Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07146841

Hearing Preservation in Cochlear Implantation Surgery

Led by UMC Utrecht · Updated on 2025-08-28

48

Participants Needed

1

Research Sites

361 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Hearing Preservation in Cochlear Implantation Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Severe hearing loss, candidate for cochlear implant
  • 18 years of age or older
  • Normal middle ear function with no acute middle ear infections
  • Proficient in Dutch language
  • Choice for Advanced Bionics implant
Not Eligible

You will not qualify if you...

  • Prior ear surgery in the implanted ear (excluding tympanostomy tube placement)
  • Presence of inner ear malformation in the ear to be implanted (e.g., ossification, Mondini malformation)
  • Retrocochlear pathology in the auditory system of the implanted ear
  • Neurocognitive disorders
  • Sudden deafness

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Medical Center Utrecht

Utrecht, Netherlands

Actively Recruiting

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Research Team

I

Imogen AML van Beurden, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

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