An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients

NCT ID: NCT06867380

Last Updated: 2025-05-28

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-31

Study Completion Date

2030-04-30

Brief Summary

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This study will evaluate a range of experimental sound coding strategies that may improve hearing for cochlear implant recipients.

Detailed Description

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Conditions

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Cochlear Implant Recipients Hearing Loss, Cochlear

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Investigational sound coding strategy and default sound coding comparator is blinded to the participant

Study Groups

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Investigational sound coding strategy/Default sound coding strategy (Sub A)

Tested with investigational and default sound coding strategies

Group Type EXPERIMENTAL

Investigational sound coding strategy

Intervention Type DEVICE

SPARC (Stimulation Place and Rate Coding) sound coding strategies

Cochlear default sound coding strategy

Intervention Type DEVICE

ACE (Advanced Combination Encoder) sound coding strategy

Interventions

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Investigational sound coding strategy

SPARC (Stimulation Place and Rate Coding) sound coding strategies

Intervention Type DEVICE

Cochlear default sound coding strategy

ACE (Advanced Combination Encoder) sound coding strategy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Users of an approved Nucleus cochlear implant.
* Aged 18 years or older (no upper age limit).
* Open set speech understanding sufficient to complete the study protocol as judged by the investigator.
* Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
* 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.
* Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
* 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cochlear

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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HEARnet Clinical studies

Carlton, Victoria, Australia

Site Status

Cochlear Melbourne

East Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Central Contacts

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Linty McDonald

Role: CONTACT

+61 456552543

Facility Contacts

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Karyn Galvin

Role: primary

Linty McDonald

Role: primary

+61 456552543

Other Identifiers

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AI5838

Identifier Type: -

Identifier Source: org_study_id

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