Hearing Preservation in Cochlear Implantation Surgery (CIPRES)

UMC Utrecht

Status: Enrolling

Conditions: Sensorineural Hearing Loss

Treatments: Device: Periomodiolar electrode array; Procedure: Round window insertion; Procedure: Cochleostomy insertion; Device: Lateral wall array

Study type: Interventional

Funder types: Other

Identifiers

NCT07146841

NL8586 (Other Identifier)

NL71233.041.19

Details and patient eligibility

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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48 participants in 4 patient groups

Group 1: RW and LW

Other group

Description:

Combination of round window insertion and lateral wall electrode array

Treatment:

Device: Lateral wall array

Procedure: Round window insertion

Group 2: RW and PM

Other group

Description:

Combination of round window insertion and perimodiolar electrode array

Treatment:

Procedure: Round window insertion

Device: Periomodiolar electrode array

Group 3: CO and LW

Other group

Description:

Combination of cochleostomie insertion and lateral wall electrode array

Treatment:

Device: Lateral wall array

Procedure: Cochleostomy insertion

Group 4: CO + PM

Other group

Description:

Combination of cochleostomy insertion and perimodiolar electrode array

Treatment:

Procedure: Cochleostomy insertion

Device: Periomodiolar electrode array