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.21 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hearing Loss

Interventions

Evaluation of speech-in-noise intelligibility and listening effortDEVICE

The speech in noise testing will be performed in lab settings; the listening effort evaluated trough a standardized questionnaire

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Western University

London, Ontario, Canada

Outcomes

Primary Outcomes

Unaided and Aided speech in noise Matrix test

Matrix Test with and without device. The outcome is Speech Reception Threshold (SRT) in dB SNR

Time frame: 1 hour

Unaided and Aided Connected speech-in-noise tests

Connected Speech Test with and without device. The outcome is the percentage score representing the number of key words correctly repeated

Time frame: 1 hour

Secondary Outcomes

Unaided vs Aided Ratings of Listening Effort

Evaluation of the listening effort with and without device trough questionnaire

Time frame: 30 minutes

Data from ClinicalTrials.gov

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