Hearing Loss
Conditions
Brief summary
This study will compare different microphone technologies in a noisy environment when the dominant speaker is at the front, back, left, or right side of the listener.
Detailed description
Understanding speech in a noisy environment can be difficult for people with hearing loss even with hearing aids. Hearing aid manufacturers have implanted various methods (i.e., directional micro-phones, noise reduction, noise cancelers) to try to improve the signal-to-noise ratio (SNR) to increase the speech understanding in these difficult listening situations. This study is evaluating different microphone technologies to determine listening effort when speech is to the back or side of the listener in noisy environment.
Interventions
DEVICEPhonak Audeo previous generation hearing aids
Receiver-in-canal (RIC) hearing aids with universal earpieces
DEVICEPhonak Audeo Lumity hearing aids
Receiver-in-canal (RIC) hearing aids with universal earpieces
Sponsors
Sonova AG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants were blinded as to which device they were wearing during the lab testing.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Moderate sensorineural hearing loss * Experienced hearing aid user * Has a significant other/communication partner that can fill out a questionnaire about hearing aid performance during the home trial * Smartphone user for receiving study alerts
Exclusion criteria
* Cognitive impairment * Not willing to wear hearing aid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech in Noise Test | Day 1 of study | A speech in noise test in which participants repeat words which are presented in the presence of background noise. In a 12-speaker array, speech is presented from speakers either on the left side of the participant (-90 degrees) or from behind the participant (180 degrees) while background noise is presented from remaining speakers. Scores are calculated as the number of words correctly repeated and expressed as a percentage. A higher percentage or score is better. |
| Subjective Perception of Listening Effort | Day 1 of study | Following the speech in noise testing in the lab, participants rated their listening effort on a scale from 1 to 10, with 1 = no effort and 10 = a lot of effort. In this case, a lower rating is better as it indicates less perceived listening effort. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Tested With Both Devices. Participants who complete lab testing and home trials with both the comparator devices and the Audeo Lumity devices. | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | All Participants Tested With Both Devices. | — |
|---|---|---|
| Age, Continuous | 75 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 14 Participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
Speech in Noise Test
A speech in noise test in which participants repeat words which are presented in the presence of background noise. In a 12-speaker array, speech is presented from speakers either on the left side of the participant (-90 degrees) or from behind the participant (180 degrees) while background noise is presented from remaining speakers. Scores are calculated as the number of words correctly repeated and expressed as a percentage. A higher percentage or score is better.
Time frame: Day 1 of study
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants Tested With Both Devices. | Speech in Noise Test | Percent correct with Lumity devices | 84.84 percentage of correct responses |
| All Participants Tested With Both Devices. | Speech in Noise Test | Percent correct with comparator devices | 77.16 percentage of correct responses |
p-value: 0.002ANOVA
Primary
Subjective Perception of Listening Effort
Following the speech in noise testing in the lab, participants rated their listening effort on a scale from 1 to 10, with 1 = no effort and 10 = a lot of effort. In this case, a lower rating is better as it indicates less perceived listening effort.
Time frame: Day 1 of study
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants Tested With Both Devices. | Subjective Perception of Listening Effort | Listening effort rating with Lumity devices | 5.82 score on a scale |
| All Participants Tested With Both Devices. | Subjective Perception of Listening Effort | Listening effort rating with comparator devices | 6.82 score on a scale |
p-value: 0.023ANOVA