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

Not Applicable

Recruiting

• Conditions: Hearing Loss

• Registration Number: NCT07074769
• Lead Sponsor: Luxottica Group S.p.A.

Brief Summary

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

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 Timeline

• Study Start: 2025-06-23
• Study First Submitted: 2025-06-30
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-18
• Last Update Submitted: 2025-07-18
• Study First Posted: 2025-07-20
• Last Update Posted: 2025-07-20
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Aided versus unaided sound-field audiogram	30 minutes	evaluation of hearing thresholds (PTA) measured in a free-field (open space) environment both with and without the device
Unaided and Aided speech in noise Matrix test	1 hour	Matrix Test with and without device. The outcome is Speech Reception Threshold (SRT) in dB SNR
Unaided and Aided Connected speech-in-noise tests	1 hour	Connected Speech Test with and without device. The outcome is the percentage score representing the number of key words correctly repeated

Secondary Outcome Measures

Name	Time	Method
Unaided vs Aided Ratings of Listening Effort	30 minutes	Evaluation of the listening effort with and without device trough questionnaire

Trial Locations

Locations (1)

Western University; 🇨🇦 London, Ontario, Canada