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Hearing Preservation in Cochlear Implantation Surgery

NCT07146841 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-08-28

No results posted yet for this study

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

Interventions

PROCEDURE

Round window insertion

Insertion of the electrode array via the round window.

PROCEDURE

Cochleostomy insertion

Insertion of the electrode array via cochleostomy.

DEVICE

Lateral wall array

Lateral wall electrode array from Advanced Bionics.

DEVICE

Periomodiolar electrode array

Perimodiolar MidScala electrode array from Advanced Bionics.

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Hans GXM Thomeer, MD, PhD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-29
Primary Completion
2027-01-01
Completion
2027-01-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07146841 on ClinicalTrials.gov