Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

This is a prospective and monocentric clinical investigation, non-interventional and non-randomized. The overall goal of this clinical study is to generate additional clinical data confirming the safety and efficacy of the remote programming functionality of Target CI version 1.5 and the AB Remote Support app. Hearing outcomes are expected to be similar whether a study subject's sound processor is programmed in the traditional method in the audiologist's office or whether programming is performed via remote fitting. Therefore, the study uses a non-inferiority design to determine whether sentence recognition in noise is no worse with remote fitting than in an in-office setting.

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

• Ability to provide informed consent

• Ability to give feedback on hearing impressions

• Aged 18 years of age or older

• Implanted with a HiResolution Bionic Ear System (HiRes 90K or HiRes 90K Advantage or HiRes Ultra or HiRes Ultra 3D) on at least one side

‣ Group 1 - Unilateral: no hearing device except contralateral routing of signals (CROS) device on the contralateral side

⁃ Group 2 - Bilateral: implanted on both sides

⁃ Group 3 - Bimodal: hearing aid on the contralateral side

• Minimum of six months of cochlear implant experience

• Minimum of one month experience with a Naída CI M or Sky CI M sound processor

• Fluent in French language

• Ability to be tested via speech perception test in noise

• Smartphone user

Locations
Other Locations
France
Groupement Hospitalier Pitié Salpêtrière
RECRUITING
Paris
Time Frame
Start Date: 2025-02-03
Estimated Completion Date: 2026-12
Participants
Target number of participants: 51
Treatments
Group 1
Unilateral users
Group 2
Bilateral users
Group 3
Bimodal users
Related Therapeutic Areas
Sponsors
Leads: Advanced Bionics AG

This content was sourced from clinicaltrials.gov