Comparison of Direct to Consumer Delivery Models for Hearing Devices, Illinois and Texas, 2020-2025 (ICPSR 39653)

Version Date: Jul 9, 2026

Cite this study |

Principal Investigator(s):
Sumitrajit Dhar, Northwestern University; Larry Humes, Northwestern University

https://doi.org/10.3886/ICPSR39653.v1

Version V1

Slide tabs to view more

Summary

In an effort to make hearing aids more affordable and accessible to U.S. adults with hearing difficulty, the Food and Drug Administration (FDA) empowered these adults to self-fit over-the-counter (OTC) hearing aids. The effectiveness of two self-fit methods, Consumer Decides (CD) and Efficient Fitting (EF), was hypothesized to be non-inferior to the professional-fit method, (Audiology Based, AB). This was evaluated for both short-term (6 weeks post-fit) and long-term (6 months post-fit) outcomes.

Citation

Dhar, Sumitrajit, and Humes, Larry. Comparison of Direct to Consumer Delivery Models for Hearing Devices, Illinois and Texas, 2020-2025. Inter-university Consortium for Political and Social Research [distributor], 2026-07-09. https://doi.org/10.3886/ICPSR39653.v1

Export Citation:

  • RIS (generic format for RefWorks, EndNote, etc.)
  • EndNote

Funding

Patient-Centered Outcomes Research Institute (PCORI) (HL-2019c1-16094)

Subject Terms

Geographic Coverage

Restrictions

Access to these data is restricted. Users interested in obtaining these data must complete a Restricted Data Use Agreement, specify the reason for the request, and obtain IRB approval or notice of exemption for their research.

Distributor(s)

Inter-university Consortium for Political and Social Research
Hide

Time Period(s)

2020 -- 2025

Date of Collection

2020 -- 2025

Data Collection Notes

  1. Relevant Medical Subject Headings (MeSH) terms for this study as listed on ClinicalTrials.gov:

    • Hearing Disorders
    • Ear Diseases
    • Otorhinolaryngologic Diseases
    • Sensation Disorders
    • Neurologic Manifestations
    • Nervous System Diseases
    • Signs and Symptoms
    • Pathological Conditions, Signs and Symptoms
    • Hearing Loss
    • Wearable Electronic Devices
    • Electrical Equipment and Supplies
    • Equipment and Supplies
    • Sensory Aids
    • Hearing Aids

Hide

Study Purpose

This study sought to compare the effectiveness of two self-fit over-the-counter hearing aids methods to the professional-fit best-practices method of hearing-aid fitting.

Study Design

Participants: 584 participants met the following inclusion criteria and enrolled:

  1. age between 50-79 years
  2. never used or tried hearing aids previously
  3. can speak, read, and understand English well
  4. willing to purchase the study hearing aids for $650/pair
  5. no diagnosis of a memory or cognitive impairment
  6. 25-item Hearing Handicap Inventory for the Elderly (HHIE) score greater than 4
  7. Montreal Cognitive Assessment (MoCA) score greater than or equal to 23
  8. were not excluded due to specific audiometric criteria.

The audiometric exclusion criteria, based on air-conduction pure-tone thresholds, were:

  1. thresholds at all frequencies (250-8000 Hz) less than 20 dB HL, for both ears (eliminating those with no hearing loss)
  2. pure-tone average for 500, 1000, 2000 and 4000 Hz (PTA4) in the better ear greater than 50 dB HL (eliminating those with more than moderate hearing loss)
  3. interaural difference greater than 20 dB at 3 or more frequencies or greater than or equal to 40 dB at 500 or 1000 Hz (eliminating those with increased medical risk of ear disease).

A randomized multi-site non-inferiority comparative-effectiveness clinical trial with three parallel branches was conducted. At each of four sites, three groups received the same hearing aids fitted either by an audiologist using best practices (Group AB) or fitted by themselves using one of two efficacious self-fit methods (Groups CD, EF). Participants were stratified into one of three hearing loss categories based on better-ear PTA4: normal (less than or equal to 20 dB HL); mild (20.1 - 35 dB HL); or moderate (35.1 - 50 dB HL) with the study powered based on those with mild or moderate hearing loss. The random assignment of sequential enrollees within each hearing-loss category to the three treatment groups made use of a site-specific pre-generated randomization list produced from a random-numbers table. It was not possible to blind the participants as to the fitting method used, but the research personnel assessing the outcomes were blinded to the treatment group. The primary outcome measure was the global score from the Profile of Hearing Aid Benefit (PHAB) and the secondary outcome measure was the benefit score (unaided - aided) for the 25-item Hearing Handicap Inventory for the Elderly (HHIE).

Sample

The data represents a convenience sample in the vicinity of study sites in Illinois and Texas who became aware of the trial through media advertisements or word of mouth.

Time Method

Longitudinal: Panel

Universe

Adults between the ages of 50 and 79 years with perceived mild or moderate hearing difficulty.

Unit(s) of Observation

Individuals

Data Type(s)

Mode of Data Collection

Response Rates

Of the 1,127 individuals who contacted the study team via an online intake survey, 1,112 completed the online survey. From those who completed the initial survey, 748 completed an in-person screening and 584 enrolled resulting in a 51.8 percent enrollment rate. These individuals reported mild or moderate hearing difficulty, used English as their first language, and had never tried hearing aids. Of the 584 individuals who enrolled in the study, 465 completed the entire study attending three in-person sessions that spanned 6 months.

Presence of Common Scales

Hearing Handicap Inventory for the Elderly (HHIE)

Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids (MARS-HA)

Montreal Cognitive Assessment (MoCA)

Patient-Reported Outcomes Measurement Information System (PROMIS)

Practical Hearing Aid Skills Test-Revised (PHAST-R)

Profile of Hearing Aid Performance (PHAP) / Abbreviated Profile of Hearing Aid Performance (APHAP)

Revised Hearing Handicap Inventory (RHHI)

Hide

Original Release Date

2026-07-09

Version History

2026-07-09 ICPSR data undergo a confidentiality review and are altered when necessary to limit the risk of disclosure. ICPSR also routinely creates ready-to-go data files along with setups in the major statistical software formats as well as standard codebooks to accompany the data. In addition to these procedures, ICPSR performed the following processing steps for this data collection:

  • Created variable labels and/or value labels.
  • Checked for undocumented or out-of-range codes.

Hide

Notes

  • The public-use data files in this collection are available for access by the general public. Access does not require affiliation with an ICPSR member institution.

  • ICPSR usually offers files in multiple formats for researchers to be able to access data and documentation in formats that work well within their needs. If you have questions about the accessibility of materials distributed by ICPSR or require further assistance, please visit ICPSR’s Accessibility Center.

  • One or more files in this data collection have special restrictions. Restricted data files are not available for direct download from the website; click on the Restricted Data button to learn more.

pcodr logo

This study is maintained and distributed by the Patient-Centered Outcomes Data Repository (PCODR). PCODR is the official data repository of the Patient-Centered Outcomes Research Initiative (PCORI).