An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App

Part of paid clinical trials in Lone Tree, Colorado.

Sponsor
Cochlear
Study ID
NCT06098482
Status
Recruiting
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Conditions

  • Hearing Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mobile Research App (MRA) — DEVICE
    The MRA (research tool) is a platform used for the delivery of speech perception material in-clinic outside the sound booth or in the home of the hearing-impaired recipients. The MRA speech testing module delivers speech material via streaming to the single implanted ears of cochlear implant recipients. The recipient listens to the speech material and responds with what was heard via the app. Speech is streamed via Bluetooth from the iOS device to the sound processor of the CI-recipient.
  • SOC/validated delivery of the speech perception test material — OTHER
    This involves the delivery of speech perception test material in the sound booth in a clinic.

Study Details

The study is a feasibility, prospective, repeated-measures, multi-country, multi-centre, study of the Mobile Research App to measure and validate speech perception endpoints in adult cochlear implant recipients.

Key Dates

Start date
Feb 5, 2024
Status verified
Apr 2025
Primary completion
May 2, 2027
Completion
May 2, 2027

Study Design

Enrollment
46 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Delivery of speech perception materials in-clinic using the Mobile Research App (MRA)
    Cochlear implant recipients will participate in this arm (sub-investigation AI5841A).
  • Experimental: Delivery of speech perception materials in-clinic and at home using the Mobile Research App (MRA)
    Cochlear implant and hearing aid recipients will participate in this arm (sub-investigation AI5841B).

Primary Outcome Measure

Percent correct performance for the test and retest runs of speech perception ability [ Time Frame: 1 day - immediately post screening. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Denver Research and Technology LabsLone TreeColorado80124-

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By research site
Denver Research and Technology Labs· Lone Tree, CO

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