Benefit of Assistive Listening Device for Lateralization

Not Applicable

Completed

• Conditions: Hearing Loss, Sensorineural
• Interventions: Device: Roger On microphone; Device: Roger Select microphone

• Registration Number: NCT05072457
• Lead Sponsor: Sonova AG

Brief Summary

Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss using a Phonak Roger microphone and hearing aid with compatible Phonak Roger receiver. Target speech will be presented from multiple directions while competing diffuse background noise is presented simultaneously. Participants will repeat back words and percent correct is calculated.

Detailed Description

Not available

Study Timeline

• 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: 2022-07-02
• Results First Submitted: 2023-04-24
• Results First Submitted QC: 2023-04-24
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-17
• Results First Posted: 2023-05-18
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

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

Inclusion Criteria

• Experienced hearing aid users, age 18 or older
• Bilateral, symmetric moderate to moderate-severe sensorineural hearing loss
• Good understanding of the English language
• Health outer ear as confirmed by otoscopy
• Informed consent as documented by signature

Exclusion Criteria

• Contraindications to the medical device noted upon otoscopy
• Known hypersensitivity or allergies to materials of the investigations device or comparator
• Inability to produce reliable test results
• Known psychological problems
• Self reported symptoms of vertigo or dizziness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Roger On microphone	All participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers.
Experimental	Roger Select microphone	All participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers.

Primary Outcome Measures

Name	Time	Method
Lateralization Hearing Ability	Day 1 of 1 day study	Participants indicate which direction (left, center, or right) target speech sentences are coming from while competing noise is also presented via four corner speakers. A higher number of correct responses indicates better lateralization ability. This will be done with two Roger microphone systems (Roger On and Roger Select)
Spatial Hearing Ability	Day 1 of 1 day study	Participants repeat sentences presented from the left speaker, while ignoring overlapping competing sentences presented from the right speaker. A higher percentage of correctly repeated words indicates a better spatial hearing score. This task will be performed using two Roger microphone systems (Roger On and Roger Select)

Trial Locations

Locations (1)

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