Hearing Loss, Sensorineural
Conditions
Keywords
hearing aids, directional microphones, cognition, compression
Brief summary
The goal of this project is to determine whether the selection of hearing aid settings should be based in part on an individual's cognitive characteristics (specifically, working memory). We anticipate the outcomes of this study to be applicable to realistic listening conditions.
Detailed description
Hearing aids have specialized features to improve access to sounds for the hearing-impaired listener. The choice of appropriate hearing aid settings is integral to the hearing rehabilitative process. Researchers and clinicians have been influenced by previous work showing that individual cognitive abilities, including working memory, are associated with hearing aid benefit, especially in adverse listening conditions. However, previous research is limited to omnidirectional microphone settings and unrealistic listening conditions. Such conditions fail to recognize that most hearing aids are fit with directional processing that may improve the listening environment, and that typical environments contain speech and noise signals in a range of spatial locations. Therefore, the broad goal of this research is to understand how patient variables interact with hearing aid signal processing in realistic listening conditions in order to effectively treat hearing-impaired individuals in communications situations that are most important to them.
Interventions
DEVICEHearing aid
Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The participant will be blinded to the hearing aid features being adjusted. The order of presentation of the hearing aid features will be randomized across participants, using a Latin-Square design. The outcomes assessor(s) (who score speech intelligibility) will also be blinded to the conditions.
Intervention model description
Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \> =18 years of age; any sex * Sensorineural hearing loss with pure-tone thresholds between 25-70 decibel hearing level (dB HL) at octave frequencies between 250 and 3000 Hz * Speak English as their primary language * Normal or corrected-to-normal vision (\<=20/50) * Participants will be in good health (self-report)
Exclusion criteria
* Clinically significant unstable or progressive medical conditions * Participants who score \< 23 on the cognitive screening test (Montreal Cognitive Assessment) * Evidence of conductive hearing loss or middle ear issues * Significant history of otologic or neurologic disorders * Evidence of significant asymmetry between ears * Non-English-speaking or non-native English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech Intelligibility (Percent Correct Scores) | ~20 mins for each intervention over the course of 1-2 days | Listeners will listen to and repeat recorded low-context sentences mixed with noise from different spatial locations. Speech intelligibility will be measured immediately following hearing aid fitting. Scoring is determined by percentage of words repeated correctly. Scores range from 0-100% (higher score indicates better performance). This task may take up to 1-2 visits (\ 2 hours each) for different combinations of hearing aid features. The device will only be worn in the laboratory for the duration of the experimental task and will be retrieved by the investigator at the end of each visit. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the local community in the Chicago area
Participants by arm
| Arm | Count |
|---|---|
| Hearing Aid Setting Hearing aid features presented in this arm include omnidirectional microphone settings, directional microphone settings, fast-acting compression, and slow-acting compression
Hearing aid: Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality. | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | Hearing Aid Setting |
|---|---|
| Age, Continuous | 72.76 years STANDARD_DEVIATION 7.32 |
| Decibel Hearing Level | 38.38 Decibel Hearing Level STANDARD_DEVIATION 9.67 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 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 | 0 Participants |
| Race (NIH/OMB) White | 42 Participants |
| Region of Enrollment United States | 42 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 21 Participants |
| Working Memory Capacity: Percentage of words recalled correctly | 44.16 Percentage STANDARD_DEVIATION 11.35 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Speech Intelligibility (Percent Correct Scores)
Listeners will listen to and repeat recorded low-context sentences mixed with noise from different spatial locations. Speech intelligibility will be measured immediately following hearing aid fitting. Scoring is determined by percentage of words repeated correctly. Scores range from 0-100% (higher score indicates better performance). This task may take up to 1-2 visits (\ 2 hours each) for different combinations of hearing aid features. The device will only be worn in the laboratory for the duration of the experimental task and will be retrieved by the investigator at the end of each visit.
Time frame: ~20 mins for each intervention over the course of 1-2 days
Population: A total of 42 participants were tested for the study. The study design was a full factorial design where each participant completed the outcome measures with all 4 settings in sub-studies 1 \& 2. In Sub-study 3, the outcome measures were completed with Settings 1 \& 3 only. Due to an error in assigning settings, 1 participant each did not listen with settings 1 \& 3 in sub-study 1; 1 participant did not listen with Setting 3 in sub-study 3.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Setting 1 | Speech Intelligibility (Percent Correct Scores) | 0.55 percentage of words correct |
| Setting 2 | Speech Intelligibility (Percent Correct Scores) | 0.59 percentage of words correct |
| Setting 3 | Speech Intelligibility (Percent Correct Scores) | 0.70 percentage of words correct |
| Setting 4 | Speech Intelligibility (Percent Correct Scores) | 0.80 percentage of words correct |
p-value: 0.529195% CI: [-0.04075, 0.02095]Mixed Models Analysis
p-value: <0.00195% CI: [0.0988, 0.1671]Mixed Models Analysis
p-value: <0.000195% CI: [0.166, 0.2371]Mixed Models Analysis
Comparison: A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)p-value: 0.242Mixed Models Analysis
Comparison: A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after controlling for age and degree of hearing loss (decibel hearing level)p-value: 0.242Mixed Models Analysis
Comparison: A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).p-value: 0.242Mixed Models Analysis
Comparison: A linear mixed model was used to assess whether there was an effect of working memory on the primary outcome measure (speech intelligibility) after accounting for age and degree of hearing loss (decibel hearing level).p-value: 0.242Mixed Models Analysis