NCT06894303

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 51 (estimated)
• Sponsor: Advanced Bionics AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cochlear Hearing Loss

Interventions

Type	Name	Description
DEVICE	Target CI v1.5 remote programming	Use of the remote programming function of Target CI v1.5 and the AB remote support application

Timeline

• Start date: 2025-02-03
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-03-25
• Last updated: 2025-03-25

Locations

1 site across 1 country: France