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Completed

NCT Number: NCT06298396

Investigating Stimulation Parameter and 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cochlear Macquarie

Macquarie Park, New South Wales, 2109, Australia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Program using default MAP

Device

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

Program using low-power 1 (LP1) MAP

Device

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

Program using low-power 2 (LP2) MAP

Device

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

Program using low-power 3 (LP3) MAP

Device

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

Primary outcomes

  1. Paired Mean Difference Score for CNC Words Correct Between Default and LP1 MAPs in Quiet

    Time frame: 10 participants completed this test at Week 4, and 10 participants completed this at week 8

    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.

  2. Paired Mean Difference Score in dB SRT (AuSTIN) Between Default and LP1 MAPs in Noise

    Time frame: 10 participants completed the test at Week 4, 10 participants completed the test at Week 8

    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.

Secondary outcomes

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

    Time frame: 10 participants completed the test at Week 4, 10 participants completed the test at Week 8

    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.

  2. Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP2 MAPs in Noise

    Time frame: 10 participants completed this test at Week 4, and 10 participants completed this at week 8

    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.

  3. Paired Mean Difference Score in Percentage CNC Words Correct Between LP1 and LP3 MAPs in Quiet

    Time frame: 10 participants completed this test at Week 4, and 10 participants completed this at week 8

    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.

  4. Paired Mean Difference Score in dB SRT (AuSTIN) Between LP1 and LP3 MAPs in Noise

    Time frame: 10 participants completed this test with at Week 4 and 10 participants completed this at week 8

    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.

  5. Switching Acceptability Rating Between LP2 and LP3 MAPs

    Time frame: 10 participants were evaluated at week 4 and 10 participants were evaluated at week 8

    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.

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Collaborators

  • Avania

Registry information

Official study title

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

Acronym: DUAL

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 7, 2024
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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