Investigating Stimulation Parameter and Electrode Mode Changes on Speech Perception in Experienced Adult Cochlear Implant Recipients
NCT ID: NCT06298396
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2024-05-27
2024-12-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Program using default MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.
Program using low-power 1 (LP1) MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.
Program using low-power 2 (LP2) MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.
Program using low-power 3 (LP3) MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.
Interventions
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Program using default MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.
Program using low-power 1 (LP1) MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.
Program using low-power 2 (LP2) MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.
Program using low-power 3 (LP3) MAP
Each MAP uses a specific combination of stimulation parameters and electrode mode.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Avania
INDUSTRY
Cochlear
INDUSTRY
Responsible Party
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Principal Investigators
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Esti Nel
Role: PRINCIPAL_INVESTIGATOR
Cochlear
Locations
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Cochlear Macquarie
Macquarie Park, New South Wales, Australia
Countries
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Other Identifiers
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CLTD5853
Identifier Type: -
Identifier Source: org_study_id