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

NCT05003674 | Completed

• 1 other identifier: AI5782
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 4

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.

Conditions

Hearing Impairment

Keywords

cochlear implantation

Outcome Measures

Primary Outcomes (1)

• Mean difference between stimulation modes for sentence perception in background noise (dB) (AuSTIN)

  7 months

Study Arms (2)

Adults cochlear implant recipients receiving alternative stimulation strategy

EXPERIMENTAL

ACE strategy, 8 maxima, alternative mode

Device: Focused stimulation strategy

Adults cochlear implant recipients receiving Standard-of-Care stimulation strategy.

ACTIVE COMPARATOR

ACE strategy, 8 maxima, monopolar mode.

Device: ACE stimulation strategy

Interventions

Focused stimulation strategy DEVICE

Investigational focused stimulation strategy

Adults cochlear implant recipients receiving alternative stimulation strategy

ACE stimulation strategy DEVICE

Standard of care stimulation strategy

Adults cochlear implant recipients receiving Standard-of-Care stimulation strategy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous or existing cochlear-implant recipient.
• Evidence of severe or greater sensorineural hearing loss prior to five years of age.
• Open-set pre-operative word score \> 70% in the contralateral ear.
• Duration of severe to profound hearing loss \> 20 years in the ear to be implanted.
• Adults with functional acoustic hearing in the ear to be implanted who desire to use an acoustic component in the implanted ear.
• Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array.
• Hearing loss of neural or central origin.
• Medical or psychological conditions that would contraindicate undergoing surgery.
• Women who are pregnant.
• Additional handicaps that would prevent or restrict participation in the audiological evaluations.
• 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.
• Inability or unwillingness to use a hand-held device to control the sound processor and to collect test and survey data.
• Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
• Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
• Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.

Sponsors & Collaborators

• Cochlear: lead

Study Sites (4)

NextSense - Deakin

Deakin, Australian Capital Territory, 2600, Australia

Location

NextSense - Broadmeadow

Broadmeadow, New South Wales, 2292, Australia

Location

Royal Victorian Eye and Ear Hospital

East Melbourne, Victoria, 3002, Australia

Location

St Vincent's Private Hospital

East Melbourne, Victoria, 3002, Australia

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: August 12, 2021
• Study Start: November 28, 2022
• Primary Completion: April 7, 2025
• Study Completion: April 7, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)