Clinical trial NCT05476328: Sound Processing Innovations in Adult and Paediatric Cochlear Implant Recipients.
Official title: A Feasibility, Prospective, Repeated-measures Investigation to Investigate Innovations in Sound Processing in Adult and Paediatric Recipients Implanted With CE Approved Nucleus Cochlear Implants: an Umbrella Investigation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
Collaborators: name: Trium Clinical Consulting
name: Avania
First posted: 2022-07-27
Enrollment: 8
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a feasibility, prospective with sequential enrolment, multicenter, clinical investigation in adults and paediatrics with a CE approved Nucleus cochlear implant.

Subjects older than 5 years will be included. Subjects will be screened and up to 120 eligible subjects will be recruited in the clinical investigation.

Subjects will attend scheduled study visits over a period up to 5 years in different sub-studies as described in the sub-study documentation.

A clinical setting can consist of therapeutic elements and evaluations. Subjects will be assessed with the commercially available Nucleus sound processor or via the xPC, NIC, etc. if required. Acute testing will be done where possible. Take home use will be applied when learning effects may play a significant role and to evaluate the acceptance of the new or improved sound coding algorithm or signal processing, in as many listening environments as possible. The subject might also be asked to complete questionnaires, to perform at-home tests etc. during this take home use and/or at the clinical visits. The time for a clinical visit will be limited to a maximum of 4 hours. The time in between clinical visits will vary with typical spacing of between 0 (acute) to 4 weeks.

The goals of this umbrella investigation are to measure hearing outcomes to assess performance and/or to achieve higher convenience for implant users and hearing care professionals. The outcomes of the study will guide Cochlear to select features for inclusion in future Nucleus cochlear implant systems and/or future models of care.


Eligibility criteria: Inclusion Criteria:

* Users of a CE approved Nucleus cochlear implant, resulting in open set speech understanding.
* Paediatrics: Older than 5 years 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 Organisations 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.

Primary outcomes:
measure: Monosyllabic Word in Quiet Scores.
timeFrame: One Day
Secondary outcomes:
Other outcomes:
Locations:
city: Carlton
country: Australia
facility: HEARnet Clinical Studies
state: Victoria
city: East Melbourne
country: Australia
facility: Cochlear Ltd. Melbourne
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende AV
city: Mechelen
country: Belgium
facility: Cochlear Technology Centre Belgium
city: Wilrijk
country: Belgium
facility: Sint-Augustinus Antwerpen
Study officials:
affiliation: Cochlear
name: Komal Arora
role: STUDY_DIRECTOR
References: