Investigating Electrical Categorical Loudness Scaling Using a Mobile Research App in Experienced Adult Cochlear Implant Participants

NCT ID: NCT07077070

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-21
• Study Completion Date: 2025-12-24

Brief Summary

This clinical study will evaluate a feature of the investigational Nexus Research System used for programming cochlear implants.

Programming a cochlear implant-commonly referred to as MAP fitting-involves activating the device, allowing recipients to acclimatize to hearing sounds, and then fine-tuning the program based on the user's perception of loudness across different sounds. This process typically occurs over several visits and requires a clinician to collect data for the fine-tuning phase.

The Nexus Research System includes an "Electrical Loudness Scaling" task, which participants can complete independently using a mobile application to collect the necessary data. Based on findings from previous studies, this feature has been revised to enable faster data collection. The current study will assess the performance of the updated feature.

The study will involve experienced cochlear implant users. Participants will use the feature, undergo a series of hearing assessments-including evaluations of loudness perception-and provide feedback on the updated feature.

Conditions

Hearing Loss, Sensorineural

Study Design

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

Study Groups

Experimental: Participants receiving both Standard and Fast ELS task

Group Type: EXPERIMENTAL

Standard Electrical Categorical Loudness Scaling task (Standard-ELS)

Intervention Type: DEVICE

The Standard-ELS task is conducted using the Mobile Research Application within the Nexus Research system. It is completed in two phases: the first phase identifies the lower and upper bounds of the loudness range based on participant ratings, while the second phase collects data from stimulations delivered within the established range.

Fast Electrical Categorical Loudness Scaling task (Fast-ELS)

Intervention Type: DEVICE

The Fast-ELS task employs an algorithm to estimate the lower and upper bounds of the loudness range using a limited number of samples. This range is then refined by collecting additional samples across various loudness categories for comprehensive coverage.

Interventions

Standard Electrical Categorical Loudness Scaling task (Standard-ELS)

The Standard-ELS task is conducted using the Mobile Research Application within the Nexus Research system. It is completed in two phases: the first phase identifies the lower and upper bounds of the loudness range based on participant ratings, while the second phase collects data from stimulations delivered within the established range.

Intervention Type: DEVICE

Fast Electrical Categorical Loudness Scaling task (Fast-ELS)

The Fast-ELS task employs an algorithm to estimate the lower and upper bounds of the loudness range using a limited number of samples. This range is then refined by collecting additional samples across various loudness categories for comprehensive coverage.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• At least three months of experience with the cochlear implant.
• Implanted with the CI600 series (CI612, CI622, CI632) or CI500 series (CI512, CI522, CI532) cochlear implant.
• Able to be programmed with ACE (Advanced Combination Encoder), a fixed pulse width (PW) MAP with a maximum PW of 50 us per channel and with ≥ 18 enabled channels on the sound processor MAP.
• Fluent speaker in the language used to conduct the study procedures, as determined by the investigator.
• Willing and able to provide written informed consent and to comply with all requirements of the protocol.

Exclusion Criteria

• Participants programmed with an acoustic component in the tested ear.
• 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 Cochlear sponsored and determined by investigator or Sponsor to not impact this investigation).

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

Sponsors

Cochlear

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anke Plasmans

Role: STUDY_DIRECTOR

Cochlear Limited

Locations

Cochlear Denver Research Centre

Lone Tree, Colorado, United States

Cochlear Technology Centre Belgium

Mechelen, Mechelen, Belgium

European Institute for Otorhinolaryngology (EIORL), ENT Department, Sint-Augustinus Antwerp

Antwerp, , Belgium

Countries

United States; Belgium

Other Identifiers

AI5862

Identifier Type: -

Identifier Source: org_study_id