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

Round window versus cochleostomy electrode array insertion with lateral wall atraumatic electrode: a prospective randomised clinical study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN34622173

Enrollment

Registered

2019-02-15

Start date

2019-03-15

Completion date

Unknown

Last updated

2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing loss Ear, Nose and Throat

Interventions

The intervention procedures are cochleostomy and round window insertion of a cochlear implant. Both surgical approaches are part of clinical standard of care and routinely practiced in the UK and abro

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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). 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). 3. Assessment of electrode position by cone beam CT scan (1 week after the operation).	—

Measure

Time frame

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). 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). 3. Assessment of electrode position by cone beam CT scan (1 week after the operation).

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026