Benefits of Assistive Listening Device for Speech Intelligibility

Not Applicable

Completed

• Conditions: Hearing Loss
• Interventions: Device: Roger microphone; Device: Phonak Audeo hearing aid

• Registration Number: NCT05072470
• Lead Sponsor: Sonova AG

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-09-28
• Study First Submitted QC: 2021-09-28
• Study First Posted: 2021-10-11
• Study Start: 2021-10-18
• Primary Completion: 2021-12-13
• Study Completion: 2021-12-13
• Results First Submitted: 2022-10-21
• Results First Submitted QC: 2022-11-16
• Results First Posted: 2022-12-02
• Last Update Submitted: 2023-02-10
• Last Update Posted: 2023-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Phonak Audeo hearing aid	Participants with bilateral moderate to severe sensorineural hearing loss
Experimental	Roger microphone	Participants with bilateral moderate to severe sensorineural hearing loss

Primary Outcome Measures

Name	Time	Method
Speech Intelligibility in Noise	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.

Trial Locations

Locations (1)

Hearts for Hearing; 🇺🇸 Oklahoma City, Oklahoma, United States