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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05270876
Other study ID # AI5763
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 19, 2020
Est. completion date March 6, 2023

Study information

Verified date February 2024
Source Cochlear
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 6, 2023
Est. primary completion date March 6, 2023
Accepts healthy volunteers No
Gender All
Age group 10 Months and older
Eligibility Inclusion Criteria: - Group 1 subjects: Users of a CE approved Nucleus cochlear implant, resulting in open set speech understanding or Group 2 subjects: Subjects assessed by their CI clinic to be suitable for implantation with a commercially available CE approved Nucleus cochlear implant. - Paediatrics: Older than 10 months and <18 years when entering the study (Belgium only) or Adults: =18 years when entering the study (Belgium and Australia) - Subject/legally designated representative is fluent speaker in the language used for assessments. - Willing and able to provide written informed consent (for paediatric populations this criterion applies to the parent/legally designated representative). 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique
Experimental: The investigational device will be a new device fitting paradigm or diagnostic/measurement technique implemented for use with the commercially available sound processor and implant.
Standard of care fitting or diagnostic measurement of Cochlear Implant and sound processor
The comparator will be the standard of care fitting or diagnostic or measurement approach.

Locations

Country Name City State
Australia HEARnet Clinical Studies - The University of Melbourne Carlton Victoria
Australia Cochlear Ltd. Melbourne East Melbourne Victoria
Belgium AZ Sint-Jan Brugge-Oostende AV Brugge België
Belgium Cochlear Technology Centre Belgium Mechelen
Belgium Sint-Augustinus Antwerpen Wilrijk België

Sponsors (1)

Lead Sponsor Collaborator
Cochlear

Countries where clinical trial is conducted

Australia,  Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean difference between standard and novel fitting method for monosyllabic word scores in quiet Percent correct word scores 0 to 4 weeks after fitting
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