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

Advanced Bionics

Status: Enrolling

Conditions: Cochlear Hearing Loss

Treatments: Device: Target CI v1.5 remote programming

Study type: Observational

Funder types: Industry

Identifiers

NCT06894303

ABInt-24-23

Details and patient eligibility

About

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.

Enrollment: 51 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

51 participants in 3 patient groups

Group 1

Description:

Unilateral users

Treatment:

Device: Target CI v1.5 remote programming

Group 2

Description:

Bilateral users

Treatment:

Device: Target CI v1.5 remote programming

Group 3

Description:

Bimodal users

Treatment:

Device: Target CI v1.5 remote programming