Evaluation of Remote Programming of Cochlear Implants in Routine Cochlear Implant Follow-up
ConditionCochlear Hearing Loss
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAdvanced Bionics AG
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Advanced Bionics adults CI users
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Target CI v1.5 remote programming
DeviceUse of the remote programming function of Target CI v1.5 and the AB remote support application
Treatment groups
51 Participants
are divided into 3 treatment groupsGroup A: Group 11 intervention
Group B: Group 21 intervention
Group C: Group 31 intervention
Trial outcomes
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.
Time frame
one-month chronic use of remotely fitted sound processorSecondary outcomes
1
Score in the Lafon phoneme test in quiet
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.
Time frame
one-month chronic use of remotely fitted sound processorSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov