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OpenTrials
Active, Not Recruiting

NCT Number: NCT05866770

A Study Evaluating the Application of Hearing Aid Technologies to Signal Processing for Adult Cochlear Implant Recipients

A feasibility, prospective, multi-centre, repeated measures investigation evaluating the application of hearing aid technologies to signal processing for adult cochlear implant recipients

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cochlear Macquarie, Sydney, New South Wales, Australia

Loading trial locations.

About this study

The Research System is comprised of several components: the processing unit, fitting software and accessories. The sound processor converts sounds into electrical signals, which it sends, via a coil, to an implant to provide hearing sensation. The application of hearing aid technologies to Cochlear Implant recipients may provide benefit through matching the signal processing technologies across ears for bimodal listeners, enhance performance for CI-alone listening, and potentially lead to efficiency in algorithm development.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Eighteen years of age or older
  • User of CI600, CI500 or CI24RE implant
  • At least 3 months experience with a TGA approved Nucleus cochlear implant in at least one ear
  • Fluent speaker of English
  • A word speech recognition score of 20% or more when using the cochlear implant alone*
  • Willing and able to provide written informed consent *This can be based on clinical data if collected within the last 12 months

Exclusion criteria

  • Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
  • 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.
  • Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device. (Unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation.

Treatment and study plan

U8

Device

The U8 Research System

N8 sound processor

Device

Nucleus 8 sound processor

Primary outcomes

  1. Percent correct monosyllabic word scores.

    Time frame: 3 months

    To determine whether the research system provides non-inferior performance to the Nucleus 8 sound processor for monosyllabic words in quiet CNC words at 60 dB SPL (sound pressure level)

    Word recognition is a score of the number of words correctly repeated, expressed as a percentage. Higher percentage scores indicate a better outcome.

  2. Adaptive sentence in noise scores (AuSTIN)

    Time frame: 3 months

    To determine whether the research system provides non-inferior performance to the Nucleus 8 sound processor for sentences in noise.

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Collaborators

  • Avania

Registry information

Official study title

A Feasibility, Prospective, Multi-centre, Repeated Measures Investigation Evaluating the Application of Hearing Aid Technologies to Signal Processing for Adult Cochlear Implant Recipients

Acronym: HATSI-MB

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 19, 2023
Registry last updated
May 22, 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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