Hearing Preservation in Cochlear Implantation Surgery

NCT07146841 | Recruiting DMC

• 2 other identifiers: NL71233.041.19NL8586
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sensorineural Hearing Loss

Keywords

Sensorineural Hearing Loss; Cochlear Implantation; Residual Hearing Preservation; Electrocochleography

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Scalar position of the electrode array

  12 months

• Electrocochleography

  12 months

• Speech perception

  12 months

Study Arms (4)

Group 1: RW and LW

OTHER

Combination of round window insertion and lateral wall electrode array

Procedure: Round window insertion; Device: Lateral wall array

Group 2: RW and PM

OTHER

Combination of round window insertion and perimodiolar electrode array

Procedure: Round window insertion; Device: Periomodiolar electrode array

Group 3: CO and LW

OTHER

Combination of cochleostomie insertion and lateral wall electrode array

Procedure: Cochleostomy insertion; Device: Lateral wall array

Group 4: CO + PM

OTHER

Combination of cochleostomy insertion and perimodiolar electrode array

Procedure: Cochleostomy insertion; Device: Periomodiolar electrode array

Interventions

Round window insertion PROCEDURE

Insertion of the electrode array via the round window.

Also known as: Round window

Group 1: RW and LW; Group 2: RW and PM

Cochleostomy insertion PROCEDURE

Insertion of the electrode array via cochleostomy.

Also known as: cochleostomy

Group 3: CO and LW; Group 4: CO + PM

Lateral wall array DEVICE

Lateral wall electrode array from Advanced Bionics.

Group 1: RW and LW; Group 3: CO and LW

Periomodiolar electrode array DEVICE

Perimodiolar MidScala electrode array from Advanced Bionics.

Also known as: Perimodiolar array

Group 2: RW and PM; Group 4: CO + PM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe hearing loss, CI candidate
• years of age or older
• normal function of middle ear (i.e. no acute middle ear infections)
• dutch language proficiency
• choice for Advanced Bionics implant

You may not qualify if:

• prior otologic surgery in the implanted ear (excluding tympanostomy tube placement)
• inner ear malformation present in the ear to be implanted (i.e. ossification, Mondini malformation)
• retrocochlear pathology present in the auditory system to be implanted
• neurocognitive disorders
• sudden deafness

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University Medical Center Utrecht

Utrecht, Netherlands

RECRUITING

Related Publications (14)

• 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.

  PMID: 21756464 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.

  PMID: 17063008 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.

  PMID: 28045786 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.

  PMID: 30624395 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.

  PMID: 29936898 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.

  PMID: 26176556 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.

  PMID: 24764083 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.

  PMID: 23640087 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.

  PMID: 17063005 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.

  PMID: 18223448 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.

  PMID: 23446225 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.

  PMID: 24556970 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.

  PMID: 23044644 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.

  PMID: 34886884 BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hans GXM Thomeer, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imogen AML van Beurden, MD

CONTACT

+31887555555; i.a.m.l.vanbeurden-5@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Model Details: 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.

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: January 29, 2020
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)