Back to resultsReal World Perspectives on Advancements in Hearing Aid Technology
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phonak Audeo previous generation hearing aids
Phonak Audeo Lumity hearing aids
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- Moderate sensorineural hearing loss
- Experienced hearing aid user
- Has a significant other/communication partner that can fill out a questionnaire about hearing aid performance during the home trial
- Smartphone user for receiving study alerts
Exclusion Criteria:
- Cognitive impairment
- Not willing to wear hearing aid
Sites / Locations
- Phonak Audiology Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Participants tested with comparator devices first, then Audeo Lumity devices
Participants who were tested with Audeo Lumity first, then comparator devices
Arm Description
All participants who completed speech in noise testing in the lab with the comparator devices first, and then the Audeo Lumity devices.
All participants who completed speech in noise testing in the lab with the Audeo Lumity devices first, and then the comparator devices.
Outcomes
Primary Outcome Measures
Speech in Noise Test
A speech in noise test in which participants repeat words which are presented in the presence of background noise. In a 12-speaker array, speech is presented from speakers either on the left side of the participant (-90 degrees) or from behind the participant (180 degrees) while background noise is presented from remaining speakers. Scores are calculated as the number of words correctly repeated and expressed as a percentage. A higher percentage or score is better.
Subjective Perception of Listening Effort
Following the speech in noise testing in the lab, participants rated their listening effort on a scale from 1 to 10, with 1 = no effort and 10 = a lot of effort. In this case, a lower rating is better as it indicates less perceived listening effort.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05468918
Brief Title
Real World Perspectives on Advancements in Hearing Aid Technology
Official Title
Real World Perspectives on Advancements in Hearing Aid Technology
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
October 26, 2022 (Actual)
Study Completion Date
October 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
4. Oversight
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
5. Study Description
Brief Summary
This study will compare different microphone technologies in a noisy environment when the dominant speaker is at the front, back, left, or right side of the listener.
Detailed Description
Understanding speech in a noisy environment can be difficult for people with hearing loss even with hearing aids. Hearing aid manufacturers have implanted various methods (i.e., directional micro-phones, noise reduction, noise cancelers) to try to improve the signal-to-noise ratio (SNR) to increase the speech understanding in these difficult listening situations.
This study is evaluating different microphone technologies to determine listening effort when speech is to the back or side of the listener in noisy environment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
Participants were blinded as to which device they were wearing during the lab testing.
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participants tested with comparator devices first, then Audeo Lumity devices
Arm Type
Experimental
Arm Description
All participants who completed speech in noise testing in the lab with the comparator devices first, and then the Audeo Lumity devices.
Arm Title
Participants who were tested with Audeo Lumity first, then comparator devices
Arm Type
Experimental
Arm Description
All participants who completed speech in noise testing in the lab with the Audeo Lumity devices first, and then the comparator devices.
Intervention Type
Device
Intervention Name(s)
Phonak Audeo previous generation hearing aids
Intervention Description
Receiver-in-canal (RIC) hearing aids with universal earpieces
Intervention Type
Device
Intervention Name(s)
Phonak Audeo Lumity hearing aids
Intervention Description
Receiver-in-canal (RIC) hearing aids with universal earpieces
Primary Outcome Measure Information:
Title
Speech in Noise Test
Description
A speech in noise test in which participants repeat words which are presented in the presence of background noise. In a 12-speaker array, speech is presented from speakers either on the left side of the participant (-90 degrees) or from behind the participant (180 degrees) while background noise is presented from remaining speakers. Scores are calculated as the number of words correctly repeated and expressed as a percentage. A higher percentage or score is better.
Time Frame
Day 1 of study
Title
Subjective Perception of Listening Effort
Description
Following the speech in noise testing in the lab, participants rated their listening effort on a scale from 1 to 10, with 1 = no effort and 10 = a lot of effort. In this case, a lower rating is better as it indicates less perceived listening effort.
Time Frame
Day 1 of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Moderate sensorineural hearing loss
Experienced hearing aid user
Has a significant other/communication partner that can fill out a questionnaire about hearing aid performance during the home trial
Smartphone user for receiving study alerts
Exclusion Criteria:
Cognitive impairment
Not willing to wear hearing aid
Facility Information:
Facility Name
Phonak Audiology Research Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Real World Perspectives on Advancements in Hearing Aid Technology
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