Hearing Loss, Bilateral, Hearing Loss, Sensorineural
Conditions
Keywords
Hearing Loss, Hearing Aids, Frequency Response Curves
Brief summary
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.
Detailed description
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.
Interventions
DEVICEHearing Aid - Standard Curve
Our current hearing aids which will be programmed to our standard frequency response curve.
DEVICEHearing Aid - Variation #1
Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
DEVICEHearing Aid - Variation #2
Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
DEVICEHearing Aid - Variation #3
Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
DEVICEHearing Aid - Variation #4
Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Sponsors
Sonova AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Streaming Sound Quality Ratings | 60 minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sound Quality Rating - Live - Counts | 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 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. |
| Sound Quality Rating - Live - Preferences | 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. |
| US Matrix Test in Quiet - SRT | 30 Minutes | 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. |
Countries
Canada
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Participants With Hearing Loss | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 23 Participants | — |
| Age, Categorical Between 18 and 65 years | 10 Participants | — |
| Age, Continuous | 67.90 years | — |
| Hearing Thresholds - PTA (500,1000,2000,4000 Hz) | 38.22 Decibals in Hearing Level (dB HL) | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 33 Participants | — |
| Sex: Female, Male Female | 13 Participants | — |
| Sex: Female, Male Male | 20 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 33 |
| other Total, other adverse events | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
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.
Time frame: 60 minutes
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Hearing Loss | Streaming Sound Quality Ratings | Numbe of times Variation 1 was preferred over variation 2 across all genres per participant. | 10.7 Mean Preference Counts per Participant | Standard Error 0.915 |
| Participants With Hearing Loss | Streaming Sound Quality Ratings | Numbe of times Variation 1 was preferred over variation 3 across all genres per participant. | 9.41 Mean Preference Counts per Participant | Standard Error 0.805 |
| Participants With Hearing Loss | Streaming Sound Quality Ratings | Numbe of times Variation 2 was preferred over variation 1 across all genres per participant. | 7.46 Mean Preference Counts per Participant | Standard Error 0.939 |
| Participants With Hearing Loss | Streaming Sound Quality Ratings | Number of times variation 2 was rated higher in sound quality than variation 3 across all samples | 5.91 Mean Preference Counts per Participant | Standard Error 0.588 |
| Participants With Hearing Loss | Streaming Sound Quality Ratings | Numbe of times Variation 3 was preferred over variation 1 across all genres per participant. | 8.32 Mean Preference Counts per Participant | Standard Error 0.815 |
| Participants With Hearing Loss | Streaming Sound Quality Ratings | Numbe of times Variation 3 was preferred over variation 2 across all genres per participant. | 8.05 Mean Preference Counts per Participant | Standard Error 0.757 |
| Participants With Hearing Loss | Streaming Sound Quality Ratings | Numbe of times Variation 1 was rated the same as variation 2 across all genres per participant. | 3.13 Mean Preference Counts per Participant | Standard Error 0.487 |
| Participants With Hearing Loss | Streaming Sound Quality Ratings | Numbe of times Variation 1 was rated the same as variation 3 across all genres per participant. | 3.59 Mean Preference Counts per Participant | Standard Error 0.462 |
| Participants With Hearing Loss | Streaming Sound Quality Ratings | Numbe of times Variation 2 was rated the same as variation 3 across all genres per participant. | 6.73 Mean Preference Counts per Participant | Standard Error 1.17 |
Comparison: This is to see if there is a difference in preference count per participant between Variation #1, Variation #2 and Same counts.p-value: <0.00195% CI: [0.2, 1]ANOVA
Comparison: This is to see if there is a difference between Variation #1 and Variation #2 preference counts per participant.p-value: 0.0295% CI: [0.41, 6.05]t-test, 2 sided
Comparison: This is to see if there is a difference in preference count per participant between Variation #1, Variation #3 and Same counts.p-value: <0.00195% CI: [0.18, 1]ANOVA
Comparison: This is to see if there is a difference between Variation #1 and Variation #3 preference counts per participant.p-value: 0.5495% CI: [-1.36, 3.55]t-test, 2 sided
Comparison: This is to see if there is a difference in preference count per participant between Variation #2, Variation #3, and Same counts.p-value: 0.23195% CI: [0, 1]ANOVA
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.
Time frame: 60 minutes
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Hearing Loss | Sound Quality Rating - Live - Counts | # of times the standard curve was rated higher in preference than variation 4 across samples - Lab | 79 Count of preferences |
| Participants With Hearing Loss | Sound Quality Rating - Live - Counts | # of times the standard curve was rated lower in preference than variation 4 across samples - Lab | 95 Count of preferences |
| Participants With Hearing Loss | Sound Quality Rating - Live - Counts | # of times the standard curve was rated the same as variation 4 in preference across samples - Lab | 46 Count of preferences |
| Participants With Hearing Loss | Sound Quality Rating - Live - Counts | # of times the standard curve was rated higher in preference than variation4 across samples-Outdoors | 86 Count of preferences |
| Participants With Hearing Loss | Sound Quality Rating - Live - Counts | # of times the standard curve was rated lower in preference than variation4 across samples-Outdoors | 104 Count of preferences |
| Participants With Hearing Loss | Sound Quality Rating - Live - Counts | # of times the standard curve was rated the same as variation4 in preference across samples-Outdoors | 30 Count of preferences |
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.
Time frame: 60 minutes
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Hearing Loss | Sound Quality Rating - Live - Preferences | # of participants that had an overall preference toward variation #4 vs. standard curve - Outdoors | 15 Count of preferences |
| Participants With Hearing Loss | Sound Quality Rating - Live - Preferences | # of participants that had an overall preference toward standard curve vs. Variation #4 - Outdoors | 6 Count of preferences |
| Participants With Hearing Loss | Sound Quality Rating - Live - Preferences | # of participants that had no preference toward standard curve vs. Variation #4 - Outdoors | 1 Count of preferences |
p-value: 0.13Chi-squared
p-value: 0.04Chi-squared
Comparison: The number of participants that showed overall preference toward variation #4 vs. the standard curve vs. no preference. - Outdoors.p-value: 0.04Chi-squared
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.
Time frame: 30 Minutes
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Hearing Loss | US Matrix Test in Quiet - SRT | Unaided - Signal to Noise Ratio at 50% correct (SRT50) | 34.1 decibels (dB) | Standard Deviation 9.9 |
| Participants With Hearing Loss | US Matrix Test in Quiet - SRT | Standard Curve - Signal to Noise Ratio at 50% correct (SRT50) | 25.8 decibels (dB) | Standard Deviation 4.3 |
| Participants With Hearing Loss | US Matrix Test in Quiet - SRT | Variation 4 - Signal to Noise Ratio at 50% correct (SRT50) | 26.1 decibels (dB) | Standard Deviation 4.21 |
Comparison: Standard Curve vs Variation #4p-value: <0.00195% CI: [0.1, 1]ANOVA
p-value: 0.85595% CI: [-2.83, 2.35]t-test, 2 sided