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

NCT06098482 | Recruiting

• 1 other identifier: AI5841
• Study Type: interventional
• Target: 46
• Locations: 3 countries
• Sites: 4

Brief Summary

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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

  1 day - immediately post screening.

Study Arms (2)

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

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.

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cochlear: lead

Study Sites (4)

Denver Research and Technology Labs

Lone Tree, Colorado, 80124, United States

COMPLETED

HEARnet Clinical Studies

Melbourne, Victoria, 3053, Australia

ACTIVE NOT RECRUITING

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

Antwerp, Antwerp, 2610, Belgium

RECRUITING

Hoorzorg van Looveren

Wommelgem, Antwerp, 2160, Belgium

RECRUITING

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Geert De Ceulaer

CONTACT

+32486893006; gdeceulaer@cochlear.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 24, 2023
• Study Start: February 5, 2024
• Primary Completion (Estimated): May 2, 2027
• Study Completion (Estimated): May 2, 2027
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); BE (2); AU (1)