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

Not Applicable

Completed

• Conditions: Hearing Loss, Sensorineural
• Interventions: 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

• Registration Number: NCT06298396
• Lead Sponsor: Cochlear

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-03-05
• Study First Posted: 2024-03-07
• Study Start: 2024-05-27
• Status Verified: 2024-12
• Primary Completion: 2024-12-16
• Study Completion: 2024-12-16
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MAPs on Cochlear™ Nucleus® 7, Nucleus® 8 and Kanso® 2 Sound Processors	Program using default MAP	Participants will receive four different MAPs to use during two take-home periods and will then complete hearing assessments using each MAP.
MAPs on Cochlear™ Nucleus® 7, Nucleus® 8 and Kanso® 2 Sound Processors	Program using low-power 1 (LP1) MAP	Participants will receive four different MAPs to use during two take-home periods and will then complete hearing assessments using each MAP.
MAPs on Cochlear™ Nucleus® 7, Nucleus® 8 and Kanso® 2 Sound Processors	Program using low-power 3 (LP3) MAP	Participants will receive four different MAPs to use during two take-home periods and will then complete hearing assessments using each MAP.
MAPs on Cochlear™ Nucleus® 7, Nucleus® 8 and Kanso® 2 Sound Processors	Program using low-power 2 (LP2) MAP	Participants will receive four different MAPs to use during two take-home periods and will then complete hearing assessments using each MAP.

Primary Outcome Measures

Name	Time	Method
Paired difference in dB SRT (AuSTIN) between default and LP1 MAPs in noise	week 4 and week 8	Speech perception in noise will be 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 SNR for 50% speech intelligibility.
Paired difference in percentage CNC words correct between default and LP1 MAPs in quiet setting	week 4 and week 8	Speech perception in quiet will be measured using recorded CNC monosyllabic words at 60 dB SPL from S0 position to emulate conversational levels. The goal of speech perception assessment in quiet is to compare % words correct for each of the conditions.

Secondary Outcome Measures

Name	Time	Method
Paired difference in percentage CNC words correct between LP1 and LP3 MAPs in quiet setting	week 4 and week 8	Speech perception in quiet will be measured using recorded CNC monosyllabic words at 60 dB SPL from S0 position to emulate conversational levels. The goal of speech perception assessment in quiet is to compare % words correct for each of the conditions.
Paired difference in dB SRT (AuSTIN) between LP1 and LP2 MAPs in noise	week 4 and week 8	Speech perception in noise will be 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 SNR for 50% speech intelligibility.
Paired difference in percentage CNC words correct between LP1 MAP and LP2 MAP in quiet setting	week 4 and week 8	Speech perception in quiet will be measured using recorded CNC monosyllabic words at 60 dB SPL from S0 position to emulate conversational levels. The goal of speech perception assessment in quiet is to compare % words correct for each of the conditions.

Trial Locations

Locations (1)

Cochlear Macquarie; 🇦🇺 Macquarie Park, New South Wales, Australia