NCT05641155

A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding in Adults.

An Early Feasibility, Prospective, Exploratory Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding Enhancements in Adult Cochlear Implant Recipients (SASC).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Cochlear · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this early feasibility study is to explore several facets of hearing performance that may show improvements for alternative modes of stimulation compared to Monopolar (MP stimulation) in cochlear implant recipients. This study will iteratively evaluate different parameter sets that intend to maximize hearing performance benefits within technical requirements. This study is exploratory in nature and will achieve its objectives through ongoing review and adjustment of device parameters and fitting

Detailed description

Alternative modes of stimulation will be investigated that may improve spectral resolution through reduced cochlear spread of excitation and in turn provide enhanced speech perception and real-world clinical benefits over MP stimulation. The purpose of this study is to balance the clinical improvements of alternative modes of stimulation with technical and usability requirements for power usage. By iteratively evaluating different sets of stimulation and sound coding parameters, this study will determine device settings and fitting techniques. Measures of speech recognition, listening effort, neural responses, electrode placement, battery life, and usability acceptance will be obtained to evaluate clinical benefits

Conditions

• Hearing Impairment, Sensorineural

Interventions

Type	Name	Description
DEVICE	Focused Multipolar Stimulation (FMS) strategy	Adult cochlear implant recipients receiving different combinations of alternative modes and, sound coding parameters.

Timeline

• Start date: 2023-06-02
• Primary completion: 2025-02-06
• Completion: 2025-12-08
• First posted: 2022-12-07
• Last updated: 2025-12-17

Locations

5 sites across 2 countries: United States, Belgium

Regulatory

• FDA-regulated device study