- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00738244
Effectiveness of Hearing-aid Based Wind-noise Algorithm
Methods of Wind Noise Suppression in Hearing Aids
Study Overview
Status
Conditions
Detailed Description
Two groups of subjects will be recruited to participate: Normal hearing adults and adults with mild to moderately severe hearing loss, ages 18-65. Pure tone audiometrics (re ANSI, 1996) will be done to ascertain the hearing sensitivity through 6ooo Hz. Normal hearing will be defined as thresholds at or better than 20 dB HL (re ANSI, 1996). The only exclusion criterion for the group exhibiting hearing loss is that no thresholds up to and including 3000 Hz will exceed 75 dB, so as to minimize the inclusion of subjects with "dead regions" in the cochlea.
Subjects will be seen for four visits to the laboratory. The first visit will involve documentation of informed consent, and measurement of hearing thresholds. The second, third and fourth visits will consist of testing with the following measures (in random order for each subject) to determine if the various implementations of the wind noise reduction algorithm 1) impact speech perception ability, and/or 2) impact sound quality perception. Each session will take approximately 1.5 hours, with a maximum of six hours over all the sessions. The two speech perception tests that will be utilized include : 1) Connected Speech Test and Hearing in Noise Test, 2) The Hearing in Noise Test (HINT) (Nilsson, Soli, & Sullivan, 1994; Koch, Nilsson & Soli, 1995. Overall Impression of Sound Quality and Ratings of Annoyance will be used as subjective, or self-reported, measures of preference. Overall Impression will be influenced by the audibility and masking effect of the noise bursts, whereas Annoyance ratings are significantly correlated to the high frequency emphasis of the stimulus, a potential impact of the extreme suppression conditions (e.g., -18 dB) (Warner & Bentler, 2002; Miedema & Vos, 2003). Both measures will be analyzed as a function of the different time constants, gain reduction levels, and level of presentation.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Iowa
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Iowa City, Iowa, United States, 52242
- Wendell Johnson Center, University of Iowa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Ages 18-75
- Normal or mild-to-moderate sensorineural hearing loss
Exclusion Criteria:
- Thresholds in excess of 75 dB HL
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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1
Normal hearing listeners
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2
Listeners with mild-to-moderate sensorineural hearing loss
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Speech Perception as measured by the Connected Speech Test (Cox et al)
Time Frame: Each of three follow-up visits
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Each of three follow-up visits
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Sound Quality
Time Frame: Each of three follow-up visits
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Each of three follow-up visits
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ruth A Bentler, PhD, University of Iowa
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2R44DC007246-02A2 (NIH)
- R44DC007246 (NIH)
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