Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients (DUAL)

A Prospective, Single Centre, Single-blinded, Within-subject Investigation, on the Effect of Stimulation Parameter Changes, and Monopolar and Dual-electrode Mode Changes, on Speech Perception in Experienced Adult Cochlear Implant Recipients

This study aims to investigate the effect of stimulation parameters and different electrode modes on speech perception in adult cochlear implant recipients.

Study Overview

• Status: Completed
• Conditions: Hearing Loss, Sensorineural
• Intervention / Treatment: Device: Program using default MAP; Device: Program using low-power 1 (LP1) MAP; Device: Program using low-power 2 (LP2) MAP; Device: Program using low-power 3 (LP3) MAP

Detailed Description

Performance of four programs (MAPs), each with a different rate, PW and stimulation mode were evaluated, all using 8 maxima: (i) 900 Hz rate, 25 µs PW Default (ii) 900 Hz rate, 50 µs PW LP1, (iii) 500 Hz rate, 100 µs PW LP2 all using Monopolar stimulation mode, and (iv) 500 Hz rate, 100 µs PW using an investigational stimulation mode LP3

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Macquarie Park, New South Wales, Australia, 2109
      • Cochlear Macquarie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI513, CI532, CI522) or Freedom Series (CI24RE(CA), CI24RE(ST), CI24RE(CS), CI422)
• At least three months after activation of the cochlear implant.
• Eighteen years or older at the time of consent.
• User of 900Hz ACE (Advanced Combination Encoder) strategy MAP.
• Score of 20% or more for CNC words presented at 60dBSPL with CI alone in the test ear.
• Fluent speaker in English.
• Willing and able to provide written informed consent.

Exclusion Criteria:

• One or more electrodes turned off in the MAP used regularly.
• 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.
• Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: MAPs on Cochlear™ Nucleus® 7, Nucleus® 8 and Kanso® 2 Sound Processors; Participants will receive four different MAPs to use during two take-home periods and will then complete hearing assessments using each MAP.

Device: Program using default MAP; Each MAP uses a specific combination of stimulation parameters and electrode mode.; Device: Program using low-power 1 (LP1) MAP; Each MAP uses a specific combination of stimulation parameters and electrode mode.; Device: Program using low-power 2 (LP2) MAP; Each MAP uses a specific combination of stimulation parameters and electrode mode.; Device: Program using low-power 3 (LP3) MAP; Each MAP uses a specific combination of stimulation parameters and electrode mode.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Paired Mean Difference Score for CNC Words Correct Between Default and LP1 MAPs in Quiet	Speech perception in quiet was measured for each MAP using recorded CNC monosyllabic words. The goal of speech perception assessment in quiet was to compare % words correct for each of the conditions. The minimum score is 0% and maximum sore is 100%. A higher score means a better outcome. An average CNC word score for each MAP was calculated by combining the data from the specified timepoints.	10 participants completed this test at Week 4, and 10 participants completed this at week 8
Paired Mean Difference Score in dB SRT (AuSTIN) Between Default and LP1 MAPs in Noise	Speech perception in noise was measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses recorded BKB-like target sentences. The goal of the speech perception test in noise is to provide the Speech Reception Threshold (SRT) in dB for 50% speech intelligibility (dB SRT) There is no minimum score. The maximum score is 15 dB. A lower score means a better outcome. An average SRT score for each MAP was calculated by combining the data from the specified timepoints.	10 participants completed the test at Week 4, 10 participants completed the test at Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Paired Mean Difference Score for CNC Words Correct Between LP1 and LP2 MAPs in Quiet	Speech perception in quiet was measured for each MAP using recorded CNC monosyllabic words. The goal of speech perception assessment in quiet was to compare % words correct for each MAP. The minimum score is 0% and maximum sore is 100%. A higher score means a better outcome. An average CNC word score for each MAP was calculated by combining the data from the specified timepoints.	10 participants completed the test at Week 4, 10 participants completed the test at Week 8
Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP2 MAPs in Noise	Speech perception in noise was measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses recorded BKB-like target sentences. The goal of the speech perception test in noise is to provide the Speech Reception Threshold (SRT) in dB for 50% speech intelligibility (dB SRT) There is no minimum score. The maximum score is 15 dB. A lower score means a better outcome. An average SRT score for each MAP was calculated by combining the data from the specified timepoints.	10 participants completed this test at Week 4, and 10 participants completed this at week 8
Paired Mean Difference Score in Percentage CNC Words Correct Between LP1 and LP3 MAPs in Quiet	Speech perception in quiet was measured for each MAP using recorded CNC monosyllabic words. The goal of speech perception assessment in quiet was to compare % words correct for each of the conditions. The minimum score is 0% and maximum sore is 100%. A higher score means a better outcome. An average CNC word score for each MAP was calculated by combining the data from the specified timepoints.	10 participants completed this test at Week 4, and 10 participants completed this at week 8
Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP3 MAPs in Noise	Speech perception in noise was measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses recorded BKB-like target sentences. The goal of the speech perception test in noise is to provide the Speech Reception Threshold (SRT) in dB for 50% speech intelligibility (dB SRT) There is no minimum score. The maximum score is 15 dB. A lower score means a better outcome. An average SRT score for each MAP was calculated by combining the data from the specified timepoints.	10 participants completed this test with at Week 4 and 10 participants completed this at week 8
Switching Acceptability Rating Between LP2 and LP3 MAPs	Participants rated the sound quality when switching between the LP2 and LP3 MAPs with the investigator asking the question: How does the sound quality of the new program compare with the previous program in terms of sound quality? The possible responses being "very different, somewhat different, similar, or the same". The number of participants in each category will be reported.	10 participants were evaluated at week 4 and 10 participants were evaluated at week 8

Collaborators and Investigators

• Sponsor: Cochlear
• Collaborators: Avania
• Investigators: Principal Investigator: Esti Nel, Cochlear

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2024
• Primary Completion (Actual): December 16, 2024
• Study Completion (Actual): December 16, 2024

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Cochlear implant; Sensorineural hearing loss; Speech perception; Programming
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Loss; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss, Sensorineural
• Other Study ID Numbers: CLTD5853

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No