The effect of surgical approach on hearing preservation in cochlear implant surgery

Not Applicable

Suspended

• Conditions: Hearing loss; Ear, Nose and Throat

• Registration Number: ISRCTN34622173
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-15
• Last Update Posted: 22 March 2021
• Study Completion: 2023-03-15

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pre-operative and post-operative unaided hearing threshold assessed at baseline, 1, 3, 6, and 12 months after the operation.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Post-operative physiological measures and fitting parameters by physiological (objective) outcome measures of the cochlear implant (electrode impedance, Evoked compound action potential (ECAP) maximum comfortable level (MCL), threshold level, eSRT). (1,3,6, and 12 months after the operation).<br> 2. Post-operative speech perception measured by (Bench-Kowal-Bamford (BKB) sentence test in noise and in quiet, City University of New York Nonsense Syllable Test (CUNY) in noise and in quiet). (1,3,6 and 12 months after the operation).<br> 3. Assessment of electrode position by cone beam CT scan (1 week after the operation).<br>