Sound Processing Innovations in Adult and Paediatric Cochlear Implant Recipients.

NCT05476328 | Completed Results

• 1 other identifier: AI5762
• Study Type: interventional
• Target: 8
• Locations: 2 countries
• Sites: 5

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

All Participants

OTHER

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; Device: OPAL-SPACE; Device: ACE; Device: Cochlear Device Interface (CDI) Tool

Interventions

SPACE DEVICE

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.

Also known as: Spread Precompensation Advanced Combination Encoder

All Participants

OPAL-SPACE DEVICE

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.

All Participants

ACE DEVICE

Advanced Combination Encoder (ACE) is the commercially available, reference sound processing strategy.

Also known as: Advanced Combination Encoder

All Participants

Cochlear Device Interface (CDI) Tool DEVICE

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.

All Participants

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cochlear: lead
• Trium Clinical Consulting: collaborator
• Avania: collaborator

Study Sites (5)

HEARnet Clinical Studies

Carlton, Victoria, 3052, Australia

Location

Cochlear Ltd. Melbourne

East Melbourne, 3002, Australia

Location

AZ Sint-Jan Brugge-Oostende AV

Bruges, 8000, Belgium

Location

Cochlear Technology Centre Belgium

Mechelen, 2800, Belgium

Location

Sint-Augustinus Antwerpen

Wilrijk, 2610, Belgium

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: PRS Specialist
• Organization: Cochlear

cltd-prs-admin@cochlear.com

+61 2 9428 6555

Study Officials

• Komal Arora

  Cochlear

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 27, 2022
• Study Start: January 22, 2020
• Primary Completion: March 17, 2023
• Study Completion: March 17, 2023
• Last Updated: February 13, 2025
• Results First Posted: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); BE (3)