Innovations in Clinical Care of CE Approved Nucleus Cochlear Implant Recipients

Cochlear

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique

Study type: Interventional

Funder types: Industry

Identifiers

NCT05270876

AI5763

Details and patient eligibility

About

This study is to evaluate new approaches to device fitting and diagnostics for cochlear implant users. The evaluation can be performed in the laboratory in an acute session or in real world environments with take-home device use to further validate their benefits. Each feature will be tested in a sub-study specific to that hearing care model. On average, each sub-study is expected to include approximately 20 subjects.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Users of a CE approved Nucleus cochlear implant, resulting in open set speech understanding
• At least three months of experience with the cochlear implant.
• Older than 18 years when entering the study.
• Subject is fluent speaker in the language used for assessments.
• Open set speech understanding sufficient to complete the study protocol as judged by the investigator.
• Willing and able to provide written informed consent

Exclusion criteria

• Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
• Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
• 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.
• Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Study cohort

Other group

Description:

Recipients of cochlear implant or suitable for implantation Interrupted time series: recipients received standard and novel fitting method

Treatment:

Device: Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique