Anatomy Based Selection of CI Array for SSD Patients

Single-Sided Deafness Clinical Trial

Official title: Anatomy-Based Cochlear Implant Array Selection for Patients With Single-Sided Deafness

Status Not yet recruiting

Clinical Trial Summary

The purpose of the study is to evaluate cochlear implant speech outcomes and subjective benefit for cochlear implant recipients with single-sided deafness using patient-specific, anatomy-based array selection versus standard of care with a fixed array size for all patients. Subjects will prospectively be assigned to receive an Anatomy-Based Electrode (FLEX26, FLEX28, or FLEXSOFT) or the Standard of Care Electrode array (FLEX28). Speech performance and subjective benefit will be evaluated between these two groups.

Clinical Trial Description

To determine the effectiveness of Anatomy-Based Electrode selection versus Standard of Care Electrode selection in SSD listeners a prospective, single-blinded study design will be used to evaluate the outcomes in these two groups by evaluating speech understanding in quiet, speech understanding in noise, subjective listening difficulty and sound quality, and datalogging.

Subjects will be randomly assigned to either group to receive an electrode based on their anatomy (ABE) or the Standard of Care electrode (SOCE). Five participants will be in each group, for a total of 10 participants.

All subjects will receive a MED-EL Cochlear Implant and will subsequently be fit with an audio processor approved by Health Canada. Post-operative evaluations will occur at one and six months post-activation. ;

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Single-Sided Deafness

• NCT number: NCT06189274
• Study type: Interventional
• Source: Nova Scotia Health Authority
• Contact: David P Morris, MD
• Phone: 902-473-1986
• Email: dp.morris@dal.ca
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Completion date: December 2025