergo pure tone audiometric testing as outlined.
- •4. Meet NICE criteria for cochlear implantation.
- •5. Working use of English.
- •6. Definable / measurable air conduction hearing threshold on pure tone audiometry at 250 Hz, 500 Hz and 1 kHz.
- •7. Patients choosing Med-El Flex28, cochlea Co.CI522 or Advanced bionic HiFocus 1j electrode array
Exclusion Criteria
- •1. Pre-operatively diagnosed cochlear obliteration.
- •2. Pre-operatively diagnosed inner ear dysplasia.
- •3. Undergoing bilateral implantation.
- •4. ‘Non-traditional’ cochlear implant candidates (pre-lingually deafened)
- •5. Contraindications to CT (e.g. pregnancy).
- •6. Contraindications to cochlear implantation (e.g. severe co-morbidity).
- •7. Contraindications to systemic steroid use (e.g. diabetes).
- •8. Previous middle ear surgery.
- •9. >90 years old.
Investigators
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