Evaluating the Safety and Usability of an Over-the-Counter Medical Device for Adults With Mild to Moderate Hearing Loss: Formative and Summative Usability Testing
Bibliographic record
Abstract
Background: Only 15% of the nearly 30 million Americans with hearing loss use hearing aids, partly due to high cost, stigma, and limited access to professional hearing care. Hearing impairment in adults can lead to social isolation and depression and is associated with an increased risk of falls. Given the persistent barriers to hearing aid use, the Food and Drug Administration issued a final rule to allow over-the-counter hearing aids to be sold directly to adult consumers with perceived mild to moderate hearing loss at pharmacies, stores, and online retailers without seeing a physician or licensed hearing health care professional. Objective: We evaluated the safety and usability of an over-the-counter hearing aid prior to Food and Drug Administration approval and market release. Methods: We first conducted a formative usability test of the device and associated app with 5 intended users to identify outstanding safety and usability issues (testing round 1). Following design modifications, we performed a summative usability test with 15 intended users of the device (testing round 2). We concurrently conducted a test with 21 nonintended users (ie, users with contraindications to use) to ascertain if consumers could determine when they should not use the device, based on the packaging, instructions, and labeling (testing round 3). Participants were asked to complete 2-5 tasks, as if they were using the hearing aid in real life. After each task, participants rated the task difficulty. At the end of each session, participants completed a 10-question knowledge assessment and the System Usability Scale and then participated in debriefing interviews to gather qualitative feedback. All sessions were video recorded and analyzed to identify use errors and design improvement opportunities. Results: Usability issues were identified in all 3 usability testing rounds. There were minimal safety-related issues with the device. Round 1 testing led to several design modifications which then increased task success in round 2 testing. Participants had the most difficulty with the task of pairing the hearing aids to the cell phone. Participants also had difficulty distinguishing the right and left earbuds. Nonintended users did not always understand device contraindications (eg, tinnitus and severe hearing loss). Overall, test findings informed 9 actionable design modifications (eg, clarifying pairing steps and increasing font size) that improved device usability and safety. Conclusions: This study evaluated the usability and safety of an over-the-counter hearing aid for adults with mild to moderate hearing loss. Human factors engineering methods identified opportunities to improve the safety and usability of this direct-to-consumer medical device for individuals with perceived mild-moderate hearing loss.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.035 | 0.063 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".