Innovations in Clinical Care of CE Approved Nucleus Cochlear Implant Recipients

Hearing Loss Clinical Trial

Official title:

A Feasibility, Prospective, Repeated-measures Investigation to Investigate Innovations in Clinical Care in Adult and Paediatric Recipients Implanted With CE Approved Nucleus Cochlear Implants: an Umbrella Investigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05270876
• Other study ID #: AI5763
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Hearing Loss

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