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Clinical Trials in the USA / NCT07763873
Starting soon Not applicable

A Study Examining Acceptability of Auditory Implant Fitting Software Technologies

NCT07763873 · tracked via the Priya Life Science USA tracker
Sponsor
Cochlear
Phase
Not applicable
Started
2026-10
Last updated
2026-08-13

Condition(s) studied

Hearing Impairment

Investigational drug(s) / intervention(s)

Investigational Software

Investigational Software: Next Generation Fitting software and Nucleus Smart App

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Recipient-Participant 1. Implanted with an auditory implant in one or both ears. 2. Aged 18 years or older. 3. Willing and able to provide written informed consent. Inclusion Criteria: Clinician-Participant 1. Tertiary qualification in a hearing healthcare discipline recognised for auditory implant or hearing aid fitting 2. At least 2 months' experience working with people with hearing impairment. 3. Willingness to participate in and to comply with all requirements of the protocol. Exclusion Criteria: Recipient-Participant 1. Additional disabilities that would prevent participation in evaluations. 2. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator. 3. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. 4. Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation. 5. 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). Exclusion Criteria: Clinician-Participant 1\) Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.

Primary outcome measure(s)

  • To evaluate clinician task-completion ratings during clinical use of the investigational device under actual-use conditions. — 3 months
    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

Trial sites (2)

FacilityCityRegionStatus
Denver Research and Technology Lab Lone Tree Colorado
Cochlear Limited Sydney New South Wales

More Cochlear trials in the USA

An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App Active, not recruiting
Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array Recruiting
Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness Active, not recruiting
Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population Active, not recruiting
A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07763873 on ClinicalTrials.gov ↗ ← All trials in the USA