Hearing Impairment, Sensorineural
Conditions
Keywords
Auditory Training
Brief summary
Although hearing aids are the most common treatment for hearing loss, and have the potential to help seniors stay active and productive, almost 50% of them who receive hearing aids rarely if ever use them, a state of affairs sometimes referred to as the hearing aid in the drawer syndrome. clEAR's customized auditory brain training has been shown to be effective in improving adults' abilities to recognize speech, in reducing their perceptual effort associated with listening with a hearing loss, and in increasing their confidence to engage in everyday conversations. In the proposed research, we will determine whether older adults who receive hearing aids for the first time report higher satisfaction with their new hearing aids and have longer daily use time as a result of having completed clEAR's auditory brain training program for new hearing aid users.
Detailed description
Auditory training as the potential to dramatically affect older persons' adjustment to a new hearing aid and to maximize the benefits they receive from wearing one. In turn, by wearing hearing aids, they experience easier and more successful communication patterns. They enhance their ability to engage in everyday conversations and will be able to become more socially involved with their family and friends. In this study we will try to determine the extent to which web-based clEAR auditory brain training, with concomitant support from a clEAR in-house audiologist, affects satisfaction with new hearing aids and increases daily use time. The study will include thirty adults over the age of 60 years who have received hearing aids for the first time. After an adjustment period, half will complete clEAR's auditory brain training program right away and the other half will complete it after a delay period, and both will complete a control condition. To establish the level of feasibility and clinical utility. We will measure hearing aid satisfaction, benefit ratings, and hearing aid use time.
Interventions
BEHAVIORALAuditory Brian Training Games/Activities
Game-based activities that encourage listening to words and sentences in noisy situations. Participants will receive subscriptions to the clEAR online auditory training activities and recommended protocol for those who recently received new hearing aids.
Sponsors
National Institute on Aging (NIA)
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Masking description
Participants are unaware if they are in the late or early intervention group.
Intervention model description
All participants experience the same interventions and assessments. Subjects are divided into either early or late intervention groups.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Must be a native English speaker * Must have a mild to severe bilateral sensorineural hearing loss * Must be a candidate for new hearing aid(s) (have never used hearing aids)
Exclusion criteria
* Cognitive impairment or any factors that would prohibit a participant from completing questionnaires * Cognitive or speech production factors that would prohibit a participant from repeating words during a speech perception test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hearing Aid Satisfaction After Auditory Training | Three weeks after hearing aid fitting and after completing the four week training protocol. | The Client Orientated Scale of Improvement (COSI), a subjective measure of improvement on self-defined goals. The scale is relative to a baseline assessed before wearing hearing aids. For each goal participants select from a scale of improvement including Worse (-1), No Difference (0), Slightly Better (+1), Better (+2), and Much Better (+3). Positive values between one and three indicate improvement, negative values indicate that the self-defined goals got worse, and zero is no improvement. COSI scores were assessed before and after participants used the Amptify DTx. The outcome measure reported is the difference between scores before and scores after using the Amptify DTx. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percent Words Correct on Speech Perception Measures After Auditory Training | At the time of hearing aid fitting (baseline), three weeks after hearing aid fitting, and after completing the four week training protocol. | The NU-6 is a standard clinical assessment of word discrimination. Lists consist of 50 words in quiet and were presented through the Amptify DTx while wearing the hearing aid. NU-6 scores are in percent words correctly identified. Scores reported here are the difference between scores measured before and after completing the Amptify DTx. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Amptify First The Amptify First group received the following order:
1. Hearing aid adjustment period (2 weeks)
2. The Amptify DTx curriculum, auditory training, and live coaching (4 weeks)
3. Watch closed caption TV for 20 minutes each day (4 weeks) | 14 |
| Amptify Second The Amptify First group received the following order:
1. Hearing aid adjustment period (2 weeks)
2. Watch closed caption TV for 20 minutes each day (4 weeks)
3. The Amptify DTx curriculum, auditory training, and live coaching (4 weeks) | 14 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | participant did not complete protocol by not training or not wearing aids. | 1 | 1 |
Baseline characteristics
| Characteristic | Amptify Second | Total | Amptify First |
|---|---|---|---|
| Age, Continuous | 70.3 Years STANDARD_DEVIATION 5.5 | 72.6 Years STANDARD_DEVIATION 6.6 | 74.8 Years STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 27 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Pure-Tone-Average Left Ear | 35.2 Sound Level in dB(HL) STANDARD_DEVIATION 9.1 | 33.5 Sound Level in dB(HL) STANDARD_DEVIATION 10.4 | 32.5 Sound Level in dB(HL) STANDARD_DEVIATION 7.3 |
| Pure-Tone-Average Right Ear | 31.7 Sound Level in dB(HL) STANDARD_DEVIATION 11.7 | 31.4 Sound Level in dB(HL) STANDARD_DEVIATION 9.8 | 30.4 Sound Level in dB(HL) STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 27 Participants | 13 Participants |
| Region of Enrollment United States | 14 participants | 28 participants | 14 participants |
| Sex: Female, Male Female | 7 Participants | 12 Participants | 5 Participants |
| Sex: Female, Male Male | 7 Participants | 16 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
Change in Hearing Aid Satisfaction After Auditory Training
The Client Orientated Scale of Improvement (COSI), a subjective measure of improvement on self-defined goals. The scale is relative to a baseline assessed before wearing hearing aids. For each goal participants select from a scale of improvement including Worse (-1), No Difference (0), Slightly Better (+1), Better (+2), and Much Better (+3). Positive values between one and three indicate improvement, negative values indicate that the self-defined goals got worse, and zero is no improvement. COSI scores were assessed before and after participants used the Amptify DTx. The outcome measure reported is the difference between scores before and scores after using the Amptify DTx.
Time frame: Three weeks after hearing aid fitting and after completing the four week training protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amptify First | Change in Hearing Aid Satisfaction After Auditory Training | 1.9 units on a scale | Standard Deviation 0.7 |
| Amptify Second | Change in Hearing Aid Satisfaction After Auditory Training | 1.7 units on a scale | Standard Deviation 0.9 |
p-value: =0.269ANOVA
Primary
Change in Hearing Aid Satisfaction After Auditory Training
The International Outcome Inventory for Hearing Aids (IOI-HA) is a hearing aid satisfaction questionnaire that averages a series of seven questions on a five-point scale (0-5 possible points of improvement). IOI-HA scores were assessed before and after participants used the Amptify DTx. The outcome measure reported is the difference between scores before and scores after using the Amptify DTx. Higher values between 1 and 5 indicate more relative satisfaction.
Time frame: Three weeks after hearing aid fitting and after completing the four week training protocol.
Population: Two participants in the Amptify First group and one participant in the Amptify second group did not complete the first IOI-HA questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amptify First | Change in Hearing Aid Satisfaction After Auditory Training | 1.1 units on a scale | Standard Deviation 0.4 |
| Amptify Second | Change in Hearing Aid Satisfaction After Auditory Training | 0.1 units on a scale | Standard Deviation 0.3 |
p-value: =0.401ANOVA
Primary
Change in Hearing Aid Satisfaction After Auditory Training
Abbreviated Profile of Hearing Aid Benefit (APHAB) is common clinical questionnaire for determining hearing aid benefit using a series of 24 questions on a seven-point scale (A-G; the scale is then converted to percent of time from 1% (Never) to 99% (Always) and 50% means half of the time). Hearing aid benefit is calculated as the difference between the performance with a hearing and and performance without a hearing aid. More positive values indicate more benefit.
Time frame: Three weeks after hearing aid fitting and after completing the four week training protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amptify First | Change in Hearing Aid Satisfaction After Auditory Training | 17.4 score on a scale | Standard Deviation 13.4 |
| Amptify Second | Change in Hearing Aid Satisfaction After Auditory Training | 19.4 score on a scale | Standard Deviation 12.3 |
p-value: =0.968ANOVA
Primary
Change in Hearing Aid Satisfaction After Auditory Training
The Speech, Spatial and Qualities of Hearing Scale (SSQ-12) is a subjective tool or assessing the quality of the sound from a hearing aid using a 12-item questionnaire. Questions focus on how well the participant could hear in various situations. The responses range on a scale from Not At All (0) to Perfectly (10). Higher values indicate better sound quality.
Time frame: Three weeks after hearing aid fitting and after completing the four week training protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amptify First | Change in Hearing Aid Satisfaction After Auditory Training | 0.7 units on a scale | Standard Deviation 2.7 |
| Amptify Second | Change in Hearing Aid Satisfaction After Auditory Training | 0.5 units on a scale | Standard Deviation 2.1 |
p-value: =0.392ANOVA
Primary
Change in Hearing Aid Satisfaction After Auditory Training
Daily use (in hours/day) is logged by the participant. Improvement is indicated by an increase in the amount of time the participant uses the hearing aid each day.
Time frame: Three weeks after hearing aid fitting and after completing the four week training protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amptify First | Change in Hearing Aid Satisfaction After Auditory Training | -.09 hours/day | Standard Deviation 2.3 |
| Amptify Second | Change in Hearing Aid Satisfaction After Auditory Training | 0.8 hours/day | Standard Deviation 1.2 |
p-value: =0.72ANOVA
Secondary
Change in Percent Words Correct on Speech Perception Measures After Auditory Training
The NU-6 is a standard clinical assessment of word discrimination. Lists consist of 50 words in quiet and were presented through the Amptify DTx while wearing the hearing aid. NU-6 scores are in percent words correctly identified. Scores reported here are the difference between scores measured before and after completing the Amptify DTx.
Time frame: At the time of hearing aid fitting (baseline), three weeks after hearing aid fitting, and after completing the four week training protocol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Amptify First | Change in Percent Words Correct on Speech Perception Measures After Auditory Training | 4.3 Percent words correct | Standard Deviation 7.8 |
| Amptify Second | Change in Percent Words Correct on Speech Perception Measures After Auditory Training | -1.0 Percent words correct | Standard Deviation 11.6 |
p-value: =0.242ANOVA