Benefits of an Assistive Listening Device for Speech Intelligibility in Noise

Sonova AG1 site in 1 country10 target enrollmentOctober 18, 2021

ConditionsHearing Loss

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hearing Loss
Sponsor: Sonova AG
Enrollment: 10
Locations: 1
Primary Endpoint: Speech Intelligibility in Noise
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss, using an assistive listening device and hearing aid, and compared to speech intelligibility in noise using hearing aids alone.

Registry

clinicaltrials.gov

Start Date

October 18, 2021

End Date

December 13, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sonova AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•adults age 18 or older with bilateral moderate to moderate severe sensorineural hearing loss, pure tone average must be between 40 and 69 dB HL (decibel Hearing Level)
•experienced hearing aid users
•symmetric hearing loss (no more than 15 dB difference between the ears at three contiguous frequencies)
•good written and spoken English language skills
•healthy outer ear as confirmed by otoscopy

Exclusion Criteria

•contradictions to medical device noted upon otoscopy
•known hypersensitivity or allergy to materials of investigational device or comparator
•inability to produce reliable test results
•known psychological problems
•self reported symptoms of dizziness or vertigo

Outcomes

Primary Outcomes

Speech Intelligibility in Noise

Time Frame: Day 1 of a one day study

The percent of correctly repeated words, when a list of 10 sentences is presented in noise. Ten sentences are presented at a certain loudness level while background noise is presented simultaneously at a specific loudness level. The number of words repeated correctly is calculated from the total number of words presented.