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

NCT05709223 | Completed

• 1 other identifier: AI5824
• Study Type: interventional
• Target: 17
• Locations: 3 countries
• Sites: 4

Brief 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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (2)

• Change in Percentage of correct monosyllabic word scores in quiet (S0) at 50 dB SPL

  To determine whether the Loudness Target (LT) MAP provides non-inferior speech understanding in quiet compared to the Behavioural MAP. Percentage of correct monosyllabic word scores in quiet (S0) at 50 dB SPL averaged across the sessions at visit 4 and visit 5. Higher the score better the outcome.

  2 days(In booth testing)

• Change in Adaptive sentence in noise scores (S0N0 test setup)

  To determine whether the Loudness Target (LT) MAP provides non-inferior speech understanding in noise compared to the Behavioural MAP. Adaptive sentence in noise scores (S0N0 test setup) averaged across the sessions at visit 4 and visit 5.

  2 days (In booth testing)

Secondary Outcomes (3)

• Speech, Spatial and Qualities of Hearing Scale (SSQ12) ratings

  4 weeks

• Percentage correct monosyllabic word scores in quiet (S0) at 60 dB SPL

  One day (in booth testing)

• Adaptive Digit Triplet Test (DTT) in noise scores

  One day (in clinic testing)

Study Arms (1)

Participants receiving both Categorical Loudness Scaling Based Fitting and behavioural fitting.

EXPERIMENTAL

Participants will receive a categorical loudness scaling based fitting (Interventional) and behavioural fitting with 4 weeks experience of both MAPS

Device: Categorical loudness scaling based fitting using the Nexus Research System.; Device: Behavioural fitting using Custom Sound Suite (CSS 6.3) Software

Interventions

Categorical loudness scaling based fitting using the Nexus Research System. DEVICE

The Nexus Research system is used in combination with other devices as part of a hearing implant system. It is intended to create and modify hearing profiles, to monitor the performance of the system and to facilitate Firmware updates of the system. It is also intended to be used with other devices of a hearing implant system to make volume adjustments to the processing unit, to download pre-defined MAPs and to collect data from tests and questionnaires using a compatible device.

Also known as: The Nexus Research System.

Participants receiving both Categorical Loudness Scaling Based Fitting and behavioural fitting.

Behavioural fitting using Custom Sound Suite (CSS 6.3) Software DEVICE

The comparator is the commercially available fitting method (i.e., the behavioural measurement of active channels) using Custom Sound Suite (CSS 6.3) software

Participants receiving both Categorical Loudness Scaling Based Fitting and behavioural fitting.

Eligibility Criteria

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

You may qualify if:

• Aged 18 years or older (no upper age limit).
• Post-lingually deafened defined as severe or greater sensorineural hearing loss onset after the age of 2 years as reported by the subject
• Unilaterally implanted with the CI600 Series (CI612, CI622, CI632) or CI500 series (CI512, CI522, CI532) cochlear implant.
• Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
• Willingness to participate in and comply with all requirements of the protocol.
• Willing and able to provide written informed consent

You may not qualify if:

• Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire.
• Subject who will be programmed with an acoustic component in the implanted ear.
• Pure tone average (average of unaided thresholds at 0.5, 1, 2 and 4 kHz) less than or equal to 30 dB HL and aided word score of more than 80% in the contralateral ear.
• Diagnosis of auditory neuropathy.
• Additional health factors, known to the investigator, that would prevent or restrict participation in the evaluations, including significant visual impairment and/or dexterity issues.
• 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). -

Sponsors & Collaborators

• Cochlear: lead
• QbD Clinical: collaborator
• Avania: collaborator

Study Sites (4)

Cochlear Americas

Lone Tree, Colorado, 80124, United States

Location

Cochlear Sydney

Sydney, Sydney, 2113, Australia

Location

HEARnet

Carlton, Victoria, 3053, Australia

Location

Medizinische Hochschule Hannover (MHH)

Hanover, Hannover, 30625, Germany

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Anke Plasmans

  Cochlear

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants are blinded to the order of fitting method. Some participants will use first the Behavioural program followed by the investigational program while the other group will use each of these conditions in the opposite order.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: February 2, 2023
• Study Start: March 14, 2023
• Primary Completion: February 26, 2025
• Study Completion: February 26, 2025
• Last Updated: April 17, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); DE (1); US (1)