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

Launched by COCHLEAR · Jul 11, 2025

Keywords

ClinConnect Summary

This clinical study is looking at a new feature in a research system designed to help program cochlear implants, which are devices that help people with hearing loss hear better. Usually, adjusting a cochlear implant to sound just right takes several visits to a clinic, where a specialist fine-tunes the device based on how loud different sounds seem to the user. This study will test a new mobile app feature that lets experienced cochlear implant users complete part of this loudness testing on their own, making the process faster and easier.

To take part, you need to have used a cochlear implant for at least three months and have a specific model of implant from the CI600 or CI500 series. Participants should be comfortable using the app in the study’s language and able to follow the study steps. During the study, users will complete hearing tests, including rating how loud sounds seem, and share their feedback on the app’s updated feature. This trial is not yet recruiting, but it offers a chance for adults with cochlear implants to help improve how these devices are programmed in the future.

Gender

ALL

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).