Hearing Loss
Conditions
Brief summary
Listeners will conduct sound quality ratings of recordings talkers in a moving car processed using three different microphone processing strategies: an investigational adaptive directional microphone, an omnidirectional microphone and a fixed directional microphone. Participants will listen to the recordings streamed via commercially-available and individually-prescribed hearing aids, and conduct ratings onsite in the lab. The procedure will involve a training session and within-subject repeated measures. Stimuli will be randomized.
Interventions
DEVICEInvestigational adaptive directional microphone strategy
A receiver-in-canal hearing aid developed by the Study Sponsor used with the investigational adaptive directional microphone strategy that is expected to improve sound quality of speech in a car.
DEVICEComparator omnidirectional microphone strategy
A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator omnidirectional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.
DEVICEComparator fixed directional microphone strategy
A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator fixed directional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.
Sponsors
Sonova Canada Inc.
Sonova AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Hearing aid processing settings are randomized and double blinded.
Intervention model description
A single cohort of participants will receive and be assessed in all treatment/intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Adults (18-99 years) with ≥3 months hearing aid experience * binaural, symmetric, sensorineural N2 (mild) to N5 (severe) hearing loss * fluent in English
Exclusion criteria
* children/teenagers * normal hearing or hearing loss exceeding N5 (severe) by 10 dB
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech Clarity | Up to 6 hours over 3 2-hour sessions | The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to Please rate the clarity of speech. Speech clarity ratings will be measured on a 100-point continuous slider from worst to best (0-Very unclear, 25- Unclear, 50-Slightly clear, 75-Clear, 100-Very clear). Speech clarity ratings are expected to be impacted by how intelligible the speech is. Participants will rate and compare speech clarity between the investigational and comparator features. |
| Noise Annoyance | Up to 6 hours over 3 2-hour sessions | The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to Please rate how annoying the noise is. Noise annoyance ratings will be measured on a 100-point continuous slider from worst to best (0- Extremely annoying, 25-Very annoying, 50-Moderately annoying, 75-Slightly annoying, 100-Not at all annoying). Noise annoyance ratings are expected to be impacted by how bothersome the background noise in the recordings is. Participants will rate and compare noise annoyance between the investigational and comparator features. |
| Spatialization | Up to 6 hours over 3 2-hour sessions | The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to Please rate your confidence that the talker is in \[a location\], with the local being either passenger of rear left. Spatialization ratings will be measured on a 100-point continuous slider from worst to best (0-I don't know where the talker is, 25-The talker might be to my \[location\], 50-The talker is probably to my \[location\], 75-The talker is to my \[location\], 100-The talker is definitely to my \[location\]). Spatialization ratings are expected to be impacted by how well the recordings preserve spatial perception. Participants will rate and compare spatialization between the investigational and comparator features. |
| Transition Annoyance | Up to 6 hours over 3 2-hour sessions | The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to Please rate how annoying the transitions are. Transitions annoyance ratings will be measured on a 100-point continuous slider from worst to best (0-Extremely annoying, 25-Very annoying, 50-Moderately annoying, 75-Slightly annoying, 100-Not at all annoying). Transition annoyance ratings are expected to be influenced by presence of unexpected sounds or transitions that occur in different microphone modes and different listening situations. Participants will rate and compare transition annoyance between the investigational and comparator features. |
| Overall Impression | Up to 6 hours over 3 2-hour sessions | The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to All things considered, please rate overall preferences. Overall preferences ratings will be measured on a 100-point continuous slider from worst to best (0-Bad, 25-Poor, 50-Fair, 75-Good, 100-Excellent). Overall impression ratings are expected to be impacted by participants' overall preferences for the different stimuli. Participants will rate and compare overall impression between the investigational and comparator features. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants With Hearing Loss. Participants with hearing loss.
Investigational adaptive directional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the investigational adaptive directional microphone strategy that is expected to improve sound quality of speech in a car.
Comparator omnidirectional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator omnidirectional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.
Comparator fixed directional microphone strategy: A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator fixed directional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Participants With Hearing Loss. |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 68 years STANDARD_DEVIATION 8.2 |
| Hearing loss severity Mild | 15 Participants |
| Hearing loss severity Moderate | 3 Participants |
| Hearing loss severity Moderate-Severe | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 20 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Canada | 20 Participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Noise Annoyance
The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to Please rate how annoying the noise is. Noise annoyance ratings will be measured on a 100-point continuous slider from worst to best (0- Extremely annoying, 25-Very annoying, 50-Moderately annoying, 75-Slightly annoying, 100-Not at all annoying). Noise annoyance ratings are expected to be impacted by how bothersome the background noise in the recordings is. Participants will rate and compare noise annoyance between the investigational and comparator features.
Time frame: Up to 6 hours over 3 2-hour sessions
Population: Two participants' data were omitted due to their results suggesting that they did not understand the task.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Hearing Loss. | Noise Annoyance | Investigational adaptive directional microphone strategy | 71.1 units on a scale | Standard Error 3.25 |
| Participants With Hearing Loss. | Noise Annoyance | Comparator omnidirectional microphone strategy | 61.4 units on a scale | Standard Error 3.25 |
| Participants With Hearing Loss. | Noise Annoyance | Comparator fixed directional microphone strategy | 60.0 units on a scale | Standard Error 3.25 |
Comparison: Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.p-value: <0.05ANOVA
Primary
Overall Impression
The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to All things considered, please rate overall preferences. Overall preferences ratings will be measured on a 100-point continuous slider from worst to best (0-Bad, 25-Poor, 50-Fair, 75-Good, 100-Excellent). Overall impression ratings are expected to be impacted by participants' overall preferences for the different stimuli. Participants will rate and compare overall impression between the investigational and comparator features.
Time frame: Up to 6 hours over 3 2-hour sessions
Population: Two participants' data were omitted due to their results suggesting that they did not understand the task.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Hearing Loss. | Overall Impression | Investigational adaptive directional microphone strategy | 61 units on a scale | Standard Error 2.8 |
| Participants With Hearing Loss. | Overall Impression | Comparator omnidirectional microphone strategy | 58.7 units on a scale | Standard Error 2.8 |
| Participants With Hearing Loss. | Overall Impression | Comparator fixed directional microphone strategy | 40.6 units on a scale | Standard Error 2.8 |
Comparison: Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.p-value: <0.05ANOVA
Primary
Spatialization
The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to Please rate your confidence that the talker is in \[a location\], with the local being either passenger of rear left. Spatialization ratings will be measured on a 100-point continuous slider from worst to best (0-I don't know where the talker is, 25-The talker might be to my \[location\], 50-The talker is probably to my \[location\], 75-The talker is to my \[location\], 100-The talker is definitely to my \[location\]). Spatialization ratings are expected to be impacted by how well the recordings preserve spatial perception. Participants will rate and compare spatialization between the investigational and comparator features.
Time frame: Up to 6 hours over 3 2-hour sessions
Population: Two participants' data were omitted due to their results suggesting that they did not understand the task.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Hearing Loss. | Spatialization | Investigational adaptive directional microphone strategy | 78.2 units on a scale | Standard Error 6.42 |
| Participants With Hearing Loss. | Spatialization | Comparator omnidirectional microphone strategy | 77.7 units on a scale | Standard Error 6.42 |
| Participants With Hearing Loss. | Spatialization | Comparator fixed directional microphone strategy | 50.5 units on a scale | Standard Error 6.42 |
Comparison: Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.p-value: <0.05ANOVA
Primary
Speech Clarity
The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to Please rate the clarity of speech. Speech clarity ratings will be measured on a 100-point continuous slider from worst to best (0-Very unclear, 25- Unclear, 50-Slightly clear, 75-Clear, 100-Very clear). Speech clarity ratings are expected to be impacted by how intelligible the speech is. Participants will rate and compare speech clarity between the investigational and comparator features.
Time frame: Up to 6 hours over 3 2-hour sessions
Population: Two participants' data were omitted due to their results suggesting that they did not understand the task.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Hearing Loss. | Speech Clarity | Investigational adaptive directional microphone strategy | 77.2 units on a scale | Standard Error 3.7 |
| Participants With Hearing Loss. | Speech Clarity | Comparator omnidirectional microphone strategy | 76.6 units on a scale | Standard Error 3.7 |
| Participants With Hearing Loss. | Speech Clarity | Comparator fixed directional microphone strategy | 63.6 units on a scale | Standard Error 3.7 |
Comparison: Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.p-value: <0.05ANOVA
Primary
Transition Annoyance
The sound quality ratings will be conducted via a computer-based questionnaire that contains sound samples that participants listen to and rate. Sound quality rating scales are continuous and range from 0 (worst) to 100 (best) with 5 descriptors unique to the dimension at 5 intervals on the scale (0, 25, 50, 75, 100) Participants will be instructed to Please rate how annoying the transitions are. Transitions annoyance ratings will be measured on a 100-point continuous slider from worst to best (0-Extremely annoying, 25-Very annoying, 50-Moderately annoying, 75-Slightly annoying, 100-Not at all annoying). Transition annoyance ratings are expected to be influenced by presence of unexpected sounds or transitions that occur in different microphone modes and different listening situations. Participants will rate and compare transition annoyance between the investigational and comparator features.
Time frame: Up to 6 hours over 3 2-hour sessions
Population: Two participants' data were omitted due to their results suggesting that they did not understand the task. The fixed directional outcome measure is not included for the transition annoyance comparator since that program does not contain transitions that can be rated and compared to the other test conditions.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Hearing Loss. | Transition Annoyance | Investigational adaptive directional microphone strategy | 71.7 units on a scale | Standard Error 3.89 |
| Participants With Hearing Loss. | Transition Annoyance | Comparator omnidirectional microphone strategy | 74.1 units on a scale | Standard Error 3.89 |
Comparison: Previous research with subjective ratings has repeatedly shown that data collected with 15-25 participants can yield significant results.p-value: <0.05ANOVA