Hearing Preservation in Cochlear Implantation Surgery

Not Applicable

Recruiting

• Conditions: Sensorineural Hearing Loss

• Registration Number: NCT07146841
• Lead Sponsor: UMC Utrecht

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-29
• Status Verified: 2025-08
• Study First Submitted: 2025-08-21
• Study First Submitted QC: 2025-08-21
• Last Update Submitted: 2025-08-21
• Study First Posted: 2025-08-28
• Last Update Posted: 2025-08-28
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Severe hearing loss, CI candidate
• 18 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Hearing preservation	12 months	Hearing preservation is the main outcome, which will be expressed in percentage. Hearing preservation is calculated by using the preoperative and postoperative puretoneaudiometry (PTA).

Secondary Outcome Measures

Name	Time	Method
Scalar position of the electrode array	12 months	Scalar position of the electrode array (scala tympani or scala vestibuli assessed by CB-CT)
Electrocochleography	12 months	ECochG (among others amplitude in µV) and eCAP (among others amplitude in µV) potentials
Speech perception	12 months	Speech perception test with/without noise in CVC words correct score (in percentage) with signal to noise ratio of 10 dB.

Trial Locations

Locations (1)

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands