RecruitingNot ApplicableNCT07146841

Hearing Preservation in Cochlear Implantation Surgery

Evaluating Cochlear Insertion Trauma and Hearing Preservation After Cochlear Implantation (CIPRES): a Study Protocol for a Randomized Single-blind Controlled Trial


Sponsor

UMC Utrecht

Enrollment

48 participants

Start Date

Jan 29, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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

Exclusion Criteria5

  • 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

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Interventions

PROCEDURERound window insertion

Insertion of the electrode array via the round window.

PROCEDURECochleostomy insertion

Insertion of the electrode array via cochleostomy.

DEVICELateral wall array

Lateral wall electrode array from Advanced Bionics.

DEVICEPeriomodiolar electrode array

Perimodiolar MidScala electrode array from Advanced Bionics.


Locations(1)

University Medical Center Utrecht

Utrecht, Netherlands

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NCT07146841


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