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| Name | Class |
|---|---|
| GZA Ziekenhuizen Campus Sint-Augustinus | OTHER |
| Universitaire Ziekenhuizen KU Leuven | OTHER |
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This is a prospective multicenter multinational randomized control trial. The duration of the study for the individual patient will be approximately 1 year (pre-operative assessments, 1 week, 3 months and 12 months follow-up assessments). Participants will be randomized to one of two surgical approaches: eRW or CO, with a 1:1 allocation in a parallel design.
Rationale: Preserving residual hearing in cochlear implant (CI) surgery has gained significant attention. It not only signifies minimally invasive implantation but also supports natural sound perception and enables electrical-acoustic stimulation, enhancing sound localization, music appreciation, and speech recognition in noisy environments. Using the Cochlear™ Nucleus® CI with Slim Modiolar electrode (Cochlear Ltd., Sydney, Australia), potential sites of residual hearing loss in surgery include approaches to the cochlear lumen, potential damage during entry, and damage during electrode insertion. Studies comparing different surgical approaches (cochleostomy (CO) and extended round window (eRW)) show varied results. Electrocochleography (ECochG) can be used to indicate intracochlear damage during electrode insertion, however, the variability observed in ECochG responses during cochlear implantation remains significant. Moreover, ECochG has not yet been used to monitor cochlear functions throughout every phase of surgery, including the insertion of the sheath or stabilization of the electrode lead.
Objective: The aim of this study is to investigate whether the type of surgical approach to the cochlea; CO or eRW using the CI632 affects the final residual hearing and secondarily, intracochlear trauma and electrode position, as determined by pure tone audiometry, EcochG and imaging.
Study population: Adult CI candidates with post-lingual onset of severe to profound hearing loss, who are scheduled to receive a Nucleus CI632 with a slim modiolar electrode array and have a preoperative audiometric low-frequency average air conduction threshold of <80 decibel (dB) hearing level at 500 Hz in the ear to be implanted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cochleostomy | Active Comparator | When employing the cochleostomy approach, a carefully positioned opening will be drilled anterior-inferior to the eRW membrane. |
|
| extended Round Window | Active Comparator | In case of the extended round window approach, the scala tympani will be accessed through the extended round window technique, involving the creation of a round window margin cochleostomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical approach: cochleostomy or extended round window | Procedure | Surgical placement of a cochlear implant electrode array |
|
| Measure | Description | Time Frame |
|---|---|---|
| Residual hearing | The difference in residual hearing per group (eRW or CO) between pre- and postoperative pure tone thresholds, averaged at 500, 750 and 1000 Hz (PTAlow). | 3-months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| ECochG thresholds after multiple surgery stages | ECochG thresholds with a promontory recording electrode after the following surgery stages: a) posterior tympanotomy (baseline), b) drilling for RW membrane exposure, c) completion of the approach to implantation (CO or eRW), d) sheath insertion, e) electrode array insertion, f) sheath withdrawal, and g) positioning of the electrode lead. | Intraoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Coby Lindeboom, MD | Contact | 024 361 14934 | Coby.lindeboom@radboudumc.nl | |
| Emmanuel Mylanus | Contact | Emmanuel.Mylanus@radboudumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Medical Center | Recruiting | Nijmegen | Netherlands |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Intracochlear electrode position | The position of electrode contacts relative to the modiolus and the angular insertion depth (AID), as assessed with pre- and post-operative CT-scan. | 3-months postoperatively |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |