A Study Evaluating the Application of Hearing Aid Technologies to Signal Processing for Adult Cochlear Implant Recipients

NCT ID: NCT05866770

Last Updated: 2025-05-22

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-11

Study Completion Date

2026-06-30

Brief Summary

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A feasibility, prospective, multi-centre, repeated measures investigation evaluating the application of hearing aid technologies to signal processing for adult cochlear implant recipients

Detailed Description

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The Research System is comprised of several components: the processing unit, fitting software and accessories. The sound processor converts sounds into electrical signals, which it sends, via a coil, to an implant to provide hearing sensation. The application of hearing aid technologies to Cochlear Implant recipients may provide benefit through matching the signal processing technologies across ears for bimodal listeners, enhance performance for CI-alone listening, and potentially lead to efficiency in algorithm development.

Conditions

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Hearing Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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U8 then N8

Participants in this arm receive U8 followed by N8

Group Type OTHER

U8

Intervention Type DEVICE

The U8 Research System

N8 sound processor

Intervention Type DEVICE

Nucleus 8 sound processor

N8 then U8

Participants in this arm receive N8 followed by U8

Group Type OTHER

U8

Intervention Type DEVICE

The U8 Research System

N8 sound processor

Intervention Type DEVICE

Nucleus 8 sound processor

Interventions

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U8

The U8 Research System

Intervention Type DEVICE

N8 sound processor

Nucleus 8 sound processor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Eighteen years of age or older
* User of CI600, CI500 or CI24RE implant
* At least 3 months experience with a TGA approved Nucleus cochlear implant in at least one ear
* Fluent speaker of English
* A word speech recognition score of 20% or more when using the cochlear implant alone\*
* Willing and able to provide written informed consent \*This can be based on clinical data if collected within the last 12 months

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 Organizations 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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Avania

INDUSTRY

Sponsor Role collaborator

Cochlear

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cochlear Melbourne

Melbourne E., melbourne, Australia

Site Status

Cochlear Macquarie

Sydney, New South Wales, Australia

Site Status

HEARnet Clinical Studies

Carlton, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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AI5837

Identifier Type: -

Identifier Source: org_study_id

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