NCT07074769

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Luxottica Group S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-06-23
• Primary completion: 2025-08-28
• Completion: 2025-08-28
• First posted: 2025-07-20
• Last updated: 2025-09-05

Locations

1 site across 1 country: Canada