NCT06189274

Anatomy Based Selection of CI Array for SSD Patients

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Nova Scotia Health Authority · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Single-Sided Deafness

Interventions

Type	Name	Description
OTHER	Anatomy-Based Electrode Array Selection	Use of pre-operative imaging to select the appropriate length electrode vs standard of care
OTHER	Standard of Care Electrode Array Selection	Use of standard of care electrode which is the FLEX 28 electrode

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2024-01-03
• Last updated: 2024-01-03

Regulatory

• FDA-regulated device study