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

NCT06894303 | Recruiting

• 1 other identifier: ABInt-24-23
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 50% SRT measured as signal to noise ratio in DB (French Matrix test in noise)

  The primary efficacy objective is to demonstrate that speech recognition in noise after remote fitting is no worse than speech recognition in noise after in-office fitting.

  one-month chronic use of remotely fitted sound processor

Secondary Outcomes (1)

• Score in the Lafon phoneme test in quiet

  one-month chronic use of remotely fitted sound processor

Study Arms (3)

Group 1

Unilateral users

Device: Target CI v1.5 remote programming

Group 2

Bilateral users

Device: Target CI v1.5 remote programming

Group 3

Bimodal users

Device: Target CI v1.5 remote programming

Interventions

Target CI v1.5 remote programming DEVICE

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

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Advanced Bionics adults CI users

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Advanced Bionics AG: lead

Study Sites (1)

Groupement Hospitalier Pitié Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 25, 2025
• Study Start: February 3, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

FR (1)