NCT07146841

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-01-29
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-08-28
• Last updated: 2025-08-28

Locations

1 site across 1 country: Netherlands