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Benefit of Assistive Listening Device for Lateralization

Sponsor
Sonova AG (Industry)
Overall Status
Completed
CT.gov ID
NCT05072457
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
8.4
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Speech intelligibility in noise will be evaluated in adults with moderate to moderate-severe sensorineural hearing loss using a Roger microphone and hearing aid with 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Roger On microphone
  • Device: Roger Select microphone
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Benefit of Assistive Listening Device for Lateralization and Spatial Hearing
Actual Study Start Date :
Oct 18, 2021
Actual Primary Completion Date :
Dec 13, 2021
Actual Study Completion Date :
Jul 2, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental

All participants in the study will have both localization and spatial hearing tested with the Roger On transmitter as well as the Roger Select transmitter.

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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 number of correctly repeated words indicates a better spatial hearing.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hearts for Hearing Oklahoma City Oklahoma United States 73120

Sponsors and Collaborators

  • Sonova AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sonova AG
ClinicalTrials.gov Identifier:
NCT05072457
Other Study ID Numbers:
  • SRF-387
First Posted:
Oct 11, 2021
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
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
Additional relevant MeSH terms:
Hearing Loss
Hearing Loss, Sensorineural

Study Results

No Results Posted as of Aug 17, 2022