Benefit of Assistive Listening Device for Lateralization

Hearing Loss, Sensorineural Clinical Trial

Official title:

Benefit of Assistive Listening Device for Lateralization and Spatial Hearing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05072457
• Other study ID #: SRF-387
• Status: Completed
• Phase: N/A
• Start date: October 18, 2021
• Est. completion date: July 2, 2022

Study information

• Verified date: May 2023
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2, 2022
• Est. primary completion date: December 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Device:
• Roger On microphone
Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids
• Roger Select microphone
Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids

Locations

Country	Name	City	State
United States	Hearts for Hearing	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Sonova AG	Hearts for Hearing

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lateralization Hearing Ability	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)	Day 1 of 1 day study
Primary	Spatial Hearing Ability	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)	Day 1 of 1 day study