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

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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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-09-11

Primary completion: 2026-06-30

Study completion finish: 2026-06-30

Study type

OTHER

Phase

Trial ID

NCT05866770

Intervention or treatment

DEVICE: U8

DEVICE: N8 sound processor

Conditions

• Hearing Loss

Condition: Hearing Loss
DEVICE: U8 and other drugs
Melbourne E., Melbourne, Australia and more
Sponsor: Cochlear

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Cochlear Melbourne

Research sites nearby

Select from list below to view details:

Cochlear Melbourne
Melbourne E., Melbourne, Australia
Cochlear Macquarie
Sydney, New South Wales, Australia
HEARnet Clinical Studies
Carlton, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
OTHER: U8 then N8 Participants in this arm receive U8 followed by N8	DEVICE: U8 The U8 Research System
OTHER: N8 then U8 Participants in this arm receive N8 followed by U8	DEVICE: U8 The U8 Research System

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Percent correct monosyllabic word scores.	To determine whether the research system provides non-inferior performance to the Nucleus 8 sound processor for monosyllabic words in quiet CNC words at 60 dB SPL (sound pressure level) Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome.	3 months
Adaptive sentence in noise scores (AuSTIN)	To determine whether the research system provides non-inferior performance to the Nucleus 8 sound processor for sentences in noise.	3 months

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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