Comparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant 3 Months Post-activation

Last updated: April 15, 2025
Sponsor: Cochlear
Overall Status: Completed

Phase

N/A

Condition

Hearing Loss

Deafness

Hearing Impairment

Treatment

Categorical loudness scaling based fitting using the Nexus Research System.

Behavioural fitting using Custom Sound Suite (CSS 6.3) Software

Clinical Study ID

NCT05709223
AI5824
  • Ages > 18
  • All Genders

Study Summary

This study aims to collect data in newly implanted cochlear implant-recipients to inform future development of fitting methods to optimally and efficiently program a cochlear implant.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Aged 18 years or older (no upper age limit).

  2. Post-lingually deafened defined as severe or greater sensorineural hearing lossonset after the age of 2 years as reported by the subject

  3. Unilaterally implanted with the CI600 Series (CI612, CI622, CI632) or CI500 series (CI512, CI522, CI532) cochlear implant.

  4. Fluent speaker in the language used to assess speech perception performance, asdetermined by the investigator.

  5. Willingness to participate in and comply with all requirements of the protocol.

  6. Willing and able to provide written informed consent

Exclusion

Exclusion Criteria:

  1. Score below 3 on the screening subset of questions from the Mobile DeviceProficiency Questionnaire.

  2. Subject who will be programmed with an acoustic component in the implanted ear.

  3. Pure tone average (average of unaided thresholds at 0.5, 1, 2 and 4 kHz) less thanor equal to 30 dB HL and aided word score of more than 80% in the contralateral ear.

  4. Diagnosis of auditory neuropathy.

  5. Additional health factors, known to the investigator, that would prevent or restrictparticipation in the evaluations, including significant visual impairment and/ordexterity issues.

  6. Unable or unwilling to comply with the requirements of the clinical investigation asdetermined by the Investigator.

  7. Investigator site personnel directly affiliated with this study and/or theirimmediate families: immediate family is defined as a spouse, parent, child, orsibling.

  8. Cochlear employees or employees of Contract Research Organizations or contractorsengaged by Cochlear for the purposes of this investigation.

  9. Current participation, or participation in another interventional clinicalstudy/trial in the past 30 days, involving an investigational drug or device (unlessthe other investigation was/is a Cochlear sponsored investigation and determined bythe investigator or Sponsor to not impact this investigation). -

Study Design

Total Participants: 17
Treatment Group(s): 2
Primary Treatment: Categorical loudness scaling based fitting using the Nexus Research System.
Phase:
Study Start date:
March 14, 2023
Estimated Completion Date:
February 26, 2025

Study Description

Firstly, it aims to collect data to investigate if the new fitting method gives a good fit of MAP for newly implanted CI-recipients in terms of performance outcomes, compared to the standard streamlined behavioural fitting after 3 months of use. Secondly, it aims to collect data to further refine the new fitting method beyond what is evaluated within this study.

Connect with a study center

  • HEARnet

    Carlton, Victoria 3053
    Australia

    Site Not Available

  • Cochlear Sydney

    Sydney, 2113
    Australia

    Site Not Available

  • Medizinische Hochschuke Hannover (MHH)

    Hannover, 30625
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover (MHH)

    Hannover, 30625
    Germany

    Site Not Available

  • Cochlear Americas

    Lone Tree, Colorado 80124
    United States

    Site Not Available

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