Focused Multipolar Stimulation for Hearing Loss

(SASC Trial)

Recruiting at4 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Cochlear

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing new methods for sending sound signals through cochlear implants to help people with severe hearing loss. The goal is to improve how well users can understand speech by making the electrical signals more precise. Researchers will adjust and test different settings to find the best ones for better hearing performance and usability. Cochlear implants are medical devices that electrically stimulate the auditory nerve to help deaf and severely hearing-impaired individuals hear again.

Research Team

Eligibility Criteria

This trial is for adults over 18 with bilateral sensorineural hearing loss who are candidates for unilateral cochlear implantation, fluent in the speech testing language, and willing to follow study requirements. Excluded are those with acoustic nerve lesions, additional handicaps affecting evaluations, unrealistic expectations about the procedure's outcomes, or current participation in other interventional trials.

Inclusion Criteria

Willing and able to provide written informed consent

Fluent in the language used for speech testing

I am 18 years old or older.

Exclusion Criteria

Pregnant at the time of surgery

Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator

You have a cochlear implant now or had one in the past.

Treatment Details

Interventions

• Focused Multipolar Stimulation (FMS) strategy (Device)

Trial Overview The study tests a new Focused Multipolar Stimulation (FMS) strategy against the standard Monopolar stimulation in cochlear implants. It aims to improve hearing by adjusting device parameters and fitting based on ongoing reviews within technical limits.

Participant Groups

Group I: Adult Cochlear implant Experimental Treatment 1 Intervention

Adult cochlear implant recipients receiving different combinations of alternative modes and, sound coding parameters

Who Is Running the Clinical Trial?

Cochlear

Lead Sponsor

Trials

96

Recruited

6,300+

Headquarters

Sydney, Australia

Dig Howitt

Cochlear

Chief Executive Officer since 2018

BE (Hons), MBA

Michael del Prado

Cochlear

Chief Medical Officer since 2022

MD, MSc, FRACP, FAAHMS, FAICD