Hearing Aids, Hearing Loss
Conditions
Brief summary
Satisfaction and benefit from hearing aids fit using two patient self fit methods will be compared against those fit using audiology-based best practices. Individuals between the ages of 50 and 79 years of age will be randomly assigned to one of three fitting methods. Benefit and satisfaction will be evaluated six weeks and six months after the initial fitting.
Detailed description
Hearing aids are the most pertinent treatment for most adults with hearing loss, a pervasive chronic health problem in \ 40% of those over the age of 60 years. Only 20% of these individuals purchase and use hearing aids. The Over-the-Counter Hearing Aid Act of 2017 is designed to increase affordability and accessibility, and thereby adoption, of hearing aids. While this legislation directs the Food and Drug Administration (FDA) to create and administer this new channel of hearing aid provision by 2020, best practices related to hearing aid provision without the involvement of a professional, licensed provider have not been explored and established. Patients do not have the evidence they need to decide between modes of acquiring hearing aids. The current proposal addresses the specific knowledge gap of efficacious direct-to-consumer hearing aid delivery models. Two methods of patient-driven methods of selecting and fitting hearing aids will be compared against audiology-based best practice fitting. Individuals who perceive mild or moderate hearing difficulty will be randomly assigned to one of three fitting arms. Satisfaction and benefit from hearing aids will be assessed at six weeks and six months after initial fit.
Interventions
DEVICEHearing Aids
Receiver-in-the-ear hearing aids.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The principle investigators and the audiologists conducting the outcome measures will be blinded to group assignment.
Intervention model description
Three arm blinded randomized control trial.
Eligibility
Sex/Gender
ALL
Age
50 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* 50 - 79 years old. * Mild or moderate hearing difficulty. * Normal cognition. * No prior hearing aid experience. * Ability and willingness to pay privately ($650.00) for hearing aids * Ability to read and understand English * Symmetric hearing loss, no greater than moderate in degree
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Profile of Hearing Aid Benefit | 6 weeks | 66-item self-assessment, disability-based inventory. Participants answer the questionnaire twice, first prior to use of hearing aids and then after hearing aid use. The questionnaire is scored between 0-99% with higher values representing greater difficulty. Benefit is reported as the difference between the two scores with a higher number signifying greater benefit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hearing Handicap Inventory for the Elderly | 6 weeks | A self-administered scale to identify problems related to hearing loss. The questionnaire has 25 items and can be scored between 0 and 100. The score after hearing aid use is subtracted from the baseline score (prior to hearing aid use) to obtain the benefit score. The higher the difference the greater the benefit. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Duration of Hearing Aid Use | 6 weeks | Average hours of hearing aid use per day. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Audiology-Based Best Practice Hearing aids will be fit using current best practices used by audiologists to fit hearing aids.
Hearing Aids: Receiver-in-the-ear hearing aids. | 190 |
| Consumer Decides Hearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying loudness levels.
Hearing Aids: Receiver-in-the-ear hearing aids. | 193 |
| Efficient Fitting Hearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying base and treble settings.
Hearing Aids: Receiver-in-the-ear hearing aids. | 201 |
| Total | 584 |
Baseline characteristics
| Characteristic | Audiology-Based Best Practice | Consumer Decides | Efficient Fitting | Total |
|---|---|---|---|---|
| Age, Continuous | 68.42 years STANDARD_DEVIATION 6.95 | 69.81 years STANDARD_DEVIATION 6.71 | 69.1 years STANDARD_DEVIATION 6.71 | 69.11 years STANDARD_DEVIATION 6.57 |
| Better Ear 4-Frequency (0.5, 1, 2, 4 kHz) Pure Tone Average | 32.1 dB HL STANDARD_DEVIATION 9.04 | 32.64 dB HL STANDARD_DEVIATION 9.21 | 31.47 dB HL STANDARD_DEVIATION 9.06 | 32.06 dB HL STANDARD_DEVIATION 9.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 5 Participants | 4 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 184 Participants | 188 Participants | 197 Participants | 569 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Hearing Handicap Inventory - Global | 39.35 units on a scale STANDARD_DEVIATION 18.83 | 39.66 units on a scale STANDARD_DEVIATION 18.26 | 37.51 units on a scale STANDARD_DEVIATION 19.37 | 38.82 units on a scale STANDARD_DEVIATION 18.82 |
| Montreal Cognitive Assessment | 26.28 units on a scale STANDARD_DEVIATION 1.93 | 26.18 units on a scale STANDARD_DEVIATION 1.9 | 26.37 units on a scale STANDARD_DEVIATION 1.96 | 26.28 units on a scale STANDARD_DEVIATION 1.93 |
| Profile of Hearing Aid Performance/Benefit | 39.77 units on a scale STANDARD_DEVIATION 14.21 | 40.05 units on a scale STANDARD_DEVIATION 14.76 | 38.55 units on a scale STANDARD_DEVIATION 14.86 | 39.44 units on a scale STANDARD_DEVIATION 14.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 2 Participants | 2 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 176 Participants | 187 Participants | 192 Participants | 555 Participants |
| Region of Enrollment United States | 190 participants | 193 participants | 201 participants | 584 participants |
| Sex: Female, Male Female | 111 Participants | 104 Participants | 114 Participants | 329 Participants |
| Sex: Female, Male Male | 79 Participants | 89 Participants | 87 Participants | 255 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 182 | 0 / 172 | 0 / 178 |
| other Total, other adverse events | 3 / 182 | 3 / 172 | 5 / 178 |
| serious Total, serious adverse events | 0 / 182 | 0 / 172 | 0 / 178 |
Outcome results
Primary
Profile of Hearing Aid Benefit
66-item self-assessment, disability-based inventory. Participants answer the questionnaire twice, first prior to use of hearing aids and then after hearing aid use. The questionnaire is scored between 0-99% with higher values representing greater difficulty. Benefit is reported as the difference between the two scores with a higher number signifying greater benefit.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Audiology-Based Best Practice | Profile of Hearing Aid Benefit | 23.34 score on a scale |
| Consumer Decides | Profile of Hearing Aid Benefit | 23.27 score on a scale |
| Efficient Fitting | Profile of Hearing Aid Benefit | 23.33 score on a scale |
Secondary
Hearing Handicap Inventory for the Elderly
A self-administered scale to identify problems related to hearing loss. The questionnaire has 25 items and can be scored between 0 and 100. The score after hearing aid use is subtracted from the baseline score (prior to hearing aid use) to obtain the benefit score. The higher the difference the greater the benefit.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Audiology-Based Best Practice | Hearing Handicap Inventory for the Elderly | 20.65 score on a scale |
| Consumer Decides | Hearing Handicap Inventory for the Elderly | 21.83 score on a scale |
| Efficient Fitting | Hearing Handicap Inventory for the Elderly | 19.15 score on a scale |
Other Pre-specified
Duration of Hearing Aid Use
Average hours of hearing aid use per day.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Audiology-Based Best Practice | Duration of Hearing Aid Use | 8.42 hours/day |
| Consumer Decides | Duration of Hearing Aid Use | 7.18 hours/day |
| Efficient Fitting | Duration of Hearing Aid Use | 6.83 hours/day |