Sound Processing Innovations in Adult and Paediatric Cochlear Implant Recipients.

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.

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: SPACE; Device: OPAL-SPACE; Device: ACE; Device: Cochlear Device Interface (CDI) Tool

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • East Melbourne, Australia, 3002
    • Cochlear Ltd. Melbourne
  • Victoria
    • Carlton, Victoria, Australia, 3052
      • HEARnet Clinical Studies
• Belgium
  • Brugge, Belgium, 8000
    • AZ Sint-Jan Brugge-Oostende AV
  • Mechelen, Belgium, 2800
    • Cochlear Technology Centre Belgium
  • Wilrijk, Belgium, 2610
    • Sint-Augustinus Antwerpen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: All Participants; Advanced Combination Encoder (ACE) sound processing strategy (reference strategy), Spread Precompensation Advanced Combination Encoder (SPACE), and Optimised Pitch and Language strategy-SPACE (OPAL-SPACE; combined OPAL and SPACE strategy) were evaluated in adult cochlear implant recipients. The evaluation order of sound strategies was counterbalanced. All strategies were programmed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool).

Device: SPACE; SPACE (Spread Precompensation Advanced Combination Encoder) is a sound coding strategy that is intended to improve spectral resolution, and hence hypothesised to improve cochlear implant (CI) speech understanding in noise. It is an alternative to the ACE sound coding strategy. It has been implemented on the Nucleus 7 CP1000 sound processor for CIC4-based implants.; Other Names: Spread Precompensation Advanced Combination Encoder; Device: OPAL-SPACE; OPAL-SPACE (combined OPAL and SPACE strategy) aims to preserve as many of the significant features encoded by both OPAL and SPACE strategies individually. Since SPACE codes spectral envelope information, while OPAL codes temporal periodicity information, it is reasonable to suggest that both coding techniques can be combined to improve perception additively.; Device: ACE; Advanced Combination Encoder (ACE) is the commercially available, reference sound processing strategy.; Other Names: Advanced Combination Encoder; Device: Cochlear Device Interface (CDI) Tool; For all strategies, programming will be performed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool). Investigational software will be used to stream stimulation sequences to a commercially available N6 sound processor using the Cochlear NIC4.1 interface.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monosyllabic Word in Quiet Scores.	Monosyllabic word in quiet scores (for conventional Advanced Combination Encoders and new sound coding strategy). Resultant score is percentage of words repeated correctly. Possible scores ranges from 0% to 100% correctly repeated. Higher percentage score means better outcome	One Day

Collaborators and Investigators

• Sponsor: Cochlear
• Collaborators: Avania; Trium Clinical Consulting
• Investigators: Study Director: Komal Arora, Cochlear

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2020
• Primary Completion (Actual): March 17, 2023
• Study Completion (Actual): March 17, 2023

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: July 24, 2022
• First Posted (Actual): July 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: AI5762

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No