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

Cochlear46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Hearing Loss

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 materialOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Denver Research and Technology Labs

Lone Tree, Colorado, United States

COMPLETED

HEARnet Clinical Studies

Melbourne, Victoria, Australia

ACTIVE_NOT_RECRUITING

European Institute for Otorhinolaryngology (EIORL) ENT department Sint-Augustinus Antwerp

Antwerp, Antwerp, Belgium

RECRUITING

Outcomes

Primary Outcomes

Percent correct performance for the test and retest runs of speech perception ability

To determine if test-retest reliability with a correlation greater than or equal to 0.8 can be achieved for speech perception ability measured on the MRA outside the sound booth, percent correct performance for the test and retest runs of the speech perception ability will be compared. Scoring: Percentage correct Range: 0-100%, higher scores equal better performance

Time frame: 1 day - immediately post screening.

Central Contacts

Geert De Ceulaer

CONTACT

+32486893006 gdeceulaer@cochlear.com

Data from ClinicalTrials.gov

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