Active — Not RecruitingNot Applicable

Speech Performance and Clinic Efficiency With Remote Care Compared With Standard of Care in Adults With a Cochlear Implant in the First 12 Months Post-activation

Australia, Belgium, Italy148 participantsStarted 2024-03-18

Plain-language summary

The aim of the study is to assess the real-world effectiveness of managing participants within the first year post-activation (between 3 and 12 months) using Cochlear's Remote Care (Remote Check and Remote Assist), as compared with standard in-clinic management. The study captures also the time and costs associated with both models of care to quantify the potential costs savings and efficiency gains possible with delivering Cochlear Implant (CI) aftercare remotely.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged 18 years or older (no upper age limit) * Post-lingually deafened or pre-lingually deafened with measurable word scores in quiet using a cochlear implant * Unilaterally implanted with a compatible Cochlear™ implant * Currently using a compatible Cochlear™ Sound Processor * 3 months, +/- 2 weeks, experience with a cochlear implant (post-activation) at the time of baseline measurements * Direct access to a compatible Smart Phone * Fluent in the languages used for the study, as determined by the investigator * Willing to participate in and comply with all requirements of the protocol, including willingness to be randomised to either arm * Willing and able to provide written informed consent Exclusion Criteria: * Patient has a MAP incompatible with Master Volume, Bass and Treble (MVBT) programming: * Non-monopolar MAPs (bipolar, common ground, variable mode) * Dynamic range of \<10 Comfortable Level (CL) * Hybrid mode enabled * Pulse widths \>100 µs * 10 or more electrodes turned off * Patient has on-going fluctuations in MAP Threshold levels (Ts) and Comfort levels (Cs) and/or impedances * Patient requires frequent individual channel measurements and/or measurements without the use of live-stimulation * Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire (MDPQ) * Abnormal cochlea anatomy and/or facial nerve stimulation that requires complex or more frequent programming, as determined by the I…

What they're measuring

Mean change in patient reported hearing ability in daily life measured with the SSQ12 (Speech, Spatial and Qualities of Hearing Scale) questionnaire between month 3 (baseline) and month 12 post-activation

Timeframe: 3 months post-activation (baseline) and 12 months post-activation

Trial details

NCT IDNCT05552118

SponsorCochlear

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09