An interventional study of Hearing Aids in Hearing Aids and Hearing Loss, sponsored by Northwestern University. Completed at 4 sites in United States. Open to participants aged 50 Years to 79 Years. Per ClinicalTrials.gov, last updated 2025-03-06.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
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.
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.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 584 is above the median of 40 across 764 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
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Exclusion Criteria:
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Hearing aids will be fit using current best practices used by audiologists to fit hearing aids.
Device: Hearing Aids
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.
Device: Hearing Aids
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.
Device: Hearing Aids
Receiver-in-the-ear hearing aids.
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
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
Duration of Hearing Aid Use
Average hours of hearing aid use per day.
Time frame: 6 weeks
| Milestone | Audiology-Based Best Practice | Consumer Decides | Efficient Fitting |
|---|---|---|---|
| Started | 190 | 193 | 201 |
| Completed | 182 | 172 | 178 |
| Not completed | 8 | 21 | 23 |
| Milestone | Audiology-Based Best Practice | Consumer Decides | Efficient Fitting |
|---|---|---|---|
| Started | 182 | 172 | 178 |
| Completed | 152 | 132 | 140 |
| Not completed | 30 | 40 | 38 |
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.
| score on a scale | Audiology-Based Best Practice | Consumer Decides | Efficient Fitting |
|---|---|---|---|
| Profile of Hearing Aid Benefit | 23.34 (21.43 to 25.26) | 23.27 (21.54 to 25) | 23.33 (21.25 to 25.12) |
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.
| score on a scale | Audiology-Based Best Practice | Consumer Decides | Efficient Fitting |
|---|---|---|---|
| Hearing Handicap Inventory for the Elderly | 20.65 (18.11 to 23.19) | 21.83 (19.42 to 24.23) | 19.15 (16.59 to 21.73) |
Average hours of hearing aid use per day.
| hours/day | Audiology-Based Best Practice | Consumer Decides | Efficient Fitting |
|---|---|---|---|
| Duration of Hearing Aid Use | 8.42 (7.91 to 8.92) | 7.18 (6.64 to 7.72) | 6.83 (6.32 to 7.34) |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Audiology-Based Best Practice | 0/182 (0%) | 0/182 (0%) | 3/182 (1.6%) |
| Consumer Decides | 0/172 (0%) | 0/172 (0%) | 3/172 (1.7%) |
| Efficient Fitting | 0/178 (0%) | 0/178 (0%) | 5/178 (2.8%) |
| Event | Audiology-Based Best Practice | Consumer Decides | Efficient Fitting |
|---|---|---|---|
| Receiver Dome in EarEar and labyrinth disorders | 2/182 | 2/172 | 4/178 |
| Ear ConditionsEar and labyrinth disorders | 1/182 | 1/172 | 2/178 |
| TinnitusEar and labyrinth disorders | 0/182 | 1/172 | 1/178 |
| Reduced HearingEar and labyrinth disorders | 0/182 | 1/172 | 0/178 |
| Age, Continuous(years) | Audiology-Based Best Practice | Consumer Decides | Efficient Fitting | Total |
|---|---|---|---|---|
| Mean | 68.42 ± 6.95 | 69.81 ± 6.71 | 69.1 ± 6.71 | 69.11 ± 6.57 |
| Sex: Female, Male(Participants) | Audiology-Based Best Practice | Consumer Decides | Efficient Fitting | Total |
|---|---|---|---|---|
| Female | 111 | 104 | 114 | 329 |
| Male | 79 | 89 | 87 | 255 |
| Ethnicity (NIH/OMB)(Participants) | Audiology-Based Best Practice | Consumer Decides | Efficient Fitting | Total |
|---|---|---|---|---|
| Hispanic or Latino | 6 | 5 | 4 | 15 |
| Not Hispanic or Latino | 184 | 188 | 197 | 569 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Audiology-Based Best Practice | Consumer Decides | Efficient Fitting | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 3 | 1 | 3 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 3 | 2 | 2 | 7 |
| White | 176 | 187 | 192 | 555 |
| More than one race | 8 | 2 | 2 | 12 |
| Unknown or Not Reported | 0 | 1 | 2 | 3 |
| Region of Enrollment(participants) | Audiology-Based Best Practice | Consumer Decides | Efficient Fitting | Total |
|---|---|---|---|---|
| United States | 190 | 193 | 201 | 584 |
| Better Ear 4-Frequency (0.5, 1, 2, 4 kHz) Pure Tone Average(dB HL) | Audiology-Based Best Practice | Consumer Decides | Efficient Fitting | Total |
|---|---|---|---|---|
| Mean | 32.1 ± 9.04 | 32.64 ± 9.21 | 31.47 ± 9.06 | 32.06 ± 9.1 |
| Montreal Cognitive Assessment(units on a scale) | Audiology-Based Best Practice | Consumer Decides | Efficient Fitting | Total |
|---|---|---|---|---|
| Mean | 26.28 ± 1.93 | 26.18 ± 1.90 | 26.37 ± 1.96 | 26.28 ± 1.93 |
| Hearing Handicap Inventory - Global(units on a scale) | Audiology-Based Best Practice | Consumer Decides | Efficient Fitting | Total |
|---|---|---|---|---|
| Mean | 39.35 ± 18.83 | 39.66 ± 18.26 | 37.51 ± 19.37 | 38.82 ± 18.82 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Data will be shared at the Patient-Centered Outcomes Data Repository
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Northwestern University