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

Hearing Impairment Clinical Trial

— FOCUS  

Official title:

A Feasibility, Prospective, Multi-centre, Repeated-measures Study Evaluating the Performance of Focused Multipolar Stimulation in Adult Cochlear Implant Recipients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05003674
• Other study ID #: AI5782
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2022
• Est. completion date: March 2025

Study information

• Verified date: September 2023
• Source: Cochlear
• Contact: Ruth English
• Phone: +61438745639
• Email: renglish[@]cochlear.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deafness
• Hearing Impairment
• Hearing Loss

Intervention

Device:
• Focused stimulation strategy
Investigational focused stimulation strategy
• ACE stimulation strategy
Standard of care stimulation strategy

Locations

Country	Name	City	State
Australia	NextSense - Broadmeadow	Broadmeadow	New South Wales
Australia	NextSense - Deakin	Deakin	Australian Capital Territory
Australia	Royal Victorian Eye and Ear Hospital	East Melbourne	Victoria
Australia	St Vincent's Private Hospital	East Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean difference between stimulation modes for sentence perception in background noise (dB) (AuSTIN)		7 months