Investigating Hearing Aid Frequency Response Curves
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Kitchener, Ontario, Canada, N2E 1Y6
- Sonova - Kitchener
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- N2 - N4 Hearing losses
- Health Outer ear
- no visible congenital or traumatic deformity of the outer ear
- Symmetrical hearing loss - no air-bone gap greater than 10 dB at all 500, 1000, 2000, and 4000 Hz.
- Ability to answer questions and repeat sentences
- No history of problematic tinnitus or pain/discomfort from loud sounds
- No history of active drainage from the ears in the past 90 daysInformed consent as documented by signature
- Willingness to wear different styles of couplings
- Willingness to wear binaural fitting
- Experienced Users = more than 3 months of hearing aid experience. If not more than 3 months, they will be considered a new user (Experience will not exclude them from study, only will be used to categorize them)
- Ability to travel throughout facility
Exclusion Criteria:
- Contraindications to the medical device (MD) in this study (e.g. known hypersensitivity or allergy to the investigational products)
- Limited mobility/not able to come to the scheduled visit
- Inability to produce reliable hearing test results
- History of active drainage from the ear in the previous 90 days
- Abnormal appearance of the eardrum and ear canal.
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 |
|---|---|
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Experimental: Participants with Hearing Loss
Individuals with hearing loss that meet the candidacy to wear hearing aids.
All interventions are associated with the fitting of binaural hearing aids with various coupling methods.
All participants will be assessed under all interventions.
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Our current hearing aids which will be programmed to our standard frequency response curve.
Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Streaming Sound Quality Ratings
Time Frame: 60 minutes
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Pre-filtered sound samples (based on frequency response curves) will be presented via a paired comparison task in which participants will determine which sound sample they prefer (i.e. better sound quality). Sound samples will be presented via hearing aids that are programmed to the participant's hearing loss. Participant's will be presented with two samples at a time and will choose which sample they prefer. For example, if Sample A was preferred over Sample B, then Sample A gets a score of 1. If Sample B was preferred over Sample A, then Sample B gets a score of 1. At the end of the task, scores will be tallied to determine which sample was preferred the most overall. There will be 5 different samples. The minimum value for the tallied score would be 0 (the sample was not preferred at all) and the maximum value would be 8 (implying that the sample was preferred in all trials). Higher scores mean that the sample was preferred more and lowers scores mean the sample was not preferred. |
60 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sound Quality Rating - Live - Counts
Time Frame: 60 minutes
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Participants will be asked to wear hearing aids and as they listen to speech in noise. They will be asked to toggle between two hearing aid programs and will be asked to make ratings in the lab and outdoors. Similar to Outcome 1, scores will be tallied at the end to see which program of the two was preferred more in the different listening environments. Scores can range from 0 (the program was not preferred at all) to unlimited (dependent on the numbers of trials run and samples tested). Higher scores will indicate that the program was preferred more than the other program and lowers scores mean the program was not preferred when compared to the other program. |
60 minutes
|
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Sound Quality Rating - Live - Preferences
Time Frame: 60 minutes
|
Participants will be asked to wear hearing aids and as they listen to speech in noise. They will be asked to toggle between two hearing aid programs and determine which program they prefer to listen to. Similar to Outcome 1, scores will be tallied at the end to see which program of the two was preferred more in the different listening environments. Scores can range from 0 (the program was not preferred at all) to unlimited (dependent on the numbers of trials run and samples tested). Highers scores will indicate that the program was preferred more than the other program and lowers scores mean the program was not preferred when compared to the other program. |
60 minutes
|
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US Matrix Test in Quiet - SRT
Time Frame: 30 Minutes
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Oldenburg Sentence Test (OLSA) sentences were presented to participants while they were aided under the standard curve, aided under curve #4, and unaided.
Participants are presented with sentences from a loudspeaker placed infront of them and asked to repeat what they heard.
Correct repitition results in the next sentence to be presented at a lower sound level.
Incorrect repetition results in an increase in presentation level for the next sentence.
20 sentences are presented for each conidition (i.e., unaided, aided with the standard curve, and aided under curve #4).
Speech Recognition Threshold at 50% (SRT50) correctness scores were calculated and compared amongst the three conditions.
SRT50 is measured in decibel (dB) which is a unit on scale.
The scale has no upper or lower limits, however lower scores indicate better performance.
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30 Minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jinyu Qian, PhD, Sonova AG
Publications and helpful links
General Publications
- Vaisberg J, Folkeard P, Levy S, Dundas D, Agrawal S, Scollie S. Sound Quality Ratings of Amplified Speech and Music Using a Direct Drive Hearing Aid: Effects of Bandwidth. Otol Neurotol. 2021 Feb 1;42(2):227-234. doi: 10.1097/MAO.0000000000002915.
- Harianawala J, Galster J, Hornsby B. Psychometric Comparison of the Hearing in Noise Test and the American English Matrix Test. J Am Acad Audiol. 2019 Apr;30(4):315-326. doi: 10.3766/jaaa.17112. Epub 2018 Sep 25.
- Wu YH, Stangl E, Chipara O, Hasan SS, Welhaven A, Oleson J. Characteristics of Real-World Signal to Noise Ratios and Speech Listening Situations of Older Adults With Mild to Moderate Hearing Loss. Ear Hear. 2018 Mar/Apr;39(2):293-304. doi: 10.1097/AUD.0000000000000486.
- Neuman AC, Bakke MH, Hellman S, Levitt H. Effect of compression ratio in a slow-acting compression hearing aid: paired-comparison judgments of quality. J Acoust Soc Am. 1994 Sep;96(3):1471-8. doi: 10.1121/1.410289.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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-3167
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
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