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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Colorado
Cochlear Denver Research Centre
RECRUITING
Lone Tree
Other Locations
Belgium
European Institute for Otorhinolaryngology (EIORL), ENT Department, Sint-Augustinus Antwerp
RECRUITING
Antwerp
Cochlear Technology Centre Belgium
NOT_YET_RECRUITING
Mechelen
Contact Information
Primary
PRS Specialist
cltd-prs-admin@cochlear.com
+61294286555
Time Frame
Start Date: 2025-09
Estimated Completion Date: 2025-12
Participants
Target number of participants: 20
Treatments
Experimental: Experimental: Participants receiving both Standard and Fast ELS task
Related Therapeutic Areas
Sponsors
Leads: Cochlear

This content was sourced from clinicaltrials.gov