Hearing Impairment
Conditions
Keywords
Audiologic rehabilitation, Counseling
Brief summary
The purpose of the study is to determine whether a new test of ability to understand speech in noise and an associated counseling program can improve hearing aid satisfaction. Participants complete routine hearing tests, some hearing-related questionnaires and the new speech test. One group of participants receives the new form of counseling, the second group does not. Hearing aid satisfaction following 10 weeks hearing aid use is compared across the groups.
Detailed description
Hearing aid dissatisfaction continues to be disappointingly high, even though hearing aid technology has improved dramatically over the last 10 years or so. Unfortunately, the results of most commonly used self-report measures cannot be directly compared with the results from performance measures since the modes of testing are very different. Thus, it is hard for clinicians to reconcile data from individuals reporting more handicap or less hearing aid satisfaction than would be expected from their performance. In this study, the investigators use a test known as the Performance-Perceptual Test (PPT) to determine whether simple counseling based upon discussion of PPT results can be used to better align perceived and measured ability to understand speech-in-noise; and, more importantly, whether such counseling can decrease reported handicap and improve hearing aid satisfaction. Hearing aid users complete the PPT for aided and unaided listening, along with standardized questionnaires measuring reported auditory disability, handicap and hearing aid satisfaction. Following this, subjects are randomly assigned to one of two groups. Subjects in Group 1 receive counseling from the experimenter in the form of an explanation and discussion of their PPT results. Subjects in Group 2 also participate in a discussion with the experimenter, but it does not include an explanation of the PPT. Two weeks after enrollment in the study subjects complete a second set of questionnaires. Ten weeks after study enrollment subjects return to the laboratory to rerun the test battery. The impact of the counseling upon PPT values, reported handicap and hearing aid satisfaction and benefit will be compared across the two groups.
Interventions
BEHAVIORALPPT-based Counseling
Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
BEHAVIORALStandard Educational Counseling
Standard educational counseling consisting of explanation of hearing tests
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Mild-to-moderate symmetrical sensorineural hearing loss * Current users of binaural hearing aids
Exclusion criteria
* Conductive hearing impairment or other otological pathology * A score less than age-based norms on the Mini Mental State Examination * Asymmetrical hearing loss * No prior use of hearing aids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychosocial Impact of Assistive Devices Scale (PIADS) | Day 70 (end of study) only | PIADS: The PIADS measures the psychosocial impact of any assistive device(s). Here that is a hearing aid. The PIADS is a 26-item self-rating scale. The user rates each item on a seven-point scale that ranges from negative 3 (maximum negative impact) to positive 3 (maximum positive impact). The midpoint, zero, indicates no impact or no perceived change resulting from device use. It measures three quality-of-life domains: (1) Adaptability that reflects the inclination or motivation to participate socially and take risks; (2) Competence that reflects perceived functional capability, independence, and performance; and (3) Self-esteem that reflects self-confidence, self esteem, and emotional well-being. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hearing Handicap Inventory (HHI) | Day 70 (end of study) | HHI: The HHI for the elderly is for individuals over age 65 years; the HHI for adults is for individuals aged 65 years and younger. Both are 25-item questionnaires that assess the social and emotional consequences of hearing loss. The versions differ in the wording of three questions. Items are answered on a scale of Yes (4 points), Sometimes (2 points), and No (0 points) with higher scores indicating greater reported hearing handicap. Scores can range from 0 (no handicap) to 100 (maximum handicap). |
| Abbreviated Profile of Hearing Aid Benefit (APHAB) | Day 70 (end of study) | APHAB: The APHAB is a 24-item questionnaire that documents hearing difficulties in specified listening situations. Items are answered on a seven-point scale from ' Always ' to ' Never ' with higher scores indicating greater reported hearing disability. The questionnaire has four subscales: Ease of communication, Reverberation, Background noise, and Aversiveness, from which a global score is computed by averaging the Ease of communication, Reverberation, and Background noise scale scores. Questions are answered for unaided and aided listening. By subtracting aided scores from unaided scores a measure of reported aided benefit is obtained. Scores can range from 0 (no disability) to 99 (maximum disability). |
| International Outcome Inventory for Hearing Aids (IOI-HA) | Day 70 (end of study) | The IOI-HA is a seven-item questionnaire for which hearing-aid use, hearing-aid benefit, residual activity limitation, hearing-aid satisfaction, residual participation restriction, impact on others, and quality of life are rated on a five-point scale. An overall IOI-HA score is generated by averaging responses to all seven items. Higher scores reflect better self-reported outcome. Scores can range from 7 (poorest outcome) to 35 (best outcome). |
Countries
United States
Participant flow
Recruitment details
Dissatisfied hearing aid users recruited from Portland VA Medical Center Audiology Clinic. Recruitment dates: 1/1/06 to 9/1/07
Pre-assignment details
Exclusion criteria were: Hearing aid dissatisfaction associated with physical fit of the hearing aids, conductive hearing loss, had not worn hearing aids for at least 3 months prior to participating, had mini mental status examination score below age and educationally-appropriate norms.
Participants by arm
| Arm | Count |
|---|---|
| PPT-based Counseling Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS | 37 |
| Standard Educational Counseling Standard educational counseling consisting of explanation of hearing tests | 37 |
| Total | 74 |
Baseline characteristics
| Characteristic | Standard Educational Counseling | Total | PPT-based Counseling |
|---|---|---|---|
| Age, Continuous | 66.1 years STANDARD_DEVIATION 7.8 | 65.8 years STANDARD_DEVIATION 8.2 | 65.4 years STANDARD_DEVIATION 8.6 |
| Education level | 15.1 years STANDARD_DEVIATION 2.4 | 15.3 years STANDARD_DEVIATION 2.8 | 15.4 years STANDARD_DEVIATION 3.1 |
| Hearing sensitivity (pure tone thresholds) | 46.4 decibels STANDARD_DEVIATION 11 | 45.7 decibels STANDARD_DEVIATION 113 | 45.0 decibels STANDARD_DEVIATION 11.6 |
| Past hearing aid use | 9.8 years STANDARD_DEVIATION 10.6 | 9.3 years STANDARD_DEVIATION 10.5 | 8.8 years STANDARD_DEVIATION 10.3 |
| Region of Enrollment United States | 37 participants | 74 participants | 37 participants |
| Sex: Female, Male Female | 5 Participants | 8 Participants | 3 Participants |
| Sex: Female, Male Male | 32 Participants | 66 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 37 | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 | 0 / 37 |
Outcome results
Primary
Psychosocial Impact of Assistive Devices Scale (PIADS)
PIADS: The PIADS measures the psychosocial impact of any assistive device(s). Here that is a hearing aid. The PIADS is a 26-item self-rating scale. The user rates each item on a seven-point scale that ranges from negative 3 (maximum negative impact) to positive 3 (maximum positive impact). The midpoint, zero, indicates no impact or no perceived change resulting from device use. It measures three quality-of-life domains: (1) Adaptability that reflects the inclination or motivation to participate socially and take risks; (2) Competence that reflects perceived functional capability, independence, and performance; and (3) Self-esteem that reflects self-confidence, self esteem, and emotional well-being.
Time frame: Day 70 (end of study) only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PPT-based Counseling | Psychosocial Impact of Assistive Devices Scale (PIADS) | 1.06 units on a scale | Standard Deviation 0.79 |
| Standard Educational Counseling | Psychosocial Impact of Assistive Devices Scale (PIADS) | 0.85 units on a scale | Standard Deviation 0.7 |
p-value: >0.05ANOVA
Secondary
Abbreviated Profile of Hearing Aid Benefit (APHAB)
APHAB: The APHAB is a 24-item questionnaire that documents hearing difficulties in specified listening situations. Items are answered on a seven-point scale from ' Always ' to ' Never ' with higher scores indicating greater reported hearing disability. The questionnaire has four subscales: Ease of communication, Reverberation, Background noise, and Aversiveness, from which a global score is computed by averaging the Ease of communication, Reverberation, and Background noise scale scores. Questions are answered for unaided and aided listening. By subtracting aided scores from unaided scores a measure of reported aided benefit is obtained. Scores can range from 0 (no disability) to 99 (maximum disability).
Time frame: Day 70 (end of study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PPT-based Counseling | Abbreviated Profile of Hearing Aid Benefit (APHAB) | 26.3 units on a scale | Standard Deviation 15.2 |
| Standard Educational Counseling | Abbreviated Profile of Hearing Aid Benefit (APHAB) | 21.9 units on a scale | Standard Deviation 14.8 |
p-value: >0.05ANOVA
Secondary
Hearing Handicap Inventory (HHI)
HHI: The HHI for the elderly is for individuals over age 65 years; the HHI for adults is for individuals aged 65 years and younger. Both are 25-item questionnaires that assess the social and emotional consequences of hearing loss. The versions differ in the wording of three questions. Items are answered on a scale of Yes (4 points), Sometimes (2 points), and No (0 points) with higher scores indicating greater reported hearing handicap. Scores can range from 0 (no handicap) to 100 (maximum handicap).
Time frame: Day 70 (end of study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PPT-based Counseling | Hearing Handicap Inventory (HHI) | 38.0 units on a scale | Standard Deviation 19.4 |
| Standard Educational Counseling | Hearing Handicap Inventory (HHI) | 34.7 units on a scale | Standard Deviation 17.6 |
p-value: >0.05ANOVA
Secondary
International Outcome Inventory for Hearing Aids (IOI-HA)
The IOI-HA is a seven-item questionnaire for which hearing-aid use, hearing-aid benefit, residual activity limitation, hearing-aid satisfaction, residual participation restriction, impact on others, and quality of life are rated on a five-point scale. An overall IOI-HA score is generated by averaging responses to all seven items. Higher scores reflect better self-reported outcome. Scores can range from 7 (poorest outcome) to 35 (best outcome).
Time frame: Day 70 (end of study)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PPT-based Counseling | International Outcome Inventory for Hearing Aids (IOI-HA) | 26.6 units on a scale | Standard Deviation 4.2 |
| Standard Educational Counseling | International Outcome Inventory for Hearing Aids (IOI-HA) | 25.5 units on a scale | Standard Deviation 4.8 |
p-value: >0.05ANOVA