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

NCT ID: NCT05709223

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-14
• Study Completion Date: 2025-02-26

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.

Detailed 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.

Conditions

Hearing Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

Categorical loudness scaling based fitting using the Nexus Research System.

Intervention Type: 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.

Behavioural fitting using Custom Sound Suite (CSS 6.3) Software

Intervention Type: 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

Interventions

Categorical loudness scaling based fitting using the Nexus Research System.

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.

Intervention Type: DEVICE

Behavioural fitting using Custom Sound Suite (CSS 6.3) Software

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

Intervention Type: DEVICE

Other Intervention Names

The Nexus Research System.

Eligibility Criteria

Inclusion Criteria

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

2. Post-lingually deafened defined as severe or greater sensorineural hearing loss onset 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, as determined 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 Criteria

1. Score below 3 on the screening subset of questions from the Mobile Device Proficiency 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 than or 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 restrict participation in the evaluations, including significant visual impairment and/or dexterity issues.

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

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

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

9. 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). -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

QbD Clinical

INDUSTRY

Sponsor Role: collaborator

Avania

INDUSTRY

Sponsor Role: collaborator

Cochlear

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anke Plasmans

Role: STUDY_DIRECTOR

Cochlear

Locations

Cochlear Americas

Lone Tree, Colorado, United States

Cochlear Sydney

Sydney, Sydney, Australia

HEARnet

Carlton, Victoria, Australia

Medizinische Hochschule Hannover (MHH)

Hanover, Hannover, Germany

Countries

United States; Australia; Germany

Other Identifiers

AI5824

Identifier Type: -

Identifier Source: org_study_id