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. 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.
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 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.
Interventions
OTHERHearing Aid - Standard Curve under Program 1
Our current hearing aids which will be programmed to our standard frequency response curve.
DEVICEHearing Aid - Variation #1 under Program 1
Hearing aids that will have the frequency response curve #1 adjusted and fit to the participant's hearing loss.
OTHERHearing Aid - Variation #2 under Program 5 - Streaming Only
Our current hearing aids which will be programmed to our standard frequency response curve.
OTHERHearing Aid - Variation #3 under Program 5 - Streaming Only
Hearing aids that will have the frequency response curve #3 adjusted and fit to the participant's hearing loss.
OTHERHearing Aid - Variation #4under Program 5 - Streaming Only
Hearing aids that will have the frequency response curve #4 adjusted and fit to the participant's hearing loss.
OTHERHearing Aid - Standard Curve under Program 2
Our current hearing aids which will be programmed to our standard frequency response curve.
OTHERHearing Aid - Variation #1 under Program 2
Hearing aids that will have the frequency response curve #1 adjusted and fit to the participant's hearing loss.
OTHERHearing Aid - Standard Curve under Program 3
Our current hearing aids which will be programmed to our standard frequency response curve.
OTHERHearing Aid - Variation #1 under Program 3
Hearing aids that will have the frequency response curve #1 adjusted and fit to the participant's hearing loss.
OTHERHearing Aid - Standard Curve under Program 4
Our current hearing aids which will be programmed to our standard frequency response curve.
OTHERHearing Aid - Variation #1 under Program 4
Hearing aids that will have the frequency response curve #1 adjusted and fit to the participant's hearing loss.
OTHERUnaided
No hearing aids worn at all and participants tested as is.
Sponsors
Sonova AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
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 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* N3 - N5 Hearing losses * Healthy 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 days * Willingness to wear different styles of couplings * Willingness to wear binaural fitting * Experienced Users = more than 3 months of hearing aid experience * Ability to travel to Sonova facilities
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 |
|---|---|---|
| Sound Quality Ratings - Overall Preference - Program 4 | 10 Minutes | 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. |
| Sound Quality Ratings - Speech Clarity - Program 3 | 10 minutes | 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. |
| Sound Quality Ratings - Noise Intrusion - Program 3 | 10 Minutes | 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. |
| Sound Quality Ratings - Listening Comfort - Program 1 | 10 Minutes | 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. |
| Sound Quality Ratings - Overall Preference - Program 1 | 10 Minutes | 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. |
| Sound Quality Ratings - Speech Clarity - Program 1 | 10 minutes | 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. |
| Sound Quality Ratings - Noise Intrusion - Program 1 | 10 Minutes | 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. |
| Sound Quality Ratings - Listening Comfort - Program 2 | 10 Minutes | 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. |
| Sound Quality Ratings - Overall Preference - Program 2 | 10 Minutes | 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. |
| Sound Quality Ratings - Noise Intrusion - Program 2 | 10 Minutes | 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. |
| Sound Quality Ratings - Listening Comfort - Program 3 | 10 Minutes | 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. |
| Sound Quality Ratings - Overall Preference - Program 3 | 10 Minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sound Quality Ratings - Streaming | 1 hour | 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. |
| US Matrix Test in Noise Results - dB SNR 50% | 30 Minutes | 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. |
Countries
Canada
Participant flow
Recruitment details
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.
Pre-assignment details
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.
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. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Review of Intake and Hearing Test Result | Removed by Investigator due to hearing loss change and no longer meeting study criteria. | 1 |
Baseline characteristics
| Characteristic | Participants With Hearing Loss | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 18 Participants | — |
| Age, Categorical Between 18 and 65 years | 7 Participants | — |
| Age, Continuous | 67.92 years | — |
| Hearing Thresholds - PTA (500,1000,2000,4000 Hz) | 56 Decibals in Hearing Level (dB HL) | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 25 Participants | — |
| Sex: Female, Male Female | 14 Participants | — |
| Sex: Female, Male Male | 11 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
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.
Time frame: 10 Minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Hearing Loss | Sound Quality Ratings - Listening Comfort - Program 1 | Mean # of times Standard Curve was preferred in terms of listening comfort. | 4.78 Mean Preference Counts per Participant | Standard Deviation 2.49 |
| Participants With Hearing Loss | Sound Quality Ratings - Listening Comfort - Program 1 | Mean # of times Variation #1 curve was preferred in terms of listening comfort. | 6.04 Mean Preference Counts per Participant | Standard Deviation 2.16 |
| Participants With Hearing Loss | Sound Quality Ratings - Listening Comfort - Program 1 | Mean # of times there was no preference between the two curves in terms of listening comfort. | 2.36 Mean Preference Counts per Participant | Standard Deviation 1.6 |
Comparison: This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.p-value: <0.001Chi-squared
Comparison: This is to see if there is a difference between Variation #1 and the standard curve in terms of mean preference counts per participant.p-value: 0.015Chi-squared
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.
Time frame: 10 Minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Hearing Loss | Sound Quality Ratings - Listening Comfort - Program 2 | Mean # of times there was no preference between the two curves in terms of listening comfort. | 1.46 Mean Preference Counts per Participant | Standard Deviation 0.519 |
| Participants With Hearing Loss | Sound Quality Ratings - Listening Comfort - Program 2 | Mean # of times Standard Curve was preferred in terms of listening comfort. | 1.55 Mean Preference Counts per Participant | Standard Deviation 0.82 |
| Participants With Hearing Loss | Sound Quality Ratings - Listening Comfort - Program 2 | Mean # of times Variation #1 curve was preferred in terms of listening comfort. | 1.71 Mean Preference Counts per Participant | Standard Deviation 0.726 |
Comparison: This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.p-value: 0.522Chi-squared
Comparison: This is to see if there is a difference in mean counts between the standard curve and variation #1.p-value: 0.27Chi-squared
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.
Time frame: 10 Minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Hearing Loss | Sound Quality Ratings - Listening Comfort - Program 3 | Mean # of times Standard Curve was preferred in terms of listening comfort. | 1.73 Mean Preference Counts per Participant | Standard Deviation 0.79 |
| Participants With Hearing Loss | Sound Quality Ratings - Listening Comfort - Program 3 | Mean # of times Variation #1 curve was preferred in terms of listening comfort. | 1.54 Mean Preference Counts per Participant | Standard Deviation 0.66 |
| Participants With Hearing Loss | Sound Quality Ratings - Listening Comfort - Program 3 | Mean # of times there was no preference between the two curves in terms of listening comfort. | 2.00 Mean Preference Counts per Participant | Standard Deviation 1 |
Comparison: This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.p-value: 0.16Chi-squared
Comparison: This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.p-value: 0.37Chi-squared
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.
Time frame: 10 Minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Hearing Loss | Sound Quality Ratings - Noise Intrusion - Program 1 | Mean # of times Standard Curve was preferred in terms of noise intrusion | 3.84 Mean Preference Counts per Participant | Standard Deviation 2.81 |
| Participants With Hearing Loss | Sound Quality Ratings - Noise Intrusion - Program 1 | Mean # of times variation #1 was preferred in terms of noise intrusion | 6.21 Mean Preference Counts per Participant | Standard Deviation 2.18 |
| Participants With Hearing Loss | Sound Quality Ratings - Noise Intrusion - Program 1 | Mean # of times there was no preference between the two curves in terms of noise intrusion | 2.72 Mean Preference Counts per Participant | Standard Deviation 1.41 |
Comparison: This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.p-value: <0.001Chi-squared
Comparison: This is to see if there is a difference in mean preference counts between the standard curve and variation #1.p-value: 0.0013Chi-squared
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.
Time frame: 10 Minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Hearing Loss | Sound Quality Ratings - Noise Intrusion - Program 2 | Mean # of times Standard Curve was preferred in terms of noise intrusion | 1.45 Mean Preference Counts per Participant | Standard Deviation 0.82 |
| Participants With Hearing Loss | Sound Quality Ratings - Noise Intrusion - Program 2 | Mean # of times variation #1 was preferred in terms of noise intrusion | 1.77 Mean Preference Counts per Participant | Standard Deviation 0.83 |
| Participants With Hearing Loss | Sound Quality Ratings - Noise Intrusion - Program 2 | Mean # of times there was no preference between the two curves in terms of noise intrusion | 1.5 Mean Preference Counts per Participant | Standard Deviation 0.52 |
Comparison: This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.p-value: 0.52Chi-squared
Comparison: This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.p-value: 0.26Chi-squared
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.
Time frame: 10 Minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Hearing Loss | Sound Quality Ratings - Noise Intrusion - Program 3 | Mean # of times Standard Curve was preferred in terms of noise intrusion | 1.75 Mean Preference Counts per Participant | Standard Deviation 0.75 |
| Participants With Hearing Loss | Sound Quality Ratings - Noise Intrusion - Program 3 | Mean # of times variation #1 was preferred in terms of noise intrusion | 1.50 Mean Preference Counts per Participant | Standard Deviation 0.65 |
| Participants With Hearing Loss | Sound Quality Ratings - Noise Intrusion - Program 3 | Mean # of times there was no preference between the two curves in terms of noise intrusion | 1.64 Mean Preference Counts per Participant | Standard Deviation 0.81 |
Comparison: This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.p-value: 0.86Chi-squared
Comparison: This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.p-value: 1Chi-squared
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.
Time frame: 10 Minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Hearing Loss | Sound Quality Ratings - Overall Preference - Program 1 | Mean # of times Standard Curve was preferred in terms of overall preference. | 4.83 Mean Preference Counts per Participant | Standard Deviation 2.62 |
| Participants With Hearing Loss | Sound Quality Ratings - Overall Preference - Program 1 | Mean # of times Variation #1 curve was preferred in terms of overall preference. | 5.85 Mean Preference Counts per Participant | Standard Deviation 2.28 |
| Participants With Hearing Loss | Sound Quality Ratings - Overall Preference - Program 1 | Mean # of times there was no preference between the two curves in terms of overall preference. | 2.33 Mean Preference Counts per Participant | Standard Deviation 1.76 |
Comparison: This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.p-value: <0.001Chi-squared
Comparison: This is to see if there is a difference in mean preference counts between the standard curve and variation #1.p-value: 0.03569Chi-squared
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.
Time frame: 10 Minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Hearing Loss | Sound Quality Ratings - Overall Preference - Program 2 | Mean # of times Standard Curve was preferred in terms of overall preference. | 1.5 Mean Preference Counts per Participant | Standard Deviation 0.85 |
| Participants With Hearing Loss | Sound Quality Ratings - Overall Preference - Program 2 | Mean # of times Variation #1 curve was preferred in terms of overall preference. | 1.79 Mean Preference Counts per Participant | Standard Deviation 0.69 |
| Participants With Hearing Loss | Sound Quality Ratings - Overall Preference - Program 2 | Mean # of times there was no preference between the two curves in terms of overall preference. | 1.54 Mean Preference Counts per Participant | Standard Deviation 0.66 |
Comparison: This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.p-value: 0.28Chi-squared
Comparison: This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.p-value: 0.11Chi-squared
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.
Time frame: 10 Minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Hearing Loss | Sound Quality Ratings - Overall Preference - Program 3 | Mean # of times Standard Curve was preferred in terms of overall preference. | 1.80 Mean Preference Counts per Participant | Standard Deviation 0.77 |
| Participants With Hearing Loss | Sound Quality Ratings - Overall Preference - Program 3 | Mean # of times Variation #1 curve was preferred in terms of overall preference. | 1.54 Mean Preference Counts per Participant | Standard Deviation 0.66 |
| Participants With Hearing Loss | Sound Quality Ratings - Overall Preference - Program 3 | Mean # of times there was no preference between the two curves in terms of overall preference. | 2.17 Mean Preference Counts per Participant | Standard Deviation 0.98 |
Comparison: This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.p-value: 0.08Chi-squared
Comparison: This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.p-value: 0.31Chi-squared
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.
Time frame: 10 Minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Hearing Loss | Sound Quality Ratings - Overall Preference - Program 4 | Mean # of times Standard Curve was preferred in terms of overall preference. | 1.30 Mean Preference Counts per Participant | Standard Deviation 0.83 |
| Participants With Hearing Loss | Sound Quality Ratings - Overall Preference - Program 4 | Mean # of times Variation #1 curve was preferred in terms of overall preference. | 1.60 Mean Preference Counts per Participant | Standard Deviation 0.51 |
| Participants With Hearing Loss | Sound Quality Ratings - Overall Preference - Program 4 | Mean # of times there was no preference between the two curves in terms of overall preference. | 1.94 Mean Preference Counts per Participant | Standard Deviation 0.92 |
Comparison: This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.p-value: 0.009Chi-squared
Comparison: This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.p-value: 0.61Chi-squared
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.
Time frame: 10 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Hearing Loss | Sound Quality Ratings - Speech Clarity - Program 1 | Mean # of times Standard Curve was preferred in terms of speech clarity | 3.24 Mean Preference Counts per Participant | Standard Deviation 1.56 |
| Participants With Hearing Loss | Sound Quality Ratings - Speech Clarity - Program 1 | Mean # of times Variation #1 was preferred in terms of speech clarity | 3.00 Mean Preference Counts per Participant | Standard Deviation 1.27 |
| Participants With Hearing Loss | Sound Quality Ratings - Speech Clarity - Program 1 | Mean # of times there was no preference between the two curves in terms of speech clarity | 2.73 Mean Preference Counts per Participant | Standard Deviation 1.8 |
Comparison: This is to see if there is a difference in mean preference counts per participant between the standard curve, variation #1, and no preference counts.p-value: 0.069Chi-squared
Comparison: This is to see if there is a difference in mean preference counts between the standard curve and variation #1.p-value: 0.6976Chi-squared
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.
Time frame: 10 minutes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Hearing Loss | Sound Quality Ratings - Speech Clarity - Program 3 | Mean # of times Standard Curve was preferred in terms of speech clarity | 1.73 Mean Preference Counts per Participant | Standard Deviation 0.79 |
| Participants With Hearing Loss | Sound Quality Ratings - Speech Clarity - Program 3 | Mean # of times Variation #1 was preferred in terms of speech clarity | 1.67 Mean Preference Counts per Participant | Standard Deviation 0.7 |
| Participants With Hearing Loss | Sound Quality Ratings - Speech Clarity - Program 3 | Mean # of times there was no preference between the two curves in terms of speech clarity | 1.90 Mean Preference Counts per Participant | Standard Deviation 0.87 |
Comparison: This is to see if there is a difference in mean counts per participant between the standard curve, variation #1, and no preference counts.p-value: 0.21Chi-squared
Comparison: This is to see if there is a difference in mean counts per participant between the standard curve and variation #1.p-value: 0.085Chi-squared
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.
Time frame: 1 hour
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With Hearing Loss | Sound Quality Ratings - Streaming | Count of times Variation #2 was rated in the middle. | 56 Ratings |
| Participants With Hearing Loss | Sound Quality Ratings - Streaming | Count of times Variation #3 was rated in the middle. | 83 Ratings |
| Participants With Hearing Loss | Sound Quality Ratings - Streaming | Count of times Variation #4 was rated in the middle. | 89 Ratings |
| Participants With Hearing Loss | Sound Quality Ratings - Streaming | Count of times Variation #2 was rated the lowest. | 128 Ratings |
| Participants With Hearing Loss | Sound Quality Ratings - Streaming | Count of times Variation #3 was rated the lowest. | 102 Ratings |
| Participants With Hearing Loss | Sound Quality Ratings - Streaming | Count of times Variation #4 was rated the lowest. | 74 Ratings |
| Participants With Hearing Loss | Sound Quality Ratings - Streaming | Count of times Variation # 2 was rated the highest. | 120 Ratings |
| Participants With Hearing Loss | Sound Quality Ratings - Streaming | Count of times Variation #3 was rated the highest. | 119 Ratings |
| Participants With Hearing Loss | Sound Quality Ratings - Streaming | Count of times Variation #4 was rated the highest | 65 Ratings |
Comparison: This is to see if there is a difference in most preferred program counts between variations #2, #3, and #4p-value: <0.01Chi-squared
Comparison: This is to see if there is a difference in most preferred program counts between variations #2 and #3.p-value: 0.94Chi-squared
Comparison: This is to see if there is a difference in most preferred program counts between variations #2 and #4p-value: 0.94Chi-squared
Comparison: This is to see if there is a difference in somewhat preferred (i.e. rated in the middle) program counts between variations #2, #3, and #4p-value: 0.017Chi-squared
Comparison: This is to see if there is a difference in somewhat preferred (i.e. rated in the middle) program counts between variations #2 and #3.p-value: 0.02Chi-squared
Comparison: This is to see if there is a difference in somewhat preferred (i.e. rated in the middle) program counts between variations #2 and #4p-value: 0.006Chi-squared
Comparison: This is to see if there is a difference in the least preferred program counts between variations #2, #3, and #4p-value: <0.0001Chi-squared
Comparison: This is to see if there is a difference in the least preferred program counts between variations #2 and #3p-value: 0.08Chi-squared
Comparison: This is to see if there is a difference in the least preferred program counts between variations #2 and #4p-value: <0.001Chi-squared
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.
Time frame: 30 Minutes
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Hearing Loss | US Matrix Test in Noise Results - dB SNR 50% | Hearing Aid - Variation # 1 - Mean SRT50% Score | -4.69 dB SNR - (units on a scale) | Standard Deviation 2.35 |
| Participants With Hearing Loss | US Matrix Test in Noise Results - dB SNR 50% | Hearing Aid - Standard Curve - Mean SRT50% Score | -5.38 dB SNR - (units on a scale) | Standard Deviation 2.15 |
| Participants With Hearing Loss | US Matrix Test in Noise Results - dB SNR 50% | Hearing Aid - Unaided - Mean SRT50% Score | -0.85 dB SNR - (units on a scale) | Standard Deviation 4.7 |
Comparison: This is to see if there is a difference in mean SRT50 scores between the standard curve, variation #1, and no preference counts.p-value: <0.00195% CI: [0.11, 1]ANOVA
Comparison: This is to see if there is a difference in SRT 50 scores between the standard curve and variation #1.p-value: 0.35795% CI: [0, 1]ANOVA