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

NCT ID: NCT06894303

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-03

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cochlear Hearing Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Unilateral users

Target CI v1.5 remote programming

Intervention Type DEVICE

Use of the remote programming function of Target CI v1.5 and the AB remote support application

Group 2

Bilateral users

Target CI v1.5 remote programming

Intervention Type DEVICE

Use of the remote programming function of Target CI v1.5 and the AB remote support application

Group 3

Bimodal users

Target CI v1.5 remote programming

Intervention Type DEVICE

Use of the remote programming function of Target CI v1.5 and the AB remote support application

Interventions

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Target CI v1.5 remote programming

Use of the remote programming function of Target CI v1.5 and the AB remote support application

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Clinical presentation indicative of potential implanted device malfunction
* Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the Investigator
* Unwillingness or inability of subject to comply with all investigational requirements as determined by the Investigator
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Advanced Bionics AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Groupement Hospitalier Pitié Salpêtrière

Paris, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Isabelle Mosnier

Role: primary

+33142162606

Other Identifiers

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ABInt-24-23

Identifier Type: -

Identifier Source: org_study_id

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