Cochlear Hearing Loss
Conditions
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.
Interventions
DEVICETarget CI v1.5 remote programming
Use of the remote programming function of Target CI v1.5 and the AB remote support application
Sponsors
Advanced Bionics AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 50% SRT measured as signal to noise ratio in DB (French Matrix test in noise) | 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
| Measure | Time frame | Description |
|---|---|---|
| Score in the Lafon phoneme test in quiet | 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. |
Countries
France
Outcome results
None listed