Hearing Impairment
Conditions
Keywords
hearing implant
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.
Interventions
DEVICEInvestigational Software
Next Generation Fitting software and Nucleus Smart App
Sponsors
Cochlear
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Australia, United States
Outcome results
None listed