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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupement Hospitalier Pitié Salpêtrière

Paris, 75013, France

Location status: Recruiting

Location contact

Isabelle Mosnier

CONTACT

[email protected]

+33142162606

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Pregnancy and breast-feeding are not exclusion criteria.

Treatment and study plan

Target CI v1.5 remote programming

Device

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

Primary outcomes

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

Time frame: one-month chronic use of remotely fitted sound processor

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.

Secondary outcomes

Score in the Lafon phoneme test in quiet

Time frame: one-month chronic use of remotely fitted sound processor

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

Sponsors and collaborators

Lead sponsor

Advanced Bionics AG

Industry

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Mar 25, 2025
Registry last updated: May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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