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| ID | Type | Description | Link |
|---|---|---|---|
| NL8586 | Other Identifier | Netherlands Trial Register (NTR) |
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In order to preserve the residual hearing in patients with sensorineural hearing loss (SNHL) receiving a cochlear implant (CI), the insertion trauma to the delicate and microscopic structures of the cochlea needs to be minimized. The surgical procedure starts with the conventional mastoidectomy-posterior tympanotomy (MPT) approach to the middle ear, and is followed by accessing the cochlea, with either a cochleostomy (CO) or via the round window (RW). Both techniques have their benefits and disadvantages. Another aspect is the design of the electrode array. There are fundamentally two different designs: a *straight* lateral wall lying electrode array (LW), or a *pre-curved* perimodiolar cochlear lying electrode array (PM). Interestingly, until now, the best surgical approach and type of implant is unknown. Our hypothesis is that the combination of a RW approach and a LW lying electrode array minimizes insertion trauma, leading to better hearing outcome for SNHL patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: RW and LW | Other | Combination of round window insertion and lateral wall electrode array |
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| Group 2: RW and PM | Other | Combination of round window insertion and perimodiolar electrode array |
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| Group 3: CO and LW | Other | Combination of cochleostomie insertion and lateral wall electrode array |
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| Group 4: CO + PM | Other | Combination of cochleostomy insertion and perimodiolar electrode array |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Round window insertion | Procedure | Insertion of the electrode array via the round window. |
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| Measure | Description | Time Frame |
|---|---|---|
| Hearing preservation | Hearing preservation is the main outcome, which will be expressed in percentage. Hearing preservation is calculated by using the preoperative and postoperative puretoneaudiometry (PTA). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Scalar position of the electrode array | Scalar position of the electrode array (scala tympani or scala vestibuli assessed by CB-CT) | 12 months |
| Electrocochleography | ECochG (among others amplitude in µV) and eCAP (among others amplitude in µV) potentials |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Imogen AML van Beurden, MD | Contact | +31887555555 | i.a.m.l.vanbeurden-5@umcutrecht.nl |
| Name | Affiliation | Role |
|---|---|---|
| Hans GXM Thomeer, MD, PhD | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Utrecht | Recruiting | Utrecht | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21756464 | Background | Rask-Andersen H, Erixon E, Kinnefors A, Lowenheim H, Schrott-Fischer A, Liu W. Anatomy of the human cochlea--implications for cochlear implantation. Cochlear Implants Int. 2011 May;12 Suppl 1:S8-13. doi: 10.1179/146701011X13001035752174. | |
| 17063008 | Background | Escude B, James C, Deguine O, Cochard N, Eter E, Fraysse B. The size of the cochlea and predictions of insertion depth angles for cochlear implant electrodes. Audiol Neurootol. 2006;11 Suppl 1:27-33. doi: 10.1159/000095611. Epub 2006 Oct 6. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 17, 2025 | Jul 17, 2025 | Prot_000.pdf |
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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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Randomized controlled single-blind trial consisting of four groups: I: RW and LW, II: RW and PM, III: CO and LW and IV: CO and PM.
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| Cochleostomy insertion | Procedure | Insertion of the electrode array via cochleostomy. |
|
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| Lateral wall array | Device | Lateral wall electrode array from Advanced Bionics. |
|
| Periomodiolar electrode array | Device | Perimodiolar MidScala electrode array from Advanced Bionics. |
|
|
| 12 months |
| Speech perception | Speech perception test with/without noise in CVC words correct score (in percentage) with signal to noise ratio of 10 dB. | 12 months |
| 28045786 | Background | Avci E, Nauwelaers T, Hamacher V, Kral A. Three-Dimensional Force Profile During Cochlear Implantation Depends on Individual Geometry and Insertion Trauma. Ear Hear. 2017 May/Jun;38(3):e168-e179. doi: 10.1097/AUD.0000000000000394. |
| 30624395 | Background | Snels C, IntHout J, Mylanus E, Huinck W, Dhooge I. Hearing Preservation in Cochlear Implant Surgery: A Meta-Analysis. Otol Neurotol. 2019 Feb;40(2):145-153. doi: 10.1097/MAO.0000000000002083. |
| 29936898 | Background | Fan X, Xia M, Wang Z, Zhang H, Liu C, Wang N, Hou L, Li C, Xu A. Comparison of electrode position between round window and cochleostomy inserting approaches among young children: a cone-beam computed tomography study. Acta Otolaryngol. 2018 Sep;138(9):815-821. doi: 10.1080/00016489.2018.1478127. Epub 2018 Jun 23. |
| 26176556 | Background | Wanna GB, Noble JH, Gifford RH, Dietrich MS, Sweeney AD, Zhang D, Dawant BM, Rivas A, Labadie RF. Impact of Intrascalar Electrode Location, Electrode Type, and Angular Insertion Depth on Residual Hearing in Cochlear Implant Patients: Preliminary Results. Otol Neurotol. 2015 Sep;36(8):1343-8. doi: 10.1097/MAO.0000000000000829. |
| 24764083 | Background | Wanna GB, Noble JH, Carlson ML, Gifford RH, Dietrich MS, Haynes DS, Dawant BM, Labadie RF. Impact of electrode design and surgical approach on scalar location and cochlear implant outcomes. Laryngoscope. 2014 Nov;124 Suppl 6(0 6):S1-7. doi: 10.1002/lary.24728. Epub 2014 May 30. |
| 23640087 | Background | Havenith S, Lammers MJ, Tange RA, Trabalzini F, della Volpe A, van der Heijden GJ, Grolman W. Hearing preservation surgery: cochleostomy or round window approach? A systematic review. Otol Neurotol. 2013 Jun;34(4):667-74. doi: 10.1097/MAO.0b013e318288643e. |
| 17063005 | Background | Gfeller KE, Olszewski C, Turner C, Gantz B, Oleson J. Music perception with cochlear implants and residual hearing. Audiol Neurootol. 2006;11 Suppl 1:12-5. doi: 10.1159/000095608. Epub 2006 Oct 6. |
| 18223448 | Background | Buechner A, Brendel M, Krueger B, Frohne-Buchner C, Nogueira W, Edler B, Lenarz T. Current steering and results from novel speech coding strategies. Otol Neurotol. 2008 Feb;29(2):203-7. doi: 10.1097/mao.0b013e318163746. |
| 23446225 | Background | Gifford RH, Dorman MF, Skarzynski H, Lorens A, Polak M, Driscoll CL, Roland P, Buchman CA. Cochlear implantation with hearing preservation yields significant benefit for speech recognition in complex listening environments. Ear Hear. 2013 Jul-Aug;34(4):413-25. doi: 10.1097/AUD.0b013e31827e8163. |
| 24556970 | Background | Skarzynski H, Lorens A, Matusiak M, Porowski M, Skarzynski PH, James CJ. Cochlear implantation with the nucleus slim straight electrode in subjects with residual low-frequency hearing. Ear Hear. 2014 Mar-Apr;35(2):e33-43. doi: 10.1097/01.aud.0000444781.15858.f1. |
| 23044644 | Background | Eshraghi AA, Nazarian R, Telischi FF, Rajguru SM, Truy E, Gupta C. The cochlear implant: historical aspects and future prospects. Anat Rec (Hoboken). 2012 Nov;295(11):1967-80. doi: 10.1002/ar.22580. Epub 2012 Oct 8. |
| 34886884 | Background | Jwair S, Boerboom RA, Versnel H, Stokroos RJ, Thomeer HGXM. Evaluating cochlear insertion trauma and hearing preservation after cochlear implantation (CIPRES): a study protocol for a randomized single-blind controlled trial. Trials. 2021 Dec 9;22(1):895. doi: 10.1186/s13063-021-05878-2. |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |