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

Luxottica Group S.p.A.

Status: Completed

Conditions: Hearing Loss

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07074769

Protocol version 4 9.6.2025

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

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