A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation in Adult Cochlear Implant Recipients

Not Applicable

Completed

• Conditions: Hearing Impairment
• Interventions: Device: Focused stimulation strategy; Device: ACE stimulation strategy

• Registration Number: NCT05003674
• Lead Sponsor: Cochlear

Brief Summary

This feasibility study is designed to explore several facets of hearing performance that may show improvements for alternative modes of stimulation compared to Monopolar (MP) stimulation within a group of adult cochlear-implant recipients. Measures of speech recognition, music appreciation, listening effort, quality of life, and real-world assessments will be gathered to determine the most promising benefits for further examination.

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 feasibility study is to explore several facets of hearing performance that may show improvements with these alternative modes of stimulation compared to MP stimulation within a group of adult cochlear-implant recipients. Measures of speech recognition, music appreciation, listening effort, quality of life, and real-world assessments will be gathered to determine the most promising benefits for further examination. Individual neural, psychophysical, cognitive, and electrode placement data will also be obtained to inform questions related to across-subject variability, and practical aspects of power consumption and device fitting will be evaluated.

Study Timeline

• Study First Submitted: 2021-07-21
• Study First Submitted QC: 2021-08-05
• Study First Posted: 2021-08-12
• Study Start: 2022-11-28
• Status Verified: 2025-04
• Primary Completion: 2025-04-07
• Study Completion: 2025-04-07
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

1. Adults 18 years of age or older.
2. Candidate for unilateral cochlear implant with Slim Modiolar electrode array as determined by the implanting centre.
3. English spoken as a primary language.
4. Willingness to comply with all investigational requirements.
5. Willing and able to provide written informed consent.

Exclusion Criteria

1. Previous or existing cochlear-implant recipient.
2. Evidence of severe or greater sensorineural hearing loss prior to five years of age.
3. Open-set pre-operative word score > 70% in the contralateral ear.
4. Duration of severe to profound hearing loss > 20 years in the ear to be implanted.
5. Adults with functional acoustic hearing in the ear to be implanted who desire to use an acoustic component in the implanted ear.
6. Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array.
7. Hearing loss of neural or central origin.
8. Medical or psychological conditions that would contraindicate undergoing surgery.
9. Women who are pregnant.
10. Additional handicaps that would prevent or restrict participation in the audiological evaluations.
11. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and prosthetic device.
12. Inability or unwillingness to use a hand-held device to control the sound processor and to collect test and survey data.
13. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
14. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
15. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
16. Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Adults cochlear implant recipients receiving alternative stimulation strategy	Focused stimulation strategy	ACE strategy, 8 maxima, alternative mode
Adults cochlear implant recipients receiving Standard-of-Care stimulation strategy.	ACE stimulation strategy	ACE strategy, 8 maxima, monopolar mode.

Primary Outcome Measures

Name	Time	Method
Mean difference between stimulation modes for sentence perception in background noise (dB) (AuSTIN)	7 months

Trial Locations

Locations (4)

NextSense - Deakin; 🇦🇺 Deakin, Australian Capital Territory, Australia

NextSense - Broadmeadow; 🇦🇺 Broadmeadow, New South Wales, Australia

Royal Victorian Eye and Ear Hospital; 🇦🇺 East Melbourne, Victoria, Australia

St Vincent's Private Hospital; 🇦🇺 East Melbourne, Victoria, Australia