A Study Examining Acceptability of Auditory Implant Fitting Software Technologies

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cochlear Limited, Sydney, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Recipient-Participant

Implanted with an auditory implant in one or both ears.
Aged 18 years or older.
Willing and able to provide written informed consent.

Inclusion criteria

Clinician-Participant

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.

Exclusion criteria

Recipient-Participant

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).

Exclusion criteria

Clinician-Participant

Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.

Treatment and study plan

Investigational software

Device

Next Generation Fitting software and Nucleus Smart App

Primary outcomes

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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Official study title

A Pre-Market, Multicentre, Prospective, Open-Label, Within-Subject, Non-Randomised, Interventional Study Examining Acceptability of Auditory Implant Fitting Software Technologies

Acronym: SUNRISE-MU

Important dates

Study start: 2026
Primary completion: 2030
Study completion: 2030
First posted: Aug 13, 2026
Registry last updated: Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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