NCT07763873

Brief Summary

Auditory implant fitting software is used by hearing healthcare professionals to adjust and optimize hearing implant systems for people with hearing loss. While these software tools are carefully tested before they are released, some challenges may only become apparent when they are used in everyday clinical practice. This research study will assess how well different fitting software technologies work in real-world clinical settings. Information will be collected to better understand how clinicians use the software, identify any usability issues, and find ways to improve the user experience and software design.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
45mo left

Started Oct 2026

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

3.7 years

First QC Date

August 9, 2026

Last Update Submit

August 9, 2026

Conditions

Hearing Impairment

Keywords

hearing implant

Outcome Measures

Primary Outcomes (1)

  • To evaluate clinician task-completion ratings during clinical use of the investigational device under actual-use conditions.

    Proportion of task-completion ratings measured on a 5-point ordinal rating scale. The scale is as follows: 1 Unable to complete, 2 Completed after using help, 3 Completed after trying an incorrect option, 4 Completed after some exploration, 5 Completed at first attempt

    3 months

Study Arms (1)

Investigational Fitting Software and App (Sub A)

EXPERIMENTAL

Investigational Fitting Software and App to be used with a commercially approved sound processor

Device: Investigational Software

Interventions

Investigational SoftwareDEVICE

Next Generation Fitting software and Nucleus Smart App

Investigational Fitting Software and App (Sub A)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Implanted with an auditory implant in one or both ears.
  • Aged 18 years or older.
  • Willing and able to provide written informed consent.
  • Tertiary qualification in a hearing healthcare discipline recognised for auditory implant or hearing aid fitting
  • At least 2 months' experience working with people with hearing impairment.
  • Willingness to participate in and to comply with all requirements of the protocol.

You may not qualify if:

  • Additional disabilities that would prevent participation in evaluations.
  • 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 Cochlear sponsored and determined by Investigator or Sponsor to not impact this investigation).
  • \) Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Denver Research and Technology Lab

Lone Tree, Colorado, 80124, United States

Location

Cochlear Limited

Sydney, New South Wales, 2109, Australia

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2026

First Posted

August 13, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2030

Last Updated

August 13, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)US(1)