An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App (VALDE-MU)

Cochlear

Status: Enrolling

Conditions: Hearing Loss

Treatments: Device: Mobile Research App (MRA); Other: SOC/validated delivery of the speech perception test material

Study type: Interventional

Funder types: Industry

Identifiers

NCT06098482

AI5841

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults 18 years of age or older.
• Uses a hearing device or devices (hearing aid/s and/or cochlear implant/s).
• Fluent speaker in the language used to assess clinical performance as judged by the investigator.
• Willing and able to provide written informed consent.

Exclusion criteria

• Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
• Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
• Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
• Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).
• Women who are pregnant.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Delivery of speech perception materials in-clinic using the Mobile Research App (MRA)

Experimental group

Description:

Cochlear implant recipients will participate in this arm (sub-investigation AI5841A).

Treatment:

Other: SOC/validated delivery of the speech perception test material

Device: Mobile Research App (MRA)

Delivery of speech perception materials in-clinic and at home using the Mobile Research App (MRA)

Experimental group

Description:

Cochlear implant and hearing aid recipients will participate in this arm (sub-investigation AI5841B).

Treatment:

Other: SOC/validated delivery of the speech perception test material

Device: Mobile Research App (MRA)