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

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

Qualifiers

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 design

Treatments tested in this trial

  • Target CI v1.5 remote programming

Treatment groups

51 Participants
are divided into 3 treatment groups

Sponsors and collaborators