- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07543770
Wind Noise Sound Quality Preference and Claims Study (WB)
Claims evidence is required for a new Wind Noise Canceller (WNC) algorithm.
Wind noise is not sound in the classic sense, as it does not correspond to pressure waves moving through the air. However, because the microphone membranes are deflected by the wind noise, the microphones translates them into a sound signal. Since the pressure fluctuations are small in size, this wind noise signal is uncorrelated between the two HI microphones (correlation decreases with increasing microphone distance), creating bothersome sounds at low and very low frequencies. Historically, wind noise cancellers have been applied to make wind noise less bothersome. However, target signal (i.e. speech) sound fidelity can become compromised as a biproduct. Therefore, an updated wind noise canceller has been proposed to improve wind noise attenuation and target signal fidelity compared to the previous iteration. Informal exploratory testing by normal hearing Sonova employees have identified the new wind noise canceller iteration to improve sound quality ratings with some dependencies on (1) wind speed, (2) wind angle and (3) target signal. Therefore, this study will aim to produce sound quality data showing a benefit for the new wind noise canceller compared to the older version for the purpose of claim substantiation.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jonathan M Vaisberg, PhD
- Phone Number: 905-745-6785
- Email: jonathan.vaisberg@sonova.com
Study Locations
-
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Ontario
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Kitchener, Ontario, Canada, N2E 1Y6
- Sonova Canada Inc.
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Contact:
- Jonathan M Vaisberg, PhD
- Phone Number: 905-745-6785
- Email: jonathan.vaisberg@sonova.com
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Principal Investigator:
- Jinyu Qian, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults (18-99 years)
- Binaural, symmetric, sensorineural N2 (mild) to N5 (moderate-severe) hearing loss
- Fluent in English
Exclusion Criteria:
- Minors (< 18 years
- Normal hearing or hearing loss > N6 (severe)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Participant group
Participants will listen to recorded scenes of target signals (speech, environmental sounds) in a wind tunnel, in which wind speed and incidence angle will be varied, recorded using the old and new versions of the wind noise canceller.
Condition order is randomized between participants and masked from participants and experimenters.
|
Updated wind noise canceller intended to improve wind noise attenuation and target signal fidelity compared to its predecessor.
Older version of the wind noise canceller
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall preference sound quality attribute
Time Frame: During a single 2-hour onsite study session
|
Participants will complete an A-B paired-comparison listening task to assess subjective preference for overall preference between two hearing aid conditions.
During testing, participants will listen to short audio recordings that vary in target signal, wind speed, and wind incidence angle.
For each trial, participants will indicate which of the two recordings (A or B) is preferred overall.
The outcome measure will be the proportion of "A preferred" versus "B preferred" responses aggregated across all trials and participants.
Binary preference data will be analyzed using inferential statistics.
|
During a single 2-hour onsite study session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Speech clarity sound quality attribute
Time Frame: During a single 2-hour onsite study session
|
Participants will complete an A-B paired-comparison listening task to assess subjective preference for speech clarity between two hearing aid conditions.
During testing, participants will listen to short audio recordings that vary in target signal, wind speed, and wind incidence angle.
For each trial, participants will indicate which of the two recordings (A or B) is preferred in terms of speech clarity.
The outcome measure will be the proportion of "A preferred" versus "B preferred" responses aggregated across all trials and participants.
Binary preference data will be analyzed using inferential statistics.
|
During a single 2-hour onsite study session
|
|
Listening comfort sound quality attribute
Time Frame: During a single 2-hour onsite study session
|
Participants will complete an A-B paired-comparison listening task to assess subjective preference for listening comfort between two hearing aid conditions.
During testing, participants will listen to short audio recordings that vary in target signal, wind speed, and wind incidence angle.
For each trial, participants will indicate which of the two recordings (A or B) is preferred in terms of listening comfort.
The outcome measure will be the proportion of "A preferred" versus "B preferred" responses aggregated across all trials and participants.
Binary preference data will be analyzed using inferential statistics.
|
During a single 2-hour onsite study session
|
|
Listening effort sound quality attribute
Time Frame: During a single 2-hour onsite study session
|
Participants will complete an A-B paired-comparison listening task to assess subjective preference for listening effort between two hearing aid conditions.
During testing, participants will listen to short audio recordings that vary in target signal, wind speed, and wind incidence angle.
For each trial, participants will indicate which of the two recordings (A or B) is preferred in terms of listening effort.
The outcome measure will be the proportion of "A preferred" versus "B preferred" responses aggregated across all trials and participants.
Binary preference data will be analyzed using inferential statistics.
|
During a single 2-hour onsite study session
|
|
Naturalness sound quality attribute
Time Frame: During a single 2-hour onsite study session
|
Participants will complete an A-B paired-comparison listening task to assess subjective preference for naturalness between two hearing aid conditions.
During testing, participants will listen to short audio recordings that vary in target signal, wind speed, and wind incidence angle.
For each trial, participants will indicate which of the two recordings (A or B) is preferred in terms of naturalness.
The outcome measure will be the proportion of "A preferred" versus "B preferred" responses aggregated across all trials and participants.
Binary preference data will be analyzed using inferential statistics.
|
During a single 2-hour onsite study session
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRF-36731
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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