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Internal research on the manufacturer's hearing aid products has idenitfied areas in which the investigators can improve the hearing aid frequency response curve. This study aims to investigate the current freqeuncy response curve in the manufacturer's products to variations of these curves to determine if hearing aid users prefer the variations over the manufacturer's standard curve.
Internal testing has identified areas in which the investigators can improve the performance of the manufacturer's hearing aid products. This should potentially lead to increased hearing aid user satisfaction due to an improvement in sound quality. However, the investigators are currently unsure if implementing these new frequency response curves will be preferred by the manufacturer's clients. Therefore, a study is proposed in which hearing aid users will compare the manufacturer's current frequency response curve to variations made to the curve and determine which one they prefer while listening to live speech/music or while streaming speech/music.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Hearing Loss | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing Aid - Standard Curve | Device | Our current hearing aids which will be programmed to our standard frequency response curve. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Streaming Sound Quality Ratings | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sound Quality Rating - Live - Counts | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinyu Qian, PhD | Sonova AG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sonova - Kitchener | Kitchener | Ontario | N2E 1Y6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32976346 | Background | 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. | |
| 30461418 | Background | 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. |
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All participants were exposed to all interventions and as mentioned previously, participants were exposed to multiple interventions at once (i.e., different hearing aid freqeuncy response curves). All 33 participants completed each test (i.e., outcome measure) while exposed to all the interventions. Different periods represent the different outcome measures and in the order in which they occured are listed below. For the final analysis, results from 22 participants was used.
Recruitment was conducted via an internal database. Participants were recruited from August 2022 - January 2023. Participants were mainly contacted via email or telephone and only seen at the listed study locations.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Hearing Aid - Standard Curve: Our current hearing aids which will be programmed to our standard frequency response curve. Hearing Aid - Variation #1: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss. Hearing Aid - Variation #2: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss. Hearing Aid - Variation #3: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss. Hearing Aid - Variation #4: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| US Matrix Test in Quiet - 30 Minutes |
| |||||||||||||
| Sound Quality Ratings - Live - 1 Hour |
| |||||||||||||
| Break Between Appointments 1 and 2 |
| |||||||||||||
| Streaming Sound Quality Ratings - 1 Hour |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Hearing Aid - Standard Curve: Our current hearing aids which will be programmed to our standard frequency response curve. Hearing Aid - Variation #1: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss. Hearing Aid - Variation #2: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss. Hearing Aid - Variation #3: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss. Hearing Aid - Variation #4: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Streaming Sound Quality Ratings | 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. | Out of 33 participants, 4 were pilot participants so their data was not analyzed for the final statistical analysis and 5 participants data was removed due to HL severity. Additionally, 2 participants data was removed for the final analysis as they struggled to understand the tasks within the study. In the end, 22 participants data was used for the final analysis. | Posted | Mean | Standard Error | Mean Preference Counts per Participant | 60 minutes |
Participants were exposed to multiple interventions at once and had the ability to cycle through the various interventions (frequency curves). For this reason, adverse event data would have been collected per task and not intervention due to the quick exposure to multiple interventions. Adverse Event Data per participant was collected and is reported below. Sound Quality Ratings - Streaming - 60 minutes Sound Quality Ratings - Live - 60 minutes US Matrix Test Task in Quiet - 30 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Hearing Aid - Standard Curve: Our current hearing aids which will be programmed to our standard frequency response curve. Hearing Aid - Variation #1: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss. Hearing Aid - Variation #2: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss. Hearing Aid - Variation #3: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss. Hearing Aid - Variation #4: Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bilal Sheikh - Research Audiologist | Sonova | 2268083260 | bilal.sheikh@sonova.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2024 | Dec 2, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D006312 | Hearing Loss, Bilateral |
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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The study is not a crossover study in it's true sense as there is only one arm. All participants will undergo all testing and will test each hearing aid variation. It should be noted that testing a different hearing aid variation (i.e., intervention) is done by simply clicking a button and having the hearing aid switch into a different variation. In this study, participants will go back and forth between different variations in order to make preference selections (Live Sound Quality task or US Matrix Test task).
Additionally, in other outcome measures, participants will listen to pre-recorded stimuli that have the various frequency response curves applied. In this case, participants once again will be exposed to different hearing aid curves while simply listening via hearing aids and making preference selections. In the end, participants can be exposed to different hearing aid variations (i.e., interventions) simultaneously and also have the ability to go back and forth.
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| Hearing Aid - Variation #1 | Device | Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss. |
|
| Hearing Aid - Variation #2 | Device | Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss. |
|
| Hearing Aid - Variation #3 | Device | Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss. |
|
| Hearing Aid - Variation #4 | Device | Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss. |
|
| 60 minutes |
| Sound Quality Rating - Live - Preferences | 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 |
| US Matrix Test in Quiet - SRT | 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. | 30 Minutes |
| 29466265 | Background | 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. |
| 7963011 | Background | 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. |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| Hearing Thresholds - PTA (500,1000,2000,4000 Hz) | Hearing thresholds are measured via a hearing test. A hearing test is conducted by a licensed professional who is trained to conduct hearing tests and determine the severity of a participant's hearing loss. Depending on the configuration and severity of the hearing loss dictates if participants meet the requirements to join a clinical study. Hearing thresholds are measured across various frequencies and certain frequencies can differ significantly between participants. The average of four frequencies (500, 1000, 2000, and 4000 Hz (i.e., Pure Tone Average (PTA)) summarizes a participants loss. | Mean | Full Range | Decibals in Hearing Level (dB HL) |
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| Secondary | Sound Quality Rating - Live - Counts | 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. | Out of 33 participants, 4 were pilot participants so their data was not analyzed for the final statistical analysis and 5 participants data was removed due to HL severity. Additionally, 2 participants data was removed for the final analysis as they struggled to understand the tasks within the study. In the end, 22 participants data was used for the final analysis. | Posted | Number | Count of preferences | 60 minutes |
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| Secondary | Sound Quality Rating - Live - Preferences | 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. | Out of 33 participants, 4 were pilot participants so their data was not analyzed for the final statistical analysis and 5 participants data was removed due to HL severity. Additionally, 2 participants data was removed for the final analysis as they struggled to understand the tasks within the study. In the end, 22 participants data was used for the final analysis. | Posted | Number | Count of preferences | 60 minutes |
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| Secondary | US Matrix Test in Quiet - SRT | 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. | Out of 33 participants, 4 were pilot participants so their data was not analyzed for the final statistical analysis and 5 participants data was removed due to HL severity. Additionally, 2 participants data was removed for the final analysis as they struggled to understand the tasks within the study. In the end, 22 participants data was used for the final analysis. | Posted | Mean | Standard Deviation | decibels (dB) | 30 Minutes |
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| 0 |
| 33 |
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| 33 |
| 0 |
| 33 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| # of times the standard curve was rated higher in preference than variation4 across samples-Outdoors |
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| # of times the standard curve was rated lower in preference than variation4 across samples-Outdoors |
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| # of times the standard curve was rated the same as variation4 in preference across samples-Outdoors |
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| 0.04 |
This is to see if there is a difference in preference counts between standard curve, variation #4, and # of time they were rated as the same. -Outdoor |
| Cramer's V |
| .20 |
| 2-Sided |
| Superiority |
| The number of participants that showed overall preference toward variation #4 vs. the standard curve vs. no preference. - Outdoors. | Chi-squared | 0.04 | Cramer's V | 0.2 | 2-Sided | Superiority |
|
Standard Curve vs Variation #4 |
| 0.855 |
Post-Hoc Pairwise Comparison |
| Mean Difference (Final Values) |
| -0.24 |
| 2-Sided |
| 95 |
| -2.83 |
| 2.35 |
| Superiority |