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

NCT06298396 | Completed Results

• 1 other identifier: CLTD5853
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hearing Loss, Sensorineural

Keywords

Cochlear implant; Sensorineural hearing loss; Programming; Speech perception

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Paired Mean Difference Score for CNC Words Correct Between LP1 and LP2 MAPs in Quiet

  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

  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

  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

  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

  10 participants were evaluated at week 4 and 10 participants were evaluated at week 8

Study Arms (1)

MAPs on Cochlear™ Nucleus® 7, Nucleus® 8 and Kanso® 2 Sound Processors

EXPERIMENTAL

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; Device: Program using low-power 1 (LP1) MAP; Device: Program using low-power 2 (LP2) MAP; Device: Program using low-power 3 (LP3) MAP

Interventions

Program using default MAP DEVICE

Each MAP uses a specific combination of stimulation parameters and electrode mode.

MAPs on Cochlear™ Nucleus® 7, Nucleus® 8 and Kanso® 2 Sound Processors

Program using low-power 1 (LP1) MAP DEVICE

Each MAP uses a specific combination of stimulation parameters and electrode mode.

MAPs on Cochlear™ Nucleus® 7, Nucleus® 8 and Kanso® 2 Sound Processors

Program using low-power 2 (LP2) MAP DEVICE

Each MAP uses a specific combination of stimulation parameters and electrode mode.

MAPs on Cochlear™ Nucleus® 7, Nucleus® 8 and Kanso® 2 Sound Processors

Program using low-power 3 (LP3) MAP DEVICE

Each MAP uses a specific combination of stimulation parameters and electrode mode.

MAPs on Cochlear™ Nucleus® 7, Nucleus® 8 and Kanso® 2 Sound Processors

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cochlear: lead
• Avania: collaborator

Study Sites (1)

Cochlear Macquarie

Macquarie Park, New South Wales, 2109, Australia

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: PRS Specialist
• Organization: Cochlear Limited

cltd-prs-admin@cochlear.com

+61 2 9428 6555

Study Officials

• Esti Nel

  Cochlear

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: There is no masking in this study as all participants receive all MAPs (single group study model). The term "single-blinded" in the official title refers to the fact that participants are blinded to the order in which they receive the MAPs.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 7, 2024
• Study Start: May 27, 2024
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: December 17, 2025
• Results First Posted: December 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)