Hearing Loss
Conditions
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.
Interventions
DEVICEEvaluation 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
Sponsors
University of Western Ontario, Canada
Luxottica Group S.p.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Unaided vs Aided Ratings of Listening Effort | 30 minutes | Evaluation of the listening effort with and without device trough questionnaire |
Countries
Canada
Outcome results
None listed