Benefit of Assistive Listening Device for Lateralization

Benefit of Assistive Listening Device for Lateralization and Spatial Hearing

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss, Sensorineural
• Intervention / Treatment: Device: Roger On microphone; Device: Roger Select microphone

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Hearts for Hearing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; All participants in the study fit with Phonak Audeo P hearing aids and compatible Phonak Roger receivers.	Device: Roger On microphone; Roger On microphone transmitter which is used with Roger receivers and Audeo P hearing aids; Device: Roger Select microphone; Roger Select microphone transmitter which is used with Roger receivers and Audeo P hearing aids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Sonova AG
• Collaborators: Hearts for Hearing

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Actual): December 13, 2021
• Study Completion (Actual): July 2, 2022

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: September 28, 2021
• First Posted (Actual): October 11, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Sensorineural
• Other Study ID Numbers: SRF-387

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes