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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. Based on the conclusions of the first study, we have identified areas that require further analysis and testing prior to implementing of the proposed frequency response curve into our products. 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 and listener comfort. 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 and while in different listening enviroments.
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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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing Aid - Standard Curve under Program 1 | Other | Our current hearing aids which will be programmed to our standard frequency response curve. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sound Quality Ratings - Listening Comfort - Program 1 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program provides increased listening comfort. Participants will be asked to make these ratings while seated in a sound booth. 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 ran 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. | 10 Minutes |
| Sound Quality Ratings - Overall Preference - Program 1 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program they prefer to listen to. Participants will be asked to make these ratings while seated in a sound booth. 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. | 10 Minutes |
| Sound Quality Ratings - Speech Clarity - Program 1 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program has better speech clarity. Participants will be asked to make these ratings while seated in a sound booth. 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 ran 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. |
| Measure | Description | Time Frame |
|---|---|---|
| US Matrix Test in Noise Results - dB SNR 50% | Oldenburg Sentence Test (OLSA) sentences were presented to participants while they were aided under the standard curve, aided under variation #1 frequency response curve, and unaided. Participants are presented with sentences from a loudspeaker placed Infront of them and noise from 7 loudspeakers placed around them (8 speakers placed 30 degrees apart from each other). Participants were asked to repeat what they heard. Correct repetition 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 condition (i.e., unaided, aided with the standard curve, and aided with the proposed frequency response curve). decibel signal to noise ratio (dB SNR) at 50% correctness scores were calculated at the end and compared amongst the three conditions. There are no minimum or maximum values, however lower scores indicate better performance. |
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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. After enrollment and prior to testing, when applicable participant's hearing loss was assessed to confirm no significant changes from their baseline test. If a change in hearing loss was detected, it was evaluated to determine if the change was sufficient to place the participant outside the study's inclusion criteria. If so, the participant would be removed from the study.
Recruitment was conducted via an internal database. Participants were recruited from May 2023 - October 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Intake and Consent Form Completion |
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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 |
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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 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 headphones and making preference selections. In the end, participants can be exposed to different hearing aid variations (i.e., interventions) simultaneously and have the ability to go back and forth between interventions.
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Participant were blinded to the type of intervention (i.e., hearing aid curve) or program they were comparing or rating. They were simply asked to specify which intervention they had a preference for.
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| Hearing Aid - Variation #1 under Program 1 | Device | Hearing aids that will have the frequency response curve #1 adjusted and fit to the participant's hearing loss. |
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| Hearing Aid - Variation #2 under Program 5 - Streaming Only | Other | Our current hearing aids which will be programmed to our standard frequency response curve. |
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| Hearing Aid - Variation #3 under Program 5 - Streaming Only | Other | Hearing aids that will have the frequency response curve #3 adjusted and fit to the participant's hearing loss. |
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| Hearing Aid - Variation #4under Program 5 - Streaming Only | Other | Hearing aids that will have the frequency response curve #4 adjusted and fit to the participant's hearing loss. |
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| Hearing Aid - Standard Curve under Program 2 | Other | Our current hearing aids which will be programmed to our standard frequency response curve. |
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| Hearing Aid - Variation #1 under Program 2 | Other | Hearing aids that will have the frequency response curve #1 adjusted and fit to the participant's hearing loss. |
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| Hearing Aid - Standard Curve under Program 3 | Other | Our current hearing aids which will be programmed to our standard frequency response curve. |
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| Hearing Aid - Variation #1 under Program 3 | Other | Hearing aids that will have the frequency response curve #1 adjusted and fit to the participant's hearing loss. |
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| Hearing Aid - Standard Curve under Program 4 | Other | Our current hearing aids which will be programmed to our standard frequency response curve. |
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| Hearing Aid - Variation #1 under Program 4 | Other | Hearing aids that will have the frequency response curve #1 adjusted and fit to the participant's hearing loss. |
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| Unaided | Other | No hearing aids worn at all and participants tested as is. |
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| 10 minutes |
| Sound Quality Ratings - Noise Intrusion - Program 1 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (Standard curve and variation #1) and determine which program has more noise intrusion. Participants will be asked to make these ratings while seated in a sound booth. 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 ran 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. | 10 Minutes |
| Sound Quality Ratings - Listening Comfort - Program 2 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program provides increased listening comfort. Participants will be asked to make these ratings while seated in a sound booth. 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 ran 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. | 10 Minutes |
| Sound Quality Ratings - Overall Preference - Program 2 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program they prefer to listen to. Participants will be asked to make these ratings while seated in a sound booth. 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. | 10 Minutes |
| Sound Quality Ratings - Noise Intrusion - Program 2 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (Standard curve and variation #1) and determine which program has more noise intrusion. Participants will be asked to make these ratings while seated in a sound booth. 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 ran 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. | 10 Minutes |
| Sound Quality Ratings - Listening Comfort - Program 3 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program provides increased listening comfort. Participants will be asked to make these ratings while seated in a sound booth. 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 ran 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. | 10 Minutes |
| Sound Quality Ratings - Overall Preference - Program 3 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program they prefer to listen to. Participants will be asked to make these ratings while seated in a sound booth. 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. | 10 Minutes |
| Sound Quality Ratings - Speech Clarity - Program 3 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program has better speech clarity. Participants will be asked to make these ratings while seated in a sound booth. 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 ran 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. | 10 minutes |
| Sound Quality Ratings - Noise Intrusion - Program 3 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (Standard curve and variation #1) and determine which program has more noise intrusion. Participants will be asked to make these ratings while seated in a sound booth. 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 ran 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. | 10 Minutes |
| Sound Quality Ratings - Overall Preference - Program 4 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program they prefer to listen to. Participants will be asked to make these ratings while seated in a sound booth. 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. | 10 Minutes |
| 30 Minutes |
| Sound Quality Ratings - Streaming | Participants will be asked to listen to various streamed stimuli via headphones. They will be asked to toggle between three programs (standard curve, variation #2, and variation #3) and determine which one they prefer the most, which one the prefer the least, and which one they prefer in the middle. Participants will be asked to make these ratings while seated in a sound booth. Scores will be tallied at the end to see which program was constantly the most preferred across the various stimuli. Highers rankings will indicate that the program was preferred more than the other program and lower rankings mean the program was not preferred when compared to the other program. | 1 hour |
| 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. |
| 30803400 | Background | Caswell-Midwinter B, Whitmer WM. Discrimination of Gain Increments in Speech-Shaped Noises. Trends Hear. 2019 Jan-Dec;23:2331216518820220. doi: 10.1177/2331216518820220. |
| 25690777 | Background | Smeds K, Wolters F, Rung M. Estimation of Signal-to-Noise Ratios in Realistic Sound Scenarios. J Am Acad Audiol. 2015 Feb;26(2):183-96. doi: 10.3766/jaaa.26.2.7. |
| 20724358 | Background | Bisgaard N, Vlaming MS, Dahlquist M. Standard audiograms for the IEC 60118-15 measurement procedure. Trends Amplif. 2010 Jun;14(2):113-20. doi: 10.1177/1084713810379609. |
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| NOT COMPLETED |
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| Review of Intake and Hearing Test Result |
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| Break Between Appointments 1 and 2 |
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| Live Sound Quality Ratings |
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| Break Between Appointments 2 and 3 |
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| US Matrix Test Task |
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| Streaming Sound Quality Ratings Task |
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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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| 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 |
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| 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 the hearing loss. Depending on the configuration and severity of the hearing loss dictates if a participant meets the requirements to join a clinical study. Hearing thresholds are measured across various frequencies and for both ears. The configuration of the hearing loss and average of 4 frequencies (500, 1000, 2000, and 4000 Hz (i.e., Pure Tone Average (PTA)) summarizes the severity of a participants hearing loss. | Mean | Full Range | Decibals in Hearing Level (dB HL) |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Sound Quality Ratings - Listening Comfort - Program 1 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program provides increased listening comfort. Participants will be asked to make these ratings while seated in a sound booth. 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 ran 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. | Posted | Mean | Standard Deviation | Mean Preference Counts per Participant | 10 Minutes |
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| Primary | Sound Quality Ratings - Overall Preference - Program 1 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program they prefer to listen to. Participants will be asked to make these ratings while seated in a sound booth. 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. | Posted | Mean | Standard Deviation | Mean Preference Counts per Participant | 10 Minutes |
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| Primary | Sound Quality Ratings - Speech Clarity - Program 1 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program has better speech clarity. Participants will be asked to make these ratings while seated in a sound booth. 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 ran 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. | Posted | Mean | Standard Deviation | Mean Preference Counts per Participant | 10 minutes |
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| Primary | Sound Quality Ratings - Noise Intrusion - Program 1 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (Standard curve and variation #1) and determine which program has more noise intrusion. Participants will be asked to make these ratings while seated in a sound booth. 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 ran 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. | Posted | Mean | Standard Deviation | Mean Preference Counts per Participant | 10 Minutes |
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| Primary | Sound Quality Ratings - Listening Comfort - Program 2 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program provides increased listening comfort. Participants will be asked to make these ratings while seated in a sound booth. 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 ran 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. | Posted | Mean | Standard Deviation | Mean Preference Counts per Participant | 10 Minutes |
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| Primary | Sound Quality Ratings - Overall Preference - Program 2 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program they prefer to listen to. Participants will be asked to make these ratings while seated in a sound booth. 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. | Posted | Mean | Standard Deviation | Mean Preference Counts per Participant | 10 Minutes |
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| Primary | Sound Quality Ratings - Noise Intrusion - Program 2 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (Standard curve and variation #1) and determine which program has more noise intrusion. Participants will be asked to make these ratings while seated in a sound booth. 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 ran 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. | Posted | Mean | Standard Deviation | Mean Preference Counts per Participant | 10 Minutes |
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| Primary | Sound Quality Ratings - Listening Comfort - Program 3 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program provides increased listening comfort. Participants will be asked to make these ratings while seated in a sound booth. 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 ran 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. | Posted | Mean | Standard Deviation | Mean Preference Counts per Participant | 10 Minutes |
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| Primary | Sound Quality Ratings - Overall Preference - Program 3 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program they prefer to listen to. Participants will be asked to make these ratings while seated in a sound booth. 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. | Posted | Mean | Standard Deviation | Mean Preference Counts per Participant | 10 Minutes |
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| Primary | Sound Quality Ratings - Speech Clarity - Program 3 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program has better speech clarity. Participants will be asked to make these ratings while seated in a sound booth. 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 ran 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. | Posted | Mean | Standard Deviation | Mean Preference Counts per Participant | 10 minutes |
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| Primary | Sound Quality Ratings - Noise Intrusion - Program 3 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (Standard curve and variation #1) and determine which program has more noise intrusion. Participants will be asked to make these ratings while seated in a sound booth. 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 ran 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. | Posted | Mean | Standard Deviation | Mean Preference Counts per Participant | 10 Minutes |
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| Primary | Sound Quality Ratings - Overall Preference - Program 4 | Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program they prefer to listen to. Participants will be asked to make these ratings while seated in a sound booth. 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. | Posted | Mean | Standard Deviation | Mean Preference Counts per Participant | 10 Minutes |
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| Secondary | US Matrix Test in Noise Results - dB SNR 50% | Oldenburg Sentence Test (OLSA) sentences were presented to participants while they were aided under the standard curve, aided under variation #1 frequency response curve, and unaided. Participants are presented with sentences from a loudspeaker placed Infront of them and noise from 7 loudspeakers placed around them (8 speakers placed 30 degrees apart from each other). Participants were asked to repeat what they heard. Correct repetition 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 condition (i.e., unaided, aided with the standard curve, and aided with the proposed frequency response curve). decibel signal to noise ratio (dB SNR) at 50% correctness scores were calculated at the end and compared amongst the three conditions. There are no minimum or maximum values, however lower scores indicate better performance. | 1 participants data was removed as they were not accurate in their response and the US Matrix test software could not accurately measure their SRT50 score although mutliple attempts were made. | Posted | Mean | Standard Deviation | dB SNR - (units on a scale) | 30 Minutes |
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| Secondary | Sound Quality Ratings - Streaming | Participants will be asked to listen to various streamed stimuli via headphones. They will be asked to toggle between three programs (standard curve, variation #2, and variation #3) and determine which one they prefer the most, which one the prefer the least, and which one they prefer in the middle. Participants will be asked to make these ratings while seated in a sound booth. Scores will be tallied at the end to see which program was constantly the most preferred across the various stimuli. Highers rankings will indicate that the program was preferred more than the other program and lower rankings mean the program was not preferred when compared to the other program. | Posted | Number | Ratings | 1 hour |
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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 - Live - 2 hours Sound Quality Ratings - Streaming - 1 hour US Matrix Test Task - 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 - Sound Quality Ratings Task - Live | 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. Interventions each participant was exposed to: Standard Curve under Program 1 Variation #1 under Program 1 Standard Curve under Program 2 Variation #1 under Program 2 Standard Curve under Program 3 Variation #1 under Program 3 Standard Curve under Program 4 Variation #1 under Program 4 Variation #2 under Program 5 - Streaming Only Variation #3 under Program 5 - Streaming Only Variation #4under Program 5 - Streaming Only Unaided | 0 | 25 | 0 | 25 | 0 | 25 |
| EG001 | Participants With Hearing Loss - Sound Quality Ratings Task - Streaming | 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. Interventions each participant was exposed to: Standard Curve under Program 1 Variation #1 under Program 1 Standard Curve under Program 2 Variation #1 under Program 2 Standard Curve under Program 3 Variation #1 under Program 3 Standard Curve under Program 4 Variation #1 under Program 4 Variation #2 under Program 5 - Streaming Only Variation #3 under Program 5 - Streaming Only Variation #4under Program 5 - Streaming Only Unaided | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Participants With Hearing Loss - US Matrix Test Task | 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. Interventions each participant was exposed to: Standard Curve under Program 1 Variation #1 under Program 1 Standard Curve under Program 2 Variation #1 under Program 2 Standard Curve under Program 3 Variation #1 under Program 3 Standard Curve under Program 4 Variation #1 under Program 4 Variation #2 under Program 5 - Streaming Only Variation #3 under Program 5 - Streaming Only Variation #4under Program 5 - Streaming Only Unaided | 0 | 25 | 0 | 25 | 0 | 25 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bilal Sheikh - Research Audiologist | Sonova | 2268083260 | bilal.sheikh@sonova.com |
| Mar 5, 2025 |
| Prot_SAP_000.pdf |
| 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 |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| >=65 years |
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| Chi-squared |
| 0.015 |
| Mean Difference (Final Values) |
| 0.544 |
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