RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Feasibility, Prospective, Repeated-measures, Within-subject, Interventional Study Investigating the Electrical Categorical Loudness Scaling Using the Mobile Research App in the Home and In-clinic Situation in Experienced Adult Cochlear Implant Participants

Quick Facts

Study Start:2025-09
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07077070

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least three months of experience with the cochlear implant.
  2. * Implanted with the CI600 series (CI612, CI622, CI632) or CI500 series (CI512, CI522, CI532) cochlear implant.
  3. * 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.
  4. * Fluent speaker in the language used to conduct the study procedures, as determined by the investigator.
  5. * Willing and able to provide written informed consent and to comply with all requirements of the protocol.
  1. * Participants programmed with an acoustic component in the tested ear.
  2. * Additional health factors, known to the investigator, that would prevent or restrict participation in the evaluations, including significant visual impairment and/or dexterity issues.
  3. * Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
  4. * Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
  5. * Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
  6. * 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).

Contacts and Locations

Study Contact

PRS Specialist
CONTACT
+61294286555
cltd-prs-admin@cochlear.com

Principal Investigator

Anke Plasmans
STUDY_DIRECTOR
Cochlear Limited

Study Locations (Sites)

Cochlear Denver Research Centre
Lone Tree, Colorado, 80124
United States

Collaborators and Investigators

Sponsor: Cochlear

  • Anke Plasmans, STUDY_DIRECTOR, Cochlear Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09
Study Completion Date2025-12

Study Record Updates

Study Start Date2025-09
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Cochlear implant
  • Sensorineural hearing loss
  • loudness scaling

Additional Relevant MeSH Terms

  • Hearing Loss, Sensorineural