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

NCT07077070 | Completed

• 1 other identifier: AI5862
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 3

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

Keywords

Cochlear implant; Sensorineural hearing loss; loudness scaling

Outcome Measures

Primary Outcomes (4)

• Change in patient reported loudness rating scores for very soft sounds (loudness category 5) between Fast-ELS and Standard-ELS within one on-site session.

  To compare the accuracy of Fast-ELS and Standard-ELS obtained on MRA using a visual analogue scale within one session on-site.

  Day 0, Day 14

• Change in patient reported loudness rating scores for loud sounds (loudness category 35) between Fast-ELS and Standard-ELS within one on-site session.

  To compare the accuracy of Fast-ELS and Standard-ELS obtained on MRA using a visual analogue scale within one session on-site.

  Day 0, Day 14

• Change in patient reported loudness rating scores for very soft sounds (loudness category 5) between Fast-ELS and Standard-ELS within one at home session.

  To compare the accuracy of Fast-ELS and Standard-ELS obtained on MRA using a visual analogue scale within one session at home.

  Day 0 - Day 14

• Change in patient reported loudness rating scores for loud sounds (loudness category 35) between Fast-ELS and Standard-ELS within one at home session.

  To compare the accuracy of Fast-ELS and Standard-ELS obtained on MRA using a visual analogue scale within one session at home.

  Day 0 - Day 14

Secondary Outcomes (8)

• Correlation coefficient of very soft sounds (loudness category 5) obtained with Fast-ELS within one session on-site.

  Day 0, Day 14

• Correlation coefficient of very soft sounds (loudness category 5) obtained with Fast-ELS within one session at home.

  Day 0 - Day 14

• Correlation coefficient of loud sounds (loudness category 35) obtained with Fast-ELS within one session on-site.

  Day 0, Day 14

• Correlation coefficient of loud sounds (loudness category 35) obtained with Fast-ELS within one session at home.

  Day 0 - Day 14

• Correlation coefficient of very soft sounds (loudness category 5) obtained with Fast-ELS obtained during multiple sessions on-site.

  14 days

Study Arms (1)

Experimental: Participants receiving both Standard and Fast ELS task

EXPERIMENTAL

Device: Standard Electrical Categorical Loudness Scaling task (Standard-ELS); Device: Fast Electrical Categorical Loudness Scaling task (Fast-ELS)

Interventions

Fast Electrical Categorical Loudness Scaling task (Fast-ELS) 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.

Experimental: Participants receiving both Standard and Fast ELS task

Standard Electrical Categorical Loudness Scaling task (Standard-ELS) 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.

Experimental: Participants receiving both Standard and Fast ELS task

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cochlear: lead

Study Sites (3)

Cochlear Denver Research Centre

Lone Tree, Colorado, 80124, United States

Location

Cochlear Technology Centre Belgium

Mechelen, Mechelen, B-2800, Belgium

Location

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

Antwerp, 2610, Belgium

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; 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 Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: July 22, 2025
• Study Start: October 21, 2025
• Primary Completion: December 24, 2025
• Study Completion: December 24, 2025
• Last Updated: January 8, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); BE (2)