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

NCT05866770 | Active Not Recruiting

• 1 other identifier: AI5837
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

U8 then N8

OTHER

Participants in this arm receive U8 followed by N8

Device: U8; Device: N8 sound processor

N8 then U8

OTHER

Participants in this arm receive N8 followed by U8

Device: U8; Device: N8 sound processor

Interventions

U8 DEVICE

The U8 Research System

N8 then U8; U8 then N8

N8 sound processor DEVICE

Nucleus 8 sound processor

N8 then U8; U8 then N8

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cochlear: lead
• Avania: collaborator

Study Sites (3)

Cochlear Melbourne

Melbourne E., melbourne, 3002, Australia

Location

Cochlear Macquarie

Sydney, New South Wales, 2113, Australia

Location

HEARnet Clinical Studies

Carlton, Victoria, 3053, Australia

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 19, 2023
• Study Start: September 11, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)