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Clinical Trials/NCT05072457
NCT05072457
Completed
N/A

Benefit of Assistive Listening Device for Lateralization and Spatial Hearing

Sonova AG1 site in 1 country10 target enrollmentOctober 18, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hearing Loss, Sensorineural
Sponsor
Sonova AG
Enrollment
10
Locations
1
Primary Endpoint
Lateralization Hearing Ability
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 18, 2021
End Date
July 2, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Sonova AG
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Lateralization Hearing Ability

Time Frame: 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

Time Frame: 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)

Study Sites (1)

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