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OpenTrials
Completed

NCT Number: NCT07074769

Evaluation of In-lab Benefit for Speech-in-noise Intelligibility With Device for Adults With 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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western University

London, Ontario, M6G 1G9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Unaided vs Aided Ratings of Listening Effort

    Time frame: 30 minutes

    Evaluation of the listening effort with and without device trough questionnaire

Sponsors and collaborators

Lead sponsor

Luxottica Group S.p.A.

Industry

Collaborators

  • University of Western Ontario, Canada

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 20, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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