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NCT Number: NCT05476328

Sound Processing Innovations in Adult and Paediatric Cochlear Implant Recipients.

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.

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Key information

Conditions

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

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HEARnet Clinical Studies, Carlton, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Spread Precompensation Advanced Combination Encoder

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.

ACE

Device

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

Other names: Advanced Combination Encoder

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.

Primary outcomes

  1. Monosyllabic Word in Quiet Scores.

    Time frame: One Day

    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

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Collaborators

  • Avania
  • Trium Clinical Consulting

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 27, 2022
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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