Evaluation of In-lab Benefit for Speech-in-noise Intelligibility With Device for Adults With Mild to Moderate Hearing Loss

NCT07074769 | Completed

• 1 other identifier: Protocol version 4 9.6.2025
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of in-lab benefit for speech-in-noise intelligibility with the device for adults with mild to moderate hearing loss.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (2)

• Unaided and Aided speech in noise Matrix test

  Matrix Test with and without device. The outcome is Speech Reception Threshold (SRT) in dB SNR

  1 hour

• Unaided and Aided Connected speech-in-noise tests

  Connected Speech Test with and without device. The outcome is the percentage score representing the number of key words correctly repeated

  1 hour

Secondary Outcomes (1)

• Unaided vs Aided Ratings of Listening Effort

  30 minutes

Study Arms (1)

A prospective in-lab within-subjects design with repeated measures

EXPERIMENTAL

Test of speech recognition in noise (the Matrix test). Assessment of speech recognition in babble (The Connected Speech Test). Device users' ratings of listening effort in noise with and without the device.

Device: Evaluation of speech-in-noise intelligibility and listening effort

Interventions

Evaluation of speech-in-noise intelligibility and listening effort DEVICE

The speech in noise testing will be performed in lab settings; the listening effort evaluated trough a standardized questionnaire

A prospective in-lab within-subjects design with repeated measures

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years and older
• symmetrical bilateral mild to moderate sensorineural hearing loss
• native speakers of English.

You may not qualify if:

• Children
• those without hearing loss
• those without symmetrical bilateral mild to moderate sensorineural hearing loss
• those who do not wish to wear the test device instead of their own spectacles during the in-lab procedure
• those who are not native speakers of English
• those who have pacemakers, other implantable devices, or insulin pumps

Sponsors & Collaborators

• Luxottica Group S.p.A.: lead
• University of Western Ontario, Canada: collaborator

Study Sites (1)

Western University

London, Ontario, M6G 1G9, Canada

Location

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 20, 2025
• Study Start: June 23, 2025
• Primary Completion: August 28, 2025
• Study Completion: August 28, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)