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

August 28, 2025 updated by: Luxottica Group S.p.A.

In-Lab Evaluation of A Hearing Aid Housed in Ophthalmic Spectacles for Mild to Moderate Hearing Loss

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This primary objective is to evaluate whether the device improves speech recognition in noise compared to the clinically relevant comparison condition of no treatment (unaided) for adults with mild to moderate hearing loss. The primary outcome will be measured using a clinically available test of speech recognition in noise that uses adaptive bracketing of signal to noise ratio (the Matrix test). The secondary outcome will also assess speech recognition in babble at ecologically valid fixed signal to babble ratios (The Connected Speech Test). Tertiary outcomes will examine device users' ratings of listening effort in noise with and without the device.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, M6G 1G9
        • Western University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A prospective in-lab within-subjects design with repeated measures
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
The speech in noise testing will be performed in lab settings; the listening effort evaluated trough a standardized questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unaided and Aided speech in noise Matrix test
Time Frame: 1 hour
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
Time Frame: 1 hour
Connected Speech Test with and without device. The outcome is the percentage score representing the number of key words correctly repeated
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unaided vs Aided Ratings of Listening Effort
Time Frame: 30 minutes
Evaluation of the listening effort with and without device trough questionnaire
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luxottica Group S.p.A.

Collaborators

University of Western Ontario, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2025

Primary Completion (Actual)

August 28, 2025

Study Completion (Actual)

August 28, 2025

Study Registration Dates

First Submitted

June 30, 2025

First Submitted That Met QC Criteria

July 18, 2025

First Posted (Actual)

July 20, 2025

Study Record Updates

Last Update Posted (Estimated)

September 5, 2025

Last Update Submitted That Met QC Criteria

August 28, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol version 4 9.6.2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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