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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Audiology-Based Best Practice | Active Comparator | Hearing aids will be fit using current best practices used by audiologists to fit hearing aids. |
|
| Consumer Decides | Experimental | 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. |
|
| Efficient Fitting | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing Aids | Device | Receiver-in-the-ear hearing aids. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Hearing Aid Use | Average hours of hearing aid use per day. | 6 weeks |
Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Sumitrajit Dhar | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States | ||
| Northwestern University Center for Audiology, Speech, Language, and Learning |
Data will be shared at the Patient-Centered Outcomes Data Repository
12 months after study completion through the PCORI data sharing platform.
Requests will be evaluated first by PCODR staff who will then consult with PIs before approving access.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6-Week Primary Observation Point |
| |||||||||||||
| 6-Month Secondary Observation Point |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Consumer Decides |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 6 weeks |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Receiver Dome in Ear | Ear and labyrinth disorders | Non-systematic Assessment | The hearing aid receiver dome remained in the ear canal after the hearing aid was removed. |
This study was initiated in 2020 before the approval of OTC hearing aids. Therefore, the devices used may not represent the quality of OTC hearing aids at any given time. The fitting methods used were derived from previous validation studies by the investigators. These results may not be valid for all self-fitting methods used in OTC hearing aids. Finally, the participants enrolled may not represent the demographic distribution of the United States or the areas in which the study was conducted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sumitrajit Dhar | Northwestern University | 847 491 8542 | s-dhar@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 4, 2024 | Dec 18, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 18, 2024 | Feb 9, 2025 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D006310 | Hearing Aids |
| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D012682 | Sensory Aids |
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Three arm blinded randomized control trial.
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The principle investigators and the audiologists conducting the outcome measures will be blinded to group assignment.
| Evanston |
| Illinois |
| 60208 |
| United States |
| Sertoma Speech and Hearing Center | Palos Hills | Illinois | 60465 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555 | United States |
| NOT COMPLETED |
|
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.
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Better Ear 4-Frequency (0.5, 1, 2, 4 kHz) Pure Tone Average | Mean | Standard Deviation | dB HL |
|
| Montreal Cognitive Assessment | The Montreal Cognitive Assessment or MoCA is a screening test for cognitive function. The minimum and maximum scores possible are 0 and 30, respectively. The higher the score the better the cognitive function. | Mean | Standard Deviation | units on a scale |
|
| Hearing Handicap Inventory - Global | The Hearing Handicap Inventory is a self-report of hearing difficulties in various situations. The scores can range between 0-100. A higher score indicates greater difficulty in hearing. | Mean | Standard Deviation | units on a scale |
|
| Profile of Hearing Aid Performance/Benefit | The Profile of Hearing Aid Performance/Benefit is a self-report of performance with hearing aids. Two measures are obtained, one prior to hearing aid use and the second with hearing aids. The difference between the two scores is the benefit score that can range between 0-99. The higher the number the greater the perceived benefit with the hearing aids. | Mean | Standard Deviation | units on a scale |
|
| OG002 | 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. |
|
|
| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 6 weeks |
|
|
|
| Other Pre-specified | Duration of Hearing Aid Use | Average hours of hearing aid use per day. | Posted | Mean | 95% Confidence Interval | hours/day | 6 weeks |
|
|
|
| 0 |
| 182 |
| 0 |
| 182 |
| 3 |
| 182 |
| EG001 | 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. | 0 | 172 | 0 | 172 | 3 | 172 |
| EG002 | 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. | 0 | 178 | 0 | 178 | 5 | 178 |
|
| Ear Conditions | Ear and labyrinth disorders | Non-systematic Assessment | Complaints of ear pain, fullness, and/or itching |
|
| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment | Experience ringing in the ear |
|
| Reduced Hearing | Ear and labyrinth disorders | Non-systematic Assessment | Complaint of reduced hearing ability |
|
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |