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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-05

Study Completion Date

2027-05-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Hearing Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

Mobile Research App (MRA)

Intervention Type 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

Intervention Type OTHER

This involves the delivery of speech perception test material in the sound booth in a clinic.

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).

Group Type EXPERIMENTAL

Mobile Research App (MRA)

Intervention Type 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

Intervention Type OTHER

This involves the delivery of speech perception test material in the sound booth in a clinic.

Interventions

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Mobile Research App (MRA)

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.

Intervention Type DEVICE

SOC/validated delivery of the speech perception test material

This involves the delivery of speech perception test material in the sound booth in a clinic.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No